Reporting PrinciplesIt follows the reporting principles, including:
Basis of the ReportThe report has been compiled in accordance with the Guidelines on the Content and Format of Information Disclosure by CompaniesPublicly Issuing Securities No. 2 - Content and Format of Annual Reports by the China Securities Regulatory Commission (CSRC),and the Guidelines on Self-regulation of Listed Companies on Shenzhen Stock Exchange No.2 - Standardized Operation of ListedCompanies on the ChiNext Market, the Guidelines on Self-regulation of Listed Companies on Shenzhen Stock Exchange No.1 -Business Processing by the Shenzhen Stock Exchange (SZSE) and other relevant regulations.
Scope of the Report｜Organizational scopeThe report covers Shenzhen Kangtai Biological Products Co., Ltd. (BioKangtai, or the Company) and its subsidiary, which is in linewith the scope of the Company’s annual report and consolidated ?nancial statements.
Full NameAbbreviationsShenzhen Kangtai Biological Products Co., Ltd.BioKangtai, the CompanyBeijing Minhai Biotechnology Co., Ltd.BioMinhai｜Time scope
From January 1, 2023, to December 31, 2023, with some representations and information being traced back to previous years asappropriate.Data DescriptionIf not otherwise stated, the ?nancial data disclosed in the report are derived from the audited ?nancial report of the Company andother data are obtained from the Company’s internal statistics and relevant documents. The currency type in the report is ChineseYuan (CNY), and amounts covered in the report are in Chinese yuan.
Report LanguageThe report is written in two languages, Chinese and English. If there is any discrepancy between the two versions, the Chineseversion shall prevail.
About this Report
Principle of MaterialityThis report identi?es and responds to material issues thatare concerned by stakeholders and have a signi?cantimpact on the Company, and focuses on such issues.
Principle of BalanceThis report discloses the Company’s active ful?llmentof its social responsibility, possible problems and plansfor improvement in detail based on the industry’scharacteristics for avoiding selective disclosure.
Principle of Quanti?cationThis report gives the statistics of quantitative ESGperformance and discloses three-year historical data.
ComparabilityThis report provides a detailed explanation of themeaning of the disclosed key quantitative performanceindicators, together with the basis for their calculation andassumptions. To the extent possible, the indicators usedare consistent during di?erent reporting periods to re?ectthe trends of performance.
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CONTENTS
Fair Employment and ProtectingEmployee Rights and Interests 58Caring for Employees and Helping Them Develop 60Safe Production and Safeguarding Employees 62
Company Overview 052023 ESG Performance 07Values and Philosophy 08Company Milestones 09Honors and Recognition 11ESG Management 13Stakeholder Communication andMaterial Issue Identi?cation 14Material Issue Identi?cation 15
About BioKangtai
People-oriented for BuildingHarmonious Relationship withEmployees
Agglomerate Mental E?orts and Party Building Leading 17Normative Governance and Steady andSustainable Growth 19Compliance Operations and Risk Prevention 23
Law-based Governing Enterprisein Good Faith Escorting SteadyDevelopment
About this Report 01
0203
R&D and Innovation to Enrich theCategory of Products 28Improvement of Quality Control to StrengthenProduct Quality 35Customer Orientation to Enhance ServiceE?ciency 45Responsible Sales and Professional Marketing 47
Strict Quality Control for CreatingBetter Vaccines
Improving Environmental Management andFul?lling Environmental Responsibilities 50Screening Environmental Impact andTackling Climate Change 52Emphasizing Waste Prevention & Control andReducing the Environmental Impact 55
Improving Products Accessibility 67Devotion to Public Welfare 68
Protecting Environment forSustainable Development
Giving Back to the Society andStaying True to the OriginalMission
Future Outlook 70ESG Key Performance 71ESG Reporting Guide Index 79
About BioKangtai
Company Overview
Since its inception in 1992, Shenzhen Kangtai Biological Products Co., Ltd. has been specialized in R&D, production and sales ofvaccines for human use. The Company is listed on the ChiNext market of the Shenzhen Stock Exchange in February 2017 (stock code:
300601). Headquartered in Shenzhen, the Company has ?ve R&D centers and industrial bases in Shenzhen and Beijing. It is one of themajor vaccine manufacturers in China. At present, the Company has 11 listed and approved products for emergency use, among which,"60?g Recombinant Hepatitis B Vaccine (Saccharomyces cerevisiae)" and "Dual-Carrier 13-Valent Pneumococcal Polysaccharide ConjugateVaccine" independently researched and developed by itself are the world’s ?rst of their kind and used for the special group of people whodo not have any response to Hepatitis B Vaccine; the self-developed DTaP-Hib Combined Vaccine (quadruple vaccine) is the domesticvaccine with the largest number of combined vaccines; and the Rabies vaccine (human diploid cell) for human use, Freeze-dried is the ?rst“Fourdoses” of rabies vaccine (human diploid cell) approved in China. The Company’s product portfolio covers both vaccines for thenational immunization program vaccines and non-immunization program vaccines, with products reaching 31 provinces, municipalitiesand autonomous regions.
The Company is an industry leader in R&D innovation and has been engaged in the vaccine industry for over 30 years, which has madeit an innovative biopharmaceutical company with strong R&D strength, rich product o?erings and leading industrial scale. As one of thecompanies with the most comprehensive vaccine R&D platforms in China, the Company has established the R&D and production capacityof virus vaccines, bacterial vaccines, genetically engineered vaccines, conjugate vaccines, combination vaccines and other products, andalso the development ability of platform technologies such as viral vectors, novel adjuvants, and nucleic acid vaccines (mRNA, DNA).Meanwhile, keeping abreast of international cutting-edge technology, the Company has been exploring the research on application of newvaccine technologies and the establishment of new technology platforms, and e?ectively applied the technology platforms through multi-product development, so as to continuously enhance the Company’s innovative R&D strength.
The Company has more than 80 patents and nearly 30 vaccine varieties under development, basically covering the key vaccinevarieties in the world. Some vaccines out of them have entered registration process, including the Inactivated Poliomyelitis Vaccine, SabinStrains (Vero Cell), the In?uenza Vaccine (Split Virion), Quadrivalent, the Diphtheria, Tetanus and Acellular Pertussis Combined Vaccine(Component), Adsorbed, the Diphtheria, Tetanus, Pertussis (Acellular, Component), Poliomyelitis (Inactivated) Vaccine and HaemophilusInfluenzae Type b Conjugate Vaccine, Adsorbed, the Diphtheria, Tetanus, Acellular Pertussis (Acellular, Component) and Poliomyelitis(Inactivated) Combined Vaccine, Adsorbed, the Reassortant Rotavirus Vaccine, Live, Oral, Pentavalent (Vero Cell), the MMR CombinedAttenuated Live Vaccine, the Adsorbed Tetanus Vaccine and the 20-Valent Pneumococcal Polysaccharide Conjugate Vaccine. TheCompany also made arrangements in the development of products such as the Inactivated Tetravalent Enterovirus Vaccine (Vero Cell), theZosterVaccine and the Respiratory Syncytial Virus Vaccine (RSV). At present, the Company has formed a diversi?ed and innovative productpipeline layout with industry competitiveness. With the upcoming release of the products under development, the Company’s sustainabledevelopment will be greatly guaranteed and its competitiveness will be further enhanced.
While the deep cultivation of the domestic market and continuous optimization of the sales network layout, the Company hascontinued to increase the international business development efforts to promote its products to the international market. Since 2022,the Company has successively signed cooperation agreements with more than 10 countries, including Indonesia, Pakistan, Saudi Arabia,Bangladesh, Egypt, Bahrain, etc., and has continued to expand the overseas layout of 13-Valent Pneumococcal Polysaccharide ConjugateVaccine, 23-Valent Pneumococcal Polysaccharide Vaccine, Inactivated Poliomyelitis Vaccine and AcellularPertussis andHaemophilusIn?uenzaeTypebCombinedVaccine, etc., for steadily promoting the internationalization strategy. In October 2023, the Company’s 13-ValentPneumococcal Polysaccharide Conjugate Vaccine was granted marketing license in Indonesia, marking that the vaccine has the basicconditions to be sold in Indonesian market. At present, the Company has already signed a sales contract for 13-Valent PneumococcalPolysaccharide Conjugate Vaccine with the partner from Indonesia. In the future, the Company will continue to increase its efforts ininternational market expansion, actively explore international market cooperation, strengthen the overseas registration of its products,develop diversi?ed sales channels for its products, striving to become a globally renowned biological vaccine supplier.
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2023 ESG Performance
Business Operation
Operating revenue
3,477.44million yuan
Owner’s equity
9,541.69
million yuanNet pro?t
861.30
million yuan
Total assets15,085.36million yuan
Total tax payment
276.65
million yuan
Products and ServiceR&D investment
542.19
million yuan
R&D projects nearly
Complaint handling rate
100%
Products marketed
(including those approved for emergency use)
+Product recall events
No
Safety and Environmental Protection
TotalenvironmentalInvestment
4.09
million yuan
Production safetyaccidentsof average or above
timesThree wastesemissioncompliance
100%
accidents relating
to occupationaldisease hazards
No
Social PerformanceCommunityinvestment
9.30
million yuan
Totalworkforce
1,902persons
Percentage offemale employees
39%
Labor contract
signing rate
100%
Values and Philosophy
The Company has always adhered to the corporate purpose of “produce the best vaccines to bene?t mankind” and the corevalue of “dedication to people’s health”. With a focus on long-term exploration in the biopharmaceutical sector, the Company aimsto become a leading and world-renowned multinational company to contribute to the development of public health sciences. We takea market-oriented approach to enhance our R&D performance and product innovation, continuously optimize our product mix, and topursue high product quality, marginal e?ciency, technological innovation, resource conservation and harmonious development.
Core ValueDedication to people’s health
MissionProduce the bestvaccines to bene?tmankind
Operation Principle
People orientation,excellence, honesty, e?ciency,
innovation and cohesion
VisionBecome a leading and world-renowned biopharmaceutical
multinational company that pursue high product quality,high corporate e?ciency, technological innovation, resource
conservation and harmonious development
Company SpiritThe backbone of ourCompany is the spirit ofdiligent, perseverant,cohesive, enterprisingand self-empowering
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1992The Company was established.1994The Company completed pilot production of 5?gHepatitis B Vaccine, which was later approved bythe Ministry of Health.1995The Company’s 5?g Hepatitis B Vaccine (0.5ml perdose) met the quality standards of Merck & Co., INC,and the vaccine acquired approval number for pilotproduction from the Ministry of Health.
1998
The vaccine acquired formal approval number fromthe China Food and Drug Administration.2000BioKangtai acquired its ?rst GMP certi?cate for itsHepatitis B Vaccine.
2002The Company introduced its 10?g Hepatitis BVaccine (1.0 ml per dose) for adults.2004The Company introduced Hepatitis B Vaccine withthree years’ e?ectiveness, which is the ?rst of itskind in China.
2005? The Company replaced its 10?g Hepatitis B Vaccine(1.0ml per dose) with 10?g Hepatitis B Vaccine (0.5mlper dose) for adults;? and acquired its second GMP certi?cate for Hepatitis Bvaccine.2008After a strategic reorganization, BioKangtai acquiredBioMinhai as its wholly-owned subsidiary.2010? The Company successfully developed the ?rst 60?gHepatitis B Vaccine (1.0ml per dose) for adults hepatitisB vaccine non-responders in China;? The Company acquired the third GMP certi?cate for itsHepatitis B Vaccine.
2011? The Company introduced its 20?g Hepatitis B Vaccine(1.0ml per dose) for grown-ups;? The Company introduced its 10?g Hepatitis B Vaccine(0.5ml per dose) for children.2012? The Company acquired a GMP certi?cate for its HibConjugate Vaccine;? The Company acquired a GMP certi?cate for its DTaP-HibCombined Vaccine.2013? The Company acquired GMP certi?cate for its Measles andRubella Combined Vaccine,Live;? BioMinhai established a postdoctoral R&D center in
Beijing.
Company Milestones
2014? The Company acquired a GMP certi?cate (2010version) for its Hepatitis B Vaccine;? The Company acquired a GMP certi?cate for its HibConjugate Vaccine (pre?lled);? The Company collaborated with INTRAVACC(Netherlands) and WHO to import InactivatedPoliomyelitis Vaccine;? BioMinhai established the Beijing NovelCombination Vaccine R&D Center, the BeijingAcademician Workstation, and the BeijingInternational Sci-Tech Cooperation Base for NovelVaccines.
2015BioMinhai established the National-Local JointEngineering Laboratory for Novel VaccineTechnologies.
2017
The Company was listed on the ChiNext Market ofShenzhen Stock Exchange.
2018
BioKangtai’s Guangming Base in Shenzhen waso?cially put into use.
2019
The Company’s 23-Valent PneumococcalPolysaccharide Vaccine received a GMP certi?cate andwas launched.
2021? The Company’s SARS-CoV-2 Vaccine, Inactivated was approved foremergency use in China;? The Company’s Recombinant COVID-19 Vaccine (Y25 Adenovirus Vector)was authorized for emergency use by the National Agency of Drug andFood Control of Republic of Indonesia;? The Company’s 13-Valent Pneumococcal Conjugate Vaccine was
Launched.2022? The Company’s production site for Recombinant COVID-19 Vaccine (Y25Adenovirus Vector) received a Declaration of Conformity issued by theEU's quali?ed person;? The Company's vaccine production site in Guangming District, Shenzhen,received a GMP Declaration of Conformity issued by the Food and DrugAdministration, Philippines.
2023
The Rabies Vaccine (human diploid cell) forHuman Use, Freeze-dried has been issued fordrugregistrationcerti?cate.
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HonorsAwarded byFirst Prize of Shenzhen Science and Technology Awards
Shenzhen Municipal People’s Government Science and TechnologyAwards CommitteeLeading Enterprise of Guangdong Pilot 100 Program
Guangdong Provincial Economic and Information Commission/Guangdong Provincial Science and Technology Department, etc.High-tech Enterprise Certi?cate
Science, Technology and Innovation Commission of ShenzhenMunicipality/Shenzhen Municipal Finance Committee/ShenzhenTax Service, State Taxation Administration/Shenzhen LocalTaxation BureauAcademician (expert) workstationShenzhen Association for Science and TechnologyGuangdong “Excellent Group Member” for Quali?ed Personin the Pharmaceutical Industry
Quali?ed Person Committee of Guangdong PharmaceuticalAssociationPioneer of the Year in COVID-19 Relief2021 Shenzhen Corporate Social Responsibility ConferenceShenzhen Advanced Grassroots Party OrganizationCPC Shenzhen Municipal Committee“Global Top 100 Pharmaceutical Enterprises” in COVID-19Relief
Torreya, a global investment bankModel Collective in Love Donation for COVID-19 PandemicPrevention and Control in 2020
Red Cross Society of China Jiangxi Branch, Jiangxi Red Cross
FoundationHonorary Certi?cate of Recognition for the Fight Against theCOVID-19 Pandemic in Shenzhen
CPC Shenzhen Municipal Committee, Shenzhen Municipal
GovernmentTop of the 2021 Brand Communication Power list of ListedCompanies in the Pharmaceutica and Medical Industry in theGreater Bay Area
Shenxin Communication ThinkJiangxi Red Cross FoundationTank of
Shen Zhen PressGroup, Qingbo IntelligentTechnology Co., Ltd."Top Ten Caring Enterprises" of the 19th Shenzhen Care ActionShenzhen Spiritual Civilization Construction CommitteeAA Rating of "2022 Wind ESG Rating", ranked in the top 10 inthe healthcare sector
Wind2022 Enterprise ESG Outstanding Social ResponsibilityPractice Case
Xinhuanet, China Enterprise Reform and Development SocietyChina’s Top 500 New Economy EnterprisesChina Enterprise Evaluation AssociationNational Enterprise Technology CenterNational Development and Reform Commission2023 Guangdong Top 500 EnterprisesGuangdong ProvincialAssociationofEntrepreneurs
Honors and Recognition
BioKangtai
BioMinhai
HonorsAwarded byHigh-tech Enterprise Certi?cate
Beijing Municipal Science and Technology Commission, BeijingMunicipal Finance Bureau, Beijing Municipal Tax Service of StateTaxation AdministrationBeijing Science and Technology AwardsBeijing Municipal People’s GovernmentBeijing Key Laboratory for Novel Conjugate Vaccine TechnologyBeijing Municipal Science and Technology CommissionBeijing Novel Vaccine Engineering LaboratoryBeijing Municipal Development and Reform CommissionPostdoctoral R&D Center
Ministry of Human Resources and Social Security, ChinaPostdoctoral Management CommitteeBeijing International Sci-Tech Cooperation Base for NovelVaccines
Beijing Municipal Science and Technology CommissionBeijing Novel Combination Vaccine R&D CenterBeijing Municipal Science and Technology CommissionNational-Local Joint Engineering Laboratory for Novel VaccineTechnologies.
