About This Report 01
Company Overview 03Corporate Culture 04Performance in 2024 05Company Milestones 07Honors 1 1Participation in Key Industry Associations 1 3
Sustainable Development Philosophy 13Communications with Stakeholders 14Material Issue Identification 15
Future Outlook 81Appendix 82
ESG Performance Overview 82Indexes 85
Table of Contents
About BioKangtai 03
Sustainable Development Governance 13
Standardized Corporate Governance for EfficientOperations 17Investor Relations Management for Safeguard-ing Shareholder Interests 20Risk Prevention and Control for Strengtheningthe Compliance Foundation 22Integrity as the Foundation and Adhering toBusiness Ethics 24
CompliantOperations for Stable andLong-Term Development
Environmental Compliance for StrengtheningPollution Prevention and Control 54Low Carbon and Energy Conservation for Address-ing Climate Change 60
Green andLow-Carbon Developmentfor Building a BeautifulEcological Home Together
Collaborative Development for Promoting Acces-sibility to Healthcare 77Giving Back to Society and Fulfilling Corpo-rate Responsibility 80
Staying Trueto Our Mission andJoining Hands to Createa Better Future
People-Oriented Approach for Protection ofEmployees’ Rights and Interests 66Safe Production for Safeguarding EmployeeHealth 72
Uniting Heartsand Efforts for Buildinga Warm and InclusiveWorkplace
Innovation-Driven for Supporting Industry Devel-opment 28Quality Control for Strengthening Product Safety 37Win-Win Cooperation for a Sustainable SupplyChain 47Information Protection for Strengthening DataSecurity 48
Innovation Leadingand Creating Excellencein Safe Vaccines
0102
This report is the Environmental, Social and Governance (ESG) Report (hereinafter referred to as the “ESG Report”)issued by Shenzhen Kangtai Biological Products Co., Ltd. Adhering to the principles of objectivity, standardization,transparency, and comprehensiveness, this report provides a detailed disclosure of the Company’s practices andperformance in the areas of environmental protection, social responsibility, and corporate governance during theyear 2024.
About This Report
Reporting ScopeThis report takes “BioKangtai” as the main reporting entity and includes its subsidiaries. Unless otherwise specified,the scope of this report is consistent with that of the Company’s annual report.
Reporting PeriodThis report covers the period from January 1, 2024, to December 31, 2024 (hereinafter referred to as the “reportingperiod”). In order to enhance the comparability and completeness of the report, some of the contents may appropri-ately trace back to previous years or have forward-looking descriptions.Impact Duration
In this report, the definitions of short-term, medium-term, and long-term impact durations are as follows: short-termrefers to within 1 year, medium-term refers to 1–5 years, and long-term refers to more than 5 years.
Preparation Basis
Data Explanation
All information and data referenced in this report are sourced exclusively from official documents, statistical reportsand financial statements of BioKangtai, as well as information related to sustainable development practices gathered,consolidated and audited across various functional departments and business units within the Company.This report doesn’t contain any false records, misleading statements, or material omissions. Unless otherwise speci-fied, all amounts in this report are expressed in RMB.
Access to this Report
This report is available for review and download on the official websites of the Company (www.biokangtai.com) andthe Shenzhen Stock Exchange website (http://www.szse.cn). This report is published in Chinese and English, with theEnglish version derived from the Chinese version. For any discrepancy between the two versions, the Chinese versionshall prevail.
Definition
Term
The Company, BioKangtai
BioMinhai
InterpretationShenzhen Kangtai Biological Products Co., Ltd.
Beijing Minhai Biotechnology Co., Ltd.
2024 Environmental, Social and Governance (ESG) Report
Shenzhen Stock Exchange Self-Regulatory Guidelines No. 17 for Companies Listed on Shenzhen Stock Exchange - Sustain-ability Report (For Trial Implementation)Shenzhen Stock Exchange Self-Regulatory Guidance No. 3 for Companies Listed on the ChiNext Market of Shenzhen StockExchange—Preparation of Sustainability ReportChinese Academy of Social Sciences (CASS) China Corporate Sustainable Development Report Guide (CASS-CSR 6.0)Task Force on Climate-related Financial Disclosures (TCFD) RecommendationsSustainable Development Goals (SDGs) of the United NationsSustainability Accounting Standards Board (SASB) Standards
Sustainability Reporting Standards of the Global Reporting Initiative (GRI Standards)
0304
Company OverviewHeadquartered in Shenzhen, Shenzhen Kangtai Biological Products Co., Ltd. has been specialized in R&D, production and sales ofvaccines for human use since its establishment in 1992. The Company was listed on the ChiNext market of the Shenzhen StockExchange in February 2017 (stock code: 300601). Since its inception, the Company has placed a strong emphasis on innovative R&D,and has grown into an innovative biopharmaceutical enterprise with robust R&D capabilities, a wide product portfolio, leading industryscale, and significant international progress. The Company has the capability to research and produce viral vaccines, bacterial vaccines,genetically engineered protein vaccines, conjugate vaccines, and combination vaccines, among others. It also possesses product devel-opment capabilities in platform technologies such as viral vectors, novel adjuvants, and nucleic acid vaccines (mRNA). BioKangtai is oneof the companies with the most comprehensive vaccine R&D platforms in China. Meanwhile, keeping abreast of internationalcutting-edge technology, the Company has been exploring the research on application of new vaccine technologies and the establish-ment of new technology platforms, and effectively applied the technology platforms through multi-product development, so as tocontinuously enhance the Company’s innovative R&D strength.The Company has been engaged in the vaccine industry for over 30 years. Its product portfolio covers both vaccines for the nationalimmunization program vaccines and non-immunization program vaccines, with products reaching 31 provinces, municipalities andautonomous regions. At present, the Company has 11 listed and approved products for emergency use, with nearly 30 products underresearch, covering key global vaccine varieties. Among these, “60?g Recombinant Hepatitis B Vaccine (Saccharomyces cerevisiae)” and“Dual-Carrier 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine” independently researched and developed by itself are theworld’s first of their kind and used for the special group of people who do not have any response to Hepatitis B Vaccine; the self-devel-oped Diphtheria, Tetanus, Acellular Pertussis and Haemophilus Influenzae Type b Combined Vaccine (DTaP-Hib Combined Vaccine)(quadruple vaccine) is the domestic vaccine with the largest number of combined vaccines; and the Rabies vaccine (human diploid cell)for human use, Freeze-dried is the first “Four doses” of rabies vaccine (human diploid cell) approved in China. The Company has formeda diversified and innovative product pipeline layout with industry competitiveness. With the upcoming release of the products underdevelopment, the Company’s sustainable development will be greatly guaranteed and its competitiveness will be further enhanced.While enhancing the cultivation of domestic market and continuously optimizing the sales network layout, the Company has adhered tothe “Bring In” and “Go Global” strategies to promote its products to the international market. Since its establishment, the Company hasundertaken the technology transfer from international vaccine giants such as Merck(USA), Sanofi(France), Intravacc(Netherlands),AstraZeneca (UK), etc. At the same time, the Company utilizes the advantages of its own rich product reserves to continue to increasethe expansion of overseas markets.Since 2022, the Company has signed cooperation agreements with partners from over ten countries,including Indonesia, Pakistan, Bangladesh, Nicaragua, Colombia, Egypt, Nigeria, Sri Lanka, and India. These agreements cover theregistration, promotion, commercialization, and technology transfer of products such as the 13-Valent Pneumococcal PolysaccharideConjugate Vaccine, 23-Valent Pneumococcal Polysaccharide Vaccine, Inactivated Poliomyelitis Vaccine, and DTaP-Hib Combined Vaccine(quadruple vaccine), etc. in overseas markets. In March 2025, the Company, the Beijing Economic-Technological Development AreaAdministrative Committee, and AstraZeneca signed the Economic Development Cooperation Agreement and Term Sheet, with the intentionof establishing a deep strategic partnership focused on vaccine investment. The parties plan to set up a joint venture in the BeijingEconomic-Technological Development Area, which will serve as a platform for developing innovative vaccines in China and supplyingvaccines to both the Chinese market and emerging markets. In the future, the Company will continue to increase its efforts in interna-tional market expansion, actively explore international market cooperation, strengthen the overseas registration of its products, anddevelop diversified sales channels for its products, striving to become a leading and world-renowned biopharmaceutical multinationalcompany.
Corporate CultureThe Company has always adhered to the corporate purpose of “produce the best vaccines to benefit mankind” and the corevalue of “dedication to people’s health”. With a focus on long-term exploration in the biopharmaceutical sector, the Companyaims to become a leading and world-renowned biopharmaceutical multinational company to contribute to the developmentof public health sciences.
CompanyCulture
PurposeProduce the best vaccines to benefit mankind
Core ValueDedication to people’s healthVisionBecome a leading and world-re-nowned biopharmaceutical multina-tional company that pursues highproduct quality, high corporateefficiency, technological innovation,resource conservation and harmoni-ous development
Company SpiritThe backbone of our Company is the spirit of diligent,perseverant, cohesive, enterprising and self-empower-
ing
Operation Principle
People orientation, excellence, honesty, efficiency,innovation and cohesion
About BioKangtai
2024 Environmental, Social and Governance (ESG) Report
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Performance in 2024
Economic PerformanceOperating Income2,651.72million yuan
Net Profit
201.55million yuan
Total Assets at Year-End
14,563.71million yuan
Various Taxes and Fees
122.50million yuan
Shareholders’ Equity
9,661.03million yuan
Basic Earnings per ShareRMB 0.18
Environmental Investment
3.8388million yuan
Indirect Greenhouse Gas Emissions
86,228.19tCO2e
Direct Greenhouse Gas Emissions19,829.65tCO2eNumber of Penalties for Violations of Environmental Laws and Regulations
Environmental Performance
Industry Value PerformanceInvestment in R&D
569.22million yuan
Percentage of R&D Personnel
18.92%
Product Recalls0case
Number of Authorized Utility Model Patents
Total hours of Quality Training11,536hours
Number of Authorized Invention Patents
Quality Training7,936times
Ratio of R&D Investment to Operating Revenue
21.47%
Number of R&D Personnel362persons
Social Performance
Total Number of Employees1,913persons
Percentage of women in management
29.41%
Social Insurance Coverage Rate
100%
Investment in Employee Training
1.0709million yuan
Employee Turnover Rate
7.52%
Female Employees721persons
Labor Contract Signing Rate100%
Investment in Social Welfare
8.4973million yuan
Percentage of Female Employees
37.69%
Environmental Training22times
GHG Emission Intensity
0.40tCO2e/10,000 yuan of revenue
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Company Milestones
1992Company founded
1994The Company completed pilot production of 5 ?g Hepatitis B Vaccine, which was later approved by the Ministry ofHealth.
1995The Company’s 5 ?g Hepatitis B Vaccine (0.5 mL per dose) met the quality standards of Merck & Co., INC, andthe vaccine acquired approval number for pilot production from the Ministry of Health.2000The Company acquired the first GMP certificate for its Hepatitis B Vaccine.
2002The Company introduced its 10 ?g Hepatitis B Vaccine (1.0 mL per dose) for adults.
2004The Company introduced Hepatitis B Vaccine with a shelf life of three years, which is the first of its kind in China.
2005
2008
After a strategic reorganization, BioKangtai acquired BioMinhai as its wholly-owned subsidiary.2010The Company successfully developed the first 60 ?g Hepatitis B Vaccine (1.0 mL per dose) for adults hepatitis Bvaccine non-responders in China;The Company acquired the third GMP certificate for its Hepatitis B Vaccine.
The Company replaced its 10 ?g Hepatitis B Vaccine (1.0 mL per dose) with 10 ?g Hepatitis B Vaccine (0.5 mL perdose) for adults.The Company acquired its second GMP certificate for Hepatitis B vaccine.
2011
The Company introduced its 20 ?g Hepatitis B Vaccine (1.0 mL per dose) for adults.The Company introduced its 10 ?g Hepatitis B Vaccine (0.5 mL per dose) for children.2012The Company acquired a GMP certificate for its Hib Conjugate Vaccine;The Company acquired a GMP certificate for its DTaP-Hib Combined Vaccine.2013
The Company acquired GMP certificate for its Measles and Rubella Combined Vaccine, Live;BioMinhai established a postdoctoral R&D center in Beijing.
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2021The Company’s SARS-CoV-2 Vaccine, Inactivated was approved for emergency use in China;The Company’s Recombinant COVID-19 Vaccine (Y25 Adenovirus Vector) was authorized for emergency use by theNational Agency of Drug and Food Control of Republic of Indonesia;The Company's 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine received drug registration certificate.
2024
Inactivated Poliomyelitis Vaccine received drug registration certificate;Minhai International Industrial Base for Novel Vaccines was officially put into operationGroup Headquarters Building—Kangtai Innovation Square inaugurated, positioning it as an important biopharmaceu-tical R&D and headquarters hub in Shenzhen.
2022
The Company’s production site for Recombinant COVID-19 Vaccine (Y25 Adenovirus Vector) received a Declarationof Conformity issued by the EU’s qualified person;The Company’s vaccine production site in Guangming District, Shenzhen, received a GMP Declaration of Conformityissued by the Food and Drug Administration, Philippines.
2023
The Rabies Vaccine (human diploid cell) for Human Use, Freeze-dried received drug registration certificate.
2014
The Company acquired a GMP certificate (2010 version) for its Hepatitis B Vaccine;The Company acquired a GMP certificate for its Hib Conjugate Vaccine (prefilled);The Company collaborated with INTRAVACC (Netherlands) and WHO to import Inactivated Poliomyelitis Vaccine;BioMinhai established the Beijing Novel Combination Vaccine R&D Center, the Beijing Academician Workstation, andthe Beijing International Sci-Tech Cooperation Base for Novel Vaccines.
2015BioMinhai established the National-Local Joint Engineering Laboratory for Novel Vaccine Technologies.
2017
The Company was listed on the ChiNext Market of Shenzhen Stock Exchange.
2018BioKangtai’s Guangming Base in Shenzhen was officially put into use.
2019The Company’s 23-Valent Pneumococcal Polysaccharide Vaccine received a GMP certificate and was launched.
2024 Environmental, Social and Governance (ESG) Report
Honors
1112
HonorsFirst Prize of Shenzhen Science and Technology AwardsLeading Enterprise of Guangdong Pilot 100 ProgramHigh-Tech Enterprise Certi?cateAcademician (Expert) Workstation
Awarded byShenzhen Municipal People’s Government Science andTechnology Awards Committee
Shenzhen Association for Science and Technology
Guangdong Provincial Economic and Information CommissionGuangdong Provincial Science and Technology Department, etc.Science, Technology and Innovation Commission of ShenzhenMunicipalityShenzhen Municipal Finance CommitteeShenzhen Tax Service, etc.
BioKangtai
Top of the 2021 Brand Communication Power list of ListedCompanies in the Pharmaceutical and Medical Industry in theGreater Bay AreaAA Rating of “2022 Wind ESG Rating”, ranked in the top 10 in thehealthcare sector2022 Enterprise ESG Outstanding Social Responsibility Practice Case
2024 Best Practice in Digital Transformation of Listed Companies
China’s Top 500 New Economy EnterprisesNational Enterprise Technology Center2023 Guangdong Top 500 Enterprises2024 Typical Board of Directors Practice Case of Listed Companies2024 Listed Company ESG Value Delivery AwardTop 300 Most Popular Listed Companies
Shenxin Communication Think Tank of ShenZhen Press GroupQingbo Intelligent Technology Co., Ltd.Wind
China Association for Public Companies
XinhuanetChina Enterprise Reform and Development SocietyChina Enterprise Evaluation AssociationNational Development and Reform CommissionGuangdong Provincial Association of EntrepreneursChina Association for Public CompaniesShenzhen Value Online Co., Ltd.Tonghuashun
Guangdong “Excellent Group Member” for Quali?edPerson in the Pharmaceutical Industry
“Global Top 100 Pharmaceutical Enterprises” in COVID-19 ReliefModel Collective in Love Donation for COVID-19 PandemicPrevention and Control in 2020Honorary Certi?cate of Recognition for the Fight Against theCOVID-19 Pandemic in Shenzhen
“Top Ten Caring Enterprises” of the 19th Shenzhen Care ActionShenzhen Spiritual Civilization Construction Committee
CPC Shenzhen Municipal Committee, Shenzhen Municipal GovernmentRed Cross Society of China Jiangxi Branch, Jiangxi Red Cross FoundationTorreya, a global investment bankShenzhen Advanced Grassroots Party OrganizationCPC Shenzhen Municipal CommitteePioneer of the Year in COVID-19 Relief2021 Shenzhen Corporate Social Responsibility ConferenceQuali?ed Person Committee of Guangdong Pharmaceutical Association
Honors
High-Tech Enterprise Certi?cate
Awarded by
Beijing Municipal Science and Technology CommissionBeijing Municipal Finance BureauBeijing Tax Service
BioMinhai
Postdoctoral R&D Center
Demonstration Enterprise in Harmonious Labor Relations in China
Beijing Advanced Enterprises in Building Harmonious Labor RelationsManufacturing EnterprisesResearch and Development of New Vaccine - Liu Jiankai Innovation StudioLeader of Beijing Association for Science and Technology Next Generation VaccineDevelopment Enterprise Innovation ConsortiumGrand Prize of Science and Technology Award of Guangdong PreventiveMedical Association - Guangdong Major Diseases Vaccine Innovation andIndustrialization
Beijing Health Enterprise
Practice Site of Examiner Practice (Beijing Zhongguancun) Base of ChinaNational Intellectual Property Administration
Beijing Science and TechnologyBeijing Key Laboratory for Novel Conjugate Vaccine TechnologyBeijing Novel Vaccine Engineering Laboratory
Daxing District Green Credit Five Star EnterpriseNational Demonstration Enterprise in Intellectual Property Right Protection
Beijing “Two Industries Integration” Pilot Enterprise2024 Excellent EHS Management Case for Pharmaceutical EnterprisesNational Green FactoryBeijing Green Factory
Beijing Novel Combination Vaccine R&D CenterNational-Local Joint Engineering Laboratory for Novel Vaccine TechnologiesBeijing Enterprise Technology CenterScience and Technology Award of the Chinese Pharmaceutical AssociationAcademician (Expert) WorkstationWorker PioneerBeijing Intellectual Property Demonstration OrganizationTop 100 Beijing Private Enterprises in Science and Technology InnovationZhongguancun High-tech Enterprise Certi?cateBeijing Model Worker’s Home
Ministry of Human Resources and Social SecurityChina Postdoctoral Management Committee
Ministry of Human Resources and Social Security of the People’sRepublic of ChinaAll-China Federation of Trade Unions, etc.
