Corporate Social Responsibility Reportand Environmental, Social and Governance Report
BIOKANGTAI
Produce the best vaccines to benefit mankind
Contents
About this Report 0 1About BioKangtai 02ESG Management Overview 08
ESG Key Performance 53ESG Reporting Guide Index 59
Responsible and Sound Operation 11
Corporate Governance 1 1Compliance Management 15
Deliver High-quality Products and Services 18
Develop High-quality Products 18Strict control of product quality 25Deliver Excellent Customer Services 33Responsible Marketing 34Adhere to Green Development 35Improve Environmental Management 35Responding to Climate Change 36Reduce the Environmental Impact of Operations 39
Grow Together with Employees 41Protect Employee Rights and Benefits 42Empower Our Employees 44Safeguard Employees 46Give Back to Society 50
Enhance Accessibility in Healthcare 5 1Create Shared Value 52
About this Report
Report LanguageThe report is written in two languages, Chinese and English. If there is any discrepancy between the two versions, theChinese version shall prevail.
Basis of the Report
The report has been compiled in accordance with theGuidelines on the Content and Format of Information Disclosureby Companies Publicly Issuing Securities No. 2: Content and Format of Annual Reports (Revised 2021)(Chapter 5:
Environmental and Social Responsibility) by the China Securities Regulatory Commission (CSRC), theGuidelines on Self-regulation of Listed Companies on Shenzhen Stock Exchange No. 2: Standardized Operation of Listed Companies on theChiNext Marketby the Shenzhen Stock Exchange (SZSE) and other relevant regulations.
Data Description
If not otherwise stated, the financial data disclosed in the report are derived from the audited financial report of theCompany and other data are obtained from the Company’s internal statistics and relevant documents. The currency typein the report is Chinese Yuan (CNY), and amounts covered in the report are in Chinese yuan.Reporting Principles
The report is underpinned by following reporting principles:
The report identifies and responds to substantiveissues that are of concern to stakeholders and alsohave a significant influence on the Company, andprovides focused reporting on these issues.
The report provides statistics on the Company’squantitative ESG performance and discloseshistorical data for the past three years.
Materiality
Quantitative
Taking into account the characteristics ofthe industry, the report makes a detaileddisclosure of the Company’s active fulfillmentof social responsibilities, possible problems andimprovement plans and avoids selective disclosure.The report provides detailed explanations of themeaning of the disclosed quantitative KPIs, as wellas the basis for their calculation and the assumedconditions. Meanwhile, indicators used in differentreporting periods are consistent to the extentpossible to reflect trends in the performance levels.
Balance
Comparability
Scope of the Report
Organizational scope: The report covers Shenzhen Kangtai Biological Products Co., Ltd. (BioKangtai, or the Company) andits wholly-owned subsidiary, which is in line with the scope of the company’s annual consolidated financial statements.The full names and abbreviations of the companies in the report are as follows.
Time scope: From January 1, 2021, to December 31, 2021, with some representations and information traced back toprevious years as appropriate.
Full NameAbbreviation
Shenzhen Kangtai Biological Products Co., Ltd.BioKangtai, the CompanyBeijing Minhai Biotechnology Co., Ltd.BioMinhai
BioKangtai specialized in R&D, production and sales of vaccines for human use. At present, the Company has fiveR&D centers and industrial bases in Shenzhen and Beijing. It is one of the major vaccine manufacturers in China. TheCompany’s main products include 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine，DTaP-Hib CombinedVaccine，23-Valent Pneumococcal Polysaccharide Vaccine， Recombinant Hepatitis B Vaccine (Saccharomycescerevisiae)， Hib Conjugate Vaccine， Hib Conjugate Vaccine, Freeze-dried,etc. The Company’s SARS-CoV-2 Vaccine(Vero Cell), Inactivated was approved for emergency use in China in May 2021, and its Recombinant COVID-19 Vaccine(Y25 Adenovirus Vector) was authorized for emergency use by the National Agency of Drug and Food Control of Republicof Indonesia. The Company’s product portfolio covers both vaccines for the national immunization program vaccines andnon-immunization program vaccines, with products reaching 31 provinces, municipalities and autonomous regions.The Company is an industry leader in R&D innovation and has been engaged in the vaccine industry for 30 years. As oneof the companies with the most comprehensive vaccine R&D platforms in China, it has mastered a number of advancedcore technologies for vaccines, and has formed a diversified vaccine product portfolio with extensive product lines,excellent product mix and good market prospect. In addition to the vaccines that have been released for sale, theCompany has more than 30 projects under development, including Diphtheria, tetanus, pertussis (acellular, component),poliomyelitis (inactivated) vaccine (adsorbed) and Haemophilus influenzae type b conjugate vaccine Reassortant RotavirusVaccine, Live, Oral, Pentavalent (Vero Cell) 4-Valent Recombinant Enterovirus Vaccine , Measles-Mumps-Rubella-Varicella(MMRV) Vaccine, Influenza Vaccine (Split Virion), Inactivated, Quadrivalent; Influenza Vaccine (Split Virion), Inactivated,Quadrivalent and 20-Valent Pneumococcal Polysaccharide Conjugate Vaccine, and other multivalent and combinationvaccines. With the upcoming release of the vaccines, the Company’s product portfolio will be greatly enriched and itscompetitiveness will be further enhanced.With its global vision, BioKangtai has implemented an international business strategy while making secondary innovationsto foreign technologies. The Company has been working closely with several internationally renowned biopharmaceuticalcompanies and R&D institutions, such as Merck (US), Sanofi-Pasteur (France), Intravacc (Netherlands) and AstraZeneca(UK), to import advanced vaccine technologies from abroad. Meanwhile, the Company has been fostering the registrationof its products overseas and has obtained registration certificates in several countries. Our Recombinant COVID-19Vaccine (Y25 Adenovirus Vector) was authorized for emergency use by the National Agency of Drug and Food Controlof Republic of Indonesia and exported in October 2021, laying a solid foundation for our internationalization strategy andfurther expansion.
About BioKangtai
Company Overview
Headquarters Location
Shenzhen,Guangdong, ChinaR&D and Production BasesAs one of the major vaccine manufacturers in China, the Company has fiveR&D and production bases in Shenzhen and Beijing, giving full play to thesynergy between BioKangtai in the South and BioMinhai in the North. Afterthe completion of BioMinhai’s International Industrial Base for Novel Vaccine(Phase I), the Company’s business scale will be further expanded.
Projects underDevelopment 30+
Marketed Products 10+(including 2 COVID-19 vaccines approved
for emergency use)
R&D Staff 460
Company History30 Years
Company NameShenzhen Kangtai Biological Products Co., Ltd.
Legal Forms of Business OwnershipListed on the Shenzhen Stock Exchange
GEM in February 2017(Stock code: 300601)Main Business
Development, production and sales of human vaccinesProduct portfolio covers national immunization program vaccines and non-
immunization program vaccines
Net Profit for Shareholders of Listed Company1,263.38
million yuanUp
86.01
% year-on-yearOperating Revenue3,652.09
million yuan
Up
61.51
% year-on-year
Community Investment
18.91
million yuanCash Dividends
595.26
million yuan
Total Tax
896.99
million yuan
Up
303.87
% year-on-yearR&D Investment
738.47
million yuanAccounting for
20.22
%of the operating revenue
up
170.10
% year-on-year
Dedication to people's healthProduce the best vaccines to benefit mankind
People orientation, excellence, honesty, efficiency, innovation and cohesionDiligent, perseverent, cohesive, enterprising and self-empowering
Become a leading and world-renowned biopharmaceutical multinational company thatpursue high product quality, high corporate efficiency, technological innovation, resourceconservation and harmonious development.
BioKangtai has always adhered to the corporate purpose of“producing the best vaccine to benefit the mankind”and thecore value of“dedication to people’s health”. With a focus on long-term exploration in the biopharmaceutical sector, theCompany aims to become a leading and world-renowned multinational company to contribute to the development ofimmunological sciences. We take a market-oriented approach to enhance our R&D performance and product innovation,continuously optimize our product mix, and to pursue high product quality, marginal efficiency, technological innovation,resource conservation and harmonious development.
Core Value
OperationPrincipleCompany
Spirit
VisionMission
Company Philosophy
Company Milestones
1992
1995
2000
2004
2008
1994
1998
2002
2005
The Company wasestablished.
The Company’s 5?gHepatitis B Vaccine(0.5ml per dose) metthe quality standardsof Merck & Co., INC,and the vaccineacquired approvalnumber for pilotproduction from theMinistry of Health.
BioKangtaiacquired its firstGMP certificatefor its Hepatitis BVaccine.
The CompanyintroducedHepatitis BVaccine withthree years’
effectiveness,which is the first ofits kind in China.
BioKangtaiacquiredBeijing MinhaiBiotechnology Co.,Ltd. (BioMinhai) asits subsidiary.
The Companycompleted pilotproduction of 5μgHepatitis B Vaccine,which was laterapproved by theMinistry of Health.
The vaccineacquired formalapproval numberfrom the ChinaFood and DrugAdministration.
The Companyintroduced its 10?gHepatitis B Vaccine(1ml per dose) forgrown-ups.
The Company replacedits 10?g Hepatitis BVaccine (1ml per dose)with 10?g HepatitisB Vaccine (0.5ml perdose), and acquiredits second GMPcertificate for hepatitisB vaccine.
2011
2013
2015
2018
2021
2010
2012
2014
2017
2019
The Companyintroduced the first60?g Hepatitis BVaccine (1ml per dose)for adult hepatitisB vaccine non-responders in China.The Companyacquired its thirdGMP certificate for itshepatitis B vaccine.
The Companyacquired a GMPcertificate for itsMeasles, Mumpsand RubellaCombined Vaccine,live.BioMinhaiestablished apostdoctoral R&Dcenter in Beijing.
BioMinhaiestablished theNational-LocalJoint EngineeringLaboratory forNovel VaccineTechnologies.
BioKangtai’sGuangmingBase inShenzhen wasofficially putinto use.
The Company’sSARS-CoV-2Vaccine, inactivatedwas approved foremergency use inChina.The Company’sRecombinantCOVID-19 Vaccine(Y25 AdenovirusVector) was authorizedfor emergency use bythe National Agencyof Drug and FoodControl of Republic ofIndonesia.The Company’s13-ValentPneumococcalConjugate Vaccinewas launched.
The Companyintroduced the first60?g Hepatitis BVaccine (1ml per dose)for adult hepatitisB vaccine non-responders in China.The Companyacquired its thirdGMP certificate for itshepatitis B vaccine.
The Companyacquired a GMPcertificate for itsHib ConjugateVaccine.The Companyacquired aGMP certificatefor its DTaP-Hib CombinedVaccine.
The Company acquireda GMP certificate (2010version) for its hepatitisB vaccine.The Company acquireda GMP certificate for itsHib Conjugate Vaccine(prefilled).The Companycollaboratedwith INTRAVACC(Netherlands) and WHOto import InactivatedPoliomyelitis Vaccine.BioMinhai establishedthe Beijing NovelCombination VaccineR&D Center, theBeijing AcademicianWorkstation, and theBeijing InternationalSci-Tech CooperationBase for Novel Vaccines
The Companywas listedon GEM ofShenzhen StockExchange.
The Company’s23-ValentPneumococcalPolysaccharideVaccinereceived a GMPcertificated andwas launched.
RecipientHonors and Special RecognitionPresented by
BioKangtai
First Prize of Shenzhen Science and Technology Awards
Shenzhen Municipal People’s Government Science andTechnology Awards CommitteeInnovative Enterprise of Guangdong
Guangdong Provincial Science and Technology Department,Guangdong Provincial Development and Reform Commission,Guangdong Provincial Economic and Information Commission,State-owned Assets Supervision and Administration Commissionof Guangdong Provincial People's Government, GuangdongProvincial Intellectual Property Bureau, Guangdong ProvincialFederation of Trade UnionsKey High-tech Enterprise of China Torch Program
Torch High-tech Industry Development Center, Ministry ofScience and TechnologyChina Key New Product Certificate
Ministry of Science and Technology / Ministry of EnvironmentalProtection / Ministry of Commerce, etc.Leading Enterprise of Guangdong Pilot 100 Program
Guangdong Provincial Economic and Information Commission/Guangdong Provincial Science and Technology Department, etc.High-tech Enterprise Certificate
Science, Technology and Innovation Commission of ShenzhenMunicipality/ Shenzhen Municipal Finance Committee/ ShenzhenTax Service, State Taxation Administration/ Shenzhen LocalTaxation Bureau2019 Top 20 Shenzhen Leading Biotech CompaniesShenzhen National High-Tech Industry Innovation CenterAcademician (expert) workstationShenzhen Association for Science and TechnologyGuangdong“Excellent Group Member”for Qualified Person in thePharmaceutical Industry
Qualified 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-19 ReliefTorreya, a global investment bankTop 10 Shenzhen Listed Companies with Development PotentialNational Business DailyWinner in Pharmaceuticals Biology of the 10th China JRJ GoldenIntelligence Award
JRJTop 10 Most Promising Listed Companies in ChiNext at the 13thChina Listed Companies Awards
Securities TimesTop 50 Most Promising Listed Companies for the 40th Anniversaryof Shenzhen Special Economic Zone
Securities Times
BioMinhai
High-tech Enterprise Certificate
Beijing Municipal Science and Technology Commission, Beijing
Municipal Finance Bureau, Beijing Municipal Tax Service of State
Taxation AdministrationKey Innovation-driven Enterprise, Beijing G20 Project for Evolutionof Biomedical Industry
Beijing Municipal Science and Technology Commission, Beijing
Municipal Development and Reform Commission, Industrial Park
Management Committee of Beijing Municipal Bureau of Economy
and Information TechnologyBeijing 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, China
Postdoctoral 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 CertificationChina Association for Science and TechnologyWorker Pioneer AwardAll-China Federation of Trade UnionsBeijing Intellectual Property Demonstration OrganizationBeijing Municipal Intellectual Property OfficeIPMS CertificateZhongzhi (Beijing) Certification 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 CertificateZhongguancun Science Park Management Committee
Honors and Recognition
ESG Approach
ESG Management Overview
BioKangtai, as a high-tech enterprise with comprehensive R&D competence, diversified product range and remarkabletechnological advantages, has introduced a five-dimensional ESG management philosophy based on the corporatepurpose of“producing the best vaccines to benefit the mankind”, core value of“dedication to people’s health”, as wellas the operation principles of“people orientation, excellence, honesty, efficiency, innovation and cohesion.”. The ESGphilosophy focuses on the protection of the rights and interests of stakeholders such as shareholders, employees,customers and suppliers, and places emphasis on normative and honest operation with a view to promoting thesustainable and balanced development of the Company, the society and the environment.