National Development and Reform Commission of ChinaBeijing Enterprise Technology CenterBeijing Municipal Bureau of Economy and Information TechnologyScience and Technology Award of the Chinese PharmaceuticalAssociation
Chinese Pharmaceutical AssociationAcademician (Expert) Workstation Certi?cationChina Association for Science and TechnologyWorker Pioneer AwardAll-China Federation of Trade UnionsBeijing Intellectual Property Demonstration OrganizationBeijing Municipal Intellectual Property O?ceIPMS Certi?cateZhongzhi (Beijing) Certi?cation Co., Ltd.Top 100 Beijing Private Enterprises in CSRBeijing Municipal Federation of Industry and CommerceTop 100 Beijing Private Enterprises in Science and TechnologyInnovation
Beijing Municipal Federation of Industry and CommerceZhongguancun High-tech Enterprise Certi?cateZhongguancun Science Park Management CommitteeBeijing Model Worker’s HomeBeijing Municipal Human Resources and Social Security BureauDemonstration Enterprise in Harmonious Labor Relations inChina
Ministry of Human Resources and Social Security of the People’s
Republic of China, All-China Federation of Trade Unions, China
Enterprise Confederation/China Enterprise Directors Association,
All-China Federation of Industry and CommercePractice Site of Examiner Practice (Beijing Zhongguancun) Baseof China National Intellectual Property Administration
Zhongguancun Intellectual Property Promotion Center, under the
supervision of Beijing Municipal Intellectual Property O?ce as
authorized by China National Intellectual Property AdministrationDaxing District Green Credit Five Star Enterprise
Joint Conference O?ce of Beijing Daxing District Green Credit
SystemNational Intellectual Property Demonstration EnterpriseChina National Intellectual Property AdministrationBeijing AdvancedEnterprises in Building Harmonious LaborRelations
Beijing Municipal Bureau of Human Resources and Social Security,
Beijing Municipal Federation of Trade Unions, Beijing Enterprise
Confederation/Beijing Enterprise Directors Association, Beijing
Federation of Industry and CommerceResearch and Development of New Vaccine - Liu JiankaiInnovation Studio
Beijing Municipal Federation of Trade Unions, Beijing Municipal
Commission of Science and TechnologyLeader of Beijing Association for Science and TechnologyNext Generation Vaccine Development Enterprise InnovationConsortium
Beijing Association for Science and Technology2023 Beijing Top 100 Manufacturing Enterprises2023 Beijing Top 100 High Precision Enterprises
Beijing Enterprise Confederation, Beijing Enterprise Directors
AssociationGrand Prize of Science and Technology Award of GuangdongPreventive Medical Association-Guangdong Major DiseasesVaccine Innovation and Industrialization
Guangdong Preventive Medicine Association
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ESG Management
ESG ApproachBioKangtai, as a high-tech enterprise with comprehensive R&D competence, diversified product range and remarkabletechnological advantages, has introduced a ?ve-dimensional ESG management philosophy based on the corporate purpose of “producethe best vaccines to bene?t mankind”, core value of “dedication to people’s health”, as well as the operation principles of “peopleorientation, excellence, honesty, e?ciency, innovation and cohesion”. The ESG philosophy focuses on the protection of the rights andinterests of stakeholders such as shareholders, employees, customers and suppliers, and places emphasis on normative and honestoperation with a view to promoting the sustainable and balanced development between the Company, the society and the environment.
High-Quality ProductsControl product quality strictly andprovide better vaccines throughtechnological innovation
For Healthy Community
Support medical development andpromote medical accessibility
For Green DevelopmentProactively address climate change and minimize the Company’s carbon footprint
Win-win with EmployeesCreate a comprehensive developmentplatform for employees to help them growtogether with the company and realize
their personal value
Sound GovernanceManage the Company in accordance withthe law and regulations, pursue sound and
stable development, strive to be a world-
class company, and continue to create
value for our shareholders审核
Stakeholder Communication and Material IssueIdentication
Stakeholder CommunicationStakeholder communication and participation is crucial for the Company to promote ESG management and achieve sustainabledevelopment. The Company attaches great importance to the demands of stakeholders and maintains two-way communicationthrough various channels with stakeholders such as shareholders, investors, governments and regulators, customers, suppliers,employees, industry associations, communities and the public. We listen and respond actively to the suggestions and feedback fromour stakeholders, and incorporate their concerns into our operations and decision-making, thereby satisfying their demands whileimproving our business management and achieving sustainable development.
Key StakeholdersIssues of InterestCommunication Channels
Shareholders and Investors
? General Meeting of Shareholders? Information Disclosure? SZSE’s Easy IR Platform? Investor Communication, Roadshows,Conference? Investor Hotline/Email
? Disclosure and Transparency? Compliance and Risk Management? Economic Performance
Government and Regulatory Agencies
(e.g., National Medical Products
Administration)
? Comply with appropriate laws andregulations? Daily Policy Implementation? Regular Work Summary and O?cialCorrespondence? Law Enforcement Supervision and Inspection
? Compliance and Risk Management? Business Ethics? Occupational Health and Safety? Emissions Management? Responding to Climate Change? Use of Resources? Environmental Protection
Customers
? Customer Satisfaction Survey? Customer Visits? Professional Communication? Customer Services and Customer Complaints
? Product Quality? R&D Innovation? Customer Service? Data Security and Privacy ProtectionSuppliers
? Supplier Assessment and Audit? Supplier Training
? Business Ethics? Supply Chain Management
Employees
? Regular Meetings? Employee Activities? Labor Union and Sta? Council? Complaints and Feedback
? Employee Rights and Bene?ts? Employee Training and
Development? Occupational Health and SafetyIndustry Associations
? Industry Associations and Organizations? Professional Communication? Project Cooperation
? R&D Innovation? Intellectual Property Rights? Industry Development
Community and Public
? Community Activities and Services? Regular Communications? Media Communication? Popularization of Vaccine Knowledge
? Social Welfare? Access to Healthcare
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Material Issue Identication
Referring to the latest policies of CSRC and SZSE and excellent practices of peers at home and abroad, the Company undertookthe identi?cation of material issues based on its own business and characteristics as well as expert opinions, with full consideration ofstakeholders’ demands and priorities of concern. After identi?cation, ranking and veri?cation, the Company identi?ed 18 material issuesas the focus of disclosure in the report, as shown in the chart below.◎ BioKangtai’s material issues matrix
Law-based GoverningEnterprise in Good Faith
Escorting Steady Development
1615
Agglomerate Mental Eorts andParty Building Leading
2023 is the opening year for the full implementation of the spirit of the 20th CPC National Congress, and the Party Committee ofthe Company solidly carries out thematic education on learning and implementing of Xi Jinping Thought on Socialism with ChineseCharacteristics for a New Era, deepens the study and understanding of the spirit of the 20th CPC National Congress, strengthens theideological armament, carries out in-depth grass-roots Party building, gives full play to the political leadership of Party grass-rootsorganizations and the pioneering role of Party members, promotes the deep integration of Party building and corporate governance,production and operation, corporate culture and social responsibility, and leads the high-quality development of our Company withhigh-quality Party building. In 2023, on the occasion of the 10th anniversary of "The Belt and Road" initiative, BioKangtai was recognizedas an excellent case of active international cooperation on vaccines and participation in the construction of "The Belt and Road" bythe national economic portal hosted by the Economic Daily, and the Party Committee of BioKangtai was awarded the honorary title of"Advanced Grass-roots Party Organization" by the Non-Public Party Committee of Nanshan District.Strengthening the Construction of OrganizationThe Party Committee of the Company strengthens organizational leadership to perform job responsibility, and always puts e?ortson strengthening and leading the team, among which, ?rstly, it deeply and practically promotes theoretical learning and enhance thecohesion, combat e?ectiveness and creativity of grass-roots party organizations by relying on the system of "three meetings and onelecture" and theme party day activities, etc.; secondly, by adhering to democratic centralism principle, it convenes the organizationlife meeting on schedule, makes democratic evaluation of party members, and actively carries out the theme educational activities,while through the study of "SelectedWorksofXiJinping" and “Questions and Answers on Xi Jinping Thought on Socialism with ChineseCharacteristics for a New Era”, it encourages party members to study hard and think well for effectively transforming the themeeducation into an e?ective way to promote the development of the enterprise.
Exerting Party Building Leading
Based on the actual situation, the Party Committee of the Company guides all party members to apply the worldview, methodologyand position and viewpoint methods of Xi Jinping Thought on Socialism with Chinese Characteristics for a New Era as the "master key" toinvestigate and solve problems. On one hand, the party members make dedication based on their positions, and the Party Committee ofBioKangtai coordinates and pushes forward the in-depth integration of party building and business for constantly forming the positiveinteraction between party building and business; on the other hand, the party members take the lead in overcoming di?culties, andthe Party Committee of BioKangtai constantly gathers the centripetal force of the party members and encourages the party membersto solve the key points, di?culties and pain points of the Company based on their positions, as well as constantly improve the workingability and level.Carrying out Party Building ActivitiesThe Party Committee of the Company enhances the vitality of the party organization through a series of party building activities,such as setting up the internal magazine "Guardian" to build a communication platform for the party group building and corporateculture; organization of "love the country, the post and the family" handwriting activities to express the feelings of the family and thecountry; carrying out a knowledge contest about "study, practice and understand, uphold original aspiration" to promote learningand performance; organization of collective viewing of patriotic ?lms and party members to visit "XionganInternational InnovationandDevelopmentExpo", carrying out study and practical education activities under the theme of "Continuing the Red Spirit, Joyful to Seethe Development of Shaanxi"; providing assistance for employees in di?culties through "Kangxin Fund". Furthermore, it has launcheda number of "heart-warming" initiatives, such as organizing collective birthday parties every month, sending gifts to the parents ofemployees on Chung Yeung Festival and Spring Festival, and visiting and consoling party members and employees who have di?cultiesin their lives, and so on.
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Normative Governance and Steady andSustainable Growth
Governance StructureThe Company strictly complies with the relevant provisions of the Company Law of the People’s Republic of China (hereinafterreferred to as the “Company Law”), the Securities Law of the People’s Republic of China (hereinafter referred to as the “SecuritiesLaw”), the Code of Corporate Governance for Listed Companies in China, the Rules Governing the Listing of Shares on the ChiNextMarket of Shenzhen Stock Exchange, the Guidelines on Self-regulation of Listed Companies on Shenzhen Stock Exchange No. 2 -Standardized Operation of Listed Companies on the ChiNext Market and other relevant laws and regulations. It has established agovernance structure consisting of the general meeting, the Board of Directors, the board of supervisors and the management, andhas formulated rules such as Rules of Procedure of the General Meeting of Shareholders, Rules of Procedure of the Board of Directors,Rules of Procedure of the Supervisory Board and Responsibilities of the President, clarifying the responsibilities and authority, rules ofprocedure and working procedures of the General Meeting of Shareholders, the Board of Directors and the management, forming ascientic and eective division of responsibilities and checks and balances mechanism, and standardizing operations. The structureof "three meetings and one management" strictly follows the provisions of the Company Law, the Articles of Association and the Rulesof Procedures, performs its own responsibilities with mutual constraints, and safeguards the legitimate rights and interests of allshareholders and creditors, especially small and medium shareholders.
The Company’s governance status was in compliance with the requirements issued by the CSRC and the SZSE in relation to thegovernance of listed companies. The Company has been improving its corporate and standardized corporate governance structure,optimizing its internal control management system, improving its risk prevention capability, promoting its standardized operation,continuously improve its corporate governance, and ensuring its compliance and sound development.
The General Meeting of Shareholders
is the highest authority of the Company
The Supervisory Board of the Company
is the supervisory body of the Company, being responsible
for the supervision and inspection of the Company’s
business operation and ?nancial status, as well as the
supervision of the directors and senior management of the
Company in performing their duties in accordance with
the law, and being responsible to the General Meeting of
Shareholders
The Board of Directorsis the business decision-making body of the Company,being responsible to the General Meeting of Shareholders
The President
presides over the daily production and operationmanagement of the Company within the authorization ofthe Board of Directors
◎ BioKangtai’s governance structure
About shareholders and Shareholders’ Meeting
The Company strictly follows the relevant regulations and requirements of the Company Law, the Rules for General Meeting ofShareholders of Listed Companies and the ChiNext Stock Market of SZSE as well as the relevant provisions of the Articles of Associationand the Rules of Procedure for General Meeting of Shareholders to regulate the convening, holding and voting procedures ofshareholders’ meetings and treat all shareholders equally. The Company holds shareholders’ meetings through a combination of on-siteand online voting to ensure that shareholders can fully exercise their rights.During the reporting period, the Company held one annual general meeting and two extraordinary general meetings, at whicheighteen motions were considered. The meetings were convened by the Board of Directors, and lawyers were invited to witness themeetings and issue legal opinions on the convening and voting procedures of the shareholders’ meetings. The convening and holdingprocedures of the shareholders’ meetings and the motions considered were in compliance with the provisions of relevant laws andregulations and the Articles of Association.
General Meeting of Shareholders
Board of Directors
O?ce of the Chairman
Remuneration andAssessment Committee
Strategy Committee
Audit Committee
Human Resources DepartmentSecurities Aairs DepartmentBiosafety OceInternational DivisionProduction & Operation CenterProject Management DepartmentQuality Assurance Management CenterFinance CenterR&D CenterSales and Marketing CenterPharmacovigilance DepartmentSupply Chain Management Department
Internal Auditing DepartmentGeneral Manager’s Oce
Nomination CommitteeBoard of Supervisors
Secretary of the Board of Directors
President
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AND ENVIROMENTAL, SOCIAL AND GOVERNANCE (ESG) REPORT
About the Company and the controlling shareholderThe Company has independent and complete business and independent operation capability, and is independent of the controllingshareholders in terms of personnel, assets, ?nance, institutions and business, with separate accounting an independent responsibilityand risk. During the reporting period, the major decisions of the Company were made by the General Meeting of Shareholders andthe Board of Directors in accordance with the law. The controlling shareholders exercise their rights through the General Meeting ofShareholders without interfering directly or indirectly in decision-making and operating activities of the Company beyond the GeneralMeeting of Shareholders. There are no circumstances such as appropriating the Company’s funds or requesting guarantees for them orguaranteeing others.About directors and Board of DirectorsThe Board of Directors of the Company consists of seven directors, including three independent directors, and the umber andcomposition of the Board of Directors are in compliance with the laws, regulations and the Articles of Association f the Company. Thedirectors of the Company attend the Board of Directors’ meetings and shareholder’ meetings actively and dutifully promote the e?ectiveoperation of the Board of Directors and scienti?c decision-making. There are four specialized committees under the Board, namely,the Strategy Committee, the Audit Committee, the Nomination Committee and the Remuneration and Assessment Committee. Eachcommittee carries out its functions in strict accordance with its own working rules to promote scienti?c decision-making of the Board,improve the e?ciency of the Board’s operation and lay an important role in the governance of the Company.During the reporting period, the Company held 9 meetings of the Board of Directors with 47 motions considered. The meetingswere all convened and chaired by the Chairman, and the convening, holding and voting procedures of the meetings were in compliancewith the relevant provisions of laws and regulations and the Articles of Association and the Rules of Procedure of the Board of Directors.