Beijing Enterprise ConfederationBeijing Association for Science and TechnologyBeijing Municipal Federation of Trade Unions, Beijing MunicipalCommission of Science and TechnologyBeijing Municipal Human Resources and Social Security BureauBeijing Municipal Federation of Trade Unions, etc.
Guangdong Preventive Medicine Association
Beijing Municipal Health CommissionBeijing Municipal Federation of Trade Unions
Zhongguancun Intellectual Property Promotion Center, under thesupervision of Beijing Municipal Intellectual Property O?ce asauthorized by China National Intellectual Property Administration
Beijing Municipal Development and Reform CommissionChina Pharmaceutical Enterprises Association
Beijing Municipal Bureau of Economy and Information Technology
Joint Conference O?ce of Beijing Daxing District Green Credit SystemState Intellectual Property O?ce
Beijing Municipal Science and Technology CommissionNational Development and Reform Commission of ChinaBeijing Municipal Bureau of Economy and Information TechnologyChinese Pharmaceutical AssociationBeijing Association for Science and TechnologyAll-China Federation of Trade UnionsBeijing Municipal Intellectual Property O?ceBeijing Municipal Federation of Industry and CommerceZhongguancun Science Park Management CommitteeBeijing Municipal Human Resources and Social Security Bureau
Beijing Municipal People’s GovernmentBeijing Municipal Science and Technology CommissionBeijing Municipal Development and Reform Commission
Ministry of Industry and Information Technology of the People’s Republicof China
2024 Beijing Top 100 Manufacturing EnterprisesBeijing Enterprise Directors Association
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Participation in Key Industry Associations
AssociationDesignation
China Association for VaccinesGuangdong Society of Biomedical EngineeringArrhythmia BranchShenzhen Public Companies AssociationBio-pharmaceutical and Health Committee
Vice President Unit
Shenzhen Life Sciences and Biotechnology AssociationShenzhen Biological Medicine Promotion AssociationGuangdong Preventive Medicine AssociationGuangdong Bio-Pharmaceutical Innovation AssociationShenzhen Bio-pharmaceutical Industry AllianceGuangdong Food & Drug Technology Association for Evaluation & Certi?cationGuangdong Bio-Pharmaceutical Innovation Technology AssociationJiangxi Preventive Medicine AssociationGuangdong Preventive Medicine AssociationHunan Preventive Medicine AssociationNanchang Preventive Medicine Association
Vice President UnitGoverning UnitVice President UnitGoverning UnitGoverning UnitMemberGoverning UnitMemberMemberVice PresidentPresident
Unit MemberChina Association for Public CompaniesMember UnitVice Chairman
Sustainable Development PhilosophyBioKangtai is committed to promoting sustainable development, adhering to the corporate purpose of “produce the bestvaccines to benefit mankind” and practicing the core value of “dedication to people’s health”. The Company insists onstandardized operations and integrity in its business practices, placing high importance on the protection of stakeholders’rights, including those of shareholders, employees, customers, and suppliers. The Company aims to promote sustainableand coordinated development between itself, society, and the environment, thereby achieving long-term value.To further strengthen ESG governance, the Company has incorporated ESG responsibilities into the Strategy Committee’sfunctions and revised the Board of Directors’ Strategy Committee Work Rules. The Strategy Committee is responsible forresearching and formulating the ESG strategy, managing key topics, reviewing ESG reports, and monitoring the progress ofgoal implementation. This ensures that the sustainable development philosophy is deeply embedded in all aspects of theCompany’s operations.
Sustainable Development Governance
Communications with StakeholdersBioKangtai has established diverse communication channels both online and offline, actively engaging with stakeholdersincluding shareholders and investors, customers, employees, suppliers and partners, government and regulatory bodies,industry associations, communities, and the public. The Company responds to the demands and expectations of each stake-holder group, promoting mutually beneficial outcomes between the Company’s development and its stakeholders.
Communication Channels
General Meeting of Shareholdersirm.cninfo.com.cnInvestor Communication, Roadshows, ConferenceInvestor Hotline/EmailCustomer VisitsIndustry ExchangesCustomer Services and Customer ComplaintsRegular MeetingsEmployee ActivitiesLabor UnionEmployees’ CongressComplaints and Feedback
Stakeholders
Shareholders and
Investors
Customers
Employees
Government andRegulatory Agencies
Industry Associations
Community and the
Public
Suppliers and
Partners
Innovation-driven
Pollutant EmissionsWaste DisposalEnvironmental Compliance ManagementAnti-commercial Bribery and Anti-corruptionAnti-unfair CompetitionCommunications with StakeholdersProduct Quality and Safety
Labor RightsEmployee Training & DevelopmentOccupational Health and SafetySupplier Evaluation and AuditingSupplier TrainingIndustry Exchanges
Industry Associations and OrganizationsIndustry ExchangesProject Cooperation
Regular Work Summary and OfficialCorrespondenceLaw Enforcement Supervision and Inspection
Supply Chain SecurityProduct Quality and SafetyInnovation-driven
Expectations and Requirements
Data Security and Customer Privacy ProtectionProduct Quality and SafetyProtection of Customers’ Rights and InterestsInnovation-driven
Community ActivitiesPublic Welfare ServicesMedia CommunicationPopularization of Vaccine Knowledge
Pollutant EmissionsWaste DisposalEnvironmental Compliance ManagementEnergy UtilizationWater Resource UtilizationContribution to SocietyResponse to Climate Change
Corporate GovernanceCompliance and Risk ManagementEconomic PerformanceInnovation-drivenSupply Chain Security
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利益相关方
Material Issue IdentificationReferring to the United Nations Sustainable Development Goals (SDGs), domestic and international ESG reporting standards,and industry-specific concerns, the Company undertook the identification of material issues based on its future developmentstrategy, business model, as well as expert opinions, with full consideration of the demands and expectations of stakehold-ers. A total of 19 issues were identified, which were then prioritized based on their impact on environmental, social, andeconomic aspects, as well as their financial significance to the Company.
Pollutant EmissionsWaste DisposalData Security and Customer Privacy ProtectionLabor RightsEmployee Training & DevelopmentOccupational Health and SafetyAnti-commercial Bribery and Anti-corruptionAnti-unfair CompetitionSupply Chain Security
Environmental Compliance ManagementEnergy UtilizationWater Resource UtilizationProtection of Customers’ Rights and InterestsContribution to SocietyDue DiligenceCommunications with Stakeholders
Importance to BioKangtai’s Financial Performance
Highly Important
Innovation-drivenProduct Quality and Safety
Response to Climate Change
Highly Important
General Materiality
Importance of Impact on Society, Economy, and Environment
Standardized Corporate Governance for Efficient Operations 17Investor Relations Management for Safeguarding Shareholder Interests 20Risk Prevention and Control for Strengthening the Compliance Foundation 22Integrity as the Foundation and Adhering to Business Ethics 24
Compliant Operations forStable and Long-Term Development
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Standardized Corporate Governance for EfficientOperationsBioKangtai, in accordance with the Company Law of the People’s Republic of China (hereinafter referred to as the “CompanyLaw”), Securities Law of the People’s Republic of China (hereinafter referred to as the “Securities Law”), Guidelines for theArticles of Association of Listed Companies, Rules Governing the Listing of Shares on the GEM of Shenzhen Stock Exchange, and No. 2Guidelines of the Shenzhen Stock Exchange for the Self-Regulation of Listed Companies - Standardized Operation of Companies Listedon ChiNext Market, has formulated the Articles of Association of Shenzhen Kangtai Biological Products Co., Ltd. (hereinafter referredto as the “Articles of Association”). The Company has established a governance structure comprising the General Meeting ofShareholders, Board of Directors, Board of Supervisors, Board Committees, and management, forming a system that is legal,compliant, and tailored to the Company’s operational needs. The system clearly defines the roles, responsibilities, andprocedural rules for each level of organization, ensuring the separation of decision-making, execution, and supervision,establishing a system of checks and balances to safeguard the Company’s compliance and healthy development.
Board of Directors
ChairmanPresident
General Meeting of Shareholders
Strategy CommitteeNomination CommitteeCompensation and Appraisal Committee
Audit Committee
Organizational Structure
Board SecretaryBoard of Supervisors
Securities Affairs DepartmentFinance CenterHuman Resources DepartmentGeneral Manager’s OfficeCorporate Development DepartmentPublic Affairs DepartmentQuality Management CenterProduction and Operation CenterBiosafety OfficeR&D CenterMarketing CenterInternational Business DepartmentPharmacovigilance DepartmentSupply Chain DepartmentAudit and Compliance Department
General Meeting of ShareholdersThe Company strictly follows the requirements of the Company Law, Rules for the General Meeting of Shareholders of ListedCompanies, and the Articles of Association to establish the Rules of Procedure for General Meetings of Shareholders. These rulesstandardize the procedures for convening, conducting, and voting at the shareholders’ meeting, ensuring that the rights andobligations of shareholders are fully protected. The Company holds General Meeting of Shareholders through a combinationof on-site and online voting, ensuring that shareholders can fully exercise their rights. A lawyer is invited to attend andprovide legal opinions. When deliberating on major issues that may affect the interests of minority investors, the votes ofminority investors are counted separately, effectively safeguarding the legal rights of shareholders, especially small andmedium shareholders.
Board of DirectorsThe Company strictly adheres to the Governance Code for Listed Companies, Articles ofAssociation, and other regulatory documents to establish the Rules of Procedure for theBoard of Directors. These rules clearly define the procedures for convening, holding, andvoting at meetings of Board of Directors, ensuring the Board of Directors’ operations arestandardized and efficient, and enhancing its core decision-making role in the Company’sstrategic planning and major decisions. The meetings of Board of Directors are convenedand chaired by the Chairman, and all procedures related to the convening, holding, andvoting of meetings comply with the relevant provisions of laws, regulations, Articles ofAssociation, and the Rules of Procedure for the Board of Directors. The Board of Directorsconsists of 7 directors, including 3 independent directors. In 2024, the Company wasawarded the 2024 Best Practice Case for Board of Directors of Listed Companies by theChina Association for Public Companies.
Best Practice for Board ofDirectors of Listed Companies
During the reporting period, the Company convened a total of
General Meetings of Shareholders, duringwhich
proposals were deliberated and adopted.
Key Performance Indicators
During the reporting period, the Company convened a total of
meetings of the Board of Directors, duringwhich
proposals were deliberated and adopted.Key Performance Indicators
Independent directors owe a duty of loyalty and diligence to the Company and all shareholders. In accordance with theIndependent Director System and the Independent Director Special Meeting Working System, they leverage their profession-al expertise to make independent, objective, and fair judgments on important matters. They provide professional opinions,oversee the Company’s compliance, safeguard the overall interests of the Company, and protect the legitimate rights ofshareholders, especially minority shareholders.
Independence
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Board of SupervisorsThe Company’s supervisors, acting in the best interests of all shareholders, adhere to the relevant provisions of the Rulesof Procedure for the Board of Supervisors and diligently fulfill their supervisory duties. They oversee significant matters,related-party transactions, financial activities, internal controls, and the legality and compliance of the duties performed bythe Board of Directors and senior management. The Board of Supervisors is composed of 3 supervisors: 1 shareholderrepresentative and 2 employee representatives.
Management of Remuneration for Directors, Supervisors, andother OfficersThe Compensation and Appraisal Committee of the Board of Directors is responsible for researching and formulating theCompensation Management System for Directors, Supervisors, and Senior Management, which is reviewed and approvedby the Board of Directors and the General Meeting of Shareholders. This system stipulates that the compensation forinternal directors, supervisors, and senior management consists of basic salary, performance-based compensation, insur-ance, and benefits. Compensation is assessed and awarded based on factors such as the Company’s overall size, operatingincome and profitability, regional salary levels, job responsibilities, professional capabilities, and performance evaluations. Atthe same time, the Company enforces a compensation policy that combines job positions and individual capabilities. Itemploys various forms such as monthly salary, annual salary, performance bonuses, and annual performance evaluations.This policy aligns the interests of shareholders, the Company, and individuals, thereby improving the cohesion and motiva-tion of senior executives and key team members, which in turn enhances the Company’s overall operational efficiency andquality.Investor Relations Management forSafeguarding Shareholder InterestsThe Company strictly adheres to relevant laws and regulations, including the Investor Relations Management Guidelines for ListedCompanies, Measures for the Administration of Information Disclosure by Listed Companies, Rules Governing the Listing of Shares onthe ChiNext Market of Shenzhen Stock Exchange, and No. 2 Guidelines of the Shenzhen Stock Exchange for the Self-Regulation of ListedCompanies - Standardized Operation of Companies Listed on ChiNext Market, as well as the provisions of its own Articles of Associ-ation. The Company has established a sound investor relations management and information disclosure system, standard-ized the interaction and information disclosure processes between the Company and investors, strengthened informationexchange with investors, and maintained a strong trust relationship between the Company and its investors.
Board of Directors Composition and Diversity
50 to 55 years old (excluding 55 years old)55 to 60 years old (excluding 60 years old)60 to 65 years old (excluding 65 years old)65 to 70 years old (excluding 70 years old)Bachelor’s DegreeMaster’s DegreeDoctoral Degree
Age
Education
1 person3 persons3 persons
When selecting members for the Board of Directors, the Company takes into account a range of factors, including age,cultural and educational background, professional experience, and skills, ensuring the scientific and efficient decision-mak-ing of the Board of Directors.
Diversity
The Board of Directors has established four special committees: the Strategy Committee, Audit Committee, NominationCommittee, and Compensation and Appraisal Committee. These committees provide strong support for decision-making byoffering diverse professional perspectives and scientific analysis, ensuring that decisions are both scientific and rational.
Board Committees
During the reporting period, the Company convened
meetings of the Audit Committee, during which
proposals were deliberated and adopted;convened
meeting of the Strategy Committee, during which
proposal was deliberated and adopted;convened
meetings of the Compensation and Appraisal Committee, during which
proposals weredeliberated and adopted;convened
meeting of the Nomination Committee, during which
proposals were deliberated and adopted.
Key Performance Indicators
During the reporting period, the Company convened a total of
meetings of the Board of Supervisors, duringwhich
proposals were deliberated and adopted.Key Performance Indicators
Non-Independent DirectorsIndependent Directors
Position
persons
persons1 person1 person2 persons3 persons
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Information DisclosureThe Company continuously improves its information disclosure process in accordance with the Information DisclosureAffairs Management System, enhancing the quality of information disclosure. The Company discloses its business opera-tions and management status, as well as significant events affecting the Company, in a truthful, accurate, timely, fair, andcomplete manner. The Company has designated Securities Times, China Securities Journal, Shanghai Securities Journal,Securities Daily, and the CNINFO website as its official channels for information disclosure, ensuring that all investors havefair access to the Company’s information. During the reporting period, there were no false statements, misleading represen-tations, material omissions, or other improper disclosures in the Company’s information releases.
During the reporting period, the Company held
performance briefing and interacted with investors
timeson the irm.cninfo.com.cn.
Key Performance Indicators
Since its listing in 2017, the Company has distributed over RMB
1.885
billion in cash dividends(including the amountfor share repurchase and cancellation and the proposed dividend amount for 2024), with the total cash dividend amountaccount ing for
45.06
% of the cumulative net profit attributable to the shareholders of the listed company.
Key Performance Indicators
During the reporting period, the Company disclosed 4regular reports and
interim reports.Key Performance Indicators
Investor Relations Management
The Company adheres to the principles of compliance, equality, proactivity, and integrity. In accordance with the InvestorRelations Management System, the Company fully showcases its cultural development and business achievements to inves-tors. Through channels such as the official website, new media platforms, telephone, email, and the irm.cninfo.com.cn, theCompany engages in open and transparent communication with investors via methods such as general meeting of share-holders, performance briefings, analyst meetings, roadshows, visitor receptions, and forums. This approach effectivelyprotects the legitimate rights and interests of investors and fosters the establishment of long-term, stable, mutuallytrustworthy, and win-win cooperative relationships between the Company and its investors.
Returns to ShareholdersThe Company values providing reasonable returns to its shareholders and has implemented the “Dual Improvement of Quality andReturn” action plan. It has also developed the Shareholder Return Plan for the Next Three Years (2024–2026), continuously improving ascientific, sustainable, and stable shareholder return mechanism. The Company takes into account various factors, including devel-opment strategy, profitability, cash flow, project investment funding requirements, and the external financing environment. Basedon a balance between providing reasonable returns to shareholders and supporting the Company’s long-term development, theCompany has made institutional arrangements for profit distribution, adopting a combination of cash, stock, or both. The Companyactively shares its development achievements with shareholders.