Sound GovernanceManage the Company in accordancewith the law and regulations, pursuesound and stable development,strive to be a world-class company,and continue to create value for our
shareholders
Win-win with EmployeesCreate a comprehensive developmentplatform for employees to help themgrow together with the company andrealize their personal value
High-Quality Products
Control product quality strictly and
provide better vaccines through
technological innovation
For Green DevelopmentProactively address climate changeand minimize the company's carbon
footprintFor Healthy CommunitySupport medical development andpromote medical accessibility
Stakeholder Communication andMaterial Issue IdentificationStakeholder CommunicationStakeholder communication and participation is crucial for the Company to promote ESG management and achievesustainable development. The Company attaches great importance to the demands of stakeholders and maintains two-way communication through various channels with stakeholders such as shareholders, investors, governments andregulators, customers, suppliers, employees, industry associations, communities and the public. We listen and respondactively to the suggestions and feedback from our stakeholders, and incorporate their concerns into our operations anddecision-making, thereby satisfying their demands while improving our business management and achieving sustainabledevelopment.
Key StakeholdersCommunication ChannelsIssues of Interest
Shareholders and Investors
?General Meeting ofShareholders
?Information Disclosure
?SZSE’s Easy IR Platform
?Investor communication,Roadshows, Conference
?Investor Hotline/Email
?Disclosure and Transparency
?Compliance and RiskManagement
?Economic Performance
Government and Regulatory Agencies(e.g., National Medical Products
Administration)
?Policy Implementation
?Regular Work Summary andOfficial Correspondence
?Law Enforcement Supervisionand Inspection
?Compliance and RiskManagement
?Business Ethics
?Occupational Health andSafety
?Emissions Management
?Responding to ClimateChange
?Use of Resources
?Environmental ProtectionCustomers
?Customer Satisfaction Survey
?Customer Visits
?Professional Communication
?Customer Services andCustomer Complaints
?Product Quality
?R&D Innovation
?Customer Service
?Data Security and PrivacyProtectionSuppliers
?Supplier Assessment andAudit
?Supplier Training
?Business Ethics
?Supply Chain ManagementEmployees
?Regular Meetings
?Employee Activities
?Labor Union and Staff Council
?Complaints and Feedback
?Employee Rights and Benefits
?Employee Training andDevelopment
?Occupational Health andSafetyIndustry Associations
?Industry Associations andOrganizations
?Professional Communication
?Project Cooperation
?R&D Innovation
?Intellectual Property Rights
?Industry DevelopmentCommunity and Public
?Community Activities andServices
?Regular Communications
?Media Communication
?Popularization of VaccineKnowledge
?Social Welfare
?Access to Healthcare
Material Issue IdentificationReferring to the latest policies of CSRC and SZSE and excellent practices of peers at home and abroad, the Companyundertook the identification of material issues based on its own business and characteristics as well as expert opinions,with full consideration of stakeholders’demands and priorities of concern. After identification, ranking and verification, weidentified 18 material issues as the focus of disclosure in the report, as shown in the chart below.
◎BioKangtai’s Material Issues Matrix
High Low
HighImportance to Stakeholders
Importance to the Company’s business
Economic IssuesEnvironmental IssuesSocial Issues
EconomicPerformanceProductQualityR&D InnovationIntellectual Property
Occupational Health and SafetySupply Chain Management
Employee Rights and Benefits
Compliance andRisk ManagementAccess to Healthcare
Employee Training and Development
InformationdisclosuretransparencyBusiness EthicsCustomer Service
Philanthropy
EmissionsManagementUse of Resource
Responding to Climate Change
Data Security andPrivacy Protection
High Material Issues
Moderate MaterialIssues
Responsible and SoundOperation
Corporate GovernanceGovernance StructureThe Company constantly improves its corporate governance and strictly complies with theCompany Law of the People’sRepublic of China(hereinafter referred to as the“Company Law”), theSecurities Law of the People’s Republic of China
(hereinafter referred to as the“Securities Law”), theCode of Corporate Governance for Listed Companies in China,theRules Governing the Listing of Shares on the ChiNext Market of Shenzhen Stock Exchange, theGuidelines on Self-regulation of Listed Companies on Shenzhen Stock Exchange No. 2: Standardized Operation of Listed Companies on theChiNext Market and other relevant laws and regulations, sectoral regulations and regulatory documents.The Company has established a corporate governance structure consisting of the the general meeting, the board ofdirectors, the board of supervisors and the management according to the principles of checks and balances, clearauthority and responsibilities, and strict and effective regulation. The powers and responsibilities of the Company’sgoverning bodies, decision-making bodies, supervisory bodies and management are clearly defined, coordinated andbalanced, so as to ensure their normative operation in accordance with the law and regulations.In 2021, the Company revised and improved its regulations and rules such as theArticles of Association of ShenzhenKangtai Biological Products Co., Ltd,Rules of Procedure of the General Meeting of Shareholders,Rules of Procedure ofthe Board of Directors,Independent Directors System,Rules of Procedure of the Supervisory Board, andResponsibilitiesof the Presidentin accordance with the relevant provisions of the latest laws, regulations and normative documentsto continuously improve the internal control system of the Company, promote its normative operation and protect thelegitimate rights and interests of the Company and all shareholders.As at the end of the reporting period, the Company's governance status was in compliance with the requirements issuedby the CSRC and the SZSE in relation to the governance of listed companies. We have been continuously improving ourcorporate governance structure, establishing and improving our internal regulation system, enhancing our capabilitiesin scientific decision-making and risk prevention, and promoting the sound, stable and sustainable development of theCompany.
◎BioKangtai’s Organizational Structure
General Meeting of Shareholders
Strategy CommitteeNomination Committee
Remuneration andAssessment Committee
Audit Committee
Board of SupervisorsSecretary of theBoard of Directors
Board of Directors
President
Office of theChairman
Securities Affairs DepartmentHuman Resources DepartmentProject Management DepartmentInternational DivisionFinance CenterGeneral Manager
’s Office
Biosafety OfficeQuality Assurance Management CenterProduction & Operation CenterR&D CenterSales and Marketing CenterPharmacovigilance DepartmentSupply Chain Management DepartmentInternal Auditing Department
About shareholders and Shareholders’ Meeting
The Company strictly follows the relevant regulations and requirements of the Company Law, the Rules for GeneralMeeting of Shareholders of Listed Companies and the ChiNext Stock Market of the Shenzhen Stock Exchange as well asthe relevant provisions of theArticles of Associationand theRules of Procedure for General Meeting of Shareholderstoregulate the convening, holding and voting procedures of shareholders’ meetings and treat all shareholders equally.During the reporting period, the Company held one annual general meeting and four extraordinary general meetings, atwhich 37 motions were considered. The meetings were convened by the Board of Directors, and lawyers were invited towitness the meetings and issue legal opinions. The convening and holding procedures of the shareholders’meetings andthe motions considered were in compliance with the relevant laws and regulations and theArticles of Association.
About Directors and Board of Directors
The Board of Directors of the Company consists of eight directors, including three independent directors, and the numberand composition of the Board of Directors are in compliance with the laws, regulations and theArticles of Associationof the Company. The directors of the Company attend the board of directors’ meetings and shareholder’meetingsactively and dutifully promote the effective operation of the board of directors and scientific decision-making. There arefour specialized committees under the Board, namely, the Strategy Committee, the Audit Committee, the NominationCommittee and the Remuneration and Assessment Committee. Each committee carries out its functions in strictaccordance with its own working rules to promote scientific decision-making of the Board, improve the efficiency of theBoard’s operation and play an important role in the governance of the Company.During the reporting period, the Company held 12 meetings of the Board of Directors with 78 motions considered.The meetings were all convened and chaired by the chairman of the Company, and the convening, holding and votingprocedures of the meetings were in compliance with the relevant provisions of laws and regulations and theArticles ofAssociationof the Company and theRules of Procedure of the Board of Directors.About the Supervisors and the Board of SupervisorsThe Board of Supervisors of the Company is composed of three supervisors, including two employee representatives,and the number and composition of the Supervisory Board are in compliance with the laws, regulations and theArticlesof Associationof the Company. The supervisors of the Company strictly abide by the requirements of the CompanyLaw, Guidelines on Self-regulation of Listed Companies on Shenzhen Stock Exchange No. 2: Standardized Operation ofListed Companies on the ChiNext Market,
Articles of Association and Rules of Procedure of the Board of Supervisors,and conscientiously perform their duties by attending the meetings of the Board of Supervisors, the meetings of theBoard of Directors and the meetings of the General Meeting of Shareholders, and supervising the development strategy,financial activities, risk management, internal control and the performance of duties of the Board of Directors and seniormanagement of the Company in accordance with the law for the benefit of the shareholders and the overall interests ofthe Company.During the reporting period, the Board of Supervisors of the Company held 11 meetings, all of which were convened andchaired by the Chairman of the Board of Supervisors, and the convening, holding and voting procedures of the meetingswere in compliance with the relevant provisions of the laws and regulations and theArticles of Associationand theRulesof Procedure of the Board of Supervisors.
About the Company and the controlling shareholderThe Company has independent and complete business and independent operation capability. It is separated from thecontrolling shareholder in terms of personnel, assets, finance, institutions and business, with separate accounting andindependent responsibility and risk. During the reporting period, major decisions of the Company were made by theGeneral Meeting of Shareholders and the board of directors in accordance with the law. The controlling shareholderexercises its rights through the General Meeting of Shareholders without interfering directly or indirectly in the decision-making and operating activities of the Company beyond the General Meeting of Shareholders.
Keep Rewarding Our ShareholdersThe Company has formulated a sustainable profit distribution policy to continuously reward its shareholders. Since itslisting, the Company has implemented its profit distribution plan in strict accordance with the relevant profit distributionpolicy and deliberation procedures of theArticles of Association, with clear and explicit criteria for dividend distributionand complete decision-making procedures and mechanisms. After consideration by the Board of Directors and the Boardof Supervisors and opinions by the independent directors, the relevant proposals are submitted to the General Meetingof Shareholders for consideration to effectively protect the legitimate rights and interests of shareholders, especially thesmall and medium shareholders.In September 2021, the Company implemented the 2021 Semi-annual Equity Distribution Plan to distribute 3 yuan cashdividends for every 10 shares to all shareholders from undistributed profits. Since its listing in 2017, the Company has paidcash dividends of 644 million yuan in total.
Full Protection of Investors’ rights and Interests
The Company strictly complies with theGuidelines on Self-regulation of Listed Companies on Shenzhen Stock ExchangeNo. 2: Standardized Operation of Listed Companies on the ChiNext Market, Guidelines for Investor Relations Managementof Listed Companies, andRules on Investor Relations Management. It has clearly defined the investor relationsmanagement mechanism, with the Secretary of the Board of Directors as the person in charge of investor relationsmanagement and the Securities Affairs Department as the functional department of investor relations management,led by the Secretary of the Board of Directors, and dedicated personnel in charge of investor reception. The Companystrengthens communication with investors and potential investors through various means, such as general meeting ofshareholders, regular reports, online results presentation, SZSE’s Easy IR Platform, investor hotline and email for investorrelations, to convey new developments of the Company, enhance investors’understanding and recognition of theCompany, and maintain a good relationship between the Company and investors.Information DisclosureWith great emphasis on information disclosure, the Company has strengthened its management of information disclosureaffairs in accordance with the provisions and requirements of the CompanyLaw,theMeasures for the Administrationof Information Disclosure of Listed Companies, the Rules Governing the Listing of Shares on the ChiNext Market ofShenzhen Stock Exchange and theGuidelines on Self-regulation of Listed Companies on Shenzhen Stock ExchangeNo. 2: Standardized Operation of Listed Companies on the ChiNext Market. We have formulated theRegulations on theManagement of Information Disclosure Matters to clarify the workflow and responsibilities on information disclosure.The Board of Directors is responsible for the information disclosure activities of the Company, and the Securities AffairsDepartment is the functional department managing the information disclosure efforts. In 2021, the Company disclosed atotal of 241 periodic reports and temporary announcements, which provided true, accurate, complete and timely disclosureof the Company’s business activities and material matters, ensuring that all investors had fair access to our informationand effectively protecting the legitimate rights and interests of investors. In July 2021, the Company secured an A gradein the annual information disclosure evaluation of listed companies announced by the Shenzhen Stock Exchange for thesecond consecutive year.