About supervisors and the Board of SupervisorsThe Board of Supervisors of the Company is composed of three supervisors, including two employee representatives, and thenumber and composition of the Supervisory Board are in compliance with the laws, regulations and the Articles of Association of theCompany. The supervisors of the Company strictly abide by the requirements of the Company Law, Guidelines on Self-regulation ofListed Companies on Shenzhen Stock Exchange No. 2- Standardized Operation of Listed Companies on the ChiNext Market, Articles ofAssociation and Rules of Procedure of the Board of Supervisors, and conscientiously perform their duties by attending the meetingsof the Board of Supervisors, the meetings of the Board of Directors and the meetings of the General Meeting of Shareholders, andsupervising the development strategy, ?nancial activities, risk management, internal control and the performance of duties of the Boardof Directors and senior management of the Company in accordance with the law for the bene?t of the shareholders and the overallinterests of the Company.During the reporting period, the Company held 8 meetings of the Board of Supervisors with 26 motions considered, all of whichwere convened and chaired by the chairman of the Board of Supervisors, and the convening, holding and voting procedures of themeetings were in compliance with the relevant provisions of the laws and regulations and the Articles of Association and the Rules ofProcedure of the Board of Supervisors.Rewarding Our ShareholdersWhile promoting the steady development of its own business, the Company has formulated a stable profit distribution policyand actively distributes cash dividends to share the returns of corporate development with investors. The Company has formulated asustainable pro?t distribution policy to continuously reward its shareholders. Since its listing, the Company has implemented its pro?tdistribution plan in strict accordance with the relevant pro?t distribution policy and deliberation procedures of the Articles of Association,with clear and explicit criteria for dividend distribution and complete decision-making procedures and mechanisms, to e?ectively protect
the legitimate rights and interests of shareholders, especially the small and medium shareholders.In September 2023, based on the total share capital as at the date of share registration as determined in the announcement about2023 Semi-annual Equity Distribution, the Company implemented the 2023 Semi-annual Equity Distribution Plan to distribute 1.80 yuan(tax-inclusive) cash dividends for every 10 shares to all shareholders from undistributed pro?ts, without bonus shares and capitalizationof capital reserves. Since its listing in February 2017, the Company has paid cash dividends of more than 1,500 million yuan in total, withtotal cash dividends as a percentage of total net pro?t attributable to shareholders of the listed company of 43.00%.At the same time, the Company enhanced returns to investors by share repurchases. 3,581,600 shares of the Company wererepurchased by the Company with a dedicated securities account for share to repurchase shares by way of centralized bidding duringthe period from September 2022 to March 2023, with a total amount of funds paid 120,967,842.86 yuan (excluding transaction fees). Allthe shares repurchased by the Company were used to cancel and reduce the registered capital, and such cancellation was completed onMarch 22, 2023. Such amount was regarded as the amount of cash dividends.Strengthening of Investor Relations ManagementThe Company strictly complies with the Guidelines on Self-regulation of Listed Companies on Shenzhen Stock Exchange No.2-Standardized Operation of Listed Companies on the ChiNext Market, Guidelines for Investor Relations Management of ListedCompanies, and Rules on Investor Relations Management. It has clearly de?ned the investor relations management mechanism, withthe Secretary of the Board of Directors as the person in charge of investor relations management and the Securities A?airs Departmentas the functional department of investor relations management, led by the Secretary of the Board of Directors, and dedicated personnelin charge of investor reception. Through diversi?ed methods such as shareholders’ meetings, online performance brie?ngs, road shows,analyst meetings, visiting receptions, SZSE’s Easy IR Platform, investor hotline, investor relations mailbox, etc., the Company strengthenscommunication with investors and potential investors, sincerely listens to investors’ opinions and suggestions, in order to convey newdevelopments of the Company, enhance investors’ understanding and recognition of the Company, and safeguard a smooth positiveinteraction between investors and channels of information exchange of the Company.Enhancing Information DisclosureWith great emphasis on information disclosure, the Company has strengthened its management of information disclosure a?airsin accordance with the provisions and requirements of the Company Law, the Measures for the Administration of Information Disclosureof Listed Companies, the Rules Governing the Listing of Shares on the ChiNext Market of Shenzhen Stock Exchange and the Guidelineson Self-regulation of Listed Companies on Shenzhen Stock Exchange No. 2 - Standardized Operation of Listed Companies on theChiNext Market. We have formulated the Regulations on the Management of Information Disclosure Matters to clarify the work?ow andresponsibilities on information disclosure.The Board of Directors is responsible for the information disclosure activities of the Company, and the Securities A?airs Departmentis the functional department managing the information disclosure. In 2023, the Company disclosed a total of 171 periodic reports andtemporary announcements, which provided true, accurate, complete and timely disclosure of the Company’s business activities andmaterial matters, ensuring that all investors had fair access to our information and e?ectively protecting their legitimate rights andinterests.
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2023 ANNUAL SOCIAL RESPONSIBILITY REPORT
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Compliance Operations and Risk Prevention
Improvement of internal control systemThe Company attaches great importance to the construction of standardized governance and internal control system, and inaccordance with the provisions of the Basic Standards for Enterprise Internal Control and its supporting guidelines, and on the basis ofstandardized corporate governance framework, it has continuously optimized the compliance management system by improving thecompliance organization structure, establishing a sound compliance system and enhancing compliance awareness, and has establishedclear internal controls and necessary internal supervision mechanisms from the corporate management level to the level of eachbusiness process to guarantee operation in accordance with the law and standardized operation.◎ The organizational structure of compliance management
A compliance management team has been established by the Company. The compliance management team consists of full-time and part-time members, where full-time compliance members are from the internal audit and legal departments and part-timecompliance members are senior sta? from each functional department, who collaborates with the full-time team members to carry outcompliance reviews in their respective sectors.
◎ Perfecting compliance system and enhancing compliance awareness
In terms of compliance management regulations, the Company has formulated the Regulations on Compliance Management,which is applicable to the compliance management for all departments, subsidiary and employees of the Company, covering businessareas such as transactions, safety and environmental protection, product quality, labor employment, finance, taxation, businesspartners, business innovation, asset management and intellectual property rights. Meanwhile, the Company starts from the guidance ofthe concept, improves the compliance awareness of all employees through compliance promotion, strengthens compliance supervision,promotes the effective implementation of compliance management, and continuously strengthens internal control and compliancemanagement to escort the Company’s stable operation.Risk Identication and ManagementThe Company identi?es and systematically analyzes potential internal and external risks in its business activities in a timely manner,and constantly improves its risk management and internal control systems. In terms of risk identi?cation, each department carries outrisk identification in its daily work according to the regulations, establishes risk database and Risk Identification List, and regularlyconducts self-inspection on risk management e?orts to identify de?ciencies and make improvements in a timely manner.
The Company applies an internal audit system to strengthen its internal risk management. In accordance with the Audit Law ofthe People’s Republic of China, Guidelines on Self-regulation of Listed Companies on Shenzhen Stock Exchange No. 2 - StandardizedOperation of Listed Companies on the ChiNext Market and the Company’s Internal Audit Regulations and Management Measures ofInternal Audit Practice, the Internal Audit Department audits, supervises and inspects the production and operation activities, economice?ciency, asset security, business ethics and anti-corruption, and the establishment and implementation of the internal control systemof the Company and its subsidiary, and makes suggestions and comments on the existing problems. The Internal Audit Department isindependent and reports directly to the Audit Committee of the Board of Directors.
In 2023, the Internal Audit Department conducted audits and inspections of important matters of the Company as planned, without?nding any violations of law or irregularities in the operations. Besides, the Company o?ers relevant information on risk control relatedlaws and regulations and policy interpretation to employees through internal communication network from time to time to enhance theirawareness of risk control.◎ Internal auditing procedure
Develop audit
plans by theInternal AuditCommittee.
Develop audit plansand audit programsfor projects
Deliver a audit
notice to theaudited units
Conduct audittasks, form auditconclusions andrecommendations
which arereviewed by theperson in charge
Settlement ofobjections toaudit results andcon?rmation andreview of matters
Follow up andsupervise theimplementation
of correctivemeasures of the
audited units
0103
0602
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Business Ethics and Anti-corruptionAiming to create a working atmosphere of compliance, integrity and honesty, the Company adheres to the bottom line ofcompliance, takes business ethics and anti-corruption as the focus of internal risk control, makes standardized requirements for allemployees and partners in terms of integrity, as well as adopts a zero-tolerance policy for unethical business practices,In terms of its own integrity norms, the Company strictly abides by the relevant laws and regulations such as the Law of thePeople’s Republic of China on Anti-Unfair Competition, the Law of the People’s Republic of China on Anti-Money Laundering, the Law ofthe People’s Republic of China on Protection of Consumer Rights and Interests and relevant standards such as ISO37001 Requirementsand Implementation Guide for Anti-Bribery Management System, while regulating mechanisms for the integrity operation of its businessactivities by formulating the Employee Handbook, Code of Professional Ethics, Rules for Integrity in Workplace, and WhistleblowingManagement Regulations, implements control measures to requires employees to strictly comply with the relevant regulations onintegrity o?ce and anti-bribery, strengthens targeted management of key links, creates a culture of integrity, and builds a monitoringand reporting mechanism to encourage the employees of the Company to supervise the implementation of integrity governance, as wellas to report suspected violations. Meanwhile, the Company requires employees in key positions to sign the Integrity Commitment. In2023, all employees in key positions of the Company signed the Integrity Commitment.
In terms of integrity cooperation with suppliers, the Company attaches importance to the prevention of business ethics risks in theprocurement process. In addition to establishing an integrity standardization mechanism with suppliers, the Company’s internal auditdepartment conducts annual audits on business ethics in the supply chain and organizes training on business ethics for supply chainemployees.In other external cooperation, clear requirements on business ethical practices are also put forward, and the behavior of allparties involved in the cooperation is regulated by signing Integrity Agreements or agreeing on anti-bribery clauses in the cooperationagreements.
Middle and seniormanagement and keyposition personnel? Comply with the law, work with integrity,sign the Integrity Commitment；? Never disseminate con?dentialinformation in violation of relevantregulations.
External co-promoters? Strictly abide by laws and regulations,stipulate compliance terms inagreements, conduct market activitiesin accordance with the law, and avoidpaying bribes to relevant departments oremployees of the Company in any form toobtain improper bene?ts.
All departments
? Contracts signed with suppliers/partners must contain an integrityagreement or related clauses, andoverseeing implementation of theintegrity agreement.
All employees
? Shall not use their authority toaccept bribes;? Shall not obtain trade secrets byimproper means;? Shall not undermine competitorsby false advertising.
Business Ethics Code
and Requirements
Whistleblower Complaint Receiver
Director of the O?ce of Internal Whistleblowing Management
Leadership GroupEmailshenjibu@biokangtai.com
◎ Compliance reporting and whistleblower protectionThe Company has formulated the Whistleblower Management System, which speci?es the reporting mechanism, managementorganization, reporting channels and acceptance procedures, and handling measures, etc. The Company has also established aninternal whistleblower management leading group, headed by the Chairman. The Company encourages employees and partners toreport suspected violations and crimes, which can be reported anonymously or in real names, and rewards for truthful reporting.The Company keeps the personal information of the whistleblowers and the reporting information provided strictly con?dentialthrough the con?dentiality management measures such as dedicated management of the reporting information and minimizing thenumber of informants to prevent the whistleblowers from being treated unfairly and to protect the legitimate rights and interests ofthe whistleblowers. For personnel who violate the con?dentiality provisions and retaliate against whistleblowers, the Company takes azero-tolerance attitude; the violators will be dismissed, terminated from the labor contract, or transferred to judicial organs if suspectedof breaking the law according to the severity of the circumstances.
◎ Procedures for handling whistleblowing
◎ BioKangtai’s Whistleblowing Channels
Director of the O?ce of InternalWhistleblowing ManagementLeadership Group receives andveri?es Whistleblowing.
Within two days after thepreliminary examination of thewhistleblowing, it will be submittedto the Internal WhistleblowingManagement Leadership Groupand a meeting on the matter will beheld. The meeting will discuss andanalyze the situation, identify itsnature, and develop accountabilityprograms and remedial andcorrective measures and reportthem to the Company.
The Company will punish liablepersons according to the opinionsof the Internal WhistleblowingManagement Leadership Group,and implement corporaterecti?cation measures. Thosewho violate the criminal law willbe transferred to the judicialorgans for a lawful treatment.
Receive Whistleblower
Complaints
Handel WhistleblowingInvestigate and Collect
Evidence
Hotline0755-26988630
ChannelsLetters, phone calls, emails, WeChat and visits, etc. Anonymous
report is supported
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Strict Quality Controlfor Creating Better Vaccines
R&D and Innovation to Enrich the Category ofProducts
The Company has been deeply engaged in the ?eld of human vaccines for over 30 years, and always insisted on the R&D modewhich is mainly of independent R&D, supplemented by cooperative R&D and secondary innovation of imported technologies. Whilestrengthening the independent R&D and innovation ability, the Company pays attention to the cooperative relations with well-knownenterprises and institutions in domestic and overseas, introduces advanced technology for absorption and use, enabling the Companyto continuously improve its R&D ability. After years of R&D investment, the Company has established diversi?ed R&D platforms such aslive attenuated virus vaccines, inactivated virus vaccines, genetically engineered protein vaccines, bacterial polysaccharide vaccines,bacterial polysaccharide conjugate vaccines, combined vaccines, viral vector vaccines, mRNA vaccines, new adjuvant technology, etc.,which complement each other and form a strong synergy e?ect, enabling the development of vaccine products and the constructionof vaccine product portfolio in a more economical and e?cient way, so as to ensure the continuous upgrading of vaccines and thesuccessful development of novel vaccines. The Company has mastered a number of core technologies such as engineered strainconstruction, cell culture, virus culture, exotoxin detoxi?cation, polysaccharide puri?cation, protein puri?cation and polysaccharide-protein conjugation, and also has R&D and production capability for viral vaccines, bacterial vaccines, genetically engineered proteinvaccines, conjugate vaccines and combination vaccines. In particular, we are at the leading edge of the development of combinationvaccines. At the same time, the Company has been keeping up with the international cutting-edge technology, continuously exploringthe research and application of novel vaccine technologies and the establishment of new technology platforms, and has the ability ofdevelopment viral vectors, novel adjuvants, nucleic acid vaccines (mRNA, DNA) and other product technology platforms.◎R&D Platforms Layout
Platform for
virusattenuated
vaccines
Platform forvirus vectorvaccinesPlatformfor genetically
engineered
proteinvaccines
Platformfor bacterialpolysaccharidevaccines
Platform fornew adjuvanttechnology
Platformfor bacterialpolysaccharide
conjugate
vaccines
Platform forcombined
vaccines
Platform forinactivated
virusvaccines
Platform formRNAvaccines
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◎ Well-developed R&D Bases
? Shenzhen Novel Vaccine Engineering Laboratory? Guangdong Therapeutic Hepatitis B Vaccine Laboratory? Beijing Key Laboratory for Novel Conjugate VaccineTechnology? Beijing Novel Vaccine Engineering Laboratory? Postdoctoral R&D Center? Beijing International Sci-Tech Cooperation Base for NovelVaccines? Beijing Novel Combination Vaccine R&D Center? Academician Workstation? National Intellectual Property Demonstration Enterprise? State-Local Joint Engineering Laboratory for Novel VaccineDevelopment
◎ Implementation of "Bring in" StrategyThe Company places emphasis on the introduction of international advanced technology to enrich its technology strategies andreserves, and improves its independent innovation capability through introduction and absorption so as to promote the achievementtransformation of independent innovation technology. Since the 1980s, the Company has imported full R&D and production technologiesof Recombinant Hepatitis B Vaccine (Saccharomyces cerevisiae), Rabies Vaccine (human diploid cell) for Human Use, Freeze-dried,Inactivated Poliomyelitis Vaccine, Sabin Strains, and Recombinant COVID-19 Vaccine (Y25 Adenovirus Vector) from Merck (USA), Sano?Pasteur (France), Intravacc (Netherlands),and AstraZeneca (UK), respectively, while has devoted to develop itself from a one-waytechnology bringer to an overseas exporter of independent technology, so as to explore a way to transfer the independent innovationtechnology to overseas, and strive to improve the accessibility and a?ordability of vaccines worldwide.
◎Implementation of "Go abroad" StrategyWhile the deep cultivation of the domestic market and continuous optimization of the sales network layout, the Company hascontinued to increase the international business development e?orts to promote its products to the international market. Since 2022,the Company has successively signed cooperation agreements with more than 10 countries, including Indonesia, Pakistan, SaudiArabia, Bangladesh, Egypt, Bahrain, etc., and has continued to expand the overseas layout of 13-Valent Pneumococcal PolysaccharideConjugate Vaccine, 23-Valent Pneumococcal Polysaccharide Vaccine, Inactivated Poliomyelitis Vaccine and AcellularPertussis andHaemophilusIn?uenzaeTypebCombinedVaccine, etc., for steadily promoting the internationalization strategy. In October 2023, theCompany’s 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine was granted marketing license in Indonesia, marking thatthe vaccine has the basic conditions to be sold in Indonesian market. At present, the Company has already signed a sales contract for13-Valent Pneumococcal Polysaccharide Conjugate Vaccine with the partner from Indonesia. In the future, the Company will continueto increase its e?orts in international market expansion, actively explore international market cooperation, strengthen the overseasregistration of its products, develop diversi?ed sales channels for its products, striving to become a globally renowned biological vaccinesupplier.
R&D AchievementsRelying on its R&D platforms and core technologies, the Company has overcome the barriers to the development of severalheavyweight vaccines, and completed the development of several world-leading vaccines with independent intellectual property rights,to contribute for immunization health of the people.
? 60μg Recombinant Hepatitis B Vaccine (Saccharomyces cerevisiae): The world’s ?rst vaccine of its kind.? DTaP-Hib Combined Vaccine: The ?rst domestically developed vaccine with the largest number of combined vaccines,and a major achievement of the National Hi-tech R&D Program (or 863 Program).? 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine: The world’s ?rst dual-vector 13-valent pneumococcalpolysaccharide conjugate vaccine; it is also a global best-selling heavyweight vaccine.? Rabies Vaccine (human diploid cell) for Human Use, Freeze-dried: The ?rst “Fourdoses” of rabies vaccine (humandiploid cell) approved in China.? Diphtheria, Tetanus, Pertussis (Acellular, Component), Poliomyelitis (Inactivated) Vaccine and Haemophilus In?uenzaeType b Conjugate Vaccine, Adsorbed: The ?rst domestic quintuple vaccine that has entered phaseIclinicaltrial inChina.