Compliant OperationsThe Company upholds the compliance philosophy of “compliance starts from top management, with active compliance fromall employees, and compliance creates value”. It has established the Compliance Management System to build a compliancemanagement framework, raise compliance awareness among all employees, and establish an effective long-term mecha-nism to mitigate compliance risks. This ensures that the Company operates in accordance with the law and complies withregulations, promoting sustainable development. Each department within the Company serves as the compliance executiondepartment and assumes primary responsibility for the effectiveness of its own compliance management. Departments areresponsible for daily compliance management tasks, improving business management systems and processes in line withcompliance requirements, proactively identifying compliance risks and potential issues, issuing compliance alerts, organizingcompliance reviews, reporting risks in a timely manner, and appropriately responding to compliance risk events. The Compa-ny has set up a compliance management team, responsible for organizing, coordinating, and overseeing compliancemanagement work, as well as providing compliance support to other departments. Additionally, the Company has estab-lished a compliance performance evaluation system, incorporating the effectiveness of compliance management into theperformance assessments of senior management, department heads, and employees.Building on the comprehensive promotion of compliance management, the Company focuses on key areas, critical process-es, and key personnel to effectively prevent compliance risks. During the reporting period, the Company’s Audit and Compli-ance Department conducted 8 special audits in accordance with the Internal Audit Assessment Management Rules and theFollow-up Audit Tracking Management Rules. The department tracked the Company’s corrective actions for special audits andissued the 2024 Annual Follow-up Audit Report on Special Audit Corrective Actions.The Company actively cultivates a compliance culture by distributing compliance handbooks, signing compliance commit-ment letters, and other measures. It strengthens the awareness of integrity and honesty among all employees and fosters avalues system based on legal compliance, honesty, and trustworthiness, thereby solidifying the ideological foundation forcompliant operations.
Risk Prevention and Control for Strengtheningthe Compliance FoundationThe Company always adheres to compliant operations and has strictly developed the Internal Control Guidelines in accor-dance with relevant laws and regulations. The Company continuously improves and optimizes its internal control system,enhancing its risk management capabilities to safeguard the compliance operating baseline. The Company updates andadjusts the internal control system in a timely manner based on development conditions and changes in the externalenvironment, ensuring the effective operation of the system. This effectively prevents compliance risks and provides solidsupport for the Company’s sustainable and stable development.
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Risk ManagementIn accordance with the Basic Standard for Enterprise Internal Control and its supporting guidelines, as well as other internalcontrol regulatory requirements, the Company has developed theRisk Management and Internal Control System Manual.Thismanual clarifies the internal control and management processes at each business level, identifies both internal and externalrisks in business activities, and conducts systematic analysis to create a risk register. The Company periodically updates andoptimizes the internal control system and revises and improves the internal control systems in accordance with the latestrelevant laws and regulations, adapting to the constantly changing external environment and the evolving requirements ofinternal control management. The Company’s Board of Supervisors, the Audit Committee of the Board of Directors, and theAudit and Compliance Department together form the Company’s internal supervision mechanism. They oversee and evalu-ate the improvement and implementation of the internal control system, as well as the Company’s business operations andfinancial status.During the reporting period, the units, businesses, and matters included in the evaluation, as well as the high-risk areas,covered the main aspects of the Company’s business operations and management, with no significant omissions. Based onthe Company’s identification of material internal control deficiencies, as of the benchmark date of the internal control evalu-ation report, the Company did not have any material internal control deficiencies related to financial or non-financial report-ing. Through the operation, analysis, and evaluation of the internal control system, the Company effectively prevented risksin business operations and promoted the achievement of internal control objectives.
Risk Assessment
Risk Early
Warning
Risk DecisionRisk Treatment
Risk Management Process
Establish RiskManagement ObjectivesSelection of RiskManagement TechniquesImplement RiskManagement PlansEvaluate RiskManagement PerformanceRisk IdentificationRisk MeasurementRisk EvaluationRisk Early Warning
In May 2024, the Company invited ShineWing Certified Public Accountants to conduct a training session for theCompany’s directors, supervisors, senior executives, and relevant business personnel. The training was deliveredthrough a combination of on-site and online meetings, focusing on the key points and practices of building aninternal control system for listed companies. The training covered topics such as the regulatory trends forinternal control of listed companies in the new era, strategies and methods for building an internal controlsystem, and common risks and control measures in key business processes. This training helped the Companystrengthen internal control awareness, improve the internal control system, enhance business managementcapabilities, and ensure the Company’s continued healthy development.
Internal Control Management Training
Tax Management
The Company strictly adheres to the Law of the People’s Republic of China on the Administration of Tax Collection, the Rules for theImplementation of the Law of the People’s Republic of China on the Administration of Tax Collection, and other relevant regulations.It exercises strict control over tax-related matters, standardizes the management of tax affairs, invoice management, tax riskmanagement, and tax documentation management to minimize tax risks. During the reporting period, the Company paid atotal of RMB 122.50 million in various taxes and fees.
Anti-Bribery and Anti-CorruptionaThe Company continues to advance the construction of its compliance and business ethics management system based onthe Anti-Commercial Bribery Compliance Manual. It establishes regulatory requirements for all employees and partners regardingintegrity in business practices and adopts a zero-tolerance policy towards unethical business conduct. During the reportingperiod, the signing rate of the Integrity Commitment Letter among key employees reached 100%.
Integrity as the Foundation and Adhering toBusiness EthicsThe Company strictly complies with relevant laws and regulations, including the Anti-Unfair Competition Law of the People’sRepublic of China, the Anti-Money Laundering Law of the People’s Republic of China, the Law of the People’s Republic of China on theProtection of Consumers’ Rights and interests, as well as the ISO 37001 Anti-Bribery Management System - Requirements withGuidance for Use. It has established systems such as the Code of Professional Ethics, the Implementation Rules for Clean OcePractices, and the Whistleblowing Management System. The Company operates its business activities in accordance withhigh standards of business ethics, opposing all forms of corruption, bribery, and unfair competition. During the reportingperiod, the Company did not face any significant litigation cases related to corruption, bribery, or unfair competition.
Comply with laws and regulations, maintain integrity in office, and sign the Integrity CommitmentLetter;Strictly prohibit the unauthorized dissemination of confidential information.Contracts with suppliers/partners must include clauses on signing integrity agreements or relatedterms, and supervise the implementation of these agreements.Strictly comply with laws and regulations, include compliance clauses in agreements, and conductmarket activities in accordance with the law. Prohibit bribery of relevant departments or companyemployees in any form to gain improper benefits.
Business Ethics Standards and Requirements
Do not use power to accept bribes;Prohibit the use of improper means to obtain trade secrets;Prohibit false advertising that harms competitors.
All EmployeesMiddle and SeniorManagement, Key PositionsDepartmentsExternal Partners andPromoters
TargetRequirements
2024 Environmental, Social and Governance (ESG) Report
2526
2024年度环境、社会和公司治理（ESG）报告
The Company has established a series of policies, including the Market Activity Management Policy and the Promoter Manage-ment Regulations, to strengthen the management of key aspects in business operations and reinforce the defense againstunethical business conduct.
Market Activity Management PolicyPromoter Management Regulations
Marketing Expense ReimbursementManagement Measures
Commercial Bribery Risk Control Points
Marketing Center Personnel Code of ConductMarketing Center Expense ReimbursementManagement Measures
System
MarketingPersonnel
BehaviorPromoterBehavior
MarketingExpenses
ExternalPromotion Fees
Control PointSpecific Actions
In the vaccine industry, the Company strictly controls the behavior of market-ing personnel by implementing a series of behavioral standards and supervi-sion mechanisms, aiming to prevent improper actions.The Company has established a series of supervisory and manage-ment mechanisms, requiring promoters to sign thePromoter Compli-ance Commitment LetterandPromoter Employee Compliance CommitmentLetter.This ensures that promoters comply with regulations duringmarket activities and eliminates improper business dealings.To ensure compliance, the Company assesses the authenticity andreasonableness of various marketing expenses, including businesspromotion fees and storage and transportation fees. Clear reimburse-ment conditions and standards are set for each type of expense toprevent industry violations at the expense expenditure level.When reviewing external promotion fees, such as business promotioncosts, storage and transportation fees, and conference expenses, theCompany requires supporting documents like valid invoices, contracts,meeting evidence, and travel reports. This ensures the authenticity andcompliance of the expenses.
Anti-unfair CompetitionThe Company is committed to maintaining a fair and just market competition environment. It firmly opposes imposing anyunreasonable restrictions on partners and ensures that all business activities comply with the requirements for fair competi-tion, promoting the healthy development of the industry’s competitive ecosystem.
Whistleblowing Channels and Protection of WhistleblowersThe Company has established a Whistleblowing Management System, which outlines the reporting organization, scope andchannels for reporting, reporting acceptance procedures, and handling measures. The Audit and Compliance Departmentis responsible for managing and implementing the whistleblowing process. The Company encourages employees andpartners to actively report any suspected illegal or unethical behavior, rewarding whistleblowers who provide truthfulinformation. The Company guarantees strict confidentiality of the whistleblower’s personal information and report details,and will severely punish any retaliatory actions. If retaliation is verified, the Company will hold individuals accountable accord-ing to relevant regulations.
Hotline: 0755-26988630Email: shenjibu@biokangtai.com
2024 Environmental, Social and Governance (ESG) Report
Innovation-Driven for Supporting Industry Development 28Quality Control for Strengthening Product Safety 37Win-Win Cooperation for a Sustainable Supply Chain 47Information Protection for Strengthening Data Security 48
Innovation Leading and CreatingExcellence in Safe Vaccines
2728
Governance
BioKangtai has established systems such as the R&D Center Project Management Regulations to standardize the management of R&D projectsand enhance the conversion capability of R&D outcomes. The Company has set up a product development management structure respon-sible for the demonstration and approval decision-making of research projects. The executive committee is responsible for approvingproject initiation, project implementation documents, and registration application materials. The advisory committee is tasked with review-ing and evaluating the initiation of R&D projects.
Innovation-Driven for Supporting IndustryDevelopment
The Company has accumulated a wealth of core technologies required for vaccine R&D and productionthrough the development of various vaccine products. It has built a team with an international perspec-tive, rich experience in vaccine product development management, and practical experience in industri-alization.R&D TeamDevelopment
2024 R&D Team Overview
Below Bachelor’s DegreeBachelor’s DegreeMaster’s DegreeDoctoral DegreeMaleFemale
Composition of R&D Personnel by Educational Background
Composition of R&D Personnel by Gender
53 Persons199 Persons102 Persons8 Persons213 Persons149 Persons
41.16%
58.84%
14.64%
54.97%
28.18%
2.21%
As of the end of the reporting period, the Company and its subsidiaries had a total of
R&D personnel, accounting for
18.92
% of the total workforce.
Key Performance Indicators
2024 Environmental, Social and Governance (ESG) Report
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The Company has been deeply engaged in the human vaccine field for over 30 years and hasgrown into an innovative biopharmaceutical enterprise with robust R&D capabilities, a wide productportfolio, leading industry scale, and significant international progress. It is one of the companieswith the most comprehensive vaccine R&D platforms in China, possessing robust vaccine R&Dcapabilities. The Company has the capability to research and produce viral vaccines, bacterialvaccines, genetically engineered protein vaccines, conjugate vaccines, and combination vaccines,among others. It also possesses product development capabilities in platform technologies such asviral vectors, novel adjuvants, and nucleic acid vaccines (mRNA). The Company holds over 80patents, with 11 listed and approved products for emergency use and nearly 30 products underresearch, covering key global vaccine varieties. Meanwhile, keeping abreast of internationalcutting-edge technology, the Company has been exploring the research on application of newvaccine technologies and the establishment of new technology platforms, and effectively appliedthe technology platforms through multi-product development, so as to continuously enhance theCompany’s innovative R&D strength.
R&D Platformsand ResearchCarriers
Nine Diversified R&DPlatforms
Platform for geneticallyengineered protein vaccinesPlatform for mRNA vaccinesPlatform for virus vector
vaccines
Beijing Key Laboratory forNovel Conjugate Vaccine
TechnologyState-Local Joint EngineeringLaboratory for Novel Vaccine
Development
Platform for virusattenuated vaccinesPlatform for new adjuvant
technologyPlatform for bacterialpolysaccharide conjugate
vaccines
Shenzhen Novel VaccineEngineering LaboratoryBeijing Novel VaccineEngineering LaboratoryBeijing Novel Combination
Vaccine R&D Center
Platform for inactivatedvirus vaccinesPlatform for bacterialpolysaccharide vaccinesPlatform for combined
vaccines
Guangdong Therapeutic
HepatitisB Vaccine LaboratoryPostdoctoral R&D CenterAcademician (Expert)
Workstation
Well-developed R&DBases
Strategy
Vaccine R&D is characterized byhigh knowledge intensity,technical complexity, complexprocesses, long developmentcycles, large financial invest-ments, and significant uncer-tainty in the successful industri-alization of research outcomes.
Strengthen basic and appliedvaccine research, promote vaccinedevelopment and innovation, focuson R&D investment and techno-logical innovation.DownstreamLong-term
IncreasedoperatingcostsDifficulty inNew ProductDevelopment
Risk Type
Financial
Impact
Response MeasuresRisk Description
ImpactDuration
Value ChainLinks of Impact
The Company will closely monitorindustry development trends andcutting-edge innovative technolo-gies, explore the application ofnew vaccine technology paths,and establish new technologyplatforms. The focus will be onimproving the R&D innovationsystem, accelerating new productR&D and industrialization progress,and constructing a diversified anddifferentiated product matrix toenhance the market competitive-ness of the Company’s products.
By continuously increasing R&Dinvestment, building ahigh-quality R&D team,overcoming key core technolo-gies, and mastering intellectualproperty, the Company cantake a leading position inmarket competition.
Operations,downstreamLong-term
IncreasedoperatingincomeTechnologicalBreakthroughand MarketLeadership
OpportunityType
Financial
Impact
Response MeasuresOpportunity Description
ImpactDuration
Value ChainLinks of Impact
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Impact, Risk, and Opportunity ManagementThe Company has established the R&D Center Project Management Regulations to standardize R&D project managementprocesses and enhance the commercialization of research outcomes.Project Initiation,Review, andDecision-Making
Aligned with corporate strategy and market demand, potential R&D projects undergotopic selection, feasibility analysis report drafting, and formal project applications.Projects are evaluated through technical, economic, and legal risk assessments,followed by an evaluation report. Upon approval, the project is officially initiated.
Acceptance
At each milestone, project leaders submit stage acceptance applications. The R&D CenterDirector organizes systematic reviews to validate completion per phase requirements.
Implementation and Control
Metrics and Targets
To drive high-quality innovation in R&D, the Company has established clear objectives, defined key performance indicators(KPIs), and implemented a monitoring and evaluation mechanism. During the reporting period, the Company’s R&D expendi-ture reached RMB 569.22 million, accounting for 21.47% of total revenue.
R&D Results
The Company adheres to the R&D policy of focusing on independent research and development, supplemented by collabo-rative development, and is committed to enhancing technological innovation and the development of new products. TheCompany is steadily advancing the R&D progress and industrialization of its ongoing projects. Currently, the Company hasnearly 30 ongoing projects, with those entering the registration process described below:
Projects Under Research
Project NameRegistration StageInactivated Poliomyelitis Vaccine, Sabin Strains (Vero Cell)NDA registration approval
NDA registration approval
Current ProcessProduction registration application acceptedAdsorbed Tetanus VaccineClinical research completedPhase I/III clinical trial summary report obtainedInactivated Hepatitis A VaccineRecombinant Hepatitis B Vaccine (Hansenula)
Diphtheria, Tetanus, Pertussis (Acellular, Component),Poliomyelitis (Inactivated) Vaccine and HaemophilusIn?uenza Type b Conjugate Vaccine, Adsorbed
Reassortant Rotavirus Vaccine, Live, Oral, Pentavalent(Vero Cell)20-Valent Pneumococcal Polysaccharide ConjugateVaccine
In Phase I, Phase II, and Phase III clinical trial stagesPhase I and II clinical trials in progress
Completed Phase I clinical trial
Phase I clinical trial in progress
Phase I clinical trial in progressPhase I clinical trial in progressPhase I clinical trial in progress
In the summary stage of clinical phaseIND obtained, clinical phase in progressIND obtained, clinical phase in progressIND obtained, clinical phase in progressIND obtained, clinical phase in progressIND obtained, clinical phase in progressIND obtained, clinical phase in progressIND obtained, clinical phase in progressIND obtained, clinical phase in progressObtained noti?cation of clinical trialapprovalObtained noti?cation of clinical trialapprovalObtained noti?cation of clinical trialapprovalInactivated Bivalent Enterovirus Vaccine (Vero Cell)In?uenza Vaccine (Split Virion), Quadrivalent (MDCK Cells) (3+ Years Age Group)
60 μg Recombinant Hepatitis B Vaccine (SaccharomycesCerevisiae) (Immunomodulator)
Obtained noti?cation of clinical trial approvalObtained noti?cation of clinical trial approvalObtained noti?cation of clinical trial approvalClinical data self-examination in progress
MMR Combined Attenuated Live VaccineDiphtheria, Tetanus, Acellular Pertussis (Acellular,Component) and Poliomyelitis (Inactivated) CombinedVaccine, AdsorbedInactivated Tetravalent Enterovirus Vaccine (Vero Cell)In?uenza Vaccine (Split Virion), Quadrivalent (6-35 Months Age Group)
Application for producing registration accepted;on-site GMP inspection completed
Completed the on-site job of Phase III clinicalresearchDiphtheria, Tetanus and Acellular Pertussis CombinedVaccine (Component), Adsorbed
Completed the on-site job of Phase III clinicalresearchCompleted Phase I clinical trial, Phase III clinicaltrial under preparation
In?uenza Vaccine (Split Virion), Quadrivalent (3+ Years Age Group)
In the summary stage of clinical phaseGroup ACYW135 Meningococcal Polysaccharide Vaccine
Has withdrawn the application for
vaccine registration approval, currently
in the clinical data self-examination
phase
The Company emphasizes industry-university-research cooperation, focusing on vaccine innovation, research and develop-ment, and industrialization. The Company strengthens its collaboration with universities, attracting top talents and technolog-ical resources. This collaboration promotes the joint development of new vaccine technologies, providing solid support forthe development and industrialization of new products.
Industry-university-research Cooperation
Project leaders oversee progress and quality control, ensuring strict compliance withthe latest Chinese Pharmacopoeia standards and policies issued by the National Medi-cal Products Administration (NMPA).The Scientific Research Management Department coordinates material reviews withadvisory committees and regulatory affairs teams.After obtaining clinical trial approval, cross-functional teams assess whether to proceedwith trials and conduct subsequent analytical research.