Compliance Management
Compliance OperationsThe Company places emphasis on compliance operations and continuously optimizes its compliance management systemby improving its organizational structure, carrying out institutional construction and enhancing compliance awareness.In terms of compliance management system structure, a compliance management team has been established under theAudit Committee of the Company. The compliance management team consists of full-time and part-time team member,where full-time team members are from the internal audit department and part-time team members are senior staff fromeach functional department, who collaborate with the full-time team members to carry out compliance reviews in theirrespective sectors.In terms of compliance management regulations, the Company has formulated theRegulations on ComplianceManagement, which is applicable to the compliance management for all departments, subsidiary and employees of theCompany, covering business areas such as transactions, safety and environmental protection, product quality, laboremployment, finance, taxation, business partners, business innovation, asset management and intellectual property rights.Meanwhile, we promote the compliance awareness of all employees through compliance promotion and support theCompany’s compliance operations in accordance with the law by guidance of compliance philosophy.◎Compliance ManagementSystem Structure
Audit CommitteeComplianceManagement TeamPart-time personnel offunctional departmentsFull-time personnel ofInternal Audit Department
R&D Center
Quality AssuranceManagement Center
Sales andMarketing CenterSupply Chain ManagementDepartment
Human Resources
DepartmentFinance Center
Risk Identification and ManagementThe Company attaches importance to risk management and control, and constantly improves its risk management andinternal control system. In terms of risk identification, each department carries out risk identification in its daily workaccording to the regulations, establishes risk database andRisk Identification List, and regularly conducts self-inspectionon risk management efforts to identify deficiencies and make improvements in a timely manner.The Company applies an internal audit system to strengthen its internal risk management. In accordance with theAuditLaw of the People’s Republic of China,Guidelines on Self-regulation of Listed Companies on Shenzhen Stock ExchangeNo. 2: Standardized Operation of Listed Companies on the ChiNext Market and the Company’sInternal Audit Regulations
andManagement Measures of Internal Audit Practice, the Internal Audit Department audits, supervises and inspectsthe production and operation activities, economic efficiency, asset security, business ethics and anti-corruption, andthe establishment and implementation of the internal control system of the Company and its subsidiary, and makessuggestions and comments on the existing problems. The Internal Audit Department is independent and reports directly tothe Audit Committee
Securities AffairsDepartment
Biosafety DepartmentGeneral Manager’s Office
In 2021, the Internal Audit Department conducted audits and inspections of important matters of the Company as planned,without finding any violations of law or irregularities in the operations. Besides, the Company offers relevant information onrisk control related laws and regulations and policy interpretation to employees through internal communication networkfrom time to time to enhance their awareness of risk control. ◎Internal Auditing ProcedureDevelopauditplans andimplementthem afterapproval bythe AuditCommittee
Settlementof objectionsto auditresults andreview andconfirmationof matters
Business Ethics
The Company insists on honest and corruption-free operation and strictly abides by the relevant laws and regulationssuch as theLaw of the People’s Republic of China on Anti-Unfair Competition, theLaw of the People’s Republic of Chinaon Anti-Money Laundering, theLaw of the People’s Republic of China on Protection of Consumer Rights and Interests
and relevant standards such asISO37001
Requirements and Implementation Guide for Anti-Bribery Management System.The Company adopts a zero-tolerance policy for unethical business practices and takes a multi-pronged approach toimprove the long-term business ethics management mechanism by formulating business ethics systems and policies,strengthening targeted management of key aspects, creating a culture of integrity and building an unobstructed reportingmechanism.In terms of system and policy construction, the Company has formulated theEmployee Handbook,Code of ProfessionalEthics,Rules for Integrity in Workplace, andWhistleblowing Management Regulations, which clearly stipulate on matterssuch as integrity in the workplace, anti-bribery and whistleblowing of violations, and require strict compliance by allemployees of the Company and its wholly-owned subsidiary. Meanwhile, the Company requires employees in key positionsto sign theIntegrity Commitment. In 2021, all employees in key positions of the Company signed theIntegrity Commitment.
?Shall not use their authority to accept bribes
?Shall not obtain trade secrets by impropermeans.
?Shall not undermine competitors by falseadvertising.
?Comply with the law, work with integrity,sign the Integrity Commitment, and neverdisseminate confidential information in violationof relevant regulations.
All employees
?Contracts signed with suppliers/partnersmust contain an integrity agreement or relatedclauses, and overseeing implementation of theintegrity agreement
?Strictly abide by laws and regulations, stipulatecompliance terms in agreements, conductmarket activities in accordance with the law, andavoid paying bribes to relevant departments oremployees of the company in any form to obtainimproper benefits.
All employeesExternal cooperated agencies
Middle and senior management andkey position personnel
Business Ethics Code and Requirements
Developaudit planand auditprogram forprojects
Deliverthe auditnotice tothe auditedunits
Conduct audittasks, form auditconclusions andrecommendations,reviewed by theperson in charge
Follow up andsupervise theimplementationof correctivemeasures of theaudited units
The Company places priority, among other things, on preventing business ethics risks in procurement. While establishingan honest and normative mechanism with suppliers, the Company’s internal audit department conducts annual audits onbusiness ethics of the supply chain and organizes business ethics training for relevant employees. In 2021, the Companyconducted a dedicated audit of suppliers and discovered that some suppliers had colluded in the bidding process; theCompany disposed of the violation by confiscating the suppliers’bid deposits. In addition, the Company has conducted acomprehensive self-examination on whether its contracts with suppliers have integrity agreements or integrity clauses. In2021, all contracts with suppliers contained Integrity Agreements or Integrity Clauses.The Company also sets clear requirements for ethical business practices in external cooperation, such as with externalcooperated agencies, and regulates the behavior of all parties to the cooperation by signingIntegrity Agreementsorstipulating anti-bribery clauses in the cooperation agreements.In terms of integrity culture and awareness, the Company enhances the top-down construction of an integrity culture,attaches importance to employees’integrity awareness, establishes a business ethics training system for all employees(including senior management employees), and formulates dedicated training plans.In terms of whistleblowing system, the Company has formulated theWhistleblowing Management Regulationsandestablished an internal whistleblowing management leadership group, headed by the chairman of the board. TheWhistleblowing Management Leadership Group provides a variety of whistleblowing channels to accept anonymous orreal-name reports from employees and other business partners, and rewards those who report truthfully. The Companypromises to keep the personal information of the whistleblowers and the information provided by them strictly confidential.For persons who violate the confidentiality provisions and retaliate against whistleblowers, the Company adopts a zero-tolerance attitude; the violators will be dismissed, terminated from the labor contract, or transferred to judicial organsaccording to the severity of the circumstances.
?Director of the Office ofInternal WhistleblowingManagementLeadershipGroup receiveswhistleblowing andverifies the situation
?Within two days after thepreliminary examination ofthe whistleblowing, it willbe submitted to the InternalWhistleblowing ManagementLeadership Group and ameeting on the matter willbe held. The meeting willdiscuss and analyze thesituation, identify its nature,and develop accountabilityprograms and remedial andcorrective measures andreport them to the Company.
?The Company will punishliable persons accordingto the opinions of theInternal WhistleblowingManagement LeadershipGroup, and implementcorporate rectificationmeasures. Those whoviolate the criminal lawwill be transferred to thejudicial organs for a lawfultreatment
◎Procedures for handling whistleblowing
◎BioKangtai’s Whistleblowing Channels
WhistleblowerComplaint Receiver
Director of the Office of Internal Whistleblowing Management Leadership Group
Hotline 0755-26988630Emailshenjibu@biokangtai.comChannelsLetters, phone calls, emails, WeChat and visits, etc. We support anonymous reporting.
Receive Whistleblower
Complaints
Investigate and CollectEvidence
Handel Whistleblowing
Develop High-quality Products
R&D Strategy and Achievements
The Company has been deeply engaged in the field of human vaccines for 30 years and has accumulated strong capabilityin the development of vaccines. We have mastered a number of core technologies such as engineered strain construction,cell culture, virus culture, exotoxin detoxification, polysaccharide purification, protein purification and polysaccharide-protein conjugation. As one of the companies with the most extensive vaccine R&D platform in China, we have asubstantial R&D and production capability for viral vaccines, bacterial vaccines, genetically engineered protein vaccines,conjugate vaccines and combination vaccines. In particular, we are at the leading edge of the development of combinationvaccines.While focusing on the development of combination vaccines and novel vaccines and upgrading of existing vaccines,we also place emphasis on the research and application of novel vaccine technologies and the establishment of newtechnology platforms, such as mRNA technology and virus vector technology, to provide support for the continuousupgrading of our products and the successful development of novel vaccines.
R&D mode: Independent R&D mainly, supplemented by cooperative R&D and
secondary innovation of imported technologies11824
Platform forattenuatedvaccines
◎11 innovation platforms
Deliver High-quality Productsand Services
innovation platformsR&D Basesadvanced core technologies
Platformfor virusattenuatedcombinedvaccinePlatform forbacterialpolysaccharideconjugatevaccines
Platform forpolyvalentbacterialpolysaccharideconjugatevaccines
Platform forcombinedvaccines
Platform forvirus vectorvaccines
Platform formRNA vaccines
Platform forinactivatedvirus vaccines
Platform forGeneticallyEngineered
Vaccines
Platform for
bacterialpolysaccharide
vaccines
Platform forpolyvalentbacterialpolysaccharide
vaccines
Relying on our R&D platforms and core technologies, we have completed the development of several world-leadingvaccines with independent intellectual property rights. Our platforms complement each other to form a strong synergyeffect, enabling us to develop vaccines and build our product portfolio in a more economical and efficient manner,providing guarantee for the continuous upgrading of our products and the successful development of novel vaccines. Atpresent, we have overcome the barriers to the development of several blockbuster vaccines.
Note: For more details on the Company’s R&D, see‘Section III: Management’s Discussion and Analysis’ in the Company’s2021 Annual Report
Important R&D Achievements
?
μg Recombinant Hepatitis B Vaccine (Saccharomyces cerevisiae) : the world’s first hepatitis B vaccinefor non-responders aged 16 and above.
?DTaP-Hib Combined Vaccine: The first quadruple vaccine in China, and a major achievement of the NationalHi-tech R&D Program (or 863 Program).
?13-Valent Pneumococcal Polysaccharide Conjugate Vaccine: The world’s first dual-vector 13-valentpneumococcal polysaccharide conjugate vaccine; it is also a global best-selling vaccine.
?23-Valent Pneumococcal Polysaccharide Vaccine : one of the world’s top 10 best-selling vaccines in 2021.
?Diphtheria, tetanus, pertussis (acellular, component), poliomyelitis (inactivated) vaccine (adsorbed)and Haemophilus influenzae type b DTaP-HiB-IPV conjugate vaccine: It is the only domestic quintuplevaccine that has obtained theNotice of Approval for Drug Clinical Trialsissued by the China National MedicalProducts Administration.
The Company has implemented a global strategy while "bring in" and "go abroad". Our products have now obtainedregistration certificates in several countries. Our Recombinant COVID-19 Vaccine (Y25 Adenovirus Vector) was authorizedfor emergency use by the National Agency of Drug and Food Control of Republic of Indonesia and exported in October2021, representing an important progress in the implementation of our internationalization strategy. We will continue toexplore the international market, step up our global strategy, promote the registration of our products overseas, seek moreinternational marketing opportunities, and develop diversified sales channels.
BioKangtai’s R&D Bases
?Shenzhen Novel Vaccine EngineeringLaboratory
?Guangdong Therapeutic Hepatitis B VaccineLaboratory
?Beijing Key Laboratory for Novel ConjugateVaccine Technology
?Beijing Novel Vaccine Engineering Laboratory
?Postdoctoral R&D Center
?Beijing International Sci-Tech CooperationBase for Novel Vaccines
?Beijing Novel Combination Vaccine R&DCenter
?Academician Workstation
◎Technology Import & Cooperation Projects
TypeVaccinePartner/ LicenseeCooperation Strategy
CollaborativeR&D
DTP-Hib-IPV Vaccine
DESMONSCONSULTING SPRL
DESMONS CONSULTING SPRL will assist theCompany in the development of DTP-Hib-IPV vaccinein accordance with the agreement.mRNA Vaccine
Immorna (Hangzhou)Biotechnology Co.,Ltd.
The two parties will cooperate in mRNA vaccinesfor human infectious diseases, and jointly develop,declare and produce mRNA vaccines.
μg RecombinantHepatitis B Vaccine(Saccharomycescerevisiae)(immunomodulator
A research institute ofthe Chinese People’sLiberation Army
BioKangtai provides the funds required for R&D, and allintellectual property rights belong to the Company.PatentLicensing
MultivalentHumanBovineRotavirus Vaccine
National Institutes ofHealth, US
NIH grants BioMinhai a non-exclusive license to useits patent for Multivalent HumanBovine RotavirusVaccine to manufacture, use and market the productworldwide, except for Europe, Canada, the US, Indiaand Brazil.
Technology
Licensing
Hepatitis B VaccineMerck, US
Merck provides the Company with the Hepatitis BVaccine production process, manufacturing know-how, technical documentation, training, RecombinantHepatitis B Vaccine strains and detailed processplans, which will only be used to meet mainlandChina’s demand for hepatitis B vaccine. After thecontract has been in effect for ten years, the productcan be exported or sold in Hong Kong SAR, MacaoSAR and Taiwan Province.Rabies Vaccine(MRC-5 cells)for Human Use,Freeze-dried
Sanofi Pasteur
Sanofi Pasteur grants BioMinhai a non-exclusive,non-transferable and non-sub-licensable license touse the materials and technology for the productionof Rabies Vaccine (MRC-5 cells) for Human Use,Freeze-dried to develop, manufacture and marketthe vaccine in mainland China (excluding Hong KongSAR, Macao SAR and Taiwan Province).InactivatedPoliomyelitisVaccine, SabinStrains(Vero cell)
INTRAVACC, theNetherlands
INTRAVACC licenses to Minhai Biologicals a non-exclusive, non-transferable technology for theproduction of inactivated poliomyelitis vaccine fromSabin strains and related assays; Minhai can use thistechnology for the production in China and worldwidedistribution of inactivated poliomyelitis vaccine fromSabin strains and related combination vaccines.Mumps VaccineStrains
IMUNA PHARM,A.S.
IMUNA PHARM, A.S. provides Mumps Vaccine Strainsto BioMinhai for use in the production and sale ofsingle or multiple doses of vaccine and monovalent ormultivalent combination vaccines in mainland Chinafor the purpose of preventing or treating humandisease.RecombinantCOVID-19 Vaccine(Y25 AdenovirusVector)
AstraZeneca
AstraZeneca has exclusively licensed BioKangtaito develop, manufacture and commercialize theRecombinant COVID-19 Vaccine (Y25 AdenovirusVector) in China (excluding Hong Kong SAR, MacaoSAR and Taiwan Province); and to market the vaccinein Pakistan and Indonesia.