◎ Some important R&D achievements
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Serial No.Vaccine NameRegistration StageCurrent Process
Inactivated Poliomyelitis Vaccine, SabinStrains (Vero cell)
NDA registration approval
Application for producingregistration accepted
Group ACYW135 MeningococcalPolysaccharide Vaccine
In the summary stage of clinicalphase
Completed the on-site job ofPhase III clinical research3Inactivated Hepatitis A Vaccine
In the summary stage of clinicalphase
Completed the on-site job ofPhase III clinical research
SARS-CoV-2 Vaccine (Vero Cell),Inactivated
Approved for emergency use inChina
Obtained Phase III clinical trialcritical data
In?uenza Vaccine (Split Virion),Quadrivalent
IND obtained, clinical phase inprogress
PhaseⅠand Ⅲ clinical trials inprogress6Adsorbed Tetanus Vaccine
IND obtained, clinical phase inprogress
PhaseⅠand Ⅲ clinical trials inprogress
Diphtheria, Tetanus and Acellular PertussisCombined Vaccine (component), Adsorbed
IND obtained, clinical phase inprogress
Completed Phase I clinical trial ,Phase III clinical trial preparationin progress
Recombinant Enterovirus A71 Vaccine(Hansenula)
IND obtained, clinical phase inprogress
Completed Phase I and II clinicaltrials
Recombinant Hepatitis B Vaccine(Hansenula)
IND obtained, clinical phase inprogress
Completed Phase I clinical trial
Reassortant Rotavirus Vaccine, Live, Oral,Pentavalent (Vero Cell)
IND obtained, clinical phase inprogress
Phase I and II clinical trials inprogress
Diphtheria, Tetanus, Pertussis (Acellular,Component), Poliomyelitis (Inactivated)Vaccine and Haemophilus In?uenzae Typeb Conjugate Vaccine, Adsorbed
IND obtained, clinical phase inprogress
Phase I clinical trial in progress
Diphtheria, Tetanus, Acellular Pertussis(Acellular, Component) and Poliomyelitis(Inactivated) Combined Vaccine, Adsorbed
IND obtained, clinical phase inprogress
Phase I clinical trial in progress13MMR Combined Attenuated Live VaccineIND obtained
Obtained noti?cation of clinical
trial approval
20-Valent Pneumococcal PolysaccharideConjugate Vaccine
Obtained noti?cation of acceptanceof clinical trial application
Obtained noti?cation of
acceptance of clinical trial
application
60μg Recombinant Hepatitis BVaccine (Saccharomyces Cerevisiae)(Immunomodulator)
Has withdrawn the applicationfor vaccine registration approval,currently in the clinical data self-examination phase
Clinical data self-examination in
progress
◎ Extensive projects under research
At present, the Company has more than 30 projects under development, basically covering the key varieties of vaccines in theworld. The main projects entering the registration process are shown as below:
Improvement of R&D and Innovation System
The Company attaches importance to the improvement of R&D and innovation system, and integrates research and innovation intoits development strategy. In accordance with the Drug Administration Law of the People’s Republic of China, Vaccine Administration Lawof the People’s Republic of China, Measures for the Administration of Drug Registration and other laws and regulations, the Companyhas established and improved R&D and innovation system, and provided continuous impetus for technology development and productinnovation through various e?ects, including creating an innovative environment, perfecting the incentive mechanism for innovation andpromoting the transformation of R&D results, so as to create its core competitiveness with innovation.
Stable R&D Team
Adhering to the belief of “talent is the primary resource for corporate innovation”, the Company has accumulated a large numberof core technologies for vaccine R&D and production through nearly 30 years of R&D innovation and technology import and absorption,and has built up a crew with international vision, rich experience in vaccine development and management, as well as practicalexperience in industrialization. Among them, the key technicians have more than 10 years of experience in vaccine R&D and haveundertaken more than 70 national, provincial and municipal projects; several project leaders have been awarded honorary titles such as“Leading Talents of Innovation Projects”. In addition, the Company has hired industry experts as its consultants to ensure the correctdevelopment direction, technical standards, R&D progress and quality of vaccines.
The Company has established comprehensive R&D talent incentive measures to promote product innovation and continuouslyrecruit high-end R&D talents with both scienti?c and technical expertise.
Environmentfor Innovation
IncentiveMechanism forInnovation
InnovationAchievementsTransformation
? Implement innovation-driven strategy and incorporate innovation into the Company’s medium-and long-term strategy? Encourage innovative approach, courage to expose defects and self-transcendence, to create asound innovation culture? Set out clear targets and executable plans for innovation? Continuously increase investment in R&D. In 2023, the Company’s R&D investment accounted for
15.59% of its operating revenue
? Formulation of R&D Center Project Management Regulations, BioKangtai’s Reward and PunishmentSystem, etc., all of which stipulate the incentive system and measures for innovation? Encourage technological innovation, benchmark with international standards, promoteheavyweight products, and forster innovation projects? Prioritize the allocation of resources required for innovation, including increasing investment in
scienti?c research and information technology, and strengthening the recruitment of leadingtalents? Establish mechanisms and capabilities to promote the transformation of innovation achievements
to commercial or social value? Form synergy between “product R&D” and “social needs” to achieve the virtuous cycle of“continuous innovation” by developing market-oriented products
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① Establish a long-term mechanism to motivate core R&D/key personnel. During the reporting period, the total
number of incentive recipients for the ?rst grant under the 2023 share option and restricted share incentive plan is462 after the implementation of such incentive plan by the Company.
② Provide incentives for R&D and registration, and awards for government projects
③ Set up an award to reward people who recommend/recruit important talents
④ Provide housing subsidies for talents in Nanshan District, Shenzhen, and solve their problems in children’s
enrollment, application of Shenzhen household registration and dwellings.
⑤ Apply for Beijing household registration for quali?ed talents: including non-Beijing-born talents, proven talents
and talents who have studied abroad
⑥ Leading talents in Daxing District: enjoy a reward of 500,000 yuan with other subsidies and bene?ts
⑦ Outstanding young talents in Daxing District: enjoy bene?ts such as funding for R&D projects
⑧ Returned overseas talents in Daxing District: enjoy an allowance for living expenses and public rental housing, etc.
R&D Talent Incentive Measures
R&D EthicsThe 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&Dpractices.◎ Ethical principles for scientic research
? The whole process of R&D should refer to and follow the relevant laws and regulations.
? Follow the scienti?c 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 andcomplete.? Respect for patents, copyrights and other forms of intellectual property rights.? Share research results and scienti?c resources openly within the permitted range.
? Clinical trials of drugs follow the principles of the Declaration of Helsinki of the World MedicalAssociation and related ethical requirements, and the rights and safety of subjects are the primaryconsideration? Follow the 3R principles (reduce, replace and re?ne) in the use of laboratory animals and research,
concern for the welfare of laboratory animals, and treat them well.
Intellectual Property Protection
We attach great importance to the protection of intellectual property rights, strictly complied with the Patent Law of the People’sRepublic of China, the Trademark Law of the People’s Republic of China and other relevant laws and regulations, and secure our legaland e?ective intellectual property rights through patent application and trademark registration to maintain our reputation and corecompetitiveness. BioMinhai, has established an enterprise intellectual property management system in accordance with the nationalstandard named Enterprise Intellectual Property Management Standards (GB/T29490-2013) and successfully obtained the certi?cation ofintellectual property management system. In November 2023, BioMinhai was awarded the National Intellectual Property DemonstrationEnterprise.When engaging in external cooperation, the Company strictly abides by the legal procedures for technology importation andpatent licensing, and signs technology licensing and R&D cooperation agreements with its partners, which clearly stipulate the rightsand obligations of both parties and the ownership of R&D intellectual property rights. The Company promotes cooperation mattersaccording to the agreements to avoid relevant disputes in respect of intellectual property rights. During the reporting period, theCompany did not have any incident related to the infringement of others’ intellectual property rights, and there was no litigation caserelated to intellectual property rights.
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Improvement of Quality Control to StrengthenProduct Quality
Quality Control SystemThe Company has always regarded product quality as the line of life since its establishment, and always given top priority toproduct quality. In accordance with the Drug Administration Law of the People’s Republic of China, the Vaccine Administration Law ofthe People’s Republic of China, the Good Manufacture Practice of Medical Products and related laws and regulations, and standards formedical product registration, the Company has established a comprehensive quality management system covering the whole life cycleof products, which sets strict quality control standards for each key part of R&D, production, storage and distribution of products, andformulated targeted quality management procedures to ensure that all requirements for safety, e?cacy and quality control in medicalproduct regulations and registration standards are systematically implemented in the process of vaccine R&D, production, qualitycontrol, product release, storage and transportation, and ensure that all procedures in raw material inspection, product R&D, productionand distribution are in compliance with the intended use and registration standards, so as to strictly ensure product quality in line withstandards.At the same time, the Company actively absorbs the cutting-edge technology and advanced quality management concepts frominternational organizations and well-known enterprises such as WHO, Sano?-Pasteur and Merck, as well as continuously improves andperfects the quality control system by benchmarking international advanced standards to constantly enhance its quality control abilityfor ever-growing upgrade of product quality. The Company has obtained declaration of compliance issued by the EU quality authorityfor Recombinant COVID-19 Vaccine (Y25 Adenovirus Vector) manufacturing base; the vaccine manufacturing base in Guangming District,Shenzhen of the Company has been granted declaration of compliance on GMP issued by the Philippine Food and Drug Administration;13-Valent Pneumococcal Polysaccharide Conjugate Vaccine (Tetanus Toxoid/Diphtheria Toxoid) of BioMinhai, a wholly-owned subsidiaryof the Company, has passed the GMP Inspection by the Food and Drug Administration of Indonesia, indicating that the Company’squality management system is in line with international standards.
◎ Quality management policy
To strictly enforce our regulations, ensure the authenticity of original data, deal with every problem in time, ensure strict monitoringof defective products, and never slacken GMP management.
◎Quality Management Committee
The Company has set up a Quality Management Committee, with members of which are core management personnel and specialexperts and scholars, to coordinate, communicate, consult and comment on quality management, for further strengthening the qualitymanagement related to production and operation, and promoting the improvement and enhancement of quality management.
◎ Product lifecycle quality management system
? Material Management Regulations, Material Supplier Management Regulations and Material Release Management
Regulations have been formulated for standardized management;? Acceptance of materials according to the bill of materials and the requirements of quality standards. The process includesprocurement, acceptance, inspection, storage, release and use management.
Source Management
? Develop inspection procedure, Sample Receipt, Inspection and Reporting Procedures and Quality Control Department
Standards Management Regulations and strictly follow them;? In accordance with the regulations, manage the laboratory’s testing process, standards, reagents, samples and other aspects,
and perform quality control by conducting quality inspections.
Quality Inspection
? Develop Assured Management Regulations, Sales Management Regulations, and Cold Chain Transporter Management
Regulations and strictly enforce these regulations;? Products are made, inspected and approved by the Quality Authorized Person before leaving the factory. The products are
transported according to the cold chain transportation requirements, ensuring that they are delivered as required and well
tracked in the market.
Release and Product Transportation
? Develop Printing and Packaging Materials Management Regulations and strictly enforce the regulations;? The design samples of product labels need to be approved by the person in charge of production management and quality
management, the person in charge of quality management and the person authorized for quality. After the product labels
are purchased and printed according to the regulations, they need to be examined by the quality department before putting
them into use.
Pharmaceutical Labeling Management
? Develop the regulations for production and operation and Production Quality Control Management Regulations and
implement production monitoring based on it;? In accordance with the regulations, process parameters and quality attributes during the process are evaluated and
continuously tracked to identify abnormal trends and achieve all-round data monitoring, ensuring a continuous and stable
production of products that meet the standard requirements.
Production Monitoring
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◎ Digital construction of quality managementThe Company has established an electronic system for vaccine traceability, which is connected with the national vaccinee-traceability platform to achieve full traceability and veri?ability throughout the process of vaccine production, quality control andproduct release, storage and transportation. The Company’s production and manufacturing execution system, laboratory informationmanagement system, group version of enterprise resource management system, etc., have been launched in succession and are stablein operation, whereby achieving a digital entire production inspection process, real-time and traceable quality management of thewhole link with accurate, reliable and traceable data.Laboratory Information Management System (LIMS)
Manufacturing Execution System (MES)
Quality audits by government departments
The Company’s LIMS covers batch management, stability management, instrument management, standardsmanagement, reagent management, and laboratory survey management. The system enables e?cient management oflaboratory resources and more reliable laboratory data management.
The Company’s MES covers production order management, electronic batch records, batch analysis, recipe management,material management, and equipment management. The system enables the generation of electronic batch recordsand realization of automatic collection of production data to ensure good traceability in all aspects of production. Inconjunction with other information systems of the Company, it builds up the information management of the "wholelifecycle" of vaccine production, constructs a more perfect quality management system of vaccine production, andprovides high-quality vaccines, while paperless production is realized, greatly reducing the use of paper records.
◎ Quality audit, supervision and inspection managementThe Company attaches great importance to internal quality supervision and inspection, and carries out comprehensive self-inspection every year. Through self-recti?cation and self-inspection of the whole process of quality management, the Company timelydiscovers the deviation and risk of quality management, and improves the quality management system in time to enhance the qualitymanagement level. Meanwhile, the Company accepts the audit of regulatory authorities at national, provincial, municipal and districtlevels every year, and the audit results for 2023 are all satisfactory.
? At present, regulatory authorities supervise and monitor the quality of our vaccines by means of supervision and inspection,which are conducted by national, provincial and municipal medical product administrations. The Company actively recti?esthe problems raised by regulatory authorities in the process of supervision and inspection and improves the quality systemcontinuously.? In 2023, BioKangtai received vaccine inspections and GMP follow-up inspections from the National Medical ProductAdministration and Guangdong Provincial Medical Product Administration for ?ve times, all of which were passed.? In 2023, BioMinhai received vaccine inspection, GMP compliance inspection, on-site veri?cation of vaccine registrationand pharmacovigilance test from the National Medical Product Administration and the Beijing Municipal Medical ProductAdministration for nine times, all of which were passed.
Regular internal supervision and inspection
? The Quality Assurance Department conducts quality supervision and inspections according to the prescribed frequency, and
checks the key control points of production batches. Meanwhile, annual self-inspection is carried out to cover the wholeprocess of production and quality control (material management, production, quality control, continuous improvement,circulation, etc).? The Quality Assurance Department carried out supervision and inspection to the production workshops or departmentsat least once a week, and every batch of products was supervised and inspected in production. The Company completedthe annual quality self-inspection audit as required, and the identi?ed problems were recti?ed and improved in a timelymanner.
◎Corrective and preventive management
The Company has formulated regulatory documents such as Deviation Management Regulations, Regulations on Change Control,Regulations on Corrective and Preventive Measures and Regulations on Customer Complaint Handling in accordance with the GMPmanagement requirements to implement deviation and change management and risk control in production to ensure that the productsmeet the intended use and vaccine registration requirements. Meanwhile, the Company have established a GMP self-inspection team toconduct comprehensive self-inspection at least once a year, with comprehensive reports generated, corrective and preventive measuresfor defects formulated and implemented, and the e?ectiveness of the measures continuously tracked. By means of GMP self-inspection,the Company has made continuous improvement and refinement in quality control and management, keeping the product qualitystable.Deviation Handling Process
Deviation closureDeviation investigationDeviation reporting
Deviations are reported to thequality assurance department ina timely manner, and necessaryemergency measures are taken.
Set up a deviation investigationteam, conduct a deviationcause investigation, evaluatethe impact caused by deviation,and formulate corrective andpreventive measures.
Complete corrective action, startCAPA, evaluate e?ectiveness,and close the deviation.
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◎Quality training for staThe Company has established a quality training system, covering new employee training, basic quality training, thematic training,external thematic training, and legal and regulatory training, to enhance the quality management awareness of sta? in each position.In 2023, the Company conducted more than 4,100 training sessions for employees on product quality and safety, covering laws andregulations, personnel control, equipment management, material control, pollution control and aseptic assurance, quality assurance,data reliability, pharmacovigilance, and job-specific skills, with a 100% pass rate for those who participated in the training forexamination.CaseTypical Training Case for the year of 2023Thematic Training on RegulationsIn 2023, BioMinhai organized a series of thematic trainings on regulations, including continuous training on regulatoryknowledge and regulatory developments for personnel in key positions, training and sharing of the new version of GMPguidelines, halal thematic training, and supervisory and management provisions on the implementation of the subject matterresponsibility for the quality and safety of medicines by the drug marketing licensee, etc., so as to ensure that the personnelkeep abreast of the requirements of the regulations and learn the advanced guideline concepts, and the vaccine productionactivities are organized in accordance with the laws and regulations.Training on Contamination Control Strategy
In 2023, BioKangtai organized four thematic trainings in conjunction with annual work priorities and industry hotspots,including the use of filters, MES system application, pollution control system personnel awareness, and equipment repairand maintenance emergency response and recovery. Through a series of targeted thematic trainings, the sta? can furtherconsolidate their mastery of the requirements of the positions they already hold, expand their business-related knowledge,and enhance their compliance and quality awareness.