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Protection of Intellectual Property Rights
The Company strictly adheres to the laws and regulations such as the Trademark Law of the People’s Republic of China and thePatent Law of the People’s Republic of China. It has established systems like the Intellectual Property Management Measures and theMeasures for the Management of Patent to strengthen intellectual property management, clarify related management responsi-bilities, encourage inventions and innovations, enhance the Company’s market competitiveness, and promote sustainabledevelopment. During the reporting period, the Company did not encounter any incidents related to the infringement ofothers’ intellectual property rights, nor were there any intellectual property-related lawsuits.
The Company attaches great importance to intellectual property protection and management. BioMinhai has been awardedthe titles of “National Demonstration Enterprise in Intellectual Property Right Protection” and “Beijing Intellectual PropertyDemonstration Organization”. BioMinhai’s “Dual-Carrier” 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine “WeiminFeibao” has been recognized as a nationally patent-intensive product. This vaccine holds several invention patents and is aresearch outcome of the National Ministry of Science and Technology’s major new drug creation project.
Intellectual Property Management
Intellectual Property Full-Process Management MechanismConduct intellectual
property surveys
Develop intellectualproperty plans
Provide intellectualproperty consultation
Supervise intellectual
property acquisition
National Demonstration Enterprise inIntellectual Property Right Protection
Beijing Intellectual PropertyDemonstration OrganizationPractice Site of Examiner Practice(Beijing Zhongguancun) Base of ChinaNational Intellectual Property
Administration
While protecting its own intellectual property, the Company also fully respects the intellectual property rights of others.During the product development process, intellectual property managers are deeply involved in all key stages, includingpatent technology research, patent infringement analysis, and the development of design schemes to avoid infringement.For different types of products, the Company formulates patent layout plans tailored to specific conditions. Throughout theentire research and development process, the Company closely monitors the output dynamics of innovative results andevaluates their patentability in a timely manner. Based on a precise understanding of the rules of various intellectual propertyapplication systems, the Company fully utilizes these rules to achieve the best patent portfolio, thereby enhancing thecommercial value of its R&D products.
Intellectual Property Protection Measures
As of the end of the reporting period, the Company has been granted a total of
invention patents,
utility model patents, and
design patent.Key Performance Indicators
Intellectual PropertySearch and Analysis
Before launching each R&D project, the Company organizes professionals to conductcomprehensive intellectual property search and analysis using commercial patentdatabases. Through systematic data mining and claims comparison, the Company identi-fies technological gaps and infringement risks, providing legal and compliance support forR&D path planning.
Dynamic Tracking
Mechanism
The Company continuously monitors intellectual property trends in relevant technologicalfields. Upon detecting any changes in trends or potential risks, the Company promptlyadjusts its R&D strategy to further reduce infringement risks, ensuring that R&D workremains legal, compliant, and forward-looking.
External Cooperation
During external cooperation, the Company conducts intellectual property ownershipchecks, infringement risk assessments, and technical value analyses based on actualneeds, either through internal professional teams or by outsourcing to external agencies.This due diligence supports commercial decision-making and ensures compliance.
Intellectual Property
Training
To strengthen intellectual property awareness among all employees, the Companyintegrates intellectual property training deeply into R&D practices. The training content ismade more targeted and practical, effectively improving training outcomes and embed-ding the concepts of respecting and protecting intellectual property into the Company’sR&D culture.
BuildingPatent-Specific
Databases
For key R&D projects, the Company has specifically built patent-focused databases. Thesedatabases integrate patent information from specific fields, providing centralized andprecise technical references for R&D personnel, which strongly promotes R&D innovation.
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R&D Ethics
The Company strictly follows R&D ethics in research and innovation, and implements the ethical principles of “regulatorycompliance, human and animal subject protection, integrity, data reliability, intellectual property protection, and openness“in its R&D practices.
Regulatory Compliance
Human and Animal Subjects
Protection
Integrity in Scientific Research
Reliable DataOpenness and Sharing
The whole process of R&D should refer to and follow the relevant laws andregula-tions.
Follow the scientific standards and the principle of honesty and trustworthiness.The whole process of R&D should be recorded, and the records must be timely,true, standardized and complete.Share research results and scientific resources openly within the permitted range.
Clinical trials of drugs follow the principles of the Declaration of Helsinki of the WorldMedical Association and related ethical requirements, and the rights and safety ofsubjects are the primary consideration;Follow the 3R principles (reduce, replace and refine) in the use of laboratory animalsand research, concern for the welfare of laboratory animals, and treat them well.
Industry ExchangesThe Company actively participates in various industry activities, sharing practical experiences and development achieve-ments, and promoting the continuous development of the industry. In the future, the Company will continue to serve asa “leader” in technological innovation within the biopharmaceutical industry, strengthening the industry cluster effectand making greater contributions to the overall high-quality development of the pharmaceutical and health sector inChina.
Invited to Attend the 23rd China Biologics Conference: Discussing AdvancedVaccine Technology R&D and Internationalization
The 23rd China Biologics Conference
In May 2024, the 23rd China Biologics Conference(CBioPC2024) was held in Guangzhou. The Company wasinvited to attend the conference, where the Chief Scientistof BioKangtai and General Manager of BioMinhai, ZhengHaifa, participated in the “Vaccine Quality and R&D” sessionand delivered a keynote speech on RSV Pre-F Antigen Design.
On November 16, the first “China Pharmaceutical Valley Future Biopharmaceutical Innovation Conference” wassuccessfully held in Beijing. The Chief Scientist of BioKangtai and General Manager of BioMinhai, Zheng Haifa,was invited to attend the conference, where he delivered a speech on the Development Trends of Next-Genera-tion Vaccines. He also joined other corporate representatives in unveiling the establishment of the “ChinaPharmaceutical Valley Biopharmaceutical Industry Alliance”.
Invited to Attend the “First China Pharmaceutical Valley Future BiopharmaceuticalInnovation Conference”
The First China Pharmaceutical Valley Future Biopharmaceutical Innovation Conference
2024 Environmental, Social and Governance (ESG) Report
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Product Quality Management
Quality Control for Strengthening Product Safety
The Company complies with relevant laws and regulations, such as the PharmaceuticalAdministration Law of the People’s Republic of China and the Vaccine Administration Law of thePeople’s Republic of China, and has developed a Quality Manual. A quality management systemcovering the entire product lifecycle has been established. Strict quality control standardsare set for key stages of product development, production, storage, and distribution.Targeted quality management procedures have been formulated to ensure that all require-ments related to safety, efficacy, and quality control in pharmaceutical regulations andregistration standards are systematically implemented throughout the drug R&D, produc-tion, quality control, product release, storage, and transportation processes. This ensuresthat all stages, including raw material testing, product R&D, production, and distribution,meet the intended use and registration standards, guaranteeing product quality accordingto strict standards.The Company has established a Quality Management Committee, consisting of core management personnel and speciallyinvited experts and scholars, to coordinate, communicate, consult, and evaluate quality management matters. This furtherstrengthens quality management in production and operations and promotes continuous improvement of quality manage-ment. As of the end of the reporting period, BioMinhai has passed ISO 9001 Quality Management System certification. Nomajor quality or safety incidents have occurred.The Company places great importance on product quality and safety, organizing training courses that include corrective andpreventive action management procedures, personnel hygiene management procedures, and more. In 2024, BioMinhaiconducted compliance training on product quality and safety through the TMS online training system. The training matrixcovers topics such as laws and regulations, biosafety, personnel control, equipment management, material control, sterilityassurance, quality assurance, data reliability, pharmacovigilance, and job-specific skills. The pass rate for personnel assess-ments was 100%.
Governance
ISO 9001 Quality Manage-ment System Certification
During the reporting period, the Company conducted 7,936quality training sessions, with a total of
150,382trainees and a total training duration of11,536hours.
Key Performance Indicators
In response to the evolving landscape of international regulatory requirements and to narrow the compliancegap between domestic practices and those of registration countries and international organizations (such asICH, WHO, and PIC/S), the Company launched a training program aimed at enhancing its quality managementsystem. Beginning in February 2024, the Company provided training on international GMP regulations and ICHguidelines to personnel from production and quality systems. Subject Matter Experts (SMEs) from internaltrainers, QA, and the Quality Compliance Department were selected to lead the sessions. The training involvedcomprehensive comparisons of WHO, PIC/S, and Chinese GMP chapters, paired with gap analyses based onthe Company’s actual practices. A total of 18 training sessions were held, with 2,160 participants in attendance.This series of training sessions further promoted the standardization, scientific rigor, and forward-thinkingdevelopment of the Company’s quality management practices.
2024 International Pharmaceutical Regulatory Training Series
The vaccine industry is subjectto stringent administrativesupervision, with strict regula-tions governing all aspectsincluding R&D, production,sales, and distribution. In recentyears, regulatory oversight inthe industry has been increas-ingly tightened, placing higherdemands on vaccine compa-nies. Under such a regulatoryenvironment, the Companymust adapt in a timely mannerto policy changes and regulato-ry requirements.
The Company upholds the philosophyof high standards and strict require-ments to ensure vaccine productquality. It stays abreast of policy devel-opments and actively implementsrelevant measures to proactivelyaddress potential regulatory changes.In parallel, it continuously enhances itsmonitoring systems across R&D,production, and sales to mitigateoperational risks arising from industrypolicy shifts.
Entire valuechainLong-term
Decreasedoperatingincome;increasedoperatingcosts
Decreasedoperatingincome;increasedoperatingcosts
Risk ofChanges inIndustryPolicies
Vaccine products are directlyrelated to public health, andthe R&D, production, sales, anddistribution of vaccines are allsubject to strict regulatoryoversight. There is a possibilitythat adverse events may occurfollowing vaccination.
The Company strictly complies withthe Vaccine Administration Law andthe Measures for the Reporting andMonitoring of Adverse Drug Reactions,among other laws and regulations. Itstrengthens quality control of itsvaccine products, improves itspharmacovigilance system, andensures timely and lawful handlingof adverse reactions following vacci-nation to mitigate related risks.
DownstreamShort-termAdverseEventsFollowingImmunization (AEFI) Risk
Risk Type
Financial
Impact
Response MeasuresRisk Description
ImpactDuration
Value ChainLinks of Impact
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With economic develop-ment and rising livingstandards, consumersare placing greateremphasis on productand service quality, aswell as safety andenvironmental sustain-ability. This demandtrend provides theCompany with opportu-nities to upgradeproduct safety andquality, and enhancebrand image and marketshare.
DownstreamLong-term
IncreasedoperatingincomeMarketOpportunities
OpportunityType
Financial
Impact
Response MeasuresOpportunity Description
ImpactDuration
Value ChainLinks of Impact
The Company will closely monitorindustry development trends andcutting-edge innovative technologies,explore the application of new vaccinetechnology paths, and establish newtechnology platforms. The focus will beon improving the R&D innovationsystem, accelerating new product R&Dand industrialization progress, andconstructing a diversified and differenti-ated product matrix to enhance themarket competitiveness of the Compa-ny’s products.Align with market trends and adoptflexible pricing strategies. In responseto the growing market demand forhigh-quality products, the Companyconducts in-depth market research andprecise analysis to optimize its productpricing system scientifically. Whilemaintaining strict quality standards andensuring reasonable corporate profits,the Company adopts more competitivepricing strategies to enhance productattractiveness and competitiveness inthe market, thereby further expandingits market share.
BioKangtai has established the Quality Risk Management Procedure, which applies scientific knowledge and experience toassess quality risks throughout the entire product lifecycle to ensure product quality. The Company conducts comprehensiveevaluation, control, communication, and review of quality risks to keep the consequences of various uncertainties within ananticipated and acceptable range, thereby ensuring product quality compliance. By leveraging sufficient knowledge, facts,and data, the Company proactively forecasts potential future events and implements risk control measures to preventhazards from occurring.
Impact, Risk and Opportunity Management
Risk Assessment
Identify potential hazard events or risks that may arise; perform qualitative or quantitativeanalysis of the identified risks to evaluate their severity and provide support for riskprevention and control.
Risk Control
Based on the risk assessment results and predefined risk acceptance criteria, if the riskexceeds an acceptable level, appropriate measures should be taken to reduce or elimi-nate the risk.
Risk Communication
Throughout each stage of the risk management process, QA and relevant departments(including drug regulatory authorities, the industry, patients, and internal company stake-holders) should exchange and share information regarding the degree of risk andmanagement practices, ensuring effective risk communication.
Risk Audit
Conduct risk monitoring. If residual risks remain unacceptable after implementingresponse measures, the response measures should be revised or replaced. The effective-ness of the new response measures must be assessed until the residual risk is within anacceptable range.
Upon completing the risk assessment report, any identified countermeasures should befollowed up through a dedicated CAPA process. Implementation of the responsemeasures must comply with the Corrective and Preventive Actions Management Procedure.Output of QualityRisk Management
“Quality is life” is the core philosophy that underpins the Company’s operations and development. Adhering strictly to thequality policy of “strict adherence to procedures, zero tolerance for falsified raw data, thorough investigation of every issue,zero release of defective products, and unwavering commitment to GMP management”, the Company continues to foster adeep-rooted culture of quality and implements a “zero-defect” strategy to secure competitive advantage through excellence.
Metrics and Targets
Product Quality Assurance Measures
BioKangtai always regards product quality as a lifeline. On the basis of full compliance with China’s vaccine regulatory frame-work, BioKangtai actively draws upon and incorporates international guidelines such as WHO, ICH, PIC/S, and EU GMP. Acomprehensive pharmaceutical quality management system covering the entire product life cycle—spanning product R&D,technology transfer, commercial production, and post-marketing management—has been established. Strict managementprocesses and requirements are implemented across all stages, including raw material control, product manufacturing,vaccine storage and transportation, and vaccine administration.
Whole-Life-Cycle Management
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Raw Material Control
The Company hasestablished proceduressuch as the MaterialManagement Procedure andSupplier ManagementProcedure to ensurestandardized control. Rawmaterials are managed in
accordance with anapproved material list and
applicable qualitystandards, with accesscontrol applied across keystages including procure-ment, acceptance, testing,storage, release, and use.
Product Manufacturing
Product-specific manufac-
turing procedures andprocess operation guide-lines are in place to guideproduction activities andquality monitoring.Ongoing quality monitor-ing and stability studiesare conducted to ensureconsistent production ofproducts that meetintended use and registra-tion requirements.
Vaccine Storage and
TransportationVaccines are subject to
stringent storage andtransportation require-ments. Cold chain facilities
and vehicles undergoperiodic validation, and anadvanced online monitor-ing system is employedfor real-time cold chaintemperature tracking,ensuring the safety andreliability of vaccinestorage and transporta-
tion.
Vaccine Administration
Safeguarding patienthealth is our core mission
and responsibility. TheCompany has established
accessible customer
feedback channels andhandling mechanisms. Adedicated pharmacovigi-
lance department is inplace to carry out signaldetection, evaluation, andresponse related to AEFI.
The Company continues to enhance product quality control and improve the scientific management level of vaccine productindustrialization. By continuously improving and perfecting the production quality management system, the Company hasimplemented a manufacturing execution system (MES) and laboratory information management system (LIMS). Thesesystems enable the digitalization of the entire production and testing process, ensuring strict quality control. This approachguarantees the quality of products, ensuring the delivery of high-quality, safe, and effective vaccine products to society.
Digital Management
Manufacturing
ExecutionSystem (MES)
This system integrates production instructions, electronic batch records, batch analysis, formulations,material and equipment management functions, enabling automatic data collection and electronicrecord-keeping for the entire production process. It ensures traceability throughout the process. Incombination with other information systems, it establishes a “lifecycle” management system forvaccine production, enhances quality management levels, guarantees high-quality vaccine production,and promotes paperless production, reducing the use of paper records.
LaboratoryInformationManagementSystem (LIMS)This system covers key aspects such as batch management, stability management, instrumentmanagement, reference material management, reagent management, and laboratory investigationmanagement. It enables efficient integration and optimization of laboratory resources, ensuring theaccuracy and reliability of laboratory data management.
The Company has developed procedures such as the Deviation Management Procedure, Change Control Management Procedure,and Corrective and Preventive Action Management Procedure in accordance with GMP management requirements. These proce-dures cover the entire production process, including deviation, change management, and risk control management, ensuringthat products meet the intended use and pharmaceutical registration requirements.
Corrective and Preventive Action Management
From March to April 2024, BioKangtai conducted a series of thematic training sessions titled “Mistakes Shouldn’tHinder Progress, Become a Better Version of Yourself”. This training, jointly organized by the Quality AssuranceDepartment and the Production Operations Center, consisted of 5 sessions. A total of 369 employees from variousdepartments participated. During the training, employees proactively shared actual issues and lessons learnedfrom their work, and discussed how to actively respond to risks that may cause mistakes. This helped promote bothteam and individual progress and fostered greater collective strength.
“Mistakes Shouldn’t Hinder Progress” Training
“Mistakes Shouldn’t Hinder Progress” Training
DeviationReporting
DeviationInvestigation
Deviation ClosureDeviation HandlingProcess
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Product RecallThe Company has developed the Finished Product Recall Procedure, which specifies the scope, responsibilities, andcontent of the recall process to ensure that the recall of finished products can be initiated at any time and carried out quick-ly and effectively. Depending on the situation, the recall is classified into voluntary recall and mandatory recall. Based onthe severity of the quality issue or other safety risks, recalls are further categorized into Level 1, Level 2, and Level 3 recalls.The Company regularly simulates recall scenarios to evaluate and ensure the effectiveness of the product recall system.During the reporting period, the Company did not experience any product recalls due to health and safety concerns.