At present, the Company has more than 30 projects under development, basically covering key vaccine types in the world.The major projects that have entered the registration procedures are as follows.Serialnumber
Vaccine NameRegistration StageCurrent Process
Rabies vaccine (human diploidcell) for human use, Freeze-dried
NDA under review
Completed on-site verificationfor registration
Freeze-dried Live AttenuatedVaricella Vaccine
Clinical phase completed
Obtained Phase I and III clinicaltrial summary report
Group ACYW135 MeningococcalPolysaccharide Vaccine
In the summary stage of clinicalphase
Completed the on-site job ofPhase III clinical research
Hepatitis A Vaccine(HumanDiploid Cell), Inactivated
In the summary stage of clinicalphase
Completed the on-site job ofPhase III clinical research
Inactivated PoliomyelitisVaccine, Sabin Strains(Vero cell)
IND obtained, clinical phase inprogress
In Phase III clinical trial
SARS-CoV-2 Vaccine (Vero Cell),Inactivated
Approved for emergency use inChina
Phase III clinical trial foroverseas is in progress
Recombinant enterovirus A71vaccine (Hansenula)
IND obtained, clinical phase inprogress
Completed Phase I and II clinicaltrials
Recombinant Hepatitis BVaccine (Saccharomycescerevisiae)
IND obtained, clinical phase inprogress
Completed Phase I clinical trial
Diphtheria, Tetanus and AcellularPertussis Combined Vaccine(component) , Adsorbed
IND obtained, clinical phase inprogress
Phase I clinical trial in progress
Diphtheria, tetanus, pertussis(acellular, component),poliomyelitis (inactivated)vaccine (adsorbed) andHaemophilus influenzae type bconjugate vaccine
IND obtained
Obtained notification of clinicaltrial approval
Diphtheria, tetanus, acellularpertussis (component) AdsorbedInactivated poliovirus vaccine
IND obtained
Obtained notification of clinicaltrial approval
μg Recombinant HepatitisB Vaccine (Saccharomycescerevisiae) (immunomodulator
Has withdrawn the applicationfor vaccine registration approval,currently in the clinical data self-examination phase
Clinical data self-examination inprogress
Reassortant Rotavirus Vaccine,Live, Oral, Pentavalent (VeroCell)
IND obtained
Phase I clinical trial inpreparation
R&D Management System ConstructionBioKangtai always attaches great importance to technological innovation and product R&D. In accordance with theDrugAdministration Law of the People’s Republic of China,Vaccine Administration Law of the People’s Republic of ChinaandMeasures for the Administration of Drug Registration, the Company has established a complete R&D system, carrying outefforts in three major directions: creating an innovative environment, improving the incentive mechanism for innovationsand promoting the transformation of R&D results.Aiming for a positive cycle of innovative development, the Company has established a scientific and fair R&D performanceassessment system and incentive mechanism for innovations to provide continuous impetus for technology developmentand product innovation. ◎Innovation Management System
?Implement innovation-driven strategy and incorporate innovation into the Company’s medium-and long-term strategy
?Encourage innovative approach, tolerance for failure, courage to expose defects and self-transcendence, to create a sound innovation culture
?Set out clear targets and executable plans for innovation
?Continuously increase investment in R&D. In 2021, the Company’s R&D investment accounted for
20.22% of its operating revenue
?Formulation ofR&D Center Project Management Regulations,BioKangtai’s Reward andPunishment System, etc., which stipulates 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 inscientific research, information technology, and strengthening the recruitment of leading talents
?Establish mechanisms and capabilities to promote the transformation of innovation results withcommercial or social value
?Form synergy between“product research and development”and“social needs”to achieve thevirtuous cycle of“continuous innovation” by developing market-oriented products
Environmentfor Innovation
Training and Retention of R&D Talents
BioKangtai attaches great importance to the construction of R&D team. Since its establishment in 1992, the Companyhas accumulated a large number of core technologies for vaccine R&D and production through nearly 30 years of R&Dinnovation and technology absorption, and has built up a crew with international vision, rich experience in vaccinedevelopment and management, as well as practical experience in industrialization. Adhering to the belief that“talent isthe primary resource for corporate innovation”, we have pooled together the best talents in the field to form a team witha reasonable talent structure for vaccine R&D, production and quality control, mainly composed of doctors and masters.Among them, the key technicians have more than 10 years of experience in vaccine R&D and have undertaken morethan 60 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 experts as consultants to ensure the technicalstandards, R&D progress and quality of vaccines.
IncentiveMechanism forInnovation
InnovationTransformation
R&D Talent Attraction Measures
1.Establish a long-term mechanism to motivate core R&D/key personnel by implementing an equity
incentive plan
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 for the Company
4.Provide housing subsidies for talents in Nanshan District, Shenzhen, and solve their problems in
children’s enrollment, application of Shenzhen hukou and dwellings
5.Apply for Beijing hukou for qualified 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 benefits
7.Outstanding young talents in Daxing District: enjoy benefits such as funding for R&D projects
8.Returned overseas talents in Daxing District: enjoy a allowance for living expenses and preferential
rental housing, etc.
The Company has established comprehensive measures to attract researchers and talents to continuously recruit high-end R&D talents with both scientific and technical expertise.
The Company has established and improved a long-term incentive mechanism to fully motivate the core R&D staff.Through the implementation of the equity incentive plan, we have effectively combined the interests of shareholders,the Company‘s interests and the interests of core teams and employees to fully motivate the senior management, coremanagement and core technical staff. By the end of the reporting period, the Company has motivated 913 employees intotal through the implementation of 2017 Restricted Stock Incentive Plan and 2019 Stock Option Incentive Plan.
Opennessand sharing
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 opennessin its R&D practices.
Intellectual Property Protection
The intellectual property rights owned by the Company, such as patents and trademarks, are an important part of thecore competitiveness of the Company. We have long attached great importance to the protection of intellectual propertyrights, strictly complied with thePatent Law of the People’s Republic of China, theTrademark Law of the People’s Republicof Chinaand other relevant laws and regulations, and secured our legal and effective intellectual property rights throughpatent application and trademark registration to maintain our reputation and core competitiveness. BioMinhai, thesubsidiary of the Company, has established an enterprise intellectual property management system in accordance withthe national standard namedEnterprise Intellectual Property Management Regulation(GB/T29490-2013) and successfullyobtained the certification of intellectual property management system.When engaging in external cooperation, the Company strictly abides by the legal procedures for technology importationand patent licensing, and signs technology licensing and R&D cooperation agreements with its partners, which clearlystipulate the rights and obligations of both parties and the ownership of R&D intellectual property rights. The Companypromotes cooperation matters according to the agreements to avoid relevant disputes in respect of intellectual propertyrights. During the reporting period, the Company did not have any incident related to the infringement of others’
intellectual property rights, and there was no litigation case related to intellectual property rights.
◎Ethical Principles for Scientific Research
RegulatoryCompliance
?The whole process of R&D should refer to and follow the relevant laws and regulations.
?Respect for patents, copyrights and other forms of intellectual property rights.
?Share research results and scientific resources openly within the permitted range.
Human
and Animal
Subjects
Protection
?Clinical trials of drugs follow the principles of theDeclaration of Helsinkiof the World MedicalAssociation and related ethical requirements, and the rights and safety of subjects are theprimary consideration
?Follow the 3R principles (reduce, replace and refine) in the use of laboratory animals andresearch, concern for the welfare of laboratory animals, and treat them well.
Integrity in
Scientific
Research
Intellectual
Property
Protection
ReliableData
?Follow the scientific standards and the principle of honesty and trustworthiness.
?The whole process of R&D should be recorded, and the records must be timely,true, standardized and complete.
Quality Control SystemThe Company always gives top priority to product quality. We continuously improves its quality control system inaccordance with the Drug Administration Law of the People’s Republic of China, theVaccine Administration Law of thePeople’s Republic of China, the Good Manufacture Practice of Medical Products, and standards for medical productregistration. We continuously improve the scientific management of vaccine production to ensure that all requirementsfor safety, efficacy and quality control in medical product regulations and registration standards are systematicallyimplemented in the process of vaccine production, quality control, product release, storage and transportation and ensurethat all procedures in product R&D, production and distribution are in compliance with the intended use and registrationstandards. During the reporting period, the Company’s vaccine batch approval rate reached 100%.The Company actively absorbs the cutting-edge technology and advanced quality management concepts frominternational organizations and well-known enterprises such as WHO, Sanofi-Pasteur and Merck. At the same time,we strictly enforce our regulations, ensure the authenticity of original data, deal with every problem in time, ensurestrict monitoring of defective products, and never slacken GMP management. By establishing a whole-process qualitymanagement system, combined with quality training for employees, correction and prevention, informatization, andsupervision and inspection, we constantly refine our quality control management system and implement comprehensivequality management throughout the product life cycle to ensure the delivery of high-quality, safe, and effective vaccines.
Whole ProcessQualityManagementSystem
Correction andPreventionManagementQuality Trainingfor Employees
Supervision andInspectionInformatizationConstruction
Strict control of product quality
The Company has established a quality management system covering all procedures including product R&D, production,sales and after-sales service.
In terms of digital construction, the Company has established an electronic system for vaccine traceability, which isconnected with the national vaccine e-traceability platform to achieve full traceability and verifiability throughout theprocess of vaccine production, quality control and product release, storage and transportation. At the same time, theCompany actively promotes the construction of digital system for product production and inspection to accelerate thedigital transformation of vaccine production and achieve more efficient, real-time and traceable quality management.In 2021, the Company successfully launched the laboratory information management system to achieve accurate datamanagement; the manufacturing execution system is steadily under construction and is expected to be completed andofficially launched in 2022.
◎Whole-process Quality Management SystemSourceManagement
ProductionMonitoring
QualityInspection
Release and
ProductTransportation
Vaccine
LabelingManagement
?Material Management Regulations and Supplier Management Regulationshave been formulatedfor standardized management.
?Acceptance of materials according to the bill of materials and the requirements of qualitystandards. The process includes procurement, acceptance, inspection, storage, release and usemanagement.
?Develop theProduction Quality Control Management Regulationsand implement productionmonitoring based on it.
?In accordance with the regulations, process parameters are evaluated and continuously tracked toidentify abnormal trends and achieve all-round data monitoring.
?DevelopSample Receipt, Inspection and Reporting Procedures,Quality Control DepartmentStandard Management Regulations, andQuality Control Department Reagent ManagementRegulations and strictly follow them.
?Control product quality by conducting quality testing involving standards, reagents, sampleretention and laboratory management, etc.
?DevelopAssured Management Regulations,Sales Management Regulations, andCold ChainTransporter Management Regulations and strictly enforce these regulations.
?Products are inspected and approved by the Quality Authorized Person before leaving the factory.The products are transported according to the cold chain transportation requirements, ensuringthat they are delivered as required and well tracked in the market.
?DevelopPrinting and Packaging Materials Management Regulationsand strictly enforce theregulations.
?The design samples of product labels need to be examined by the person in charge of productionmanagement and quality management, and approved by the medical products administration.After the product labels are purchased and printed according to the regulations, they need to beexamined by the quality management center before putting them into use.
In terms of supervision and inspection, the Company carries out internal quality supervision and inspection to ensure theeffective operation and continuous improvement of the quality management system. Meanwhile, the Company accepts theaudit of regulatory authorities at national, provincial, municipal and district levels every year, and the audit results are allsatisfactory.
◎Digital System Construction
◎Supervision and Inspection
?The Company’s LIMS covers batch management, stability management, instrument management,standards management, reagent management, and laboratory survey management. The system enablesefficient management of laboratory resources and more reliable laboratory data management.
?The LIMS is launched successfully in December 2021.
?The Company's MES covers recipe management, production order management, electronic batch records,batch analysis, material management, and equipment management. The system enables the generation ofelectronic batch records to ensure good traceability in all aspects of production.
?The MES is expected to be officially launched in 2022.
?At present, regulatory authorities supervise and monitor the quality of our vaccines by means ofaudits, which are conducted by national, provincial and municipal medical product administrations. TheCompany actively rectifies the problems raised by regulatory authorities and improves the quality systemcontinuously.
?In 2021, the Company received vaccine inspections and GMP follow-up inspections from the NationalMedical Product Administration and Guangdong Provincial Medical Product Administration for four times,all of which were passed.
?In 2021, BioMinhai received vaccine inspection, GMP compliance inspection and on-site verification ofvaccine registration from the National Medical Product Administration and the Beijing Municipal MedicalProduct Administration for five times, all of which were passed.
?The Quality Assurance Department conducts quality supervision and inspections according to theprescribed frequency, and checks the key control points of production batches. Meanwhile, annualself-inspection is carried out to cover the whole process of production and quality control (materialmanagement, production, quality control, continuous improvement, circulation, etc.)
?In 2021, the Quality Assurance Department carried out at least one supervision and inspection to theproduction workshops or departments once a week, and every batch of products was supervised andinspected in production. The Company completed the annual quality self-inspection audit as required, andthe identified problems were rectified and improved in a timely manner.
Laboratory Information Management System (LIMS)
Quality audits by government departments
Manufacturing Execution System (MES)
Regular internal supervision and inspection
In terms of corrective and preventive management, the Company strictly implements GMP management requirements,and has formulated regulatory documents such asDeviation Management Regulations,Regulations on Change Control,Regulations on Corrective and Preventive MeasuresandRegulations on Customer Complaint Handlingto implementdeviation and change management and risk control in production to ensure that the products meet the intended use andvaccine registration requirements. Moreover, we have established a GMP self-inspection team to conduct comprehensiveself-inspection at least once a year, with comprehensive reports generated, corrective and preventive measures fordefects formulated and implemented, and the effectiveness of the measures continuously tracked. By means of GMP self-inspection, the Company has made continuous improvement and refinement in quality control and management, keepingthe product quality stable.
In terms of quality culture construction, the Company has established a quality training system, covering new employeetraining, basic quality training, thematic training, external thematic training, and legal and regulatory training, to enhancethe quality management awareness of staff in each position. In 2021, the Company conducted more than 2,000 trainingsessions for employees on product quality and safety, covering laws and regulations, personnel control, equipmentmanagement, material control, aseptic assurance, quality assurance, data reliability, pharmacovigilance, and job-specificskills, with a 100% pass rate for those who participated in the training.
◎Deviation HandlingDeviationreportingDeviationinvestigation
Deviationclosure
Deviations are reported to the quality assurance department in a timely manner, andnecessary emergency measures are taken.Set up a deviation investigation team, conduct a deviation cause investigation, evaluate theimpact caused by deviation, and formulate corrective and preventive measures.Complete corrective and preventive measures and evaluate their effectiveness, and closethe deviation.