One-to-one Training on MicrobiologyIn July 2023, BioMinhai invited experts to conduct training on microbiological knowledge, key factors in environmental microbialmonitoring and simulated ?lling for relevant departments. Through targeted training and integrating regulatory requirementswith practical work, the understanding of microbial knowledge and relevant regulatory requirements were deepened.Training on Simulation of Cleaning Validation and Aseptic ProcessIn November 2023, BioMinhai organized the training on simulation of cleaning validation and aseptic process to provide on-site guidance and Q&A and standardize the aseptic production operation in clean area, in order to e?ectively reduce the riskof microbial contamination, and promote the e?ective implementation and continuous improvement of quality managementwork.
Pharmacovigilance ManagementDrug safety is a major livelihood and public safety issue, related to people’s health and social harmony and stability. The Companyattaches great importance to the product lifecycle pharmacovigilance management, and continuously improved the pharmacovigilancesystem, and monitors, identi?es, evaluates and controls suspected adverse events following immunization (AEFI) through its e?ectiveoperation and maintenance in accordance with the provisions of the Drug Administration Law of the People’s Republic of China, theVaccine Administration Law of the People’s Republic of China, the Measures for the Administration of Adverse Drug Reaction Reportingand Monitoring, and the Guidelines for Good Pharmacovigilance Practices.
◎Establishment of special pharmacovigilance administration departmentsThe Company has set up pharmacovigilance administration departments, and established a Committee on Safety of Medicines (CSM)in 2020 which is responsible for dealing with major matters in pharmacovigilance. As being established in 2021, the PharmacovigilanceDepartment is responsible for the Company’s pharmacovigilance activities, which has clear job responsibilities with the full-timepharmacovigilance staff and pharmacovigilance system (PVMS) to form a whole-process and three-dimensional drug safety riskmonitoring mode, which helps ensure the smooth development of pharmacovigilance activities, timely deal with and solve the problemswith potential risks of products, and guarantee the safe use of drugs for consumers.In 2023, the Company accepted one pharmacovigilance special inspection and one pharmacovigilance inspection of ShenzhenInstitute of Pharmacovigilance and Risk Management and Market Supervision Administration of Shenzhen Municipality GuangmingDistrict Bureau during the GMP inspection, respectively, all of which were passed.
Department Committee on Safety of Medicines (CSM)
The Committee on Safety of Medicines (CSM), as the decision-making body for pharmacovigilance activities, is responsible formajor risk identi?cation, disposal of major or emergency adverse events, risk control decisions, and other major matters related topharmacovigilance.Pharmacovigilance DepartmentThe Pharmacovigilance Department, as an independent functional department, has the following main responsibilities:
? Daily operation and management of the pharmacovigilance system, including the establishment and maintenance of the system;? Monitoring, reporting and organizing investigations of adverse events following immunization (AEFI);? Management of vaccine safety signals;? Development and evaluation of risk minimization measures;? Development and implementation of pharmacovigilance plans;? Preparation and submission of periodic safety updates for vaccines and annual reports for marketing licensees, etc;? Communication of drug safety information;? Pharmacovigilance management and coordination with internal audits;? Organize pharmacovigilance-related education and training, etc.
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◎Improvement of the phamacovigilance system construction
In terms of system construction, according to the new regulations issued by the national regulatory authorities, the Company hasactively improved the construction of the pharmacovigilance related document system. At present, the Company has developed 39procedures related to pharmacovigilance and 56 record ?les related to pharmacovigilance that can meet the full lifecycle managementrequirements for all pharmacovigilance management during the clinical trial and after marketing. In 2023, the PharmacovigilanceDepartment comprehensively sorted out and revised the Company’s protocols and records in accordance with the newly issued relevantregulations by the national regulatory authorities, revising the protocol documents for a total of 25 times and the record documents fora total of 17 times, so as to make the Company’s work system documents and procedure contents related to pharmacovigilance more inline with the requirements of the regulations and the Company’s actual work needs.
◎Key links of pharmacoviligance
Key LinksQuality ProceduresMeasures and Actions
Clinical ResearchPharmacovigilance
Strictly comply with theGuidelines for Good ClinicalPractices and relatedregulations to fully protect therights and interests of subjects.
? The Company’s Pharmacovigilance Department hasconducted pharmacovigilance management for the phaseI clinical studies of Reassortant Rotavirus Vaccine, Live,Oral, Pentavalent (Vero Cell) and phase I and III clinicalstudies of In?uenza Vaccine (Split Virion), Quadrivalentby establishing management protocols for clinicalpharmacovigilance in accordance with the requirementsof relevant rules to ensure the smooth conduct of clinicalstudies.
AEFI Monitoring
and Reporting
Documents such as Monitoringand Handling Proceduresfor Suspected Post-marketingAEFI and Procedures forHandling PharmacovigilanceData are formulated for themonitoring and handling ofAEFI and data management.
? The Company proactively, comprehensively and e?ectivelycollects AEFI information during the use of the Company’smanufactured vaccines through a variety of means,including proactive visits to vaccinating doctors by salessta?, making 400 phone calls, literature searches, andfeedback from regulatory agencies, and monitors andprocesses it according to regulations.? The Company has launched and completed validationof a pharmacovigilance data management system formanaging safety-related data, which is a web-basedapplication for collecting AEFI reports during the clinicaltrial phase and post-marketing AEFI reports.
Risk Identication,
Assessment
and Control after
Marketing
Formulate the StandardOperational Procedures forthe Management of VaccineSafety Signals, the OperationalProcedures for Vaccine RiskAssessment and Control andOperational Procedures forVaccine Risk Communicationfor vaccine risk assessment andcontrol.
? The Company regularly conducts signaling tests forAEFI collected by various means every year; developsa Pharmacovigilance Plan and conducts routinepharmacovigilance activities; monitors the occurrence ofAEFI in real time; and identi?es new drug safety risks in atimely manner.? The Company assesses the safety risks of novel vaccines,analyzes the in?uencing factors, describes the riskcharacteristics, determines the type of risks, and appraiseswhether risk control measures are needed.
◎ Focusing on pharmacovigilance training
Pharmacovigilance training is necessary to realize the quality management objectives of pharmacovigilance. The PharmacovigilanceDepartment, based on regulatory requirements, comprehensively analyzes the needs of each position in the Company and the ability ofpersonnel, develops a scienti?c annual plan for pharmacovigilance training, and carries out training according to the plan.In order to regulate the quality management of pharmacovigilance and enhance the awareness of all staff, the Companyformulated the Training Procedures for Pharmacovigilance Management, and included the training into the Annual Training Plan ofthe Company, focusing on the special training of staff, including the pharmacovigilance training for specialized pharmacovigilancepersonnel, the pharmacovigilance training of new staff and the annual pharmacovigilance training of all staff. For the staff of ourmarketing center, the Company will conduct AEFI information collection and processing training at least once a year. In 2023, theCompany organized more than 33 internal and external trainings on pharmacovigilance.
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◎ Product Recall ManagementThe Company has formulated the Product Recall Management Regulations, detailing the recall procedure ?ow and the requirementsof each link. Since its establishment, the Company has not experienced any recall ordered by the medical product administrations oractive recalls. The Company conducts a mock recall at least once every two years to evaluate and ensure the e?ectiveness of the productrecall system.
◎ Supply Chain ManagementSupply chain quality management is an important part of product quality management. The Company continues to carry outregular quality management on suppliers to ensure the quality of products and solutions from the source. The Company has formulatedthe Supplier Management Regulations and the Material Management Regulations, which clearly stipulate the requirements andstandards for supplier audit, new admission, changes, auditing, quality assessment and ?le management and ensure the selection ofquali?ed suppliers to satisfy its quality requirements. In daily management, the Company conducts regular quality audit of suppliers,dynamically tracks their quality situation, assists suppliers to find problems and urges them to continuously improve their qualitymanagement system and promote their e?orts for the improvement of quality management so as to ensure product quality. For keyraw and auxiliary material suppliers, the Company reserves 2 or 3 backup suppliers to ensure proper market supply under unexpectedcircumstances.Based on the materials to be used for production provided by suppliers, the Company classi?es materials into six grades of qualityrisk control: A1, A2, B1, B2, C1 and C2, and implements di?erent quality control strategies accordingly.
Supplier Management
? Strict management of suppliers, set general quali?cation requirements and quali?cation requirements for certain materials,strictly audit the business quali?cation of suppliers and quality of materials to ensure compliance with the quality and technicalstandards of production;? The Supplier Management Regulations speci?es procedures including initial supplier selection and data review, sampleevaluation, process veri?cation, product stability research, data compilation and audit, and supplier approval;? The Company formulates an audit program every year to carry out audits and evaluations according to the classi?cation ofsuppliers;? there are regular on-site audits, written audits and remote video audits; the frequency is once a year or once every two yearsaccording to the importance of the suppliers; the suppliers of the auxiliary materials and internal packaging materials in A1complete at least one audit per year; audit coverage: supplier quali?cations, quality management systems and regulatorymeasures; supervise the improvement of de?ciencies, and discontinue or revoke the quali?cation of suppliers who do not meetthe requirements;? The Company signs Quality Assurance Agreement with suppliers of A1, A2 and B1 grades to ensure that the products providedby them meet the Company’s quality standards and requirements.
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Customer Orientation to Enhance Service Eciency
Customer Services
The Company has built perfect customer communication channels and complaint management procedures, and collects customerfeedback through 400 customer service hotline and other ways, thus providing timely and e?ective communication access and solutionsfor customers. The Company has formulated the Customer Feedback and Complaint Management Procedures to standardize thework?ow of solving customer feedback. After receiving customer feedback, the Company ?rst carries out internal communication andinvestigation for the issues, and organizes relevant departments to formulate corrective measures and preventive measures to ensuretimely and proper resolution of the issues raised by customers.Customer satisfaction is one of the indicators to measure the performance of product and service quality. The Companycontinuously conducts annual customer satisfaction surveys and obtains feedback from customers on its products and services throughthe Customer Feedback Collection Form, so as to fully understand customer opinions and suggestions and constantly improve thequality of service. In 2023, the Company conducted satisfaction surveys with disease control and prevention organizations as customerswith generally high satisfaction scores.
◎ Customer feedback management procedure
Sales and Marketing Center
Related Departments
Sales and Marketing CenterCollect customer feedbackand receive complaints
Quality Management Centerorganizes relevant departmentsto carry out investigation anddevelop corrective andpreventive measures
Assist in the investigation, replyto customers and closecomplaint
Information Security and Customer Privacy Protection
The Company strictly abides by the Personal Information Protection Law of the People’s Republic of China, the Data Security Lawof the People’s Republic of China and other relevant laws and regulations, and has formulated the IT-01-001-Information ManagementRegulations and the C-00-I-0-009 Personal Information Security Regulations, which provide strict data security management andpersonal information security. In 2023, the Company carried out an assessment on information security multi-level protection inaccordance with the Information Security Multi-Level Protection Management Rules, which provides support for information security.In terms of customer privacy protection, the Company implements a strict confidentiality agreement system and sets exclusivepermissions for customer information. The information department of the Company will regularly check the permissions, and maketimely corrections to any discovered problems. We attach great importance to cybersecurity and privacy protection, and has addedsecurity measures for the server to enhance privacy protection. In 2023, the Company did not have any incidents of customer informationor privacy leakage.The Company invites external experts to conduct relevant training to improve employees’ awareness and recognition ofinformation protection. The Company actively carried out cybersecurity online and offline simultaneous publicity during the "2023National Cybersecurity Awareness Week" which was from September 11, 2023 to September 17, 2023, mainly including knowledge onnetwork security prevention, ransomware prevention, personal information protection, and anti-telecommunications fraud, to improveemployees’ awareness of cybersecurity and personal information protection.
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Responsible Sales and Professional Marketing
As for the marketing, the Company strictly abides by the Advertising Law of the People’s Republic of China, the Trademark Lawof the People’s Republic of China and other relevant laws and regulations, and industry norms. With strictly adhering to the principlesof accuracy, clarity and transparency of marketing, the Company actively carries out diversi?ed academic exchanges and promotionactivities about the research results in the ?eld of vaccines, product knowledge, disease prevention, vaccine immunization schedulethrough various means, such as academic conferences, expert lectures, online and o?ine knowledge promotion, and always insistson ethical, scientific and objective promotion to enable the public to better obtain information about vaccine products and betterunderstand the knowledge of vaccine-related diseases.In addition, the information published on professional pharmaceutical magazines by the Company is in compliance with therequirements of the Pharmaceutical Advertising Laws of Guangdong Provincial Food and Drug Supervision Administration, and hasobtained relevant advertising approvals.
AccuracyClarityTransparency
Promotional or stated
information is consistent with
approved labels, with no
advertising or promotional
materials that have not been
approved by compliance and
marketing departments.
Product information used ordisseminated to the public iscomplete and clear, with no falseor misleading statements.
The products’ performanceand safety information isdescribed comprehensively,without concealing itspotential risks, so as not tocause any form of informationinequality or misinterpretationof information.
◎ Three principles of responsible marketing
Three principles
Strict Review of Promotion MaterialsIn order to standardize the compliance review of promotional materials, the Company has formulated the Regulations on theProduction, Collection and Management of Promotional Materials and Items, which specifies the production process and approvalprocedures for promotional materials. The promotional materials for products were prepared by product division, and reviewed bymedical department, then jointly re-checked by marketing and medical director. It can be only put into use after the approval by thehead of marketing center. Review and check at stages are placed for ensuring the accuracy, clarity and transparency of promotionalmaterials or declarative information.
◎ Trainings on Responsible MarketingIn order to strengthen the standardized management of the responsible marketing, through online and offline approaches,the Company organizes trainings on responsible marketing and related compliance matters for employees in the sales positions inaccordance with the requirements of the Sales Management Regulations, to improve employees’ compliance awareness and businessskills, in respect with related laws and regulations, internal regulatory, compliance and integrity, product related knowledge, etc. Withregard to product information, the sales sta? shall not disseminate functions and information beyond the product description, andshould never exaggerate the functions of products and technologies or conceal their potential risks.
◎ Establish Vaccine Science Popularization Base
In December 2019, the first vaccine science popularization base of Chinese Preventive Medicine Association was officiallyinaugurated in BioKangtai, which was jointly built by BioKangtai and Chinese Preventive Medicine Association as a leading, authoritativeand professional vaccine science popularization base in domestic to integrate vaccine science resources, give full play to professionaladvantages, carry out academic exchanges, and popularize vaccine technology and knowledge scientifically, deepen the public’sscienti?c understanding of vaccines, as well as protect the healthy development of China’s vaccination.
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Protecting Environmentfor Sustainable Development
Adhering to the concept of resource conservation and economic and environmental sustainable development,BioKangtai has developed a number of management systems and procedures in accordance with the EnvironmentalProtection Law of the People’s Republic of China, the Law of the People’s Republic of China on the Prevention and Controlof Atmospheric Pollution, the Law of the People’s Republic of China on the Prevention and Control of EnvironmentalPollution by Solid Waste, the Law of the People’s Republic of China on the Prevention and Control of Water Pollution andlocal laws and regulations, to continue to build and improve the environmental management system, strengthen thepolicy guarantee of environmental management, give priority to the comprehensive utilization of resources, energyconservation and emission reduction, and strictly implement environmental protection requirements such as emissionpermits and pollutant discharge standards. With the aim to save resources, reduce energy consumption, pollution andcarbon, improves quality and e?ciency, BioKangtai actively ful?lls the social responsibility of environmental protectionand adheres to green development through upgrading equipment and facilities, energy conservation and consumptionreduction, rational use of resources and e?ective waste management measures. In 2023, BioMinhai was underwent acomprehensive green credit evaluation by Ecological Environment Bureau of Beijing Daxing District on the environmentalcompliance, pollution control and emission reduction, low-carbon cycle, scienti?c management and social contribution,and was honored as the "Five-star Green Enterprise in Daxing District".
Improving Environmental Management andFullling Environmental Responsibilities
Environmental Management OrganizationThe Company takes “strict pollution control, scienti?c management, energy conservation and emission reduction, and continuousimprovement of energy e?ciency” as its management principles and has established an environmental management structure withwell-de?ned responsibilities. The Environmental Health & Safety (EHS) committee is the Company’s environmental management body,and the O?ce of Safety, Health and Environmental Management is responsible for the regular environmental management. We requireall employees to sign a letter of responsibility for EHS targets, and associate environmental management performance with the quarterlyperformance appraisal of middle and senior management.Person in ChargeMain ResponsibilitiesDirector of EHS Committee
? Responsible for the approval of the Company’s annual environmental targets and
related policiesDeputy Director of EHSCommittee
? Responsible for the approval of environmental protection issues within the scope of
responsibility? Responsible for the approval of environmental protection evaluation resultsHeads of Departments
? Responsible for organizing and supervising the implementation of environmental
protection e?orts in all teams and departments of the Company? Responsible for the evaluation of the environmental protection e?orts by teams and
departmentsO?ce of Safety, Healthand Environmental Management
? Responsible for the implementation of the departmental environmental protection
e?orts, and break down the department’s annual environmental protection goals to
each team? Responsible for supervising the implementation of environmental management in the
department, and organizing self-assessmentHeads of Teams
? Responsible for the implementation of the annual environmental protection e?orts of
the team? Responsible for the self-assessment of the completion of the team’s annual
environmental protection goalsEnvironmental Management Procedures
The Company strictly abides by relevant laws and regulations on environmental protection, and has formulated a series ofenvironmental management systems and procedures, such as Environmental Protection Management Regulations, Solid WasteManagement Regulations, Operating Procedures for Wastewater Treatment System, and Management Procedures for WaterQuality Monitoring in Wastewater Treatment Stations, to standardize environmental monitoring, pollution prevention and control,comprehensive utilization of Three Wastes (industrial wastewater, waste gases and residues), “Three Simultaneities” for constructionprojects, and management and maintenance of environmental protection facilities, so as to ensure the effective operation ofenvironmental management.