Quality IncidentReport to the Committee on Safety of MedicinesInitiate Investigation and Assessment of Pharmaceutical Safety Risks
Decide Whether to RecallMandatory Recall by NMPARelevant Departments
Develop and ImplementCorrective and Preventive Measures
Track the EffectRecall
Develop and Implement Correctiveand Preventive Measures
Track the Effect
Close the Recall Action
Documentation
Mandatory Recall
Yes
Meet the Requirements
No
Not Meet theRequirements
Meet the Requirements
Recall Flowchart
Not Meet the Requirements
The Company has formulated the Pharmacovigilance Management Training Procedure and incorporated pharmacovigilancetraining into its Annual Training Plan. Training in pharmacovigilance knowledge is generally provided to two groups: dedicat-ed pharmacovigilance personnel (members of the Pharmacovigilance Department) and non-dedicated personnel (employ-ees outside the Pharmacovigilance Department). For non-dedicated personnel, the training includes company-widesessions, onboarding training for new employees, and training for Marketing Center staff. With “protecting patient safety” asthe core objective, the Company promotes continuous awareness and training to help all employees internalize and imple-ment this fundamental requirement. In accordance with the Annual Training Plan, the Company provides systematic trainingfor dedicated pharmacovigilance personnel to comprehensively enhance their professional capabilities. These trainings helppersonnel expand their knowledge base, improve technical skills, master risk identification and assessment methods, andstrengthen their ability to respond to drug safety risks—ultimately improving both the efficiency and quality of pharmacovigi-lance work and ensuring the stable operation of the pharmacovigilance system. In line with compliance and risk preventionrequirements, the Company conducts at least one annual training for Marketing Center staff on the collection and handlingof suspected Adverse Events Following Immunization (AEFI). These sessions aim to deepen employees’ understanding ofAEFI monitoring and reporting, and to strengthen their awareness and ability to report safety information.
Pharmacovigilance Training
Pharmacovigilance
The Company has established and continuously improves its pharmacovigilance system in accordance with the Pharmaceuti-cal Administration Law of the People’s Republic of China, the Vaccine Administration Law of the People’s Republic of China, and thePharmacovigilance Quality Management Standards and other relevant laws and regulations. The Company has formulated andcontinuously refined pharmacovigilance system documents to guide and regulate the smooth implementation of pharma-covigilance work. A Pharmaceutical Safety Committee has been established to handle major risk assessments, urgent orsignificant drug events, risk control decisions, and other major matters related to pharmacovigilance. A dedicated Pharma-covigilance Department is responsible for managing and improving the Company’s pharmacovigilance activities.
Pharmacovigilance Management
Ensure that personnel involved in pharmacovigilance activities fulfill theirresponsibilities and actively participate in the pharmacovigilance processes;
Ensure the efficient use of drug safety information to maintain a favorable risk-benefitbalance for pharmaceutical products, ensuring public medication safety;Ensure that pharmacovigilance activities meet regulatory requirements;
Prevent harm to patients resulting from adverse reactions after vaccine use;Contribute to protecting patient and public health.
PharmacovigilanceManagement Policy
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On March 13, 2024, the Pharmacovigilance Department organized a study session on the Operational Guidelinesfor Pharmacovigilance Quality Management Standards for MAHs in Beijing-Tianjin-Hebei Region (Trial). Throughthis training, the department enhanced its professional knowledge and revised the Company’s pharmacovigi-lance system documentation in accordance with the guidelines. This ensures that pharmacovigilance activitiesremain compliant with current regulatory requirements.
Study Session on the Operational Guidelines for Pharmacovigilance QualityManagement Standards for MAHs in Beijing-Tianjin-Hebei Region (Trial)
The Company conducts monitoring, identification, assessment, and control of risks associated with its products duringclinical trials and post-marketing use, and formulates corresponding response measures for different risk stages.Pharmacovigilance Management Measures
The Company actively expands information collection channels by means suchas telephone communication and on-site visits to collect AEFI data related to theuse of its vaccines. All data are monitored and managed according to establishedprocedures.A pharmacovigilance data management system has been introduced to collectand manage AEFI reports during both the clinical trial and post-marketingphases.
The Company has developed a Pharmacovigilance Plan to monitor the occur-rence of AEFI in real time and conduct vaccine safety risk assessments.
The Pharmacovigilance Department of the Company has established themanagement procedures of clinical pharmacovigilance in accordance with therequirements of the relevant regulations, and standardized the management ofpharmacovigilance for the clinical research of oral pentavalent reconstituted liveattenuated rotavirus vaccine (Vero cell) and tetravalent influenza virus lysatevaccine, which ensured the smooth progress of the clinical research work.Pharmacovigilance in
Clinical Trials
Post-Marketing RiskIdentification, Evaluation,
and Control
Post-Marketing AEFIMonitoring and Reporting
Protection of Customers’ Rights and Interests
The Company has established comprehensive customer communication channels and complaint management procedures.By utilizing various means such as the 400 customer service hotline and feedback collection mechanisms, the Companypromptly gathers customer feedback to ensure smooth communication. The Company has formulated the Standard Operat-ing Procedure for Medical Consultation and Complaint Handling and the User Complaint Management Procedure, which respectivelydefine the handling processes for medical inquiries and quality-related complaints. Upon receiving an inquiry, the Companyresponds in accordance with the Standard Operating Procedure for Medical Consultation and Complaint Handling. Upon receivinga quality complaint, the Company follows the User Complaint Management Procedure to promptly initiate internal communi-cation and investigation, coordinate with relevant departments to formulate corrective and preventive actions, and ensurethat issues are resolved in a timely and appropriate manner.
Customer Service Management
The Company strictly complies with the Advertising Law of the People’s Republic of China, the Trademark Law of thePeople’s Republic of China, and other relevant laws and regulations, and adheres to the principles of accuracy, clarity, andtransparency in marketing and promotion. False advertising is strictly prohibited in all marketing activities. The Company hasestablished the Regulations on the Production, Distribution, and Management of Promotional Materials and Items, whichdefine the production process and approval procedures for promotional materials, and standardize the compliance reviewof marketing materials. Product promotional materials are prepared by the product team, with content reviewed by theMedical Affairs Department, jointly reviewed by the Marketing and Medical Directors, and finally approved by the Head ofthe Marketing Center, ensuring the accuracy, clarity, and transparency of marketing communications.
Responsible Marketing
Customer Quality Complaint Handling Process
The Marketing Centercollects customer feedback
and receives complaintinformation
The Marketing Centerassists in the investigation,responds to the customer,and closes the complaint.
The Quality AssuranceDepartment organizesrelevant departments toconduct an investigation andformulate corrective and
preventive action
The Company’s productdivision drafts promotional
materials for products
The medical department isresponsible for reviewing the
content of the materials
The final draft is jointly reviewedby the product division and themedical departmentPrinting for use
Approval by the head ofmarketing center
Approval by marketing and
medical director
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Win-Win Cooperation for a Sustainable Supply Chain
The Company has formulated the Supplier Management Measures, Procurement Management Regulations, and other relevantpolicies to standardize procurement processes, improve supervision mechanisms, optimize supplier management, andenhance the stability of the supply chain. Suppliers are classified into four categories: key suppliers, strategic suppliers,general suppliers, and temporary suppliers, with distinct selection criteria established for each category.
Admission of Suppliers
Strict control over supplier qualification, with general qualification requirements set andcategory-specific qualification criteria established based on the type of goods supplied.Suppliers’ business qualifications and material quality standards are thoroughly reviewedto ensure compliance with product quality and technical standards.
Suppliers are important partners in the Company’s commitment to its purpose of “produce the best vaccines to benefitmankind” and advancing sustainable development. To promote a sustainable supply chain, the Company has developed andimplemented the Supplier Code of Conduct, which sets clear requirements for suppliers in areas such as legal compliance,human rights and labor, environmental protection, and business ethics. The Company is dedicated to working with itspartners to build a compliant, trustworthy, and sustainable supply chain system. Additionally, the Company utilizes a digitalprocurement system, making the procurement inquiry and price comparison process more convenient and intuitive, reduc-ing the error rate in the contract approval to material warehousing process, and improving overall work efficiency.
When a supplier informs the Company of any changes, the purchasing staff shouldidentify and confirm whether the change will affect the subsequent material supply orservices. For changes in suppliers of production materials, the change should alsocomply with the change control management documents of the GMP system.
Elimination of Suppliers
Suppliers that do not meet the standards should be eliminated promptly;The elimination of suppliers for production materials should strictly follow the Compa-ny’s GMP system supplier management procedures.
Supplier Evaluationand Assessment
Supplier InformationChanges
The Company establishes a supplier audit and evaluation team that uses a quantitativescoring system to assess suppliers. Evaluation criteria include quality control, deliverytimeliness, cost management, service levels, and other factors;When evaluating suppliers, evaluators should complete the Supplier Evaluation Formand take appropriate actions based on the results;After the evaluation, the purchasing staff should promptly notify the supplier in writingof the evaluation standards and results, and take corresponding actions based on theevaluation outcomes, offering suggestions to the supplier;
Information Protection for Strengthening DataSecurity
BioKangtai strictly complies with the Cybersecurity Law of the People’s Republic of China, the Data Security Law of thePeople’s Republic of China, the Personal Information Protection Law of the People’s Republic of China, and the Data SecurityManagement Measures in the Industrial Sector among other laws and regulations. Following the ISO 27001 InformationSecurity Management System certification standards, the Company has established a comprehensive information securitymanagement system in five areas: organization, management, technology, training, and supervision. The Company hasclearly defined its cybersecurity and privacy protection policies, ensuring their integration into all stages of production,inspection, and operations. The Information Center is responsible for organizing and coordinating the Company’s informa-tion security efforts and has set up dedicated positions to ensure the implementation of information security protectionstrategies and procedures. During the reporting period, the Company did not experience any major information securitybreaches.The Company actively conducts information security training. Every year, in June and November, phased information secu-rity training is provided to all employees, covering topics such as updates to information security policies and procedures.In response to Information Security Week, the Company emphasizes the importance of information security through variouschannels, including departmental annual training, new employee onboarding training, and company bulletin boards. Duringthe reporting period, the Company held a total of 10 information security training sessions.
Information Security Management
Information Security Training
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Information Security Management Measures
The Company places high importance on information security protection. Through four key measures—strengtheningnetwork risk prevention and control, strictly managing account passwords and permissions, ensuring the security and stabil-ity of information systems, and improving emergency response mechanisms for unforeseen situations—the Company hasbuilt a robust information security barrier, ensuring the safe operation of information systems.
By deploying advanced security technologies and tools(such as firewalls, situational awareness systems, WAF,intrusion prevention systems (IPS), database auditingsystems, log auditing systems, vulnerability scanning,baseline checks, etc.), the Company ensures networksecurity.
Network Security Risk Prevention
Strictly enforces the Computerized System AccountManagement Regulations to ensure that user permissionsand password controls are properly allocated andeffectively managed.
Account Password and Permission Management
Strictly follows the Computerized System Security Manage-ment Regulations and the Operation and MaintenanceAuditing & Risk Control System Operating Procedures toensure the stable operation and security of systems,with IT personnel’s permissions classified, tiered, andminimized.
Information System Security and Stability
The Company has developed a detailed Network and Informa-tion System Emergency Response Plan and conducts emergen-cy drills annually to enhance the ability to respond to unfore-seen incidents.
Emergency Response for Unexpected Situations
On July 26, 2024, the Information Center organized the 2024 Information Center Data Center Power Outage EmergencyDrill, with coordinated participation from the Equipment Department, Quality Assurance Department, and variousbusiness departments. This drill, which simulated a real power outage scenario, comprehensively tested the datacenter’s business continuity protection mechanisms and the effectiveness of the emergency response plan. Itvalidated the efficacy of the emergency procedures in the event of a power interruption and enhanced the team’sability to collaborate and respond to emergencies. Based on the potential risks exposed during the drill, theInformation Center will further revise and improve the emergency response plan, clarifying responsibility assign-ments and response time requirements.
Information Center Power Outage Emergency Drill
Data Protection Measures
The Company adopts multi-layered, end-to-end protection measures to safeguard data security.
Technical
Level
Sensitive data is encrypted using high-strength encryption algorithms, and encryption softwareensures that data remains encrypted during storage, transmission, and backup.Encryption technology is used to ensure files are usable in designated environments, while showingas garbled text outside the environment.Hidden file watermarks and screen watermarks are applied to prevent data leakage due to softwarescreenshots or phone photos, which cannot be traced.
Data Encryption and Masking
Data access permissions are assigned based on the “least privilege principle”, with access levelsdivided according to employee roles to prevent unauthorized personnel from accessing sensitiveinformation.Multi-factor authentication (MFA) is deployed, combining passwords, biometrics, and other verifica-tion methods to enhance account security.
Access Control and Permission Management
Intrusion Detection Systems (IDS) tools are used for real-time monitoring to identify abnormalaccess behaviors and trigger alerts.Operational logs are recorded to track file creation, modification, and transmission activities, facilitat-ing traceability and risk analysis.Internet behavior management is employed to effectively control the internal network and monitorabnormal traffic.
Security Audits and Real-Time Monitoring
Management
Level
Physical and
ExternalProtection
Develop data classification and grading standards, clearly defining lifecycle management regulationsfor storage, transmission, destruction, and other processes.Establish emergency response plans and conduct regular data recovery drills to ensure the availabili-ty of backup data.
Policy and Process Development
Conduct regular security training covering topics such as phishing email identification and secureoperating procedures, reinforcing risk awareness among all employees.Conduct simulated attack tests (such as phishing drills) to assess employees’ response capabilitiesand improve training programs based on the results.Deploy enterprise-level firewalls to block external attack paths and implement segmented manage-ment of the internal network for effective network isolation.Control the use of external devices such as USB drives on the production network, restricting unau-thorized devices from copying files.Lock data on the production network to limit modifications and deletions.
Employee Training and Awareness Enhancement
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Customer Privacy ProtectionThe Company places high importance on customer privacy protection and strictly enforces confidentiality agreements.Exclusive access permissions are set for customer information to ensure compliance with information access policies. TheInformation Center regularly reviews permission configurations and promptly corrects any misassignments to preventinformation leakage. At the same time, the Company strengthens network security defenses by adding application serverisolation and bastion host protection measures to fully safeguard customer information security.Digital TransformationBioKangtai’s digital transformation focuses on production, covering anintegrated business model from procurement and warehousing toproduction, inspection, and sales. The importance of this transformationis the Manufacturing Execution System (MES) project, which connectspersonnel, equipment, materials, and environments that are dispersedacross different locations, regions, and departments. By integratingthese systems across regions through the MES, the Company achievesefficient division of labor and rapid response capabilities. The use of anadvanced industrial internet system enhances production and executionefficiency, thereby improving the overall utilization of resources atBioKangtai.
The group’s ERP system is used for unifiedmanagement of sales orders and shipping,enabling real-time tracking of product sales flowSales
The Company has introduced the SRM systemfor procurement source managementPurchasing
In warehousing, the WMS system is imple-mented to enable traceability of raw andauxiliary materials, as well as product tracking,through “one product, one code”
Storage
For production, the MES system is used tocomprehensively manage electronic batchrecords, ensuring full control of the productionprocesses
Production
The Company employs the LIMS system for laboratory management,
ensuring that the inspection process is controllable and thatinspection reports are automatically generated
Inspect
Digital Transformation
Business Model
2024 Best Practice in Digital Transformation
of Listed Companies
Embeds production recipe design and process
requirements into system workflowsProvides full-process management andmonitoring of workshop productionEnsures error-proofing and traceability of
materials andproduction data throughout the entire process
Real-time automatic collection,monitoring, processing, storage, utilization,and weighing of equipment parameters,seamlessly integrating with weighing equipment,operational containers, surrounding systems,
and devices
数字化转型技术框架Pharmaceutical ProductionBusiness Management LayerPharmaceutical ProductionWorkshop Operations Layer
Production Manufacturing
System (MES)
Managers can promptly and accurately grasp the productionquality status of each process through the MES system
Digitalized Production
Digital Transformation Business Model
2024 Environmental, Social and Governance (ESG) Report
Environmental Compliance for Strengthening Pollution Prevention and Control 54Low Carbon and Energy Conservation for Addressing Climate Change 60
Green and Low-Carbon Developmentfor Building a Beautiful EcologicalHome Together
5354
Environmental Compliance for StrengtheningPollution Prevention and Control
The Company strictly complies with the Environmental Protection Law of the People’s Republic of China and other relevantregulations. It has established the Environmental Protection Management Procedures, Environmental Factors and HazardSource Identification and Control Procedures, and other systems. These procedures regulate environmental monitoring,environmental information reporting, and emergency response for environmental incidents, standardizing the Company’senvironmental practices in production and operations. The goal is to reduce pollutant emissions and promote the Compa-ny’s sustainable development.The Company takes “strict pollution control, scientific management, energy conservation and emission reduction, andcontinuous improvement of energy efficiency” as its management principles and has established an environmental manage-ment structure with well-defined responsibilities. The Environmental Health & Safety (EHS) committee is the Company’senvironmental management body, and the Office of Safety, Health and Environmental Management is responsible for theregular environmental management. We require all employees to sign a letter of responsibility for EHS targets, and associateenvironmental management performance with the quarterly performance appraisal of middle and senior management.During the reporting period, the Company invested 3.8388 million yuan in environmental protection, and there were noinstances of administrative penalties due to violations of environmental protection laws and regulations.