Training on Contamination Control StrategyIn October 2021, the Company organized a thematictraining session on contamination control practices,mainly for personnel whose work involves asepticoperation. The training session effectively deepenedthe employees’understanding of contaminationcontrol strategies.Basic Biochemistry TrainingIn April 2021, BioMinhai organized a training sessionon the basics of biochemistry, mainly for the frontlinemanagers. The training effectively deepenedthe employees' understanding of the basics ofbiochemistry.
Thematic Training on Quality Management ModuleIn December 2021, the Company organized a thematictraining session on the QM module, mainly facing themanagement staff at the primary level. The trainingsession allowed staff from all departments to furtherconsolidate their knowledge on quality managementand promoted the effective implementation andcontinuous improvement of quality management inthe Company.Training on contamination control of sterile drugsand microbial identificationIn October 2021, BioMinhai organized a trainingsession on asepsis, mainly for departments involvedin the investigation of microbiological data deviationsand aseptic operations. The training session allowedthe personnel of relevant departments to furtherconsolidate their knowledge on the analysis andinvestigation of microbial data deviations and strainidentification methods in environmental monitoring,and promoted the standardization and continuousimprovement of aseptic operations.
Examples of Training Sessions in 2021
Pharmacovigilance Management
We attach great importance to pharmacovigilance management throughout the product life cycle. In 2021, we built apharmacovigilance system based onGuidelines for Good Pharmacovigilance Practices. The system monitors, identifies,evaluates and controls suspected adverse events following immunization (AEFI) through its effective operation andmaintenance.The Company has established a Committee on Safety of Medicines (CSM) and set up a Pharmacovigilance Departmentwith clear responsibilities to ensure the smooth implementation of pharmacovigilance activities. We receive annualpharmacovigilance inspections from national regulatory authorities. In 2021, we received five inspections, including fourinspections from the provincial medical products administration and one inspection from the national medical productsadministration, all of which were passed.
In terms of system construction, we have upgraded to 37 regulatory documents based on the original 14 regulatorydocuments in 2021. As of the end of the reporting period, the documents and system, which are systematic,standardized and practical, fully cover the requirements for all pharmacovigilance management procedures such aspost-marketing pharmacovigilance and pharmacovigilance during the clinical trial.For key aspects of pharmacovigilance, the Company has formulated corresponding procedural documents to continuouslyimprove the system and carry out daily management actions.
DepartmentFunctions
Committee on Safety of
Medicines (CSM)
The Committee on Safety of Medicines (CSM), as the decision-making body forpharmacovigilance activities, is responsible for major risk identification, disposal of majoror emergency adverse events, risk control decisions, and other major matters related topharmacovigilance.
PharmacovigilanceDepartment
The Pharmacovigilance Department, as an independent functional department, has thefollowing responsibilities:
?Daily operation and management of the pharmacovigilance system, including theestablishment and maintenance of the system.
?Monitoring, reporting and organizing investigations of adverse events followingimmunization (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 reportsfor marketing licensees, etc.
?Communication of vaccine safety information.
?Pharmacovigilance management and coordination with internal audits.
?Organize pharmacovigilance-related education and training, etc.
Key LinksQuality ProceduresMeasures and Actions
Clinical ResearchPharmacovigilance
Strictly comply with theGuidelines for Good ClinicalPractices and relatedregulations to fully protect therights and interests of subjects.
?In 2021, the Company's Pharmacovigilance Departmentconducted pharmacovigilance management for theoverseas phase III clinical studies of its COVID-19vaccine by establishing a clinical study department inaccordance with the requirements of relevant rules toensure the smooth conduct of clinical studies.Pre-marketingPreparation of
Vaccines beforelaunch
Procedures such as theVaccine Risk ManagementPlanwere established forregulating the pre-marketingrisk assessment
?In May 2021, the Company formulated theRiskManagement Plan for SARS-CoV-2 Vaccine,Work Plan forEmergency Use ofSARS-CoV-2Vaccine,AEFI MonitoringPlan for Emergency Use of SARS-CoV-2 VaccineandWork Plan for Post-Emergency Use of SARS-CoV-2Vaccineto regulate the pharmacovigilance efforts afteremergency use ofSARS-CoV-2 vaccine.
To improve employees’pharmacovigilance awareness, the Company has formulated theTraining Regulations onPharmacovigilance Managementand incorporated pharmacovigilance training into the Company’sAnnual TrainingPlan, which mainly includes pharmacovigilance training for new employees and all employees to enhance the staff’spharmacovigilance awareness. For marketing center personnel, the Company carries out training on collection andhandling of AEFI at least once a year.The pharmacovigilance department pays close attention to the changes of pharmacovigilance-related regulationsand policies, actively participates in the training and study organized by medical products administration and industryassociations, and delivers the changes and requirements to the Company’s employees. In 2021, the Company organizedmore than 40 internal and external trainings on pharmacovigilance, and all related trainings and examinations wereincorporated into the Company’s GMP training management system.
Key LinksQuality ProceduresMeasures and Actions
AEFI Monitoring and
Reporting
Documents such asMonitoring and HandlingProcedures for SuspectedPost-marketing AEFIandProcedures for HandlingPharmacovigilance Dataareformulated for the monitoringand handling of AEFI and datamanagement.
?The Company obtains AEFI information throughinformation sources such as the National HealthCommission of the PRC and the China Center forDisease Control and Prevention and processes itaccording to regulations.
?In April 2021, the Company launched and completedvalidation of a pharmacovigilance data managementsystem for managing safety-related data, which isa web-based application for collecting AEFI reportsduring the clinical trial phase and post-marketing AEFIreports.Risk Assessment and
Control
Formulate theOperationalProcedures for Vaccine RiskAssessment and ControlandOperational Procedures forVaccine Risk Communication
for vaccine risk assessmentand control.
?Assess the safety risks of novel vaccines, analyze theinfluencing factors, describe the risk characteristics,determine the type of risks, and appraise whether riskcontrol measures are needed.
Product Recall ManagementThe Company has formulated theProduct Recall Management Regulations, detailing the recall procedure flow and therequirements of each link. Since its establishment, the Company has not experienced any recall ordered by the medicalproduct administrations or active recalls. The Company conducts a mock recall at least once every two years to evaluateand ensure the effectiveness of the product recall system
Quality IncidentsReport to the Committee on Safety of
MedicinesInitiate investigation and assessmentof vaccine safety risksDecide whether to recall
Recall
Mandatory recall by medicalproducts administration
Develop and implement correctiveand preventive measuresDevelop and implement corrective and
preventive measuresTrack the effectTrack the effect
Close the recall actionDocumentation
Mandatory recall
Not meet therequirementsNot meet therequirements
Meet the requirements
Meet the requirements
Yes
No
◎BioKangtai’s Product Recall Procedures
Supply Chain Management
Supply chain quality management is an important part of product quality management. To ensure that the productsprovided by suppliers can meet the quality requirements, the Company has formulated theSupplier ManagementRegulations,Supplier Management Procedures,andMaterial Management Regulations, which clearly stipulatethe requirements and standards for supplier audit, new admission, changes, auditing, quality assessment, and filemanagement, as well as promote their efforts for the improvement of quality management to ensure product quality. Forkey raw and auxiliary material suppliers, the Company reserves 2 or 3 backup suppliers to ensure proper market supplyunder unexpected circumstances.Based on the grade of quality risk control of materials provided by suppliers, the Company classifies materials into sixgrades: A1, A2, B1, B2, C1 and C2, and implements different quality control strategies accordingly.
?Strict management of suppliers, set general qualification requirements and qualificationrequirements for certain materials, strictly audit the business qualification of suppliers and qualityof materials to ensure compliance with the quality and technical standards of production.
?TheSupplier Management Regulationsspecifies procedures including initial supplier selection anddata review, sample evaluation, process verification, product stability research, data compilationand audit, and supplier approval.
?Conduct written audits and on-site audits of new suppliers to assess their own quality assurancecapability, in addition to on-site audits of the supplier's own quality management system,production safety management measures, and production equipment conditions.
?The Company signsQuality Assurance Agreementwith suppliers of A1, A2 and B1 grades to ensurethat the products provided by them meet the Company’s quality standards and requirements.
?The Company formulates an audit program every year to carry out audits and evaluationsaccording to the importance of suppliers.
?Audit types and frequency: there are regular on-site audits and written audits; the frequency isonce a year or once every two years according to the importance of the suppliers; the suppliers ofthe auxiliary materials and internal packaging materials in A1 complete at least one audit per year.
?Audit coverage: supplier qualifications, quality management systems and regulatory measures.
?Enhancement measures for suppliers: regularly evaluate the quality management system ofsuppliers, supervise the improvement of deficiencies, and discontinue or revoke the qualificationof suppliers who do not meet the requirements.
Supplier Onboarding
Supplier Evaluation and Audit
Deliver Excellent Customer Services
Customer Services
The Company actively builds customer communication channels, collects customer feedback through 400 customerservice hotline and other ways, thus providing timely and effective communication access and solutions for customers.The Company has formulated theCustomer Feedback and Complaint Management Proceduresto standardize theworkflow of solving customer feedback. After receiving customer feedback, the Company first carries out internalcommunication and investigation for the issues, and organizes relevant departments to formulate corrective measures andpreventive measures to ensure timely and proper resolution of the issues raised by customers.The Company conducts annual customer satisfaction surveys and obtains feedback from customers on its products andservices through theCustomer Feedback Collection Form. In 2021, the Company received feedback on satisfaction frommore than 60 disease control and prevention organizations with generally high satisfaction scores. ◎Customer Feedback Management ProceduresSales and Marketing CenterRelated DepartmentsSales and Marketing Center
?Collect customerfeedback andreceive complaints
?Quality ManagementCenter organizesrelevant departments tocarry out investigationand develop correctiveand preventive measures
?Assist in theinvestigation, reply tocustomers and closecomplaints
Information Security and Customer Privacy ProtectionThe Company strictly abides by thePersonal Information Protection Law ofthe People’s Republic of Chinaand other relevant laws and regulations, andhas formulated theIT-01-001-Information Management Regulationsand theC-00-I-0-009 Personal Information Security Management Regulations, whichprovide strict data security management and personal information security.In 2021, the Company carried out an assessment on information securitymulti-level protection in accordance with theInformation Security Multi-LevelProtection Management Rules, and obtained the Level-2 certificate, whichprovides a strong support for information security.In terms of customer privacy protection, the Company implements a strictconfidentiality agreement system and sets exclusive permissions for customerinformation. The information department will regularly check the permissions,and make timely corrections to any discovered problems. We attaches greatimportance to cybersecurity and privacy protection, and has added securitymeasures for the server to enhance privacy protection. In 2021, the Companydid not have any incidents of customer information or privacy leakage.The Company invites external experts to conduct relevant training to improveemployees’awareness and recognition of information protection. In May2021, the Company invited Guangming Internet police and technical staffof Shenzhen NST Technology to conduct information security training forall employees, mainly including knowledge on network security prevention,ransomware prevention, personal information protection, and anti-telecommunications fraud, to improve employees’awareness of cybersecurityand personal information protection.
Responsible MarketingThe Company strictly abides by theAdvertising Law of the People’s Republic of China, theTrademark Law of the People’sRepublic of Chinaand other relevant laws and regulations, and always insists on ethical, scientific and objective promotionto ensure that regulatory authorities, medical professionals and customers receive timely, truthful and accurate productinformation and academic information.In terms of product promotion, the latest information on the research results and clinical practice of the Companyis delivered to the public through various means such as academic conferences, expert lectures, online and offlineknowledge promotion, and disease prevention knowledge is spread. In product promotion, all promotional information ofthe Company meets the requirements of accuracy, clarity and transparency. For the key promotional information of thevaccines, the Company will specify the relevant reference sources. In addition, the information published on professionalpharmaceutical magazines by the Company is in compliance with the requirements of the Guangdong Provincial Food andDrug Supervision Administration and Advertising Law, and has obtained relevant advertising approvals.
◎Three Principles of Responsible Marketing
Promotional or stated informationis consistent with approved labels,with no advertising or promotionalmaterials that have not beenapproved by compliance andmarketing departments
Product information used ordisseminated to the public iscomplete and clear, with no false ormisleading statements
The products’performance andsafety information is describedcomprehensively, withoutconcealing its potential risks,so as not to cause any formof information inequality ormisinterpretation of information.
AccuracyClarityTransparency
With regard to the compliance and review for product promotion materials, the Company has formulated theRegulationson the Production, Collection and Management of Promotional Materials and Items, which specifies the productionprocess and approval procedures for promotional materials to ensure the accuracy, clarity and transparency of marketinginformation or statements.Thecompany'sproductdivisiondraftspromotionalmaterials forproducts
Through online and offline approaches, the Company organizes trainings on responsible marketing and related compliancematters for employees in the sales positions in accordance with the requirements of theSales Management Regulations, tohelp sales staff understand laws and regulations and internal regulatory requirements. With regard to product information,the sales staff shall not disseminate functions and information beyond the product description, and should neverexaggerate the functions of products and technologies or conceal their potential risks. The Company conducts responsiblemarketing trainings for sales persons in all levels on a regular or irregular basis. We conduct compliance training once ortwice a year for employees in sales positions and requires quarterly training for sales teams at provincial level; the trainingshould cover compliance and integrity, market policies and regulations, product information, etc.
The medicaldepartmentis responsiblefor reviewingthe contentof thematerials.
The finaldraft isjointlyreviewed bythe productdivision andthe medicaldepartment.
Approval bymarketingand medicaldirector
Approval bythe head ofmarketingcenter
Printing andput into use
Environmental Management SystemThe Company takes“strict pollution control, scientific management, energy conservation and emission reduction, andcontinuous improvement of energy efficiency”as its management principles and has established an environmentalmanagement structure with well-defined responsibilities. The Environmental Health & Safety (EHS) committee isthe Company’s environmental management body, and its Office of Safety, Health and Environmental Management isresponsible for the regular environmental management. We require all employees to sign a letter of responsibility for EHStargets, and associate environmental management performance with the quarterly performance appraisal of middle andsenior management.The Company has formulated documents such as Environmental Protection Management Regulations andSolid WasteManagement Regulationsto stipulate the requirements for its environmental protection practices, covering environmentalmonitoring, pollution prevention and control, comprehensive utilization of Three Wastes (industrial wastewater, wastegases and residues),“Three Simultaneities”for construction projects, and management and maintenance of environmentalprotection facilities.