2023 ANNUAL SOCIAL RESPONSIBILITY REPORT
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Environmental Impact AnalysisThe main business of BioKangtai is the R&D, production and sales of vaccines for human use. Through the use of biologicaland chemical raw materials, vaccine production is conducted with processes of cell fermentation, harvesting, crushing, puri?cation,inactivation and adsorption, consuming energy such as electricity, natural gas and steam, and generating waste water, waste gas,harmless waste and hazardous waste. The Company complies with the provisions of the Pollutant Discharge Permit, monitors andrecords pollutants by manual and automatic methods, and properly disposes of all types of solid waste to strictly control the impact ofproduction discharges on the environment.
Pursuant to the Implementation Measures of Shenzhen Compulsory Liability Insurance for Environmental Pollution, BioKangtai hasproactively responded to the compulsory liability insurance system for environmental pollution management, accepted a third-partyassessment and purchased compulsory liability insurance for environmental pollution to avoid environmental incidents by means ofthird-party risk management and environmental management.
Screening Environmental Impact and TacklingClimate Change
Emission Source Identication and Carbon Accounting
The main types of energy consumed by the Company in production are electricity, steam, natural gas and minor amounts ofgasoline, diesel and lique?ed petroleum gas (LPG). Electricity for production is provided by the city’s public power grid, mainly usedfor production equipment; steam is used mainly for utilities and equipment supporting production; natural gas is used mainly forboilers; gasoline and diesel are used for vehicles of the Company, and diesel is also used for emergency power generation and regularmaintenance of generators; LPG is used for the Company canteens. We identified the carbon emissions for Scope I and Scope II asfollows:
Scope of GHG EmissionsSourceProcess
Scope I
Natural gasDieselGasolineLPG
Boilers and canteensThe Company’s transportation vehicles and generatorsThe Company’s passenger vehiclesThe Company’s canteens
Scope II
Purchased electricitySteam
Production department,auxiliary production department andother departmentsPublic works and equipment
In 2023, BioKangtai veri?ed its carbon emission to produce a greenhouse gas quantitative report and quantitative inventory, andcarried out carbon trading on Shenzhen Emission Rights Exchange Co., Ltd., actively realizing the green and low-carbon development ofthe enterprise.
In 2023, to further understand the main sources of carbon emissions and emission data, BioKangtai commissioned ShenzhenCarbonet Technology Development Co., Ltd. and BioMinhai commissioned China Quality Certification Centre to conduct a carbonaccounting, which determined their organizational boundaries and carbon emissions.
In 2023, BioMinhai purchased 4,150 MWh of green power through market-based trading of electricity, reducing carbon emissions byapproximately 2,500 tons.
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◎ Energy Management System
Energy Management TeamThe Company has an energy management team, headed by the production manager, with members fromdi?erent departments. There is an energy consumption statistician in the team responsible for the Company’senergy consumption statistics, which are archived in the energy utilization and management platform.Meanwhile, the Company has carried out energy audit and clean production to continuously improve itsenergy management level.Establishing Energy Supervision SystemThe Company strengthens energy control based on its energy management system and conducts regularsupervision, inspection and assessment.
Energy StatisticsEnergy statistics is an important aspect of the Company’s energy management. To this end, we have set upstatistical units at three levels: company, area and workshop. Energy statisticians have been set up at eachlevel for energy statistics and reporting to the energy management team. By establishing a statistical accountof energy consumption, we have realized IT-based management of energy consumption at all levels, which isconducive to statistical analysis of energy consumption.Energy-saving Performance AssessmentThe Company has established an accountability system for energy-saving targets and an energy savingevaluation system, taking the annual energy-saving target and the monthly energy consumption data asthe energy consumption pointer. Meanwhile, the Company has collected the energy-saving managementmeasures of each workshop, set up projects, make modi?cations and evaluate their e?ectiveness; eachenergy-using department is assessed, and the assessment results are directly related to the monthlyperformance and annual assessment performance of the responsible person.Energy Saving TrainingThe Company actively carries out publicity and training on energy saving, analyzes the status of energy useevery month, discusses and con?rms abnormal consumption, formulating a report. The Company also holdsquarterly energy consumption analysis meetings to discuss problems in the Company’s energy consumptionand management, as well as the orientation for energy saving and clean production.
Energy Management
The Company attaches importance to energy management. Through the establishment and improvement of energy managementteam, energy management system, energy measurement system and energy-saving performance assessment and training, weconstantly improve our energy management capability and the employees’ awareness of energy saving and emission reduction.In 2023, based on the energy planning report of 2022, BioKangtai continued to strengthen energy management, improved the rateof equipping of the Company’s metering instruments, and carried out the Lean Production Competition, energy waste site inspectionand assessment and other activities, so as to improve the e?ciency of the Company’s use of energy resources.
In 2023, BioMinhai commissioned Guorun Venture Capital (Beijing) Technology Co., Ltd. for green diagnostic service, formulating anenergy diagnostic report. Through the energy diagnostic, it helps enterprises to explore their potential, improve the e?ciency of energyresource use and management, and reduce pollutant emissions, thus laying the foundation for applying for green factories.
Improve Energy Eciency, Reduce Cost and Increase EciencyThe Company has established a multi-dimensional system of energy saving and emission reduction measures, involving thepurchase of energy-saving equipment, renovation of equipment for energy saving and equipment operation with intelligent frequencyto meet energy saving and sustainable development of production. In addition, the Company carries out leakage inspection in dailyequipment management and regularly maintains the equipment and facilities to ensure their integrity and avoid energy waste.◎ Measures for energy eciency improvement
Purchase of Energy-
savingEquipment
? The Company considers the brand, e?ciency and capacity of the equipment in its procurement.
Equipment with energy-saving inverter and intelligent centralized control system, such as airconditioners, pumps and refrigeration equipment, are selected for higher energy e?ciency.
EquipmentRenovation forEnergy-saving
The Company carries out renovation of some equipment and facilities for energy-saving operationand maintenance control：
? Replace the round cooling water tower with energy-saving square water tower? Replace all lights to LED lights, renovate smart sensor lights and increase solar lights on the roof? Design RO and steamcabinetsterilization and vacuum vump domestic drinking water system for
wastewater recycling for cooling towers? Replace the cooling towers, chillers and humidi?ers? Renovate the power station for heat recycling? Replace insulation material for 2A water injection station pipeline? Replace low temperature coolers for 2B power station? Install intelligent centralized control energy saving system for the chilled-water system? Reuse of cold air from roof exhaust system? Lower the steam heating temperature of the water-for-injection distribution system? Replace the insulation materials and steam traps that have been used for many years in somefacilities and equipment.? Switch the facility equipment on and o? on demand? Renovate 2B water system to replace the puri?ed water machine and distilled water machine withhigher energy e?ciency? Add a power monitoring system for 5# power distribution room and direct the main distributionroom
Equipment Runningwith Intelligent
Frequency
? For integrated energy management, the Company adjusts the operation of some public
engineering equipment to intelligent frequency, reasonably distributes the load, and reduces
energy waste on the premise of meeting the needs for production, R&D, storage and inspection.
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Emphasizing Waste Prevention & Control andReducing the Environmental ImpactThe Company strictly complies with the relevant laws and regulations, such as the Measures on the Administration of PollutantDischarge Permits, and applies for Pollutant Discharge Permit. We conduct regular pollution discharge inspection and ?ll in quarterlyand annual implementation reports on the National Management Platform for Pollutant Discharge Permits in accordance with relevantregulations. In 2023, the Company did not receive any relevant administrative penalties for excessive pollutant discharge.
◎ Wastewater ManagementAs a vaccine manufacturer, wastewater treatment and discharge in compliance is the focus of our environmental protection e?orts.The main pollution indicators for wastewater produced by the Company include pH, chemical oxygen demand (COD), suspended solids,ammonia nitrogen (NH3-N), total nitrogen, volatile phenols, and total phosphorus.
The Company strictly complies with the provisions of relevant laws, regulations and normative documents, such as Law of thePeople’s Republic of China on Prevention and Control of Pollution from Water Pollution, Discharge Standards for BioengineeringPharmaceutical Wastewater and Integrated Wastewater Discharge Standard, and has formulated management documents such asOperating Procedures for Wastewater Treatment System, Management Procedures for Water Quality Monitoring in Wastewater TreatmentStations and Operating Procedures for Wastewater Discharge, which provide guidance on the Company’s wastewater treatment,monitoring and operation.The Company has wastewater treatment stations, which are operated in strict accordance with the requirements of relevantenvironmental protection regulations of the country. Industrial wastewater is discharged into the public sewerage network aftertreatment at the wastewater treatment stations. We have established an online monitoring system to monitor COD, ammonia nitrogen,pH, total phosphorus and other pollution indicators in wastewater on a daily basis, and commissioned a third party to conduct regularsampling and testing of wastewater to ensure compliance with wastewater discharge standards. In 2023, BioMinhai completed theprocess control optimization of wastewater treatment stations for remote monitoring. During the reporting period, the Company did nothave any incidents of excessive or illegal discharge of wastewater.
◎Air Emission Management
The main pollutants in the air emission produced by the Company are volatile organic compounds. We strictly abide by theprovisions of relevant laws, regulations and normative documents such as Law of the People’s Republic of China on Prevention andControl of Air Pollution, Discharge Standards for Odorous Pollutants, Discharge Standards for Air Pollutants for the PharmaceuticalIndustry, and Emission Control Standard for Industrial Enterprises Volatile Organic Compounds, and have formulated the EnvironmentalProtection Management Regulations to clarify the management requirements for air emission.
All our air emission vents are designed and installed in accordance with national standards; production waste gas and odorousair from animal rooms are treated by high-e?ciency ?lters and activated carbon adsorption before discharge; fumes from canteensare treated by fume puri?ers before discharge. Meanwhile, we have commissioned a third party to conduct regular air emission testingto ensure that the emission concentrations of pollutants in waste gas comply with national standards. During the reporting period, theCompany did not have any incidents of excessive or illegal emission of waste gas.
◎ Waste ManagementThe waste produced by the Company includes general waste and hazardous waste. We strictly abide by the Law of the People’sRepublic of China on the Prevention and Control of Environmental Pollution by Solid Waste, Management Measures for HazardousWaste Transfer and other relevant laws and regulations. We manage and store hazardous waste, such as medical waste, waste organicsolvents, waste alcohol, waste hazardous chemicals and waste reagents, in accordance with the regulations, and hand them overto qualified organizations for disposal through the Company’s EHS department. For domestic waste, general industrial solid wasteand other non-hazardous waste, we hand over them to the sanitation department for disposal by complying with the Measures ofShenzhen Municipality on the Classi?cation and Reduction of Domestic Garbage and the Beijing Municipal Regulations on Managementof Domestic Waste and other relevant regulations. During the reporting period, the Company did not commit violations of laws andregulations related to waste disposal.
◎ Use of Water ResourcesThe Company consumes water from the municipal water supply, which is not a major resource in production, leading to a low riskof water shortage. We have developed a water conservation management system and have taken active action to drive the achievementof related targets. By improving the utilization of circulating and recycling water from boiler steam condensate process and coolingtower, the Company achieved water conservation e?ectively.
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The Company always adheres to the core values of "dedication to people’s health", has developed a series of humanresource management systems such as employee employment, training, promotion, welfare, rights and interestsprotection, and is committed to creating a safe, warm and harmonious o?ce environment, building harmonious andstable labor relations, e?ectively safeguarding the legitimate rights and interests of employees, and realizing thecommon growth of employees and the enterprise.
? Talent is the core force of company development and the cornerstone for sustainable development. We believe that weshould let capable sta? take up important positions, mediocre employees be laid o? and those with average ability engagein general work.? The employees with good moral character, healthy body and mind, excellent performance and innovative spirit are themost valuable assets of the Company.
Our Talent Philosophy
The Company adheres to the principle of equal employment and provides equal opportunities for employees. By strictly complyingwith the requirements of the Labor Law of the People’s Republic of China, the Labor Contract Law of the People’s Republic of China andother laws and regulations, the Company has standardized the labor and employment system to ensure that employees are treatedequally without discrimination based on their age, gender, race, place of origin, religious beliefs and other factors, and that child laboror forced labor is strictly prohibited. Meanwhile, the Company has formulated the Labor Contract Management Measures, Compensationand Welfare Management Rules, Attendance and Leave Management Measures, Performance Management Rules, Work-related InjuryManagement Rules, and other regulations to protect the legitimate rights and bene?ts of employees.
Recruitment
Management
? Recruitment: We insist on fair employment and prohibit the employment of child labor or forced labor.? Dismissal: We terminate labor contracts of di?erent types in accordance with our Labor
Contract Management Measures to protect the legitimate rights and interests ofemployees.
Compensation
Management
? Compensation: We provide competitive compensation and bene?ts based on the principle
of equity. Our compensation system is based on the value of positions, andwe reward employees fairly based on their performance, after taking intoaccount the continuous and indirect contributions of each position. Weadhere to the performance-oriented principle and encourage value creation.? Commercial insurance: We provide supplementary medical insurance services for employees,
and our retired employees and interns are covered by accidentinsurance policies.
Working Hours
and Leave
? Overtime: Overtime pay is paid according to the Labor Law of People’s Republic of China.? Leave: Legal holidays and paid leave such as wedding leave, maternity leave, sick leave,
and paternity leave are implemented according to national laws and regulations;employees are entitled to annual leave as stipulated by the Company.
Treatment of
Work-related
Injuries
Employees are entitled to leave for work-related injuries. The Company has formulated theManagement Measures for Work-Related Injuries in accordance with the Regulations onWork-Related Injury Insurance of Guangdong, which stipulates details of work-related injuryidenti?cation, declaration, and treatment, as well as matters such as labor relations anddispute handling.
Overview of BioKangtai’s employee recruitment and basic rightspolicies
Fair Employment and Protecting Employee Rightsand Interests
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People-orientedfor Building Harmonious Relationship withEmployees
Employee Welfare SystemThe Company has established a perfect welfare management system and providing diversified benefits for different kinds ofemployees. As for strengthening the standardized management of employee bene?ts, we have formulated Welfare Measures for Workersand Implementation Measures for Special Funds for Trade Union Employees to ensure the transparency and e?ective implementation ofour welfare policies.
Creating a good working atmosphere
Employeesympathygift and welfare
for needyemployees
Benets for
femaleemployees
Annualhealthcheckups
Complementarymedicine
Housingallowance
Holiday benet
Allowance foroccupational safetyand positions ofspecialresponsibility
Wedding gift,condolences for
bereavement
Seniorityallowance
Birthday
benet
Travelallowance
Meal allowance,high temperature
/ heatingallowance
◎ Employee welfare
The Company adheres to a people-oriented approach and has established a labor union. As a platform for communication withemployees, the labor union takes the initiative to listen to employees’ voices and respond to their demands;
in addition, employees can feedback problems or give suggestions to the department head or other responsible personsthrough face to face or communication.Meanwhile, the Company carries out various activities as humanistic care to create conditions for employees to maintain a work-life balance and a friendly and energetic working atmosphere, enhancing the sense of belonging and cohesion of employees inthe Company.
Caring for Employees and Helping Them Develop
In order to continuously improve the know-how knowledge, professional level and comprehensive quality of employees andcultivate an excellent staff team, the Company has formulated the Training and Management System and Employee InductionManagement Procedures, establishing a sound staff training system. Through post knowledge and skills training, GMP relatedknowledge training and core sta? career improvement training, the comprehensive quality and professional ability of employees arecontinuously improved, and employees’ recognition of corporate culture is strengthened, so as to realize the common growth andmutual achievement of employees and the Company. Employee Training
Training for New Employee
After new employees join the company, they must
receive induction training; they can start working
only after they are quali?ed.
Professional and Technical Training
For the sta? responsible for production and qualitysystems, we provide systematic training on relevantlaws and regulations, professional knowledge andthe ability to solve regular problems.
Management Training
Develop Eagle Training Camps, advanced workshop
training programs and management program to
nurture the Company’s management sta? and
support them to realize their potential at all levels.
For the management personnel, we provide targeted
rolling lectures and management practical exercises
to enhance the internal cycle of the Company’s talent,
motivate talent, reduce the loss of talent, ensuring
the sustainable development of the Company.
External and Outsourced TrainingParticipate in external training, academic exchangesand visits, or outsource senior experts andprofessional trainers to the Company to provideprofessional training to employees.