Governance
Director of EHS Committee
Deputy Director of EHSCommitteeHeads of Departments
Office of Safety, Healthand EnvironmentalManagement
Heads of Teams
Responsible PersonResponsibilitiesResponsible for the approval of the Company’s annual environmental targets andrelated policiesResponsible for the approval of environmental protection issues within the scope ofresponsibilityResponsible for the approval of environmental protection evaluation results
Responsible for the implementation of the annual environmental protection efforts ofthe teamResponsible for the self-assessment of the completion of the team’s annual environ-mental protection goals
Responsible for organizing and supervising the implementation of environmentalprotection efforts in all teams and departments of the CompanyResponsible for the evaluation of the environmental protection efforts by teams anddepartmentsResponsible for the implementation of the departmental environmental protectionefforts, and break down the department’s annual environmental protection goals toeach teamResponsible for supervising the implementation of environmental management in thedepartment, and organizing self-assessment
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As of the end of the reporting period, BioKangtai andBioMinhai had obtained ISO 14001 EnvironmentalManagement System certification and passed cleanproduction audits. BioKangtai was awarded the“Green Enterprise” title by Shenzhen City. In 2024,BioMinhai received both the national-level “GreenFactory” title and the “Green Factory” title fromBeijing City.The Company continuously enhances employees’ environmental management awareness and professional capabilitiesthrough environmental protection training. During the reporting period, the Company conducted training sessions such asSolid Waste Management Training, General Industrial Solid Waste Training, and monthly EHS training. The Company alsoorganized environmental protection engineers to participate in the Shenzhen Environmental Protection Director CapabilityEnhancement Assessment held by the Shenzhen Municipal Bureau of Ecology and Environment, and they obtained certifica-tion. BioMinhai organized environmental protection engineers to attend the Automatic Monitoring Compliance Trainingorganized by the Ministry of Ecology and Environment, where they also obtained certification. During the reporting period,the Company conducted a total of 22 environmental protection training sessions.
BioKangtai
BioMinhai
StrategyRisk Type
Financial
Impact
Response Measures
Operations,downstreamShort tomediumterm
DecreasedoperatingincomeRisk of Damageto Reputation
Negative environmen-tal incidents reportedby the media may leadto reduced consumertrust and causepartners to reassessbusiness relationships.
Actively disclose environmentalprotection measures, respondpromptly to incidents, and strength-en brand public relations.
Risk Description
ImpactDuration
Impact onValue Chain
Increase investment ingreen and environmen-tally friendly productiontechnologies, promotethe use of renewableenergy, implementenergy-saving controlsand upgrades, reducecarbon emissions, andimprove resourceefficiency, ultimatelyreducing costs.
OperationsMedium tolong term
IncreasedoperatingincomeGreen Techno-logy Innovation
Optimize production processes,reduce pollutant emissions, andimprove resource utilization.
Opportunity
Type
FinancialImpact
Response MeasuresOpportunity Description
ImpactDuration
Impact onValue Chain
Impact, Risk, and Opportunity Management
Risk Identification
In accordance with the List of Signicant Environmental Aspects, the Company identifiesenvironmental factors involved in operational activities. Four major categories have beenidentified: solid waste, exhaust gas, wastewater, and noise. The results are recorded in theEnvironmental Aspect Identication and Evaluation Form.
Risk Evaluation
The EHS Office organizes departments to conduct risk evaluations of hazards, assessingthe likelihood of safety incidents, employee capabilities, and monitoring data. These evalu-ations consider the frequency of exposure to risks and the severity of potential conse-quences. Risk levels of each environmental factor are determined based on the results.
Risk Monitoring
The Company monitors changes and additions to relevant laws and other requirements,conducts annual reviews, and sets environmental targets for the following year accord-ingly.
The Company strictly complies with the Environmental Impact Assessment Law of the People’s Republic of Chinaand otherrelevant laws and regulations, fully implementing the “Three Simultaneities” principle for construction projects. During thereporting period, BioMinhai completed the self-inspection and acceptance of the newly constructed boiler project and thenew international vaccine industrial base project. It also obtained the approval of the environmental impact report for thenucleic acid vaccine R&D and pilot-scale production project. In January 2025, BioKangtai submitted the environmentalimpact report for the technical development project of the Reassortant Rotavirus Vaccine, Live, Oral, Pentavalent (Vero Cell)to the Ecology and Environment Bureau and received official approval.In accordance with theImplementation Measures for Mandatory Environmental Pollution Liability Insurance in Shenzhen,BioKangtaiengaged a third-party assessment agency and purchased mandatory environmental pollution liability insurance. By integrat-ing third-party insurance risk management with environmental management, the Company aims to prevent environmentalpollution incidents.
Environmental Management MeasuresEnvironmental Impact Assessment
The Company has formulated the Environmental Factors and Hazard Source Identification and Control Procedure to identifyand assess environmental aspects in its operations, and to develop and implement targeted plans and measures.
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The Company strictly monitors pollutant indicators and complies with the provisions of thePollutant Discharge Permit,utilizingboth manual and automated methods to record and monitor pollutants. During the reporting period, the Company conduct-ed comprehensive monitoring of wastewater, exhaust gas, and noise within the plant in accordance with the permit require-ments. A total of 1,031 monitoring data points were collected, with 100% compliance.
Environmental Monitoring and Management
The Company has established the Emergency Response Plan for Environmental Emergencies and other related systems toimprove emergency handling mechanisms for unexpected environmental events. These efforts aim to enhance the Com-pany’s emergency response capabilities and ensure that such incidents are managed in a timely, orderly, efficient, andappropriate manner. During the reporting period, the Company carried out emergency drills simulating scenarios such asorganic solvent leakage in the hazardous waste warehouse and pipeline rupture/effluent discharge exceeding limits at thewastewater station. These exercises strengthened the Company’s overall emergency response capabilities and improvedits environmental risk management.
Emergency Response Plan for Environmental Incidents
On October 24, 2024, BioKangtai conducted an emergency drill for a scenario involving a rupture of the waste-water pipeline or excessive discharge. The drill simulated an emergency in which the effluent exceededdischarge standards or the wastewater pipeline ruptured. Focusing on operational standards, emergencyresponse, and risk awareness, the drill improved employees’ understanding of the risks associated with exces-sive wastewater discharge, enhanced the Company’s emergency handling capabilities, and raised environmen-tal awareness among staff.
Emergency Drill for Non-Compliant Wastewater Quality/Pipeline Rupture
The Company’s wastewater primarily originates from production processes and domestic sewage. Key monitoring indicatorsinclude COD, ammonia nitrogen, total nitrogen, and pH. The Company strictly adheres to the Law of the People’s Republic ofChina on the Prevention and Control of Water Pollution, Emission Standards for Water Pollutants from Pharmaceutical Industry ofBiotechnology, Integrated Wastewater Discharge Standard, and other relevant laws, regulations, and normative documents. Ithas established internal policies such as the Standard Operating Procedures for Sewage Treatment System, Wastewater Treat-ment Station Water Quality Monitoring and Management Regulations, Drainage Standard Operating Procedures, and WorkshopDrainage Management System to standardize the processes, monitoring, and operational requirements for wastewatertreatment, ensuring that all generated wastewater is properly treated.
Pollution Prevention and ControlWastewater Management
Wastewater Treatment Measures and Operational PerformanceThe Company has a dedicated wastewater treatment station. Industrial wastewater is directed to the stationfor treatment before being discharged into the municipal sewage network.An online wastewater monitoring system is installed to monitor parameters such as COD and ammonianitrogen daily. In addition, the Company engages third-party agencies to conduct regular sampling and testingto ensure compliance with discharge standards.The wastewater treatment station operates in strict accordance with national environmental protection regula-tions. All facilities, signs, and labels are in good condition, and records are complete and updated in real time.A professional environmental engineering company is commissioned to manage the operation of the waste-water treatment station, perform routine safety inspections of wastewater facilities within the plant, andpromptly address any malfunctions.
Indicators
Chemical Oxygen Demand (COD)
Ammonia NitrogenTotal NitrogenTotal PhosphorusTotal Industrial Wastewater Discharge
tontontontonm3
Unit
27.24
3.05
0.19
0.04
1,075,107.08
2024
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Waste Gas ManagementThe primary air pollutant generated by the Company is total volatile organic compounds (TVOCs). The Company strictlycomplies with the Law of the People’s Republic of China on the Prevention and Control of Atmospheric Pollution, EmissionStandard for Odor Pollutants, Emission Standard of Air Pollutants for Pharmaceutical Industry, Emission Control Standardfor Volatile Organic Compounds (VOCs) from Industrial Enterprises, and other relevant laws, regulations, and normativedocuments. The Exhaust Gas Emission Management System has been established to standardize exhaust gas emissionsand daily emission practices, ensuring stable operation of all exhaust gas treatment facilities and proper treatment of alltypes of industrial emissions. During the reporting period, the Company discharged a total of 251,816,447 cubic meters ofexhaust gas.
Exhaust Gas Treatment Measures and Operational PerformanceExhaust gases are treated using high-efficiency filters and activated carbon adsorption before discharge.Kitchen fume emissions are treated by dedicated fume purification devices before being released.The Company engages qualified third-party organizations to conduct regular exhaust gas testing in accordancewith regulatory requirements to ensure all emissions comply with relevant standards.
The Company classifies solid waste into general industrial solid waste, general domestic waste, hazardous waste, and medi-cal waste based on their sources and characteristics. The Company has established the Solid Waste Management Systemto standardize the waste disposal process and ensure that all types of solid waste generated by the Company are properlytreated.The Company follows the principles of “reduction, harmlessness, and resource utilization” in solid waste management. Thedepartments generating waste are responsible for managing the entire process, from waste generation to transfer. Thisincludes recording the initial waste generation, packaging and barreling, labeling, and internal transportation. For hazardousand medical waste, the Company entrusts qualified third parties for disposal. For general industrial solid waste, qualifiedthird parties are also commissioned for treatment, while general domestic waste is handed over to the sanitation departmentfor processing.
Waste Management
Indicator
General Industrial Solid WasteGeneral Waste Generation per Unit Revenue
Hazardous WasteHazardous Waste Generation per Unit Revenue
Unittonkg/10,000 yuan
tonkg/10,000 yuan
142.79
0.54
231.63
0.87
2024
BioKangtai actively responds to the national “dual carbon” strategy, giving high priority to the challenges posed byclimate change. The Company practices the concept of green development through concrete actions, contributing tothe protection of the Earth’s ecology and alleviating the climate crisis.
Low Carbon and Energy Conservation forAddressing Climate Change
The Company combines management-driven energy conservation with technology-driven energy-saving measures. Itcontinuously improves its energy management structure, energy management system, energy measurement system, andenergy-saving performance assessment and training programs. By strengthening energy control, the Company formulatesannual energy control implementation plans and sets specific energy-saving and emission reduction targets.The Company adheres to the Energy Conservation Law of the People’s Republic of China, Energy Management SystemRequirements and Guidelines, and other relevant laws and regulations. It has established the Energy Management Systemto standardize energy management practices, improve overall energy utilization efficiency, and respond to national energyconservation and emission reduction policies. The Company has set up an energy management team, led by the productionhead, with department staff as team members. The team is responsible for energy consumption, quota control, and dailystatistics and analysis. As of the end of the reporting period, BioMinhai has passed ISO 50001 Energy Management Systemcertification.The Company engages a third-party agency to conduct energy audits, providing a comprehensive assessment of the Com-pany’s energy management level and energy usage, identifying problems and weaknesses in energy utilization, uncoveringenergy-saving potential, exploring energy-saving directions, reducing energy consumption and production costs, andimproving overall economic performance.The Company has established the Energy Reward and Penalty Regulations, integrating energy management and energy-sav-ing efforts into the performance appraisal system. These are treated as key indicators for year-end evaluations, with astandardized reward and penalty system to promote continuous improvement in energy management. Additionally, theCompany places great emphasis on cultivating employees’ energy-saving awareness and provides training on warehouseenergy-saving measures and energy control implementation plans.
Governance
2024 Environmental, Social and Governance (ESG) Report
Strategy
Operations,downstreamShort-term
DecreasedoperatingincomeAcuteRisks
Frequent typhoons and floods inSouth China may damage produc-tion facilities and disrupt cold chainlogistics.
Reinforce disaster-resilient plantdesign (e.g., flood protectionfacilities); purchase property andliability insurance.OperationsLong-term
IncreasedoperatingcostsChronicRisks
Rising average annual tempera-tures in South and North Chinalead to increased energy consump-tion for cleanroom cooling, drivingup production costs.
Upgrade high-energy-consumingcooling equipment.
OperationsMid-term
Increasedoperatingcosts
PolicyRisks
Stricter domestic “dual carbon”policies lead to increased carbonemission costs.
Participate in the carbon tradingmarket to offset part of theemissions.
Risk Type
Financial
Impact
Response MeasuresRisk Description
ReportingPeriod
Value ChainStage
Phy-sicalRisks
Tran-sfor-ma-tionRisks
6162
ImprovedEnergyEfficiency
By adopting advanced energymanagement and conservationtechnologies, energy efficiencycan be enhanced, reducingenergy consumption and costs.
Improve energy efficiencythrough energy audits,equipment upgrades, andemployee training.
The Company places great importance on the risks and opportunities brought about by climate change, continuously moni-toring changes in the external environment and adjusting internal business planning accordingly. It dynamically optimizes itsclimate risk response strategies.
Impact, Risk, and Opportunity Management
OpportunityType
Response MeasuresOpportunity Description
DownstreamLong-term
Decreasedoperating
costs
Financial
ImpactImpactDuration
Impact onValue Chain
PreparationImplementationEvaluation andReportingCorrection
At the beginning of each year, the Safety and Environmental Protection Office formu-lates the Annual Audit Plan, establishes an internal audit team, and prepares an internalaudit implementation plan.Internal audits are carried out through both document review and on-site inspections.In accordance with the Hazard Identification and Inspection System, non-conformities areidentified and classified as general, major, or observations. After the audit, relevant depart-ments and personnel prepare an internal audit report.Based on the corrective action records and audit report, departments develop correctivemeasures. When implementing these measures, departments must complete records ofnon-conformities, corrective actions taken, and supporting evidence. The audit teamleader reviews the materials before further corrective actions are taken, and all supportingdocumentation is collected.
The Company primarily consumes electricity, steam, natural gas, and small amounts of gasoline, diesel, and liquefied petro-leum gas during production. Electricity is sourced from the municipal power grid and is mainly used for production equip-ment. Steam is primarily used for process equipment and air conditioning. Natural gas is mainly consumed in boiler opera-tions and the cafeteria. Gasoline is used for company vehicles, while diesel is used for emergency power generation androutine generator maintenance.
Metrics and Targets
Natural Gas
Gasoline
DieselTotal Purchased Electricity
Total Purchased Heat
10,000 ｍ3
tontonkWh
GJ
889.86
37.54
124.42
96,606,866227,379.62
IndicatorUnit2024
GHG EmissionScope
SourceUsage Phase
Natural GasDieselGasoline
Boilers and cafeteriaMainly used for diesel generators and transport vehiclesPassenger vehiclesScope 1
Purchased Electricity
Steam
Production departments, auxiliary departments, and non-pro-duction departmentsProcess equipment and air conditioning
Scope 2
Direct GreenhouseGas EmissionsIndirect GreenhouseGas EmissionsTotal GHG Emissions(Scope 1 & Scope 2)Greenhouse Gas Emission per Unit Revenue
tCO2etCO2etCO2etCO2e/10,000 yuan of revenue
19,829.6586,228.19106,057.84
0.40
IndicatorUnit2024
2024 Environmental, Social and Governance (ESG) Report
6364
The Company actively implements targeted and effective energy-saving measures to reduce energy consumption, achievingboth economic and environmental benefits.
Climate ActionTechnological Upgrades
EntityProject NameOperation Status and Results
The air conditioning hot water system operates at different temperaturesin summer and winter. In summer, the supply temperature is lowered toreduce the temperature difference with the environment, minimizingunnecessary heat loss and reducing operating costs. This saves approxi-mately 18.26 tce/year, generating RMB 150,000 in economic benefitsannually.Two air compressors at 2B Power Station were replaced to improve equip-ment efficiency and reduce operational costs. This saves approximately
9.73 tce/year, generating RMB 80,000 in economic benefits annually.
The air conditioning hot water units were modified to include a conden-sate recovery device indoors instead of direct discharge, thereby enhanc-ing waste heat utilization.
Hot Water System Temperat-ure Adjustment ProjectAir Compressor ReplacementProject
BioMinhai
Waste Heat Utilization ProjectDigital Management
BioKangtai has established a regular reporting mechanism for energy usage, with monthly reports on natural gas and electric-ity consumption. Departments are required to develop and implement energy control plans to strengthen energy manage-ment. BioMinhai has implemented a Smart Building Energy Management System, enabling automatic generation of energyreports and statistical analysis. This system supports functions such as energy diagnostics and monitoring, enhancing bothenergy efficiency and the Company’s capacity for refined energy management.
Smart Management System
BioKangtai and its subsidiary BioMinhai have actively addressed climate change through carbon trading and the purchase ofgreen electricity, laying a solid foundation for sustainable development and green transformation. In 2024, BioKangtai fulfilledits compliance obligations by purchasing 328 tonnes of carbon emission quotas and procuring 7,580 MWh of green electricity,thereby reducing 2,932.70 tonnes of CO? emissions. BioMinhai purchased 12,364.8 MWh of green electricity through electrici-ty market transactions, achieving a CO? emissions reduction of 8,378.39 tonnes, effectively contributing to energy structureoptimization and emission reduction goals. Moreover, BioMinhai has signed a multi-year interprovincial bilateral agreementfor green electricity trading for 2025–2027, which will secure a stable supply of electricity with green attributes at fixed pricesthroughout the contract period—further advancing the Company’s sustainable development objectives.Note: CO? emission reduction data are calculated based on the regional average power grid CO? emission factorpublished in the Ministry of Ecology and Environment’s 2022 Carbon Emission Factors for Electricity.
Using Clean Energy
The Company’s water supply is sourced from the municipal water system. Water is not a primary resource consumed duringproduction processes, and the risk of water scarcity remains low. In addition, the facility is equipped with production watertanks and greywater storage tanks to mitigate short-term water shortage emergencies. BioMinhai implements multiplewater-saving initiatives, including the establishment of rainwater reuse systems, greywater recycling systems, and advancedpurified water preparation systems. It also utilizes water-saving sanitary fixtures and recovers boiler steam condensate toreduce water consumption. As of the end of the reporting period, BioMinhai had been recognized as a Water-Saving Enter-prise of Beijing.