Improve Environmental Management
BioKangtai adheres to the path of green development and strictly complies with the laws, regulations and industryguidelines related to environmental protection, and has built an environmental management system accordingly. Byupgrading energy-saving and environmental protection technologies, reasonably utilizing energy and other resources,taking effective measures for energy saving, emission reduction and waste management, we constantly reduce thenegative impact of our operations on the environment and contribute to the sustainable development of the Company andsociety.
Person in ChargeMain ResponsibilitiesDirector of EHS Committee
?Responsible for the approval of the Company’s annual environmental targets andrelated policies.Deputy Director of EHS
Committee
?Responsible for the approval of environmental protection issues within the scope ofresponsibility.
?Responsible for the approval of environmental protection evaluation resultsHeads of Departments
?Responsible for organizing and supervising the implementation of environmentalprotection efforts in all teams and departments of the Company
?Responsible for the evaluation of the environmental protection efforts by teams anddepartments.Office of Safety, Health andEnvironmental Management
?Responsible for the implementation of the departmental environmental protectionefforts, and break down the department’s annual environmental protection goals toeach team.
?Responsible for supervising the implementation of environmental management in thedepartment, and organizing self-assessment.
Heads of Teams
?Responsible for the implementation of the annual environmental protection efforts ofthe team.
?Responsible for the self-assessment of the completion of the team's annualenvironmental protection goals.
Adhere to Green Development
Environmental Impact Analysis
The 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,purification, inactivation and adsorption, consuming energy such as electricity, natural gas and steam, and generatingwaste water, waste gas, harmless waste and hazardous waste. The Company complies with the provisions of the PollutantDischarge Permit, monitors and records pollutants by manual and automatic methods, and properly disposes of all types ofsolid waste to strictly control the impact of production discharges on the environment.In July 2021, Shenzhen issued theImplementation Measures of Shenzhen Compulsory Liability Insurance for EnvironmentalPollution, marking that Shenzhen became the first city in China to establish a compulsory liability insurance system forenvironmental pollution management. To support the policy, BioKangtai accepted a third-party assessment and purchasedcompulsory liability insurance for environmental pollution to avoid environmental incidents by means of third-party riskmanagement and environmental management.
In 2021, to further understand the main sources of carbon emissions and emission data, BioKangtai and BioMinhaicommissioned Shenzhen Environmental Engineering Technology Center and China General Certification Center in Beijing,respectively, to conduct a carbon accounting, which determined their organizational boundaries and carbon emissions.
Emission Source Identification and Carbon AccountingThe main types of energy consumed by the Company in production are electricity, steam, natural gas and minor amountsof gasoline, diesel and liquefied petroleum gas (LPG). Electricity for production is provided by the city’s public power grid,mainly used for production equipment; steam is used mainly for utilities and equipment supporting production; natural gasis used mainly for boilers; gasoline and diesel are used for vehicles of the Company, and diesel is also used for emergencypower generation and regular maintenance of generators; LPG is used for the Company canteens. We identified the carbonemissions for Scope I and Scope II as follows:
Responding to Climate Change
Scope of GHG EmissionsSourceProcess
Scope I
Natural gasBoilers and canteensDieselThe Company’s transportation vehicles and generatorsGasolineThe Company’s passenger vehiclesLPGThe Company’s canteensScope II
Purchased electricityProduction department, auxiliary production department
and other departmentsSteamPublic works and equipment
◎Energy Management System
EnergyManagement
Team
EnergySupervision
System
The Company has an energy management team, headed by the production manager, withmembers from different departments. There is an energy consumption statistician in the teamresponsible for the Company’s energy consumption statistics, which are archived in the energyutilization and management platform. Meanwhile, the Company has carried out energy audit andclean production to continuously improve its energy management level.
The Company strengthens energy control based on its energy management system and conductsregular supervision, inspection and assessment.
Energy statistics is an important aspect of the Company’s energy management. To this end, wehave set up statistical units at three levels: company, area and workshop. Energy statisticianshave been set up at each level for energy statistics and reporting to the energy managementteam. By establishing a statistical account of energy consumption, we have realized IT-basedmanagement of energy consumption at all levels, which is conducive to statistical analysis ofenergy consumption.The Company has established an accountability system for energy-saving targets and an energy-saving evaluation system , taking the annual energy-saving target and the monthly energyconsumption data as the energy consumption pointer. Meanwhile, the Company has collected theenergy-saving management measures of each workshop, set up projects, make modifications andevaluate their effectiveness; each energy-using department is assessed, and the assessmentresults are directly related to the monthly performance and annual assessment performance ofthe responsible person.The Company actively carries out publicity and training on energy saving, and holds quarterlyenergy consumption analysis meetings to discuss problems in the Company’s energyconsumption and management, as well as the orientation for energy saving and clean production.
Energy ManagementThe Company attaches importance to energy management. Through the establishment and improvement of energymanagement team, energy management system, energy measurement system and energy-saving performanceassessment and training, we constantly improve our energy management capability and the employees’awareness ofenergy saving and emission reduction.In 2021, the Company commissioned Shenzhen Greem Industrial to conduct an energy audit, formulating an energy auditreport, an energy planning report, an energy saving diagnosis report and an energy efficiency benchmarking report.Through the energy audit, we have further understood our own energy efficiency and improvement potential in production,thus laying the foundation for improving energy efficiency.
EnergyStatistics
Energy-savingPerformanceAssessment
Energy Saving
Training
◎Measures for Energy Efficiency ImprovementPurchaseof Energy-
savingEquipment
EquipmentRenovationfor Energy-
saving
EquipmentRunning withIntelligentFrequency
The Company considers the brand, efficiency and capacity of the equipment in itsprocurement. Equipment with energy-saving inverter and intelligent centralized control system,such as air conditioners, pumps and refrigeration equipment, are selected for higher energyefficiency.
For integrated energy management, the Company adjusts the operation of some publicengineering equipment to intelligent frequency, reasonably distributes the load, and reducesenergy waste on the premise of meeting the needs for production, R&D, storage and inspection.
The Company carries out renovation of some equipment and facilities for energy-savingoperation and maintenance control.
?Replace the round cooling water tower with energy-saving square water tower
?Replaced all lights in the Company to LED lights with smart sensor
?Design RO system for wastewater recycling for cooling towers
?Replace the cooling towers, chillers and humidifier s
?Renovate the power station for heat recycling
?Replace insulation material for 2A water injection station pipeline
Improve Energy EfficiencyThe Company has established a multi-dimensional system of energy saving and emission reduction measures, involvingthe purchase of energy-saving equipment, renovation of equipment for energy saving and equipment operation withintelligent frequency to meet the requirements for sustainable development. In addition, the Company carries out leakageinspection in daily equipment management and regularly maintains the equipment and facilities to ensure their integrityand avoid energy waste.
Wastewater ManagementAs a vaccine manufacturer, wastewater treatment and discharge in compliance is the focus of our environmental protectionefforts. 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 asLawof the People's Republic of China on Prevention and Control of Pollution from Wastewater, Discharge Standards forPharmaceutical Wastewater and Integrated Wastewater Discharge Standard, and has formulated management documentssuch as Operating Procedures for Wastewater Treatment System, Management Procedures for WaterQuality Monitoringin Wastewater Treatment StationsandOperating Procedures for Wastewater Discharge, which provide guidance on theCompany’s wastewater treatment, monitoring and operation.The Company has wastewater treatment stations, which are operated in strict accordance with the requirements ofrelevant environmental protection regulations of the country. Industrial wastewater is discharged into the public seweragenetwork after treatment at the wastewater treatment stations. We have established an online monitoring system tomonitor COD, ammonia nitrogen, pH, total phosphorus and other pollution indicators in wastewater on a daily basis, andcommissioned a third party to conduct regular sampling and testing of wastewater to ensure compliance with wastewaterdischarge standards. In 2021, BioMinhai upgraded and renovated the on-site terminal of its online wastewater monitoringsystem, including the replacement of data collectors, the installation of automatic water quality samplers, UPS andstabilized power supply and camera surveillance. The acceptance and registration of the new system has been completed.During the reporting period, the Company did not have any incidents of excessive or illegal discharge of wastewater.
The Company strictly complies with the relevant laws and regulations, such as theMeasures on the Administration ofPollutant Discharge Permits, and applies for Pollutant Discharge Permit. We conduct regular pollution discharge inspectionand fill in quarterly and annual implementation reports on theNational Management Platform for Pollutant DischargePermitsin accordance with relevant regulations. In 2021, the Company did not receive any relevant administrativepenalties for excessive pollutant discharge.
Reduce the Environmental Impact ofOperations
Air Emission Management
The main pollutants in the air emission produced by the Company are volatile organic compounds. We strictly abide bythe provisions of relevant laws, regulations and normative documents such asLaw of the People’s Republic of China onPrevention and Control of Air Pollution,Discharge Standards for Odorous Pollutants,Discharge Standards for Air Pollutantsfor the Pharmaceutical Industry, andEmission Control Standard for Industrial Enterprises Volatile Organic Compounds, andhave formulated theEnvironmental Protection Management Regulationsto clarify the management requirements for airemission.All our air emission vents are designed and installed in accordance with national standards; production waste gas andodorous air from animal rooms are treated by high-efficiency filters and activated carbon adsorption before discharge;fumes from canteens are treated by fume purifiers before discharge. Meanwhile, we have commissioned a third party toconduct regular air emission testing to ensure that the emission concentrations of pollutants in waste gas comply withnational standards. During the reporting period, the Company did not have any incidents of excessive or illegal emission ofwaste gas.Waste ManagementThe waste produced by the Company includes general waste and hazardous waste. We strictly abide by theLaw ofthe People’s Republic of China on the Prevention and Control of Environmental Pollution by Solid Waste,ManagementMeasures for Hazardous Waste Transferand other relevant laws and regulations. We manage and store hazardouswaste such as medical waste, waste organic solvents, waste alcohol, waste hazardous chemicals, and waste reagentsin accordance with the regulations, and hand them over to qualified organizations for disposal through the Company’sEHS department. For domestic waste, general industrial solid waste and other non-hazardous waste, we comply with theMeasures of Shenzhen Municipality on the Classification and Reduction of Domestic Garbageand theBeijing MunicipalRegulations on Management of Domestic Wasteand other relevant regulations, and hand over such waste to the sanitationdepartment for disposal. During the reporting period, the Company did not commit violations of laws and regulationsrelated 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 alow risk of water shortage. We have developed a water conservation management system and have taken active action todrive the achievement of related targets. By improving the utilization of circulating and recycling water from boiler steamcondensate process and cooling tower, the Company achieved water conservation effectively. In 2021, we used recycledwater of 55,915 m?; our total water consumption for the year was approximately 315,200 m
, a decrease of 37,400 m? fromthe plan at the beginning of the year.
With our people-oriented corporate culture that emphasizes excellence, integrity, efficiency, innovation and cohesion,BioKangtai provides a safe, fair and harmonious workplace for the employees. We continuously optimize our humanresource management to foster the development of our employees with a clear promotion mechanism and a sound careerdevelopment platform, so as to realize a win-win situation for both the Company and employees.
BioKangtai’s Talent Philosophy
?Talent is the core force of company development and the cornerstone for sustainable development. Webelieve that we should let capable staff take up important positions, mediocre employees be laid off andthose with average ability engage in general work.
?The employees with good moral character, healthy body and mind, excellent performance and innovativespirit are the most valuable assets of the Company.
Grow Together with Employees
Employee Rights and Benefits
By strictly complying with the requirements of theLabor Law of the People’s Republic of China, theLabor Contract Lawof the People’s Republic of Chinaand other laws and regulations, the Company has established a labor and employmentsystem to ensure that employees are treated equally without discrimination based on their age, gender, race, placeof origin, religious beliefs and other factors, and that child labor or forced labor is strictly prohibited. Meanwhile, theCompany has formulated theLabor Contract Management Measures,Compensation and Welfare Management Rules,
Attendance and Leave Management Measures,Performance Management Rules,Work-related Injury Management Rules,
and other regulations to protect the legitimate rights and benefits of employees.
Protect Employee Rights and Benefits
◎Overview of BioKangtai’s Employee Recruitment and Rights Policies
RecruitmentManagement
CompensationManagement
Working Hoursand Leave
Treatment ofWork-relatedInjuries
?Recruitment: We insist on fair employment and prohibit the employment of child laboror forced labor.
?Dismissal: We terminate labor contracts of different types in accordance with ourLabor Contract Management Measuresto protect the legitimate rights and interests ofemployees.
?Compensation: We provide competitive compensation and benefits based on theprinciple of equity. Our compensation system is based on the value of positions, andwe reward employees fairly according to their performance, taking into account thecontinuous and indirect contributions of each position. We adhere to the performance-oriented principle and encourage value creation.
?Commercial insurance: We provide packages of commercial insurance and accidentinsurance for all employees, covering workers under labor contracts, labor dispatchworkers, rehired retirees, and interns.
?Overtime: Overtime pay is paid according to the Labor Law of People’s Republic ofChina.
?Leave: Legal holidays and paid leave such as wedding leave, maternity leave, sickleave, and paternity leave are implemented according to national laws and regulations;employees are entitled to annual leave as stipulated by the Company.
?Employees are entitled to leave for work-related injuries. The Company has formulatedtheManagement Measures for Work-Related Injuriesin accordance with theRegulationson Work-Related Injury Insurance of Guangdong, which stipulates details of work-related injury identification, declaration, and treatment, as well as matters such as laborrelations and dispute handling.
Employee CareThe company is committed to establishing a perfect welfare management system and providing diversified benefits fordifferent kinds of employees. We have formulatedWelfare Measures for WorkersandImplementation Measures for SpecialFunds for Trade Union Employees to ensure the transparency and effective implementation of our welfare policies.
The Company attaches importance to the physical and mental health of employees and advocates a work-life balancelifestyle. As a platform for communication with employees, the company’s labor union takes the initiative to listen toemployees’voices, respond to their demands, and carry out various activities for them on a regular basis, such as birthdayparties, interactive activities, tours, ball games, and annual performances. These activities have greatly enriched their life,created a friendly and energetic working atmosphere, and enhanced employees team cooperation in the Company.