◎ School-enterprise collaborationThe Company attaches great importance to school-enterprise collaboration, and sets up management training classes, professionaltraining classes, vaccine-featured classes, etc. through collaboration with well-known universities, to provide educational opportunitiesfor outstanding management and technical talents and encourage employees to improve themselves. We fully encourage and supportfront-line employees to acquire academic certi?cates and professional and technical quali?cations by taking examinations and furthereducation, so as to connect employee learning and talent development closely to enable them grow.
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To improve the professional and management abilities of employees in a targeted manner, as of July 2023, the Company sent 13 Keyemployees to pursue and ?nished part-time master’s degrees in colleges and universities, such as programs in MBA and Biochemistryand Molecular Biology Technology at Jinan University, which provide opportunities for further education for sta? with bachelor’s degree.The Company provides programs for di?erent sta?ng levels via an online learning platform to empower management and promotionpersonnel at all levels. The Company jointly plans and organizes check and training planning projects with external consulting agencies,and carries out more than 40 mentoring training and discussion activities to provide solutions for training and cultivation of key talents.At the same time, some key technicians were invited by relevant colleges and universities to teach students majoring in biotechnologyand participate in the cultivation of future talents in the industry.Grant multiple awardsIn order to improve employees’ enthusiasm, promote the advanced culture and set up exemplary models, the Companyannually awards and honors individuals and teams who have made outstanding contributions to its business development, e?ciencyimprovement and compliance operation e?ciency, to encourage employees to keep forging ahead.
? Outstanding Employees, Excellent Manager? Excellent Department, Excellent Team, Excellent Group? Excellent Activists, Excellent Party Members? Annual Special Contribution, Special Diligence·Advanced Collective
? Winners will be honored at the Company’s annualmeeting and receive bonuses
Performance and Promotion
In order to stimulate the work enthusiasm of employees and meet its strategic development needs for talent security andemployees’ own career development needs, the Company has formulated the Promotion Management Rules, Performance ManagementMeasures, Monthly Employee Bonus Plan and Annual Performance Evaluation & Merit Pay System to standardize the career developmentof employees and ensure the rationality, objectivity and justice of employee promotion.
In terms of standardizing promotion management, the Company has gradually established a sound promotion system and careerdevelopment channel for employees, carried out promotion evaluation in the form of professional knowledge written test, 360-degreetalent evaluation, promotion defense and continued to carry out professional technical review and management personnel evaluationsystem, so that the multi-channel development mode is further closely related to employee development. Competition for the job,trial, evaluation and recruitment is operated at levels; leveraging established BioKangtai 678 leadership model, clear standards areput forward for di?erent managements. According to business and personnel characteristics of each technical department, promotionstandard is established at technical sequence. At the same time, we will constantly standardize the promotion process, and carry outtracking and support for promotion.
In terms of performance management, we can provide basis for human resource decisions such as salary adjustment or grading,job change, talent cultivation and employee motivation through scientific and reasonable evaluation of employees’ performance;the Company regularly conducts performance evaluations for middle and senior sta? as well as junior sta?, where the performanceevaluation for junior sta? is carried out monthly with a performance-based bonus system. In addition, the Company has set up awardsand rewards system to recognize advanced employees and motivate all employees to strive for excellence.
AwardsPresentation of Awards
Safe Production and Safeguarding Employees
By strictly abiding by “Law of the People’s Republic of China on Work Safety”, “FirePreventionLawofthePeople’sRepublicofChina” and other relevant laws and regulations, the Company establishes a perfect work safety managementsystem to carry out the policy of "safety first, prevention first, comprehensive treatment" for building a healthy and safe workingenvironment.Biosafety ManagementAs a manufacturer specializing in the research, development, production and sales of human vaccines, the Company deeplyunderstands the importance of biosafety management under the new situation from the overall national security strategy. Basedon the Biosecurity Law of the People’s Republic of China, Biosafety Standards for Vaccine Production Workshop and other biosafetylaws and regulations, the Company continues to strengthen the bottom line thinking and risk awareness, and actively ful?lls the mainresponsibility of biosafety in the post epidemic era. In 2023, the Company destroyed the new coronavirus strains and infectious samplesand sent for storage in the light of the relevant requirements of National Health Commission. At the same time, the Company promotesthe implementation of national key research and development program topics, actively promotes the communication of constructionof biosafety laboratories industry, and improves the biosafety management system covering the whole company based on systematicanalysis and assessment of biosafety risks. Through e?ective operation and maintenance of the system, daily biosafety inspections andregular emergency drills, the Company e?ectively applies the biosafety standards into the whole chain of vaccine production, so as tosafeguard the safety of vaccines for the public.
At the Guangming base and Xili base, the Company has constructed BSL-2 laboratories and completed the filing processaccordingly in 2023 for better facilitating the R&D and experimental activities for vaccine production.◎ Biosafety management systemKey Area RiskManagement
? Laboratory facility safety: Ensure that the buildings and facilities meet national standards.? Management system (covering all steps for production operations and control of articles): Strict controlof core personnel in biosafety risk workshops and laboratories access; standardization of operationsat each workstation; strict control of article sterilization; waste disposal and regular monitoring of theenvironment; update management requirements according to the policy dynamics.
DailyMonitoring and
Management
? Implement the monitoring and supervision by full-time and part-time biosafety sta?; conduct self-inspection of biosafety risk workshops and laboratories from time to time; face on-site inspections bycompetent authorities at all levels; conduct annual reviews.
Enhancement
of SafetyAwareness
? Graded training: Training is divided into company-level, department-level and job-level, and the trainingcontent of each job is clearly de?ned according to the job training matrix.? Training assessment: Regularly complete biosafety job quali?cations to ensure personnel have biosafetyskills.? Emergency drills: The Company regularly conducts biosafety emergency drills, with scenarios including:
infectious material spill, broken isolator gloves, experimentalists’ hands stabbed by sharp objects,anti-terrorism drills, information security, ?re extinguishing and escape. All employees in the biosafetylaboratory participated in the drills.
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Emergency drill
? In 2023, the Company organized 11 emergency drills for accidents among 1,200 employees,covering ?re evacuation, elevator entrapment, hazardous chemical leakage, etc., whichcomprehensively enhanced the Company’s employees’ ability to deal with accidents and safetyawareness;? In 2023, the Company organized ?re escape emergency drills, emergency drills for hazardous
chemical leakage, practical drills in limited space, and emergency drills for elevator entrapment.
◎Biosafety Training
In 2023, the Company conducted biosafety training on multiple topics, focusing on the learning of biosafety-related laws andregulations and risk assessment, for managing risk in biosafety risk workshops and laboratories to continuously improve the safetyawareness and performance of employees. The Company actively participates in and organizes various biosafety forums in respect ofthe latest trends in the industry, actively promotes industry exchanges on biosafety laboratory construction, and shares the managementexperience on high-biosafety risk workshop to makes progress together, broaden the vision and keep improving with good socialbene?ts.Production Safety and ManagementAdhering to the policy of "safety first, prevention first and comprehensive treatment", the Company attaches great importanceto employees’ occupational health and safety production, and strictly abides by relevant laws and regulations such as the Law of thePeople’s Republic of China on Safety Production, the Law of the People’s Republic of China on Fire Fighting, the Law of the People’sRepublic of China on Safety of Special Equipment, and the Regulations on Safety Management of Dangerous Chemicals. The Companyhas established a series of production safety rules and regulations, fully implemented an accountability system, and also increased theinvestment in production safety, materials, technology and personnel to ensure safety and actively improve production conditions.The Company ensures safe production by improving safety production standards, creating a culture of safe production, developingan accident emergency response system, strictly controlling hazardous chemicals, and strengthening management of firefightingand other special equipment. The Company had no production safety accidents of average or above in the past three years. In 2023,BioMinhai was honored as the winner of Ankang Cup in Daxing District, Beijing.
◎Compliance management on safe production
I’m responsible for the safety of myself, others, and the Company; all those responsible for safety problems must be held accountable.
BioKangtai’s safety philosophy
Safety management in production? Improve the EHS management system and revise various management systems, such as Labor
Protection Supplies Management System, Competence Awareness Management System, and EmergencyPreparedness and Response Control Procedures;? Identify all kinds of workplace hazards by regularly carrying out safety inspections, and strengthen the
hidden danger indenti?cation to promote timely recti?cation.
Safety production training? Revise the Manual for Three-level Safety Training for New Employees to optimize the process of three-level safety training for new employees, and clarify the responsibilities of each department;? Organize a total of 12 safety trainings in 2023, covering a number of contents such as emergency rescue,tra?c safety, risk source control and training of entire sta?;? Organize visits to emergency science education bases by all departments of the Company, carry out
movie watching activities about production safety, and actively promote production safety laws andregulations.
◎ Key elements in production safety management
? Strict implementation of the System of Dangerous Chemicals Safety Management to control the purchasing,transportation, storage, use and disposal of hazardous chemicals;?Timely update hazardous chemicals storage ledgers, strictly control personnel access management,
actively cooperate with government regulatory departments for special inspections, and strengthen safetymanagement and control measures for hazardous chemical warehouses.? Regular training of the safe management on hazardous chemicals is carried out to improve the safe operation
and emergency response capability of the employees.? In 2023, the Company implemented the requirements of the Beijing Laboratory Special Recti?cation Programand passed the acceptance of the Beijing Laboratory Special Rectification organized by the EmergencyResponse Bureau.? Update the Company’s ?re?ghting formation personnel and ?re accident escape emergency drill program,regularly organize all employees to participate in ?re evacuation and escape drills, and carry out training onpractical ?re?ghting skills.? Regularly maintain ?re protection facilities, and replace parts and components in a timely manner to ensuresmooth operation of the ?re protection system and timely and e?ective warning information.? Organize employees to participate in intermediate ?re?ghting operator skills training, strengthen employees’practical ?re?ghting facility ability, improve the mechanism of communicating early warning information,and ensure the check of monitoring area in a timely manner.? In 2023, the Company completed the construction of "Four Fast" ?re control room in Beijing.? Revise the Special Equipment Safety Manual to amend the annual inspection report template for specialequipment based on the views of the regulatory authorities and the use of the Company’s departments.? According to the requirements of the Market Supervision Administration, conduct the "daily control, weeklyinspection, monthly scheduling" and daily safety inspections of special equipment, hold regular safetymeetings to eliminate risks and hidden dangers of equipment operation in a timely manner.? Organize the workshop sta? to participate in the special equipment safety operation procedures training toenhance the sta?’s safety operation and emergency disposal capacity.◎ Occupational Health and Safety Management
The Company attaches importance to the occupational health of employees and strictly abides by the Law of the People’s Republicof China on the Prevention and Treatment of Occupational Diseases , the Regulations on the Management of Occupational Health inthe Workplace and other laws and standards, and has formulated the Occupational Health Management Regulations and the LaborProtection Equipment Management Regulations, to prevent, control and eliminate occupational hazards and protect the employees.The occupational disease hazards involved in the Company’s production include high temperature, noise, ultraviolet radiation,sodium hydroxide, formaldehyde, phenol, and nitrogen dioxide. We protect our employees’ occupational health through compliancewith occupational health procedures, good occupational health supervision and protection, enhancement of on-site occupational healthmanagement, and regular occupational health-related training. As of the end of the reporting period, the Company had no accidentsrelated to occupational disease hazards.In 2023, BioMinhai was awarded the title of "Beijing Healthy Enterprise" because of perfecting the health management system,improving the healthy environment, creating a healthy culture and comprehensively improving the health level according to theTechnical Guidelines for the Evaluation of the Construction of Healthy Enterprises in Beijing.
HazardousChemicalsManagement
FireManagement
SpecialEquipment
FireManagement
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◎ Occupational health management
? Revise the Occupational Health ManagementSystem, and prepare the occupational healthoperating procedures for key posts;? Strictly abide by the “Three Simultaneities”procedures: occupational disease preventionfacilities are designed, constructed and putinto production and use with the main projectsimultaneously；? Develop the emergency rescue plan againstoccupational disease hazards and conductemergency drill for occupational hazards.
? Set up safety marks or warning marks in conspicuousplaces where operational risks arise or exist,workplaces where occupational disease hazardsoccur, jobs, equipment, materials (products)packaging and storage places;? Supervise the wearing of protective equipment inworkplace and proper use of occupational hazardprotection facilities;? Regular maintenance and checks on occupationalhazard protection facilities.
? Engage quali?ed organizations to carry out workplace occupational hazards inspection with all inspection resultsmeeting standards;? Implement the reporting of occupational hazards, and obtain the Receipt of Occupational Hazards Reporting.
? Complete occupational health ?les and workers’health monitoring ?les;? Organize regular physical examinations foremployees and equip them with protectiveequipment against occupational diseases；? In 2023, the Labor Protection Supplies ManagementSystem was revised to comprehensively regulatethe management of procurement, transportation,storage and issuance of labor protection supplies,strictly implement the wearing of labor protectionsupplies in workplaces, and grasp all occupationaldisease prevention and control measures.
? Provide regular occupational health training for
employees before and during their employment;? Carry out the training and assessment mode, andemployees who have passed the assessment maybe engaged in the corresponding operations.
Occupational Health Regulations
On-site Management ofOccupational Health
Detection and Reporting of Occupational Hazards
Occupational Health Supervision
Occupational Health Education
and Training
Giving Back to the Society and Staying True to the Original Mission
With the aim of “produce the best vaccines for mankind”, the Company is dedicated to R&D and manufacture ofhigh-quality vaccines, and committed to human immunization health. While promoting the steady developmentof its main business, the Company actively ful?lls its social responsibility to create shared values for the industryand society. In 2023, the Company invested a total of
9.2966
million yuan in social welfare.
6665
Improving Products Accessibility
Active eorts for R&D and industrialization of products
Vaccination is the most economical and e?ective measure for us to control and prevent infectious diseases. With the aim of “producethe best vaccines for mankind”, the Company actively promotes the R&D and industrialization of products in the prevention of hepatitisB, pneumonia, tDAP, novel coronavirus infection and other diseases. At present, the Company has 11 listed and approved products foremergency use, of which, hepatitis B vaccines has been produced and sold more than 1 billion doses in total, helping more than 400million people protect themselves from hepatitis B virus. At the same time, the Company expands R&D and innovation on the basisof existing products, and actively layouts the R&D of novel vaccines and multi-conjugate multi-valent vaccines with market demand-oriented to provide more quality vaccine products for the society.Pricing policy
By strictly abides by the requirements of the Vaccine Administration Law of the People’s Republic of China, the Company setsreasonable vaccine prices with reference to the production costs and market research results, and is committed to providing thecommunity with safe, e?ective and high-quality products at a?ordable prices.
CorporateLevel
Based on raw and auxiliarymaterials, labor, logistics,R&D, medical, overhead,insurance and other relatedcosts, we set reasonableprices after scienti?ccalculations.
Based on the research results of thecurrent market situation (annualbatch volume of similar products,end-market batch volume, marketstrategies, etc.) and the prices of othervaccines in the market, reasonableprices are set based on the principlesof increasing market share and brandacceptance, product competitiveness,etc.
MarketLevel
In terms of domestic vaccine pricing, the procurement pricesof vaccines for the National Expanded Program on Immunization(EPI) are determined through centralized bidding or negotiationorganized by the competent health authorities and the Ministryof Finance of the State Council; other EPI vaccines and non-EPI vaccines are procured through provincial public resourcetrading platforms under the guidance of provincial and municipalgovernments and autonomous regions directly under the CentralGovernment.
Devotion to Public Welfare
The Company has been devoted to engaging in public welfare, and has totally donated more than
million yuan to thesociety, including poverty-stricken areas, Red Cross societies at all levels and scienti?c research institutions, making contributions tobuilding public immunity barriers, supporting medical development and helping rural revitalization.
Vaccine and Materials Donations
In 2023, the Company’s major vaccine and materials donations are as follows:
20232023August 2023Donated Hepatitis B Vaccine(Saccharomyces Cerevisiae) toGuizhou, Guangdong, Shanghaiand other provinces for hepatitisb vaccination of relevant people.
Donated 13-Valent PneumococcalPolysaccharide Conjugate Vaccineto Hunan, Guizhou, Jiangxi,Guangdong, Shandong, Yunnanand other provinces, whichwere used to vaccinate relevantpersons.
Donated 1 million yuan toTsinghua University EducationFoundation to support theconstruction and developmentof Tsinghua University.
Support the Development of HealthcareWhile pursuing corporate growth, BioKangtai gives full support to medical research and the cultivation of talents in public health,and works together with foundations, universities and research institutes to create a win-win situation and shared value for the industryand society.
we donated 20 million yuan to China Foundationfor Hepatitis Prevention and Control (in four years)for related academic activities, hepatitis B researchprojects, and hepatitis B prevention and control.
we donated 10.3660 million yuan to China Foundationfor Hepatitis Prevention and Control (in three years) forthe protection program for family members of peopleinfected with the hepatitis B virus initiated by ChinaFoundation for Hepatitis Prevention and Control, andsupporting hepatitis B prevention and control.
Support Medical Research
In December 2021In January 2024
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Support Rural RevitalizationBioKangtai not only supports the development of medical care by leveraging its own advantages, but also responds to the nationalcall for rural revitalization by supporting poverty alleviation and rural revitalization efforts through charitable donations and othermeans.