Water Resource Management
Water Consumption (Municipal)Water Consumption per Unit Revenue
m3m?/10,000 yuan
1,297,970
4.89
IndicatorUnit2024
2024 Environmental, Social and Governance (ESG) Report
Uniting Hearts and Efforts for Buildinga Warm and Inclusive Workplace
6566
People-Oriented Approach for Protection of Employees’ Rights and Interests 66Safe Production for Safeguarding Employee Health 72
The Company upholds the core value of “dedication to people’s health”, and strictly complies with relevant laws and regula-tions such as the Labor Law and the Labor Contract Law. A comprehensive suite of human resource management systemshas been established covering recruitment, development, promotion, benefits, and employee rights protection, aiming tofoster a harmonious and stable labor relationship. The Company firmly prohibits all forms of child labor and forced labor,and is committed to creating a workplace environment that is equal, inclusive, democratic, and harmonious, thereby cultivat-ing a positive and healthy corporate culture for all employees.
The Company has established a series of internal regulations, including the Labor Contract Management Measures andRecruitment Management Measures, to continuously optimize the employee hiring and management system, ensuringcompliance in recruitment and employment practices while fully protecting employee rights.Adopting a talent attraction strategy based on “career appeal, compensation appeal, development appeal, and culturalappeal”, the Company places great emphasis on cooperation with research institutions and universities. It recruits outstand-ing talent through multiple channels, including online recruitment, headhunting services, campus recruitment, internalrecommendations, and on-site recruitment events. The Company also offers positions for veterans and disabled individuals.
Labor Management
People-Oriented Approach for Protection ofEmployees’ Rights and Interests
During the reporting period, the Company hired
new employees, including
female employ-ees and
male employees;
employees left, with an employee turnover rate of
7.52
%.As of the end of the reporting period, the Company employed a total of1,913employees, including
disabled employees and
employees from minority ethnic groups;
% of labor contractswere signed.
[Key Performance Indicators]
2024 Environmental, Social and Governance (ESG) Report
The company advocates the values of labor governance featuring diversity, equality, and inclusion. Upholding the principleof equal pay for equal work, it adheres to the orientation of job requirements, ensuring that there is no discrimination of anyform in terms of gender, age, cultural and educational background, race, religious belief, etc. It fully respects and acceptsindividual differences. To further clarify this commitment, the company has issued the "Public Statement on Employee Diver-sity Initiatives," firmly believing that the diversity of employees is a key force driving continuous innovation and achievinghigh-quality development. In order to create a more inclusive work environment, the company actively promotes respect fordiverse cultures and values, and facilitates understanding and trust among employees. At the same time, the company hasestablished a dedicated reporting channel to effectively prevent and address inappropriate behaviors such as discrimination,harassment, and bullying, and earnestly safeguard the legitimate rights and interests of employees.
1,160
Number ofEmployees
(by Age)
1,192
Number ofEmployees(by Gender)
1,060
Number ofEmployees(byAcademicQualification)
FemaleMale
Doctoral DegreeMaster’s Degree
Bachelor’s DegreeBelow Bachelor’sDegree30 to 50 years old<30years old> 50 years old
6768
The Company fully respects employees’ right to freely associate and actively safeguards their rights to information, supervi-sion, and participation. The Company has established a labor union responsible for organizing the employee congress. Itsupports employees in exercising their democratic rights in accordance with the law, represents employees in seeking legiti-mate and lawful rights and interests, with a focus on protecting the rights of female employees, disabled employees, andother groups. This promotes the continuous optimization of internal information flow and democratic management. Theproportion of union members among active employees is 87.5%. During the reporting period, BioKangtai conducted anemployee satisfaction survey, with a result of 80.95%.
Democratic Governance
The Company formulates the Compensation Management Measures in alignment with its business strategy, implementinga compensation policy that combines position and individual capabilities. Adhering to the principle of “efficiency first,fairness considered, and distribution based on labor”, the Company continuously improves its compensation system toenhance the core competitiveness of its human resources. The structure of employee compensation consists of basic salary,position salary, confidentiality allowance, performance bonus, subsidies (allowances), welfare expenses, and special wages.Employee compensation is closely linked to daily work performance. Based on individual performance assessments andannual reviews, employees are evaluated for their job levels and salary adjustments, resulting in a reasonable salary ladderdistribution that motivates employees’ enthusiasm and creativity, providing high-quality human capital for the Company’ssustainable development.
Compensation and Benefits
Employee Compensation
The Company has established systems such as the Compensation Management Measures, Performance ManagementSystem, and Compensation Calculation Guidelines to standardize the compensation assessment and feedback processes.These systems follow the PDCA (Plan-Do-Check-Act) cycle, with a primary focus on quantitative performance evaluation andsupplementary qualitative assessments. The Company continuously improves the compensation and performance systembased on job value and individual capabilities, strengthening the connection between employee income levels and the Com-pany’s business performance. Upholding the principle of two-way communication, the Company addresses issues employ-ees may encounter in achieving performance targets and provides necessary assistance, continually enhancing employeework performance and job satisfaction. Department supervisors evaluate employee performance through performanceappraisal forms. If employees have any doubts about the results, they can contact their supervisors to provide feedback orfile an appeal.
Performance Appeals and Feedback
PerformanceImprovementPerformance Management
Performance Plan
PerformanceImplementation
PerformanceEvaluation
The Company has established systems such as the Compensation and Benefits Management System, Benefits Manage-ment Measures, and Five Social Insurances and One Housing Fund Management Measures to continuously improve itsbenefits system.
Employee Benefits
Pension insurance,medical insurance,work-related injuryinsurance, unem-ployment insurance,maternity insurance,
and housing provi-
dent fund
Seniority subsidy,educational subsidy,housing subsidy,overtime pay, mealsubsidy, high-tem-perature/heatingsubsidy, night shiftallowance, etc.
InternationalWomen’s Daygifts, birthdaygifts, holiday
allowances
Annual HealthCheck-up
Paid leave, sick
leave, workinjury leave,
maternityleave, etc.
StatutoryBenefits
Subsidized
Benefits
FestiveBenefits
HealthWelfare
VacationBenefits
2024 Environmental, Social and Governance (ESG) Report
Training CategoriesContent
New employees must undergo orientation training after their probation period. Onlythose who pass the training are allowed to begin working.Based on the knowledge/skills required for each position and career developmentcharacteristics, various departments focus on developing and enhancing professionalskills.According to the Company’s human resources development needs, the HR departmentmanages the management pipeline in a tiered and classified manner, developing andimplementing personalized development plans.
New Employee TrainingProfessional Technical TrainingManagement Training(Succession Planning)
In accordance with the External Training and Assignment Management Measures, theHR department plans and arranges for management and technical personnel to partici-pate in external training, academic exchanges, site visits, or invites senior experts andprofessional trainers to conduct specialized training at the Company.External Training andAssignments
The Company attaches great importance to talent cultivation and development. Based on the Company’s strategy andthe needs of its talent pipeline, the Company has formulated the Training and Development System and annual trainingplans. It has established a talent development platform and training system to continuously enhance employees’ vision,professional competence, and to reinforce professional ethics, ensuring the talent support necessary for the Company’sstrategic goals and sustainable development. During the reporting period, the Company invested 1.0709 million yuan inemployee training.
Training and DevelopmentEmployee Training
The Company attaches great importance to employees’ career development and has formulated the Promotion Manage-ment Guidelines. It adopts a graded management strategy combining trials, evaluations, and appointments, and hasestablished three career development paths: the “Management Sequence”, “Professional Sequence”, and “ResearchSequence”. These paths provide employees with diversified growth opportunities, allowing them to define their careerdevelopment based on their strengths and characteristics, and facilitating the efficient alignment of talent with positions.During the reporting period, 387 employees were internally transferred, accounting for 18.42% of the total workforce.
Employee Development
DepartmentClassification
ChannelClassification
Career Development Pathways
FunctionalDepartmentPromotion
R&D CenterPromotion
Suitable for positions involving management work withpersonnel management authority (excluding mentor-ing relationships and business coaching roles), leadingteams to operate designated business areas.
Suitable for positions involving management workwith personnel management authority, leadingteams to operate designated business areas.Suitable for positions in R&D, including quality, regis-tration, clinical, pilot scale-up, and process optimiza-tion roles.Suitable for positions in R&D, including qualityresearch, process research,clinical and non-clinicalprotocol design, etc.
ManagementSequence
Suitable for positions in administration, finance, quali-ty, equipment, engineering, procurement, auditing,human resources, information technology, etc.ProfessionalTechnicalSequence
Management
SequenceProfessional
Technical
Sequence
Research
Sequence
BioKangtai encourages employees to pursue continuing education and self-improvement in accordance with the BenefitsManagement Measures. Employees who obtain professional certificates relevant to their positions through self-study exams,online education, professional qualification exams, title examinations, or various training programs organized by externalorganizations will receive various types of support measures from the Company, depending on the situation.
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2024 Environmental, Social and Governance (ESG) Report
The Company shows care for employees who are hospitalized due to illness, offers condolences to the families of deceasedcolleagues, and proactively applies for hardship subsidies for employees suffering from serious illnesses. BioKangtai hasestablished the Kangxin Fund specifically to support employees in need.
Employee CareSupport for Employees in Difficulty
The Company is committed to supporting the development of female employ-ees by providing equal employment opportunities. On International Women’sDay, the Company organizes themed activities to show appreciation andenhance the sense of belonging among female employees. During the report-ing period, women accounted for 29.41% of the Company’s management; 50employees took maternity leave, with a 100% return-to-work rate; and 130employees took parental leave, also with a 100% return-to-work rate.
Caring for Female Employees
Safety Production Management System
ISO 45001 Occupational Health and Safety Management System Certification
The Company adheres to the principle of “safety first, with a focus on prevention”, and strictly complies with relevant lawsand regulations such as the Law of the People’s Republic of China on Work Safety and the Law of the People’s Republic ofChina on Prevention and Control of Occupational Diseases. A comprehensive occupational health and safety managementsystem has been established to create a healthy and safe working environment for employees. During the reporting period,the Company did not experience any major safety incidents.
The Company has established an internal safety production management system in accordance with policies such as theIndustrial Safety Management Procedures, EHS System Policy, Objectives and Management Plan, EHS Job Responsibilities,and Hazardous Chemical Management System. The Company designates the principal executive as the first personresponsible for work safety, who provides overall leadership for safety management. The Safety Director assists in oversee-ing safety operations, while all departments collaborate to minimize or control risks in the production process, preventaccidents, and reinforce the safety defense line. As of the end of the reporting period, BioKangtai and BioMinhai hadobtained ISO 45001 Occupational Health and Safety Management System certification.The Company strictly enforces the work safety accountabilitysystem by organizing all employees to sign safety responsibili-ty agreements annually, ensuring that every employee clearlyunderstands their respective safety duties. Each year, theCompany formulates an annual safety management plan,setting clear safety goals and indicators for each department.Departmental audits are conducted through managementreviews to reinforce safety management at all levels. Inaddition, the Company actively promotes a culture of safetyby organizing safety knowledge competitions, Safety Consul-tation Day events, and safety education and training sessionsto continuously enhance employees’ awareness of worksafety.
Safety Production Management
Safe Production for SafeguardingEmployee Health
7172
The Company actively organizes a variety of employee activities to foster a vibrant corporate culture. Activities are plannedaround traditional festivals to create a festive atmosphere. Basketball games and parent-child events are held to enhanceteam cohesion and unity. Departmental team-building activities are promoted to strengthen collaboration, and scienceknowledge quizzes are organized to improve overall literacy.
Employee Activities
Team Building Activities
Team-Building ActivitiesBasketball Matches
Mid-Autumn Festival Events
Women's Day Flower Arranging Activity
2024 Environmental, Social and Governance (ESG) Report
During the 23rd National “Work Safety Month”, the Company hosted the 2024 “Ankang Cup” Safety Knowledgeand Skills Competition to foster a strong atmosphere aligned with the theme “Everyone Talks Safety, EveryoneKnows Emergency Response — Ensuring Unobstructed Life Channels”. The competition comprised both atheoretical quiz and hands-on practical challenges, featuring rich content with a strong focus on assessingsafety skills. Multiple teams competed intensely, and various awards were presented. After the event, safetymanuals were distributed to safety officers. This competition injected new vitality into the Company’s safetyculture, strengthened the foundation of its safety management efforts, and further promoted the ongoingdevelopment of a robust safety culture to support the Company’s sustainable and healthy growth.
Organizing the “Ankang Cup” Knowledge Competition
“Ankang Cup” Knowledge Competition
Hazard Identification and Risk Assessment Management Procedure
Safety Production Risk Management
Risk Identification and Assessment
The Company has established standardized procedures for hazard identification, control, and hidden danger investiga-tion based on the Hazard Identification and Risk Assessment Management Procedure and the Industrial Safety Manage-ment Procedure. A dedicated Hazard Identification and Risk Assessment Team has been established to identify, evaluate,and implement tiered control of risks. For each identified hazard, the team assesses the likelihood of occurrence,frequency of exposure, and severity of potential consequences, and formulates corresponding risk control measuresaccording to the classification level.
Identification ofHazard Sources
Classification: Physical hazards, chemical hazards, biological hazards, psychological orphysiological hazards, behavioral hazards, etc.Methods: Basic Analysis Method, Job Safety Analysis (JSA), Preliminary Hazard Analysis(PHA), Event Tree Analysis (ETA)Make a Comprehensive Hazard List
Risk Evaluation
The Company applies the LEC method to assess risks: L (Likelihood): the probability of anaccident occurring; E (Exposure): the frequency of exposure to the hazardous environment;C (Consequence): the severity of potential consequencesHazardous sources are classified into five risk levels, with Level 1 identified as a majorhazard sourceRisk Classificationand Control
Hazards are classified into major hazards and general hazardsBased on the classification level, different control measures are implemented, includingtargeted management programs, operational controls, emergency response plans, moni-toring and surveillance, and training programs. These measures ensure that operationalprocesses and risk control capabilities are aligned with the level of risk.Record Management
EHS-2-KT-9-F-01 Hazard Identification and Risk Assessment FormEHS-2-KT-9-F-02 Major Hazard Source Inventory
Hazard Identification
The Company has established a regular safety hazard identification mechanism based on the EHS-3-KT-S-02 EHSHazard Identification and Rectification System, organizing personnel to conduct comprehensive hazard inspectionsperiodically. Safety hazards and issues identified are registered, and a rectification tracking system is established.
The Company relies on its safety production management system and, in combination with its main risks, implementscontrol measures for special equipment, biosafety, and other areas, effectively reducing the occurrence of safetyaccidents caused by critical hazard points.
During the reporting period, the Company organized
special safety inspections, with additional inspectionsincluding construction inspections, holiday inspections, departmental self-inspections, fire safety inspections, androutine inspections.
[Key Performance Indicators]
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2024 Environmental, Social and Governance (ESG) Report
Emergency Plans and DrillsThe Company has developed the Safety Production Emergency Preparedness and Response Control Procedure, and hasprepared corresponding comprehensive plans, special plans, and on-site disposal plans based on the severity of produc-tion accidents to effectively respond to potential emergencies. The Company conducts comprehensive plan drills andspecial plan drills annually, and each department performs an on-site disposal plan drill once a year to enhance employ-ees’ emergency response and self-rescue capabilities, thereby effectively reducing accident losses and casualties duringincidents. Additionally, the Company continuously improves the plans based on drill outcomes to ensure their practicalityand relevance. During the reporting period, the Company carried out 58 emergency drills.
Key StageSpecific Actions
The Company implements full-process management of special equipmentthrough measures such as equipment declaration and certification, informationverification, establishing records, training operators to prevent unlicensed opera-tions, conducting regular inspections, and performing routine maintenancechecks and handling of abnormalities.Special Equipment Management
Identifying the characteristics of pathogenic microorganisms, risks associatedwith production processes, and product inspections.Considering legal and regulatory requirements, implementation costs, andexpected outcomes, and selecting individual or combined measures whilebalancing stakeholder interests and preferences for measures.Biosafety Management
In accordance with the requirements of the ISO 45001Occupational Health and Safety Management System,the Company has established a comprehensive occupa-tional health and safety management system by devel-oping policies such as the Occupational Health Manage-ment Procedure and the Labor Protection EquipmentManagement System. The EHS Committee is responsi-ble for approving the goals of occupational health andoccupational disease prevention work and the plans toachieve these goals, as well as regularly supervising andinspecting the implementation of these plans. The EHSOffice is tasked with carrying out specific activities andis equipped with personnel responsible for occupationalhealth management.
Occupational Health Management
Visit to the “National Professional Technical TalentTraining Base for Occupational Disease Prevention
and Control”
Collaborative Development for Promoting Accessibility to Healthcare /77Giving Back to Society and Fulfilling Corporate Responsibility /80
Staying True to Our Mission andJoining Hands to Create a Better Future
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2024 Environmental, Social and Governance (ESG) Report
Expanding Product Coverage and Geographic Reach
While deepening its presence in the domestic market, the Company actively broadens its international perspective, expand-ing its overseas operations to enhance global health and well-being. The Company signed a licensing and technology trans-fer agreement for the Dual-Carrier 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine with its partner in Indonesia,and has already begun the technical transfer work, including the vaccine’s verification and repackaging. This represents akey aspect of the Company’s internationalization strategy, highlighting the important steps it has taken in the global healthsector.Currently, the Company has reached cooperation agreements with partners in countries such as Indonesia, Pakistan, Bangla-desh, Colombia, Egypt, and India for the registration, promotion, commercialization, and technology transfer of productsincluding the 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine, 23-Valent Pneumococcal Polysaccharide Vaccine,Inactivated Poliomyelitis Vaccine, acellular DTaP-Hib Combined Vaccine (quadruple vaccine), and other products in overseasmarkets. Together, we are building a health barrier.
Enhancing Public Health CapacityBioKangtai continues to promote vaccine awareness and donation programs. Through various forms of health educationactivities, the Company aims to educate the public on vaccine knowledge and the importance of vaccination, thereby raisingpublic health awareness. At the same time, the Company actively donates vaccines to regions in need, contributing to thebalanced development of healthcare resources.