◎Employee Welfare
Seniorityallowance
AcademicallowanceAnnual healthcheckups
HousingallowanceEmployeesympathy gift
Allowance foroccupationalsafety andpositionsof specialresponsibilityBenefitsfor famaleemployees
Meal allowance,high temperature/
heatingallowanceShoppingcards,in-kindbenefits
Maternityleave,maternitybenefits
ChildcareleaveHolidaybonus
The Company provides educational opportunities for outstanding management and technical talents and encouragesemployees to improve themselves. We fully support frontline employees to acquire academic certificates and professionaland technical qualifications by taking examinations and further education.To improve the professional and management abilities of employees in a targeted manner, in 2021, we have sent 13employees to pursue parttime 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 staff withbachelor’s degree. In addition, the Company has organized 17 newly promoted employees to attend the online study ofHighly Effective Manager by China Europe International Business School (CEIBS).
Employee Training and DevelopmentWith high emphasis on talent cultivation, the Company is committed to the win-win situation for both the organizationand the employees. To this end, the Company has formulated theTraining Management MeasuresandTraining andDevelopment System to continuously improving the capabilities and values of employees through a targeted and multi-faceted training system.
Performance and PromotionThe Company provides a clear and transparent promotion channel for every employee, and has formulated thePerformance Management Measures,Monthly Employee Bonus PlanandAnnual Performance Evaluation & Merit PaySystem to promote the career development of employees.In terms of performance management, the Company regularly conducts performance evaluations for middle and seniorstaff as well as junior staff, where the performance evaluation for junior staff is carried out monthly with a performancebased bonus system. In addition, the Company has set up awards and rewards system to recognize advanced employeesand motivate all employees to strive for excellence.
Empower Our Employees
Annual health checkups
Management Training
Professional and Technical Training
External and Outsourced Training
After new employees join the company, they mustreceive induction training; they can start workingonly after they are qualified.
Develop Eagle Training Camps and advancedworkshop training programs to nurture thecompany's management staff and support themto realize their potential at all levels.
For the staff responsible for equipment, technology,R&D, and testing, we provide systematic training onrelevant professional knowledge and the ability tosolve regular problems.
Participate in external training, academic exchangesand visits, or outsource senior experts andprofessional trainers to the company to provideprofessional training to employees.
◎Employee Training Overview
By the construction of talent echelon, we recruit, train and reserve talents reasonably from the society and within theCompany to optimize our human resource allocation. We help employees to clarify their personal development goals andopen up career development paths in both professional and management positions. At the end of each year, the Companyconducts performance evaluation of the outstanding personnel in the talent echelon, and continues to grant promotions.In 2021, the Company conducted professional and technical evaluation for relevant personnel to provide standards foremployee promotion with the establishment of evaluation standards for core positions, improvement of evaluation processand practical implementation of evaluation.
Awards
Presentation ofAwards
?Outstanding Employees
?Excellent Management Staff
?Advanced Collective
?Elite Sales
?Special awards: selected according to employees’ special contribution to the Company
?Winners will be honored at the Company’s annual meeting and will receive bonuses
Biosafety Management
As a vaccine manufacturer, the Company strictly implements accountability for biosafety and abides by the laws andregulations such asBiosafety Law of the People’s Republic of ChinaandGeneral Requirements for Biosafety in VaccineProduction Workshopsbiological safety related laws and regulations, technical standards. Based on systematic andcomprehensive identification and in-depth analysis of biosafety risks, we have established a sound biosafety managementsystem covering all procedures of vaccine production. Meanwhile, we have established a biosafety training system,improved emergency plans, conducted emergency drills, created a strong culture of biosafety, and enhanced employees’
awareness of biosafety risk to ensure the achievement of biosafety targets for vaccine production and fully guarantee thesupply of vaccines.The Company has established two production workshops at its Xili base for the production of inactivated SARS-CoV-2vaccines. As the first production workshops with high biosafety risk in South China, the two production workshops passedthe joint biosafety inspection organized by the National Health Commission in 2021. The Company’s Guangming base hasthree BSL-2 laboratories, which mainly R&D and experimental activities for vaccine production, and all of them have beenregistered and approved by the Guangdong Provincial Health Commission.
Safeguard Employees
Inactivated SARS-CoV-2 Vaccine Production WorkshopsBSL-2 LaboratoriesSecurityLevel
The production workshops are constructedand managed in accordance with the GeneralRequirements for Biosafety in VaccineProduction Workshops, conforming with BSL-3requirements.
The laboratories meet the requirements forBSL-2 laboratories. The three laboratories are:
?Viral vaccine laboratory
?Microbial vaccine laboratory
?Bacterial laboratory
SystemConstruction
Based on the biosafety risk assessment, theCompany has established systematic documentson biosafety management in accordancewith 210 inspection items in theGeneralRequirements for Biosafety in Vaccine ProductionWorkshops, which cover the whole productionprocess in workshops with high biosafety riskand provide comprehensive control over thepersonnel, facilities and processes involved.The system documents include biosafety riskreport, emergency plan, management manual,secondary procedure documents, tertiaryoperation procedures and quaternary recordforms.A safety manual has been prepared foreach work area to ensure that the biosafetymanagement requirements are met.
Biosafety management proceduresunder GMPsystem are applied, and the formulation ismainly based onLaboratory Biosafety Manual
(GB19489).
Audit andInspection
In 2021, after passing the joint biosafetyinspection initiated by the National HealthCommission and putting into operation,the two production workshops received 11biosafety inspections organized by governmentdepartments, all of which were passed.The Company also performs key biosafetyinspections. One management review, 2 internalaudits and 76 daily biological inspections werecompleted in 2021.
In 2021, the BSL-2 laboratories received andpassed 1 biosafety inspection organized bygovernment departments.In terms of internal audit, the Office of Safety,Health and Environmental Management isresponsible for the regular inspection of thelaboratories. One annual inspection, 1 internalaudit and 12 daily departmental inspectionswere completed in 2021.
For vaccine production, biosafety in the R&D and production is particularly important. The Company strictly complies withthe laws and regulations such as theBiosafety Law of the People’s Republic of China, established a biosafety managementsystem applicable to production workshops with high biosafety risk in 2021 based on theGeneral Requirements forBiosafety in Vaccine Production Workshops, and successfully passed the joint national biosafety inspection. The biosafetymanagement system mainly focuses on the whole process risk management, daily supervision and reinforcement ofbiosafety awareness to prevent the biosafety risks in vaccine production.
In 2021, the Company conducted biosafety training on multiple topics, focusing on the learning of biosafety-relatedlaws and regulations and the wearing of personal protective equipment to continuously improve the safety awarenessand performance of employees. In 2021, the Company organized 51 corporate biosafety training sessions with 3,101attendances; 504 department-level job training sessions with 6,518 attendances; 25 external supplier training sessionswith 284 attendances; and 15 external expert training sessions with 115 attendances.In addition, the Company conducted 21 biosafety emergency drills with simulated scenarios including infectious materialspill, critical equipment failure, production equipment leakage, power interruption, fire extinguishing and escape. Allemployees in the guarded area participated in the drills.
?Laboratory facility safety: ensure that the buildings and facilities meet national standards.
?Management system (covering all steps of production operations and control of articles): strict control ofpersonnel access; standardization of operations at each workstation; strict control of article sterilization; wastedisposal and regular monitoring of the environment; regular inspection of workshop personnel's nucleic acid testresults; implementation of annual psychological evaluation and physical examination; strict pandemic preventionand control.
?Submit a monitoring plan: report daily activities to the biosafety office for monitoring and supervision by full-timeand part-time biosafety staff; conduct weekly self-inspections in guarded areas; conduct monthly verifications;conduct annual reviews.
?Graded training: Training is divided into company-level, department-level and job-level, and the training content ofeach job is clearly defined according to the job training matrix.
?Training assessment: The frequency of training for positions in guarded areas is once every six months, and thefrequency of training for positions in non-guarded areas is once a year, with a full score of 100 points, requiring a100% training pass rate.
?Emergency drills: The company has formulated theInactivated COVID-19 Vaccine Production Workshop BiosafetyEmergency Plan which mainly for the employees in the guarded area.
Key Area Risk Management
Daily Monitoring and Management
Enhancement of Safety Awareness
Production SafetyThe Company attaches importance to employees’occupational health and safety production, and strictly abides byrelevant laws and regulations such as theLaw of the People’s Republic of China on Safety Production, theLaw of thePeople’s Republic of China on Fire Fighting, theLaw of
the People’s Republic of China on Safety of Special Equipment, andtheRegulations on Safety Management of Dangerous Chemicals. The Company has established an accountability systemand production safety rules and regulations for all employees, and has increased the investment in production safety,materials, technology and personnel to ensure safety and actively improve production conditions.We ensure 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 offirefighting and other special equipment. The Company has had no production safety accidents of average or above in thepast three years.
◎Biosafety Management System
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
?DevelopSafety RiskAssessment and ManagementRulesandHidden DangerIdentification and ManagementRules.
?Identify and evaluate allkinds of workplace hazardsby carrying out safetyinspections.
?All new employees mustattend the three-level safetyeducation and training andpass the examination beforestarting work.
?Conduct regular productionsafety training to enhanceemployees’awareness of safeoperation and emergencyresponse.
?The Company has formulatedtheProduction SafetyAccident Emergency Responseand Rescue Plan,includingcomprehensive plan, specialplan and on-site plan).
Standardized SafetyProduction
Safety ProductionCulture Construction
Accident Response ◎Safety Management in Production
?The Company has formulatedtheDangerous ChemicalsManagement Procedures,Regulations on the Managementof Dangerous and Highly ToxicChemicals,Regulations onthe Management of Explosiveand Hazardous Chemicalsandother regulations to controlthe purchasing, transportation,storage, use and disposal ofdangerous chemicals.
?In 2021, the Companycompleted the acceptance andevaluation report of the securitysystem of the storage sitefor explosive and hazardouschemicals and finished thechange of registration, andcompleted the upgrading andtransformation of QC reagentroom and gas cylinder room.
?The Company formulatedtheFire Safety ManagementRegulations,Regulations on theManagement of Fire FightingEquipment and Facilities,Special Emergency Plan for FireAccidentsand other regulations,and regularly conductsinspections, maintenance andtesting of firefighting systems.
?In 2021, the Companyconducted 4 fire emergencydrills, the main items of whichincluded fire escape drillsand use of fire extinguishingequipment, covering 1,400employees with a coverage rateof 90%. BioMinhai conducted25 fire emergency drills andhazardous chemical emergencydrills, covering 1,137 employeeswith a coverage rate of 76%.
?The Company has formulatedthe Special EquipmentSafety Manual and ElevatorSafety Manual, requiring theregistration of newly installedspecial equipment and regularsupervision and inspection ofexisting special equipment andsafety accessories.
Hazardous ChemicalsManagement
Special EquipmentManagementFire Management ◎Key Elements in Production Safety Management
Occupational Health
The Company attaches importance to the occupational health of employees and strictly abides by theLaw of the People’sRepublic of China on the Prevention and Treatment of Occupational Diseases, theRegulations on the Managementof Occupational Health in the Workplaceand other laws and standards, and has formulated theOccupational HealthManagement Regulationsand theLabor Protection Equipment Management Regulations, to prevent, control and eliminateoccupational hazards and protect the employees.The occupational disease hazards involved in the Company’s production include high temperature, noise, ultravioletradiation, sodium hydroxide, formaldehyde, phenol, and nitrogen dioxide. We protect our employees’occupationalhealth through compliance with occupational health procedures, good occupational health supervision and protection,enhancement of on-site occupational health management, and regular occupational health-related training. As of the endof the reporting period, the Company had no accidents related to occupational disease hazards.
The Company cares about the mental health of employees and provides them with regular mental health lectures. ln 2021,the Company invited psychologists from Shenzhen Kangning Hospital to give online and offline lectures on mental health,with 313 employees attending the lectures.
◎Occupational Health Management
OccupationalHealthRegulations
?Strictly abide by the“Three Simultaneities”procedures: occupational disease preventionfacilities are designed, constructed and put into production and use with the mainproject simultaneously.
?Regularly update the monitoring and evaluation system of occupational disease hazardsand the emergency rescue plan against occupational disease hazards.
?Complete occupational health files and workers' health monitoring files.
?Organize regular physical examinations for employees and equip them with protectiveequipment against occupational diseases.
?Set up warning signs and Chinese warning instructions at the entrance of the workplaceand in conspicuous locations near the work stations and equipment with occupationaldisease hazards.
?Supervise the wearing of protective equipment in workplace.
?Regular maintenance and checks on occupational hazard protection facilities.
?Provide regular occupational health training for employees before and during theiremployment.
?Employees are required to pass the training examination, and the examination papersare submitted to the Human Resources Department for archiving.
?Regularly ask qualified organizations to carry out workplace occupational hazardsinspection, report occupational hazards, and obtain theReceipt of Occupational HazardsReporting.
Occupational
HealthSupervisionOn-siteManagementofOccupationalHealthOccupationalHealthEducationand TrainingDetectionandReporting ofOccupationalHazards
The vaccine industry has the important mission of building a line of defense for diseases and protecting people’s health.With the aim of“providing best vaccines for mankind”, BioKangtai actively participates in social welfare activities whilecontinuously manufacturing high-quality vaccines to create shared values for the industry and society. In 2021, theCompany invested a total of 18.91 million yuan in social welfare.