The Company has been supporting the public welfare of Xingan County, Jiangxi Province for a long time and caring about localdisadvantaged groups. Since 2018, a total of
million yuan has been donated to the Civil A?airs Bureau of the county to help theelderly living in retirement homes (including the disabled), orphans and de facto unsupported.
In 2023, the Company actively supported "630" Campaign for Rural Revitalization of 2023 initiated by ShenzhenNanshanDistrictUrbanRenewaland Land DevelopmentBureau through making donation to Shenzhen Nanshan District Charity Association.
for deepening the cooperation
between industry, academia and
research institutes, the Company
donated
million yuan (in three
years) to the Education Development
Foundation of Jinan University in
Guangdong for the establishment
of JNUBioKangtai Biomedical
Development Fund to promote the
high-quality development of the
disciplines of public health and the
cultivation of public health talents；
in order to support the developmentof education and scienti?c researchof College of Pharmacy in ShenzhenTechnology University, the Companydonated
million yuan (in ?ve years)for the establishment of "BioKangtai"Outstanding Freshman Scholarship.
the Company donated 500,000 yuan(in ?ve years) to Huizhou Universityfor the establishment of BioKangtaischolarship and fellowship.
Industry-Academia-Research Institute Collaboration
In July 2021In September 2021In November 2021
Future Outlook
Looking forward to the future, with the aim of “produce the best vaccines to bene?t mankind”, the Company will continuouslyfocus on the main business, orient to R&D and innovation, adhere to the "lifeline" of quality, gradually enrich and improve the productstructure, strengthen the construction of marketing system, steadily advance the internationalization strategy, promote the Company’svaccine products to go abroad and to the world, and take measures to improve the comprehensive competitiveness of the enterpriseto strengthen the foundation of the high-quality development of the enterprise, so as to provide power to ensure that the Companywill become a ?rst-class domestic and internationally famous large-scale biopharmaceutical multinational company, making greatercontributions to the construction of China’s health industry.While continuously standardizing corporate governance, the Company will establish a sense of return to shareholders, andcreate long-term value for shareholders; actively assume social responsibility, practice the theory of ESG sustainable development,and promote green and low-carbon development; pay attention to the needs of various stakeholders, gather consensus, and striveto improve operational e?ciency and development quality, so as to pursue win-win cooperation for creating social value, and worktogether for a sustainable future.
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ESG Key Performance
8.1 Economic Performance
8.2 Environmental Performance
IndicatorsUnit202320222021Operating revenueRMB’0,000347,744315,740365,209Total assetsRMB’0,0001,508,5361,378,6351,414,898Owners’ interestsRMB’0,000954,169898,534916,674
Total taxRMB’0,00027,66551,76390,602Total number of sharesissued by the Company
Shares
1,116,916,5521,120,493,735687,093,526Net assets per shareRMB8.548.0213.34
IndicatorsUnit202320222021
Energy Use
Total electricity consumption
MWh63,421.5274,09278,114Total natural gas consumptionm?7,080,0822,747,7883,573,871Total heat consumptionGJ208,916.86230,389181,352Diesel consumptionTons10,058.52131125Gasoline consumptionTons454049LPG consumptionTons831916
IndicatorsUnit202320222021
GHG Emissions
Total GHG EmissionstCO
e105,11891,01573,659Total GHG emissions in Scope I
tCO
e15,9526,7668,326Total GHG emissions in Scope IItCO
e89,16584,24965,333GHG emissions per unit of revenuetCO
e/RMB10,0000.300.290.2
Water Use
Total waterm?1,290,714.331,000,2161,024,860
Bysource
Water consumption frompublic water supply
m?1,207,202908,194952,447Water from barrels and steamconversions
m?83,512.33122,47172,413
Discharge Management
Total air emissionsm?324,426,363266,618,494253,578,606Total VOCsTons0.2540.19390.43Exhaust emissions per unit of revenuem?/RMB10,000933844694Total industrial wastewater dischargem?653,872553,540564,561Ammonia nitrogen dischargeTons1.66163.42.96CODTons32.319641.8533.13Total nitrogenTons0.5440.310.77
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Notes:
① The statistical caliber of environmental performance covers Shenzhen Kangtai Biological Products Co., Ltd. and its wholly-
owned subsidiary, which is consistent with the scope of the annual report and consolidated ?nancial statements. The increaseof air emissions, hazardous and non-hazardous waste discharge comes from the expansion of the Company’s production scale.
② The Company’s total electricity consumption comes from purchased electricity.
③ The sources of Scope I GHG emissions include natural gas, gasoline, diesel and LPG. The calculation method of carbon emissions
from natural gas, gasoline, diesel and LPG refers to the Guideline for Accounting and Reporting of Greenhouse Gas Emissionsfrom Enterprises: Power Generation Facilities (revised edition of 2022) by Ministry of Ecology and Environment of the People’sRepublic of China).
④ The sources of Scope II GHG emissions include purchased electricity and heat. The calculation method of carbon emissions from
electricity and heat refers to the Guideline for Accounting and Reporting of Greenhouse Gas Emissions from Enterprises PowerGeneration Facilities (revised version of 2022) by the Ministry of Ecology and Environment of the People’s Republic of Chinaand the Guideline for Accounting and Reporting of Greenhouse Gas Emissions from Enterprises in Other Industries (for TrialImplementation) by the National Development and Reform Commission of the People’s Republic of China. 。
IndicatorsUnit202320222021Total phosphorusTons0.02970.020.07Industrial wastewater discharge per unitof revenue
m?/RMB10,0001.881.751.55Total hazardous wasteTons304.24348246Hazardous waste generated per unit ofrevenue
kg/RMB10,0000.871.10.67Total general non-hazardous wasteTons380.79204196General waste generated per unit ofrevenue
kg/RMB10,0001.090.650.54Use of Resources for Production
Annual environmental expenditureRMB10,0004094251,700Number of environmental awarenesstraining sessions
Times202115Number of Incidents punished forenvironmental law violations
Cases000
8.3Social Performance
◎ Liabilities to employees
IndicatorsUnit202320222021Total number of employeesPeople1,9022,0182,445By gender
MalePeople1,1681,2301,505FemalePeople734788940
By employment
type
Full-time contract workersPeople1,8831,9942,413Full-time dispatched workersPeople000
Part-timePeople182331Other typesPeople111
By age group
> 50 years oldPeople65646630 to 50 years oldPeople1,1081,1541,288
< 30 years oldPeople7298001,091
By region
Mainland employeesPeople1,9012,0182,445Employees from Hong KongMacao, Taiwan and overseas
People100
By rank
Junior employeesPeople1,78119032,332Middle managersPeople1119497Senior managersPeople102116
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IndicatorsUnit202320222021
By education
Employees with Doctoral DegreePeople151517Employees with Master's DegreePeople201194210
Employees with Bachelor's
Degree
People1,02910361,200Employees with JuniorCollege Degree and below
People6577731,018Employment and Employee Rights
Labor contract signing rate%100100100Social insurance coverage rate%100100100Coverage rate of employee medical checkups%100100100Number of employees covered by collective bargaining
agreements (end of period)
People1,9021,3231,491
Occupational Health and Safety
Number of employees in positions at risk of occupational
diseases
People367166168Number of employees with occupational diseasePeople000Number of employees who died due to work-related
injuries
People000Number of workdays lost due to work-related injuriesDays153131365Notes:
① The statistical caliber of employees covers Shenzhen Kangtai Biological Products Co., Ltd. and its wholly-owned subsidiary,
which is consistent with the scope of annual report and consolidated ?nancial statements.
② The number of employees by age group only includes contracted workers.
③ The number of employees by region only includes contracted workers.
④ The number of employees by rank only includes contracted workers.
⑤ The number of employees by education only includes contracted workers.
◎ Product liability
◎ Community investment
IndicatorsUnit202320222021Complaint handling rate
%100100100Percentage of sold products that had to be takenback due to safety and health issues
%000Number of incidents involving violations of laws andregulations on products and services
Cases000R&D InvestmentRMB10,00054,21999,35673,847Ratio of R&D investment to operating revenue%15.5931.4720.22Number of R&D personnelPeople360465460Percentage of R&D personnel%18.9323.0418.81Number of patents granted in the reporting periodPcs11218Number of patent applications in the reporting periodPcs11910
IndicatorsUnit202320222021
Amount of community investmentRMB’0,000929.661,464.641,891.30Of which: Investment in educationRMB’0,00021.6531.801,011.80Investment in the medical and health careRMB’0,00048.89579.47648.38Amount of charitable donationsRMB’0,000859.12853.37231.12
Note:
① The complaint handling rate in this report is calculated according to this formula:
complaint handling rate = number of complaints handled/total number of complaints received × 100%.
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8.4 Compliance Operations
During the reporting period, the Company did not violate any laws and regulations related to product quality, customer service,intellectual property protection, environmental protection and employment. The main domains and laws and regulations that theCompany is involved in are listed in the table below.
DomainsLaws and Regulations
Compliance orNon-compliance
Non-compliance
Drug Administration Law of the People’s Republic of China,Vaccine Administration Law of the People’s Republic of China,Measures for the Administration of Drug Registration,Good Manufacturing Practice of Medical Products,Guidelines for Good Clinical Practices,Measures for the Supervision and Administration of Drug Production, etc.
Compliance
Product Researchand Development
Drug Administration Law of the People’s Republic of China,Vaccine Administration Law of the People’s Republic of China,Measures for the Administration of Drug Registration,Guidelines for Good Clinical Practices,Good Manufacturing Practice of Medical Products,Measures for the Supervision and Administration of Drug Production, etc.
Compliance
Intellectual PropertyProtection
Patent Law of the People’s Republic of China,Copyright Law of the People’s Republic of China,Trademark Law of the People’s Republic of China,Regulations on the Protection of Intellectual Property Rights in ShenzhenSpecial Economic Zone, etc.
Compliance
Customer ServiceLaw of the People’s Republic of China on Consumer Rights and Interests, etc.Compliance
Information security
Law of the People’s Republic of China on the Protection of PersonalInformation
Compliance
DomainsLaws and Regulations
Compliance orNon-compliance
Environmental
Protection
Law of the People’s Republic of China on Environmental Protection,Law of the People’s Republic of China on Prevention and Control of AirPollution,Law of the People’s Republic of China on Prevention and Control ofEnvironmental Pollution by Solid Waste,Law of the People’s Republic of China on Prevention and Control of Pollutionfrom Wastewater,Law of the People’s Republic of China on Promotion of Cleaner Production,Law of the People’s Republic of China on Energy Conservation,Guangdong Environmental Protection Regulations, etc.
Compliance
Employment andLabor
Labor Law of the People’s Republic of China,Labor Contract Law of the People’s Republic of China,Social Insurance Law of the People’s Republic of China,Law of the People’s Republic of China on Mediation and Arbitration of LaborDisputes,Law of the People’s Republic of China on Trade Unions,Law of the People’s Republic of China on the Protection of Women’s Rightsand Interests, etc.
Compliance
BiosafetyBiosafety Law of the People’s Republic of China, etc.Compliance
OccupationalHealth and Safety
Law of the People’s Republic of China on Prevention and Control ofOccupationalDiseases, etc.
Compliance
Business Ethics
Criminal Law of the People’s Republic of China,Law of the People’s Republic of China Against Unfair Competition,Interim Provisions on the Prohibition of Commercial Bribery,China Internal Auditing Standards,Basic Standards for Enterprise Internal Control,Anti-Money Laundering Law of the People’s Republic of China, etc.
Compliance
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ESG Reporting Guide IndexGuide Index of Guidelines on Self-regulation of Listed Companies on Shenzhen Stock Exchange No. 2 – Standardized Operation ofListed Company on the ChiNext Market.Clause and DisclosuresChapters
9.1 Overview
2.1 ESG Approach
2.2Stakeholder Communication and Material Issue
Identi?cation
9.2 Business Principles
3.1 Agglomerate Mental E?orts and Party Building Leading
3.2 Normative Governance and Steady and Sustainable
Growth
3.3 Compliance Operations and Risk Prevention
4.1 R&D and Innovation to Enrich the Category of Products
4.4 Responsible Sales and Professional Marketing
9.3 CSR Strategy and Mechanisms2.1 ESG Approach
9.4：(1)CSR system construction
4.2 Improvement of Quality Control to Strengthen Product
Quality
5.1 Improving Environmental
Management and Ful?lling Environmental Responsibilities
6.1 Fair Employment and Protecting Employee Rights and
Interests
6.3 Safe Production and Safeguarding Employees
7.2 Devotion to Public Welfare
8.4ESG Key Performance - Compliance Operations
9.4：(2)
De?ciencies and problems in ful?llingCSR
Irrelevant
9.4：(3)
Improvement measures and timeschedule
5.2 Screening Environmental Impact and Tackling Climate
Change
9.5 Return to Shareholders3.1 Normative Governance and Steady and Sustainable Growth
9.6 Financial soundness8.1 ESG Key Performance – Economic Performance
9.7 Protection of Employee Rights and Interests
6.1 Fair Employment and Protecting Employee Rights and
Interests
9.8：(1)
Compliance with environmentalprotection laws, regulations and industrystandards
5.1 Improving Environmental
Management and Ful?lling Environmental Responsibilities
9.8：(2)Environmental Protection Plan
5.1 Improving Environmental
Management and Ful?lling Environmental Responsibilities
9.8：(3)Use of natural resources
5.1 Improving Environmental
Management and Ful?lling Environmental Responsibilities
5.2 Screening Environmental Impact and Tackling Climate
Change
8.2 ESG Key Performance – Environmental Performance
9.8：(4)Pollutant disposal
5.3 Emphasizing Waste Prevention & Control and Reducing the
Environmental Impact
9.8：(5)Pollution prevention and control facilities
5.3 Emphasizing Waste Prevention & Control and Reducing the
Environmental Impact
9.8：(6)
Payment of environmental protection-related taxes and fees
Irrelevant
Clause and DisclosuresChapters
9.8：(7)Supply chain and environmental safety
4.2 Improvement of Quality Control to Strengthen Product
Quality
9.8：(8)
Other environmental protectionresponsibilities
5.2 Screening Environmental Impact and Tackling Climate
Change
9.9：(1)
Environmental protection policy,targets and e?ectiveness
5.1 Improving Environmental
Management and Ful?lling Environmental Responsibilities
9.9：(2)Total annual resource consumption8.2 ESG Key Performance – Environmental Performance
9.9：(3)
Environmental investment andenvironmental technology development
5.2 Screening Environmental Impact and Tackling Climate
Change
9.9：(4)Pollutant discharge management
5.3 Emphasizing Waste Prevention & Control and Reducing the
Environmental Impact
9.9：(5)
Construction and operation ofenvironmental protection facilities
5.3 Emphasizing Waste Prevention & Control and Reducing the
Environmental Impact
9.9：(6)
Waste treatment and disposal,comprehensive utilization of recycledwaste
5.3 Emphasizing Waste Prevention & Control and Reducing the
Environmental Impact
9.9：(7)
Voluntary agreements withenvironmental protectiondepartments
5.1 Improving Environmental
Management and Ful?lling Environmental Responsibilities
9.9：(8)
Rewarded by environmental protectiondepartments
Irrelevant
9.9：(9)Other voluntary disclosure8. ESG Key Performance
9.10 Environmental Protection Policy Implementation
5.1 Improving Environmental
Management and Ful?lling Environmental Responsibilities
5.2 Screening Environmental Impact and Tackling Climate
Change
5.3 Emphasizing Waste Prevention & Control and Reducing the
Environmental Impact
9.11 Environmental Information Disclosure8.2 ESG Key Performance – Environmental Performance
9.12：(1)
Product safety laws, regulations andindustry standards
4.2Improvement of Quality Control to Strengthen Product
Quality
9.12：(2)Production environment and process6.3 Safe Production and Safeguarding Employees
9.12：(3)
Product quality and safety assurancemechanism and emergency responseplan
4.2 Improvement of Quality Control to Strengthen Product
Quality
9.12：(4)Other quality and safety responsibilities
4.2 Improvement of Quality Control to Strengthen Product
Quality
6.3 Safe Production and Safeguarding Employees
8.3 ESG Key Performance – Social Performance
9.13：(1)
Sta? management system and violationhandling measures
6.1 Fair Employment and Protecting Employee Rights and
Interests
9.13：(2)
Prevention of occupational hazards andancillary safety measures
6.3 Safe Production and Safeguarding Employees
9.13：(3)Employee training6.2 Caring for Employees and Helping Them Develop
9.13：(4)
Other responsibilities for employee rightsprotection
6.1 Fair Employment and Protecting Employee Rights and
Interests
9.14 Ethics of Science4.1 R&D and Innovation to Enrich the Category of Products
9.15 Supervision and Monitoring
3.2 Compliance Operations and Risk Prevention
4.2 Improvement of Quality Control to Strengthen Product
Quality
5.2 Screening Environmental Impact and Tackling Climate
Change
6.3 Safe Production and Safeguarding Employees
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