Collaborative Development for Promot-ing Accessibility to Healthcare
In November 2024, the launch meeting of the Egyptian VaccineManufacturers Alliance (EVMA) was successfully held in Cairo.During the meeting, BioKangtai, in collaboration with Egypt’sGennvax company, signed a technology transfer agreement forthe 13-Valent Pneumococcal Polysaccharide Conjugate Vaccineand the DTaP-Hib-sIPV pentavalent vaccine. This collaborationaims to promote the technology transfer of the “dual-vector”13-valent pneumococcal vaccine and pentavalent vaccine,independently developed by BioMinhai, to Egypt. The initiativewill contribute to Egypt’s local vaccine production capacity andfurther empower the construction of the African vaccine industrychain, fostering regional collaborative development and benefit-ing the health of more people.
Signing of Technology Transfer Agreement for 13-Valent PneumococcalPolysaccharide Conjugate Vaccine and DTaP-Hib-sIPV Pentavalent Vaccinewith Egyptian Vaccine Manufacturer
Signing of Agreement with theEgyptian Vaccine Manufacturer
BioKangtai, in collaboration with the Chinese Preventive Medicine Association, has established a leading domestic vaccinescience popularization base with a clear theme and authoritative expertise. This initiative integrates vaccine educationresources, leverages professional advantages, promotes academic exchanges, and disseminates vaccine technology andknowledge to deepen the public’s scientific understanding of vaccines, ensuring the healthy development of China’s immu-nization program. In addition, on global health days such as World Immunization Week, World Pneumonia Day, and WorldCancer Day, the Company actively undertakes the responsibility of spreading health knowledge. Utilizing the advantages ofnew media platforms, the Company publishes educational articles on public platforms, presenting complex health knowl-edge in a simple, easy-to-understand way through engaging text and images. Furthermore, the Company produces a seriesof animated videos, Kangkang’s Adventure, which cleverly incorporate health knowledge into entertaining stories, using afun and educational approach to contribute to the protection of public health.
Conducting Health Education
Vaccination is the most economical and effective measure for the prevention and control of infectious diseases. Upholdingthe corporate purpose of “produce the best vaccines to benefit mankind”, the Company remains dedicated to the research,development, and production of high-quality vaccines, contributing to global immunization efforts. To date, the Companyhas received marketing approval or emergency use authorization for 11 products. Among them, more than 1 billion dosesof the hepatitis B vaccine alone have been produced and sold, protecting over 400 million people from hepatitis B virusinfection. While ensuring steady growth in its core business, the Company also leverages its industrial strengths to donatevaccines and support the development of public health. During the reporting period, the Company donated hepatitis Bvaccines (Saccharomyces cerevisiae) to Guangdong, Hainan, Anhui, Shandong, and Guizhou provinces; 13-Valent Pneumo-coccal Polysaccharide Conjugate Vaccines to Guangdong, Hunan, Hainan, and Jiangxi provinces; 23-Valent PneumococcalPolysaccharide Vaccines to Jiangxi and Sichuan provinces; and DTaP-Hib Combined Vaccines to Hainan Province, support-ing the immunization of relevant populations.
Vaccine Donation
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2024 Environmental, Social and Governance (ESG) Report
Enhancing Product AffordabilityBioKangtai remains committed to its purpose of “produce the best vaccines to benefit mankind” and strictly adheres tothe relevant provisions of the Vaccine Administration Law of the People’s Republic of China. While fully consideringproduction costs—including raw and auxiliary materials, labor, logistics, and R&D—alongside current market conditions,the Company sets vaccine prices in a scientific and reasonable manner. Through these efforts, BioKangtai strives toprovide the public with reasonably priced vaccines, ensuring broad access to safe, effective, and high-quality productsat affordable prices.The Company’s product portfolio includes both National Immunization Program (NIP) vaccines and non-NIP vaccines.NIP vaccines are centrally procured through public bidding or unified negotiation organized by the National Health Com-mission in conjunction with the Ministry of Finance and other relevant departments. The resulting bid-winning or negoti-ated prices are publicly announced, and provinces, autonomous regions, and municipalities directly under the centralgovernment implement unified procurement based on these prices. For other local immunization program vaccines thatfall outside the national scope, procurement is carried out through local centralized bidding or negotiation, with bidprices similarly published and procurement organized at the local level. For non-NIP vaccines, procurement is conduct-ed by provincial-level public resource trading platforms. After a vaccine is granted provincial-level market accessthrough bidding, individual districts and counties place orders via the respective provincial platforms. The Company thensigns contracts with each district or county and delivers the vaccine products to local disease prevention and controlagencies or similar institutions.In developing countries, the Company formulates regionally appropriate pricing strategies based on local policies andactual conditions. In certain areas where vaccines are included in national immunization schedules, the Company takesinternational procurement prices into account when setting local prices. This approach helps ensure the accessibilityand affordability of vaccines, contributing to improved population immunity and better meeting the public health needsof local communities.
Giving Back to Society and FulfillingCorporate ResponsibilityThe Company actively participates in public welfare initiatives and has established the External Donation ManagementPolicy to standardize its donation practices, strengthen oversight of donation-related activities, and better fulfill its corpo-rate social responsibilities. This framework also supports comprehensive and effective promotion of the Company’sbrand and corporate image. Since 2022, BioKangtai has donated more than RMB 100 million in cash and goods tovarious sectors of society, including underprivileged regions, Red Cross organizations at all levels, and research institu-tions. These contributions have played a significant role in strengthening public immunization efforts, supporting health-care development, and advancing rural revitalization initiatives.Supporting EducationThe Company contributes to the development of education by establishing scholarships at universities. In November2021, BioKangtai donated RMB 500,000 to Huizhou University (to be distributed over five years) to support the establish-ment of the “BioKangtai” Student Aid and Teaching Excellence Fund. During the reporting period, the Company donatedRMB 100,000 to Huizhou University under this initiative.Contributing to Rural RevitalizationIn response to the national call for rural revitalization, the Company supports poverty alleviation and rural developmentthrough charitable donations and related initiatives, aiming to improve living conditions in underdeveloped regions.During the reporting period, the Company donated RMB 1 million to the Ji’an Red Cross Foundation, designated forsupporting the red tourism and cultural initiatives of Jinggangshan through Ji’an Xinrong Culture and Film Co., Ltd. Addi-tionally, the Company donated RMB 900,000 to Shenzhen Guangming District People’s Hospital to support its medicalassistance programs, which aim to improve the health conditions of impoverished patients and alleviate the burden ontheir families.Supporting the Healthcare SectorWhile pursuing its own development, BioKangtai actively supports medical research and the cultivation of talent in publichealth and health sciences. The Company collaborates with foundations, universities, and research institutes to createshared value for the industry and society.In 2024, BioKangtai plans to donate RMB 10.366 million (to be distributed over three years) to the China Foundation forHepatitis Prevention and Control to support its “Protection Program for Family Members of Hepatitis B Carriers”, contrib-uting to hepatitis B prevention and control efforts.
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2024 Environmental, Social and Governance (ESG) Report
Driving Sustainable Development through Technological Innovation and Building a High-Quality Vaccine PortfolioThe Company will continue to increase R&D investment and enhance its independent innovation capabilities. Focusing onresearch and development in novel vaccines, multivalent combination vaccines, and innovative vaccines, the Companyaims to promote the sustainable innovation of its vaccine products. By establishing a product pipeline that spans theentire lifecycle, the Company is committed to addressing global public health needs, improving vaccine accessibility, andcontributing to the well-being of people worldwide.Accelerating Internationalization and Promoting Global Health Equity
The Company is actively advancing its internationalization strategy. Leveraging its robust portfolio of commercialized andpipeline products, along with world-class expertise in R&D, quality control systems, and industrialization manufacture, itis expediting access to overseas markets and progressing toward WHO prequalification (PQ). The Company is focused onexpanding its presence in Southeast Asia, South Asia, Africa, the Middle East, Latin America, and other Belt and Roadregions to promote equitable access to vaccines globally. Additionally, the Company is strengthening partnerships withleading global vaccine enterprises to foster the high-quality development of the global vaccine industry and contributeto international health security.
Deepening Market Presence and Enhancing Brand Social Influence
Guided by public health needs, the Company will further optimize its market and sales network to improve the marketcoverage and penetration of its core products. Through brand building, science communication, and digital promotion,the Company aims to raise public awareness of vaccines, increase vaccination rates, and support disease preventionefforts, thereby continuously enhancing the social value of its brand.
Building an Intelligent Operations System to Improve Resource Utilization Efficiency
The Company will continue to advance its intelligent R&D system, accelerating the development of novel vaccines andleveraging technological innovation to shorten R&D cycles and reduce resource consumption. Smart manufacturing willbe employed to optimize production processes, enhance efficiency, and improve quality management. Supported by adigital management system, the Company will utilize big data to analyze market demand, enabling data-driven decisionsfor precise supply chain management, optimized inventory allocation, and reduced resource waste and operational risks.By implementing end-to-end intelligent operations, the Company will boost overall efficiency and promote sustainable,green development in the industry.Upholding Compliance and Practicing ESG for Sustainable DevelopmentThe Company remains committed to the core principle of “quality first, compliant operations”, strictly adhering to domes-tic and international Good Manufacturing Practices (GMP) for vaccines and reinforcing a comprehensive quality manage-ment system. Actively fulfilling its social responsibilities, the Company strengthens ESG management by promoting greenmanufacturing, energy conservation, emissions reduction, and optimized supply chain management to reduce its carbonfootprint and support the development of a low-carbon economy. Dedicated to building a sustainable business model,the Company strives to safeguard global public health while creating long-term social value and achieving balanceddevelopment across economic, environmental, and social dimensions.
Future Outlook
IndicatorOperating IncomeNet ProfitTotal AssetsShareholders’ EquityVarious Taxes and FeesBasic Earnings per Share
UnitMillion YuanMillion YuanMillion YuanMillion YuanMillion Yuan
RMB
2024
2,651.72
201.55
14,563.719,661.03
122.50
0.18
ESG Performance Overview
Appendix
Economic Performance
Social Performance
Protection of Employees’ Rights and Interests
Employee Diversity and Equal Opportunity
Number of Employees (by Gender)
Number of Employees (by Age)
Indicato
Percentage of Contract WorkersSocial Insurance Coverage RatePer Capita Paid Annual Vacation DaysTotal Number of EmployeesNumber of Employees with DisabilitiesNumber of Employees of Minority Nationalities
Unit%%DaysPersonPersonPerson
2024
1,913
FemaleMale> 50 years old30 to 50 years old< 30 years old
PersonPersonPersonPersonPerson
1,192
1,160
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2024 Environmental, Social and Governance (ESG) Report
Environmental Performance
Environmental Compliance Management
Energy Utilization
Indicato
Environmental InvestmentNumber of Environmental Training Sessions ConductedNumber of Penalties for Violations of Environmental Laws
and Regulations
Unit
Million Yuan
TimesCase
2024
3.8388
Total Purchased ElectricityTotal Natural Gas Consumption
Total Heat Consumption
Diesel ConsumptionGasoline Consumption
kWh10,000 m3GJtonton
96,606,866
889.86
227,379.62
124.42
37.54
Greenhouse Gas (GHG) EmissionsTotal GHG EmissionsScope 1 Greenhouse Gas EmissionsScope 2 Greenhouse Gas EmissionsGreenhouse Gas Emissions per Unit Revenue
tCO2etCO2etCO2etCO2e /10,000 yuan
106,057.8419,829.6586,228.19
0.40
Water Resource Utilization
Water Consumption (Municipal)Water Consumption per Unit Revenue
m3Cubic meters/10,000 Yuan
1,297,970
4.89
Emission ManagementsTotal Waste Gas EmissionsTotal Volatile Organic CompoundsWaste Gas Emissions per Unit Revenue
Total Industrial Wastewater DischargeAmmonia Nitrogen EmissionsChemical Oxygen Demand (COD)
Total NitrogenTotal PhosphorusIndustrial Wastewater Discharge per Unit Revenue
m3tonCubic meters/10,000 Yuan
m3tontontontonCubic meters/10,000 Yuan
251,816,447
0.52
949.63
1,075,107.08
3.05
27.24
0.19
0.04
4.05
8384
Number of Employees (by Academic Qualification)
Protection of the Rights and Interests of Female Employees
Indicato
Doctoral DegreeMaster’s DegreeBachelor’s DegreeCollege Degree or BelowProportion of Female ManagersNumber of Employees on Maternity LeaveReturn Rate from Maternity LeaveNumber of Employees Who Took Parental Leave
Return Rate from Parental Leave
UnitPersonPersonPersonPerson%Person%Person%
2024
1,060
29.41
R&D and InnovationInvestment in R&DPercentage of R&D Investment in Operating Income
Total R&D Team MembersProportion of R&D Personnel to Total Employees
Million Yuan%Person%
Million Yuan%Person%
569.22
21.47
18.92
Community InvestmentCommunity Public Welfare Investment
Including: Medical and Health Field
Including: Education AssistanceIncluding: Charitable Donations
Million YuanMillion YuanMillion YuanMillion Yuan
8.4973
4.3973
2.20
1.90
Product ResponsibilityNumber of Quality Trainings Conducted
Number of Quality TrainingTotal Hours of Quality Training
Product Recall
TimesPersonHourscase
7,936150,382
11.536
Employee TrainingEmployee DevelopmentInvestment in Employee TrainingNumber of Employees Having SuccessfullyTransitioned or Applied Internally
1.0709
18.42
Proportion of Internal Transfers or Applications by Employees
2024 Environmental, Social and Governance (ESG) Report
Emission ManagementIndicatoTotal Hazardous Waste GeneratedHazardous Waste Generation per Unit Revenue
Total General Waste GeneratedGeneral Waste Generation per Unit Revenue
Unit
tonkg/10,000 yuan
tonkg/10,000 yuan
2024
231.63
0.87
142.79
0.54
Indexes
2-1/2-62-14/2-16/2-29/3-1/3-2/3-3
P3.1/P3.3/P3.4G1.1.1/G1.1.2/G1.1.6/G1.1.8
/G1.1.11/G1.3.1/G1.3.2
Chapters and
Sections
Article 4Article 6About BioKangtaiSustainable Development
Governance
CompliantOperationsfor Stableand Long-Term Dev-elopment
InnovationLeadingandCreatingExcellencein SafeVaccines
StandardizedCorporateGovernancefor EfficientOperations
2-9/2-10/2-11/2-12/2-13/2-1
8/2-19/2-20/2-27/
201-1/405-12-16/2-27
//
//
Sustainability ReportingStandards of GlobalSustainability StandardsBoard (GRI Standards)
Guide to CorporateSustainability Reporting inChina (CASS-ESG6.0)
Self-Regulatory Guidelinesfor Listed Companies No. 17- Sustainability Report (forTrial Implementation)
Article 5 Article 9 Article 11Article 12 Article 53
Investor RelationsManagement forSafeguardingShareholderInterests
207-2//Risk Preventionand Control forStrengtheningthe ComplianceFoundation
2-23/2-24/2-27/205-1
G2.1.1/G2.1.2/G2.1.3/G2.1.4/G2.2
.1/G2.2.2
Article 55Article 56/
S2.1.1/S2.1.2/S2.1.3/S2.1.4/S2.1.5/S2.1.6/S2.1.7/S2.1.8/S2.1.10/S2.1.11/S2.1.12/S2.1.13
Article 42416-1/416-2
S3.3.1/S3.3.2/S3.3.3/S3.3.4/S3.
3.5/S3.3.6
Article 47
Integrity as theFoundation and
Adhering toBusiness EthicsInnovation-Drivenfor SupportingIndustryDevelopmentQuality Control forStrengtheningProduct Safety
/S3.1.1/S3.1.2/S3.1.3Article 452-27S3.4.1/S3.4.2/S3.4.3Article 48
Win-Win Coopera-tion for a Sustain-able Supply Chain
InformationProtection forStrengtheningData Security
About this Report
2-1/2-2/2-3P1
/
303-1/303-4/306-1/306-2/306-3/306-4/306-5
E2.1.1/E2.1.6/E2.2.1/E2.2.3/E2.2.5/E2.2.6
Article 29Article 30Article 31EnvironmentalCompliance forStrengtheningPollutionPrevention andControGreen andLow-Car-bonDevelop-ment forBuilding aBeautifulEcologicalHomeTogetherUnitingHearts andEfforts forBuilding aWarm andInclusiveWorkplaceStayingTrue toOurMissionandJoiningHands toCreate aBetterFuture
Appendix
Future Outlook
201-2/302-1/303-1
E1.1.1/E1.1.2/E1.1.3/E1.1.4/E1.1.6/E1.1.7/E1.1.8/E3.1.4/E3.2/E3.3.2
Article 21 Article 22 Article23 Article 24 Article 35Article 36 Article 37201-1/401-1/401-2/401-3/405-1/406-1/408-1/409-1
S4.1.1/S4.1.3/S4.1.4/S4.1.11/S4.1.12
Article 49Article 50
Low Carbon andEnergyConservation forAddressingClimate ChangePeople-OrientedApproach forProtection ofEmployees’Rights andInterests
403-1/403-2/403-3/403-5/403-6/403-7
S4.2.1/S4.2.2/S4.2.3/S4.2.4/S4.2.6
Article 50Safe Productionfor Safeguard-ing Employee
Health
413-1/413-2/415-1S1.2.1/S1.2.2Article 402-22A1//A2Article 6
Giving Back to
Society and
FulfillingCorporateResponsibility
ESG Perfor-
mance
Overview
/A3Article 57Indexes
CollaborativeDevelopmentfor PromotingAccessibility to
Healthcare
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Chapters andSections
Sustainability Reporting
Standards of GlobalSustainability StandardsBoard (GRI Standards)
Guide to CorporateSustainability Reporting in
China (CASS-ESG6.0)
Self-Regulatory Guidelinesfor Listed Companies No. 17
- Sustainability Report (for
Trial Implementation)
2024 Environmental, Social and Governance (ESG) Report