As the COVID-19 pandemic spreads around the world, our society is facing many challenges in pandemicprevention and control, developing the economy and proper functioning of society. As a leading vaccinemanufacturer in China, BioKangtai has always actively assumed social responsibility. Based on ourbusiness features and advantages, we have been making every effort to promote the development andindustrialization of COVID-19 vaccines for China and the whole world. In November 2021, the Companywas honored as the“Pioneer of the Year in COVID-19 Relief”in the 2021 Corporate Social ResponsibilityConference in Shenzhen, China.All-out efforts for COVID-19 vaccine developmentVaccination is the most economical and effective measure for us to control and prevent infectious diseases.At the early stage of the COVID-19 outbreak, we made strategic plans in a timely manner and devotedall resources possible for the development of COVID-19 Vaccine. Company actively contributes to theCOVID-19 prevention and control in China and abroad. Our SARS-CoV-2 Vaccine Inactivated was approvedfor emergency use in China in May 2021. Our Recombinant COVID-19 Vaccine (Y25 Adenovirus Vector) wasauthorized for emergency use by the National Agency of Drug and Food Control of Republic of Indonesia inOctober 2021 and was successfully exported.Vaccine donation for herd immunityVaccine is an important weapon for pandemic prevention and control, playing a vital role in creating herdimmunity and recovering our social life. Since the outbreak in 2020, the Company has donated vaccines andsupplies worth nearly 20 million yuan to Hubei, Liaoning, Hebei, Guangdong, Henan and other provinces.
Responding to COVID-19
Give Back to Society
In terms of domestic vaccine pricing, the procurement prices of vaccines for the National Expanded Program onImmunization (EPI) are determined by the centralized bidding or negotiation organized by the competent health authoritiesand the Ministry of Finance of the State Council; other EPI vaccines and non-EPI vaccines are procured through provincialpublic resource trading platforms under the guidance of provincial and municipal governments and autonomous regionsdirectly under the Central Government.
Based on raw and auxiliary materials, labor, logistics, R&D, medical, overhead,insurance and other related costs, we set reasonable prices after scientificcalculations.
Based on the research results of the current market situation (annual batchvolume of similar products, end-market batch volume, market strategies, etc.)and the prices of other vaccines in the market, reasonable prices are set basedon the principles of increasing market share and brand acceptance, productcompetitiveness, etc.
Corporate
Level
Market Level
Charitable Donations for More People
The Company donated vaccines to society to help more people to be protected from the virus. In 2021, the Company'smajor vaccine donations are as follows:
TimeVaccine Donations
August, 2021
Donated 23-Valent Pneumococcal Polysaccharide Vaccine and supplies worth 10 millionyuan to Henan Province to support post-disaster reconstruction.November, 2021
Donated 23-Valent Pneumococcal Polysaccharide Vaccine worth 1.12 million yuan to 12districts/counties in Sichuan Province.
Pricing StrategyThe Company strictly abides by the requirements of theVaccine Administration Law of the People’s Republic of Chinaandsets reasonable vaccine prices with reference to the production costs and market research results. We are committed toproviding the community with safe, effective and high-quality products at affordable prices. For hepatitis B vaccine alone,we have produced and sold more than 1.4 billion doses, helping more than 400 million people to be protected from thehepatitis B virus.
Enhance Accessibility in Healthcare
Support the Development of HealthcareWhile pursuing corporate growth, BioKangtai gives full support to medical research and the cultivation of talents in publichealth, and works together with foundations, universities and research institutes to create a win-win situation and sharedvalue for the industry and society.
Support Rural RevitalizationBioKangtai not only supports the development of medical care by leveraging its own advantages, but also responds tothe national call for rural revitalization by supporting poverty alleviation and rural revitalization efforts through charitabledonations and other means.The Company has been supporting the public welfare of Xingan County, Jiangxi Province for a long time and caring aboutlocal disadvantaged groups. Since 2018, a total of 15 million yuan has been donated to the Civil Affairs Bureau of thecounty to help the elderly living in retirement homes (including the disabled), orphans and de facto unsupported children.In 2021, the Company actively supported the Guangdong Poverty Relief Day activity by donating 30,000 yuan to theShenzhen Nanshan District Charity Association and the Guangming District Charity Association for key poverty reliefprojects in the province.
Create Shared Value
SupportMedicalResearch
Industry-Academia-
Research
InstituteCollaboration
?In October 2021, we donated 50 doses of 20 ?g Recombinant Hepatitis B Vaccine(Saccharomyces cerevisiae) to Guangxi University of Traditional Chinese Medicine for subjectresearch.
?In December 2021, we donated 20 million yuan to the China Foundation for Hepatitis Preventionand Control (in four years) for related academic activities, hepatitis B research projects, andhepatitis B prevention and control.
?In July 2021, for deepening the cooperation between industry, academia and researchinstitutes, the Company donated 30 million yuan (over three years) to the EducationDevelopment Foundation of Jinan University in Guangdong for the establishment of JNU-BioKangtai Biomedical Development Fund to promote the high-quality development of thedisciplines of public health and the cultivation of public health talents.
?In November 2021, the Company donated 500,000 yuan (in five years) to Huizhou Universityfor the establishment of BioKangtai scholarship and fellowship.
ESG Key PerformanceEconomic Performance
Environmental Performance
IndicatorsUnit201920202021Operating revenueRMB 1,0001,943,330 2,261,180 3,652,090Total ProfitRMB 1,000663,450 772,410 1,439,250Net profit attributable toshareholders of the listedcompany
RMB 1,000574,510 679,190 1,263,380Cash dividendsRMB 1,0000201,750595,260Total taxRMB 1,000220,630222,100896,990Total number of shares issuedby the Company
Shares645,220,910 684,927,132 687,093,526Net assets per shareyuan4.2710.9013.34
IndicatorsUnit201920202021
Energy UseTotal electricity consumption
MWh45,66248,85978,114Total natural gas consumptionm?1,014,5201,250,828 3,573,871Total heat consumptionGJ147,816 158,416 181,352Diesel consumptionTons105 93125Gasoline consumptionTons383949LPG consumptionTons261416Total energy consumptionMWh44,44759,29391,315Energy consumption per unit ofrevenue
MWh/ RMB1,0002.292.622.50
GHG Emissions
Total GHG EmissionstCO
e46,83950,39873,659Total GHG emissions in Scope I
tCO
e2,7203,163 8,326Total GHG emissions in Scope IItCO
e44,11847,23565,333GHG emissions per unit ofrevenue
tCO
e/ RMB1,0002.412.232.02
Water Use
Total water consumptionm?545,784 581,494 1,024,860By source
Waterconsumptionfrom publicwater supply
m?486,893 518,380 952,447Water frombarrelsand steamconversions
m?58,891 63,114 72,413
IndicatorsUnit201920202021
Discharge Management
Total air emissionsm?37,232,625 98,882,171 253,578,606Total VOCsTons0.15 0.22 0.87Exhaust emissions per unit ofrevenue
m?/ RMB 1,0001,9204,370 6,940Total industrial wastewaterdischarge
m?371,306 393,813 564,561Ammonia nitrogen dischargeTons0.581.45 2.96COD Tons31.28 29.20 33.13Total nitrogenTons0.35 0.13 0.77Total phosphorusTons0.01 0.01 0.07Industrial wastewaterdischarge per unit of revenue
m?/ RMB 1,00019.11 17.42 15.46Total hazardous wasteTons66 84 246Hazardous waste generatedper unit of revenue
kg/ RMB 1,0003.383.72 6.73Total Non-hazardous wasteTons246 176 196Non-hazardous wastegenerated per unit of revenue
kg/ RMB 1,00012.63 7.79 5.36
Environmental Management
Annual environmentalexpenditure
RMB 1,0008,3902,730 17,000Number of environmentalawareness training sessions
Times8 16 15Number of Incidents punishedfor environmental lawviolations
Times0 0 0
Notes:
[1]. The statistical caliber of environmental performance covers Shenzhen Kangtai Biological Products Co., Ltd. and its wholly-ownedsubsidiary, which is consistent with the scope of the annual report and consolidated financial statements. The increase of energy consumption,air emissions, waste water discharge, hazardous and non-hazardous waste discharge comes from the continuous expansion of the company'sproduction scale.. In 2020, the Company’s Xili base was officially put into operation, so the environmental performance in 2020 includes the Xilibase’s data after it was put into operation. The environmental performance in 2021 includes the the Xili base’s data for the whole year.[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 fromnatural gas, gasoline, diesel and LPG refers to theGuideline for Accounting and Reporting of Greenhouse Gas Emissions from Enterprises:
Power Generation Facilities (revised edition of 2022) by Ministry of Ecology and Environment of the People’s Republic of China).[4] The sources of Scope II GHG emissions include purchased electricity and heat. The calculation method of carbon emissions from electricityand heat refers to theGuideline for Accounting and Reporting of Greenhouse Gas Emissions from Enterprises Power Generation Facilities
(revised version of 2022) by the Ministry of Ecology and Environment of the People’s Republic of China and theGuideline for Accountingand Reporting of Greenhouse Gas Emissions from Enterprises in Other Industries(for Trial Implementation) by the National Development andReform Commission of the People’s Republic of China. In particular, the carbon emissions of purchased electricity are calculated based on thegrid emission factor, which is obtained from the Ministry of Ecology and Environment and is taken as 0.6101 kg CO
e/kWh in 2020 and 0.5810kg CO
e/kWh in 2021.
Social Performance
IndicatorsUnit201920202021
Total number of employeesPeople1,3362,0432,445By gender
MalePeople7921,2511,505FemalePeople544792940
By employment type
Full-time contract workersPeople1,2962,0152,413Full-time dispatchedworkers
People000Part-timePeople152831Other typesPeople2501By age group
>50 years oldPeople38546630 to 50 years oldPeople8151,1951,288<30 years oldPeople4837941,091By region
Mainland employeesPeople1,3362,0432,445Employees from HongKong, Macao, Taiwan andoverseas
People000By rank
Junior employeesPeople1,2461,9392,332Middle managersPeople758697Senior managersPeople151816
By education
Employees with DoctoralDegree
People71417Employees with Master’sDegree
People125181210Employees with Bachelor’sDegree
People5548851,200Employees with JuniorCollege Degree and below
People6509631,018Employment and Employee RightsLabor contract signing rate%100100100Social insurance coverage rate%100100100Coverage rate of employee medical checkups%100100100Number of employees covered by collective bargainingagreements (end of period)
People9971,4381,491
Liability to employees
IndicatorsUnit201920202021
Occupational Health and WellnessNumber of employees in positions at risk ofoccupational diseases
People121127168Number of employees with occupational diseasePeople000Number of employees who died due to work-relatedinjuries
People000Number of workdays lost due to work-related injuriesDays090365Notes:
[1]. The statistical caliber of employees covers Shenzhen Kangtai Biological Products Co., Ltd. and its wholly-owned subsidiary, which isconsistent with the scope of annual report and consolidated financial 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.
Notes:
[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%.
Product Liability
IndicatorsUnit201920202021
Complaint handling rate
%100100100Percentage of sold products that had to be taken backdue to safety and health issues
%000Number of incidents involving violations of laws andregulations on products and services
times000R&D InvestmentRMB 1,000215,453273,401738,467Ratio of R&D investment to operating revenue%11.0912.0920.22Number of R&D personnelPeople244425460Percentage of R&D personnel%18.2620.8018.81Number of Trademarks ApprovedPcs013Number of trademark applicationsPcs006Number of patents grantedPcs168Number of patent applications in the reporting periodPcs191610
Anti-corruption
Community Investment
IndicatorUnit201920202021Number of anti-corruption-related training sessions toemployees
Times111Number of employees participating in anti-corruptionrelated training
People331597947Hours of anti-corruption training received byemployees
Hours111
IndicatorsUnit201920202021Amount of community investmentRMB 1,0001,3249,30918,913Of which: Investment in education RMB 1,000181810,118
Investment in the medical and health careRMB 1,000845,854 6,484Amount of charitable donationsRMB 1,0001,222 3,437 2,311Number of employees participating in volunteeractivities
People232725Total volunteer service hours of employeesHours805120320
Compliance OperationsDuring the reporting period, the Company did not violate any laws and regulations related to product quality, customerservice, intellectual property protection, environmental protection and employment. The main domains and laws andregulations that the Company is involved in are listed in the table below.DomainsLaws and Regulations
Compliance orNon-complianceProduct Quality
Drug Administration Law of the People’s Republic of China, VaccineAdministration Law of the People’s Republic of China, Measures for theAdministration of Drug Registration, Good Manufacture Practice of MedicalProducts, Guidelines for Good Clinical Practices, Measures for the Supervisionand Administration of Drug Production, etc.
Compliance
ProductDevelopment
Drug Administration Law of the People’s Republic of China, VaccineAdministration Law of the People’s Republic of China, Measures for theAdministration of Drug Registration, Good Manufacture Practice of MedicalProducts, Guidelines for Good Clinical Practices, Measures for the Supervisionand Administration of Drug Production, etc.
ComplianceIntellectualPropertyProtection
Patent Law of the People's Republic of China, Copyright Law of the People'sRepublic of China, Trademark Law of the People's Republic of China,Regulations on the Protection of Intellectual Property Rights in ShenzhenSpecial Economic Zone,etc.
ComplianceCustomerService
Law of the People's Republic of China on Consumer Rights and Interests, etc.ComplianceInformationsecurity
Law of the People's Republic of China on the Protection of Personal InformationComplianceEnvironmentalProtection
Law of the People's Republic of China on Environmental Protection, Law ofthe People's Republic of China on Prevention and Control of Air Pollution, Lawof the People's Republic of China on Prevention and Control of EnvironmentalPollution by Solid Waste, Law of the People's Republic of China on Preventionand Control of Pollution from Wastewater, Law of the People's Republic of Chinaon Promotion of Cleaner Production, Law of the People's Republic of China onEnergy Conservation, Guangdong Environmental Protection Regulations, etc.
Compliance
Employment andLabor
Labor Law of the People's Republic of China, Labor Contract Law of thePeople's Republic of China, Social Insurance Law of the People's Republic ofChina, Law of the People's Republic of China on Mediation and Arbitration ofLabor Disputes, Law of the People's Republic of China on Trade Unions, Lawof the People's Republic of China on the Protection of Women's Rights andInterests,etc.
ComplianceBiosafetyBiosafety Law of the People's Republic of China,etc.ComplianceOccupationalHealth andSafety
Law of the People's Republic of China on Prevention and Control ofOccupational Diseases,etc.
ComplianceBusiness Ethics
Criminal Law of the People's Republic of China, Law of the People's Republicof China Against Unfair Competition, Interim Provisions on the Prohibitionof Commercial Bribery, China Internal Auditing Standards, Basic Standardsfor Enterprise Internal Control, Anti-Money Laundering Law of the People'sRepublic of China,etc.
Compliance
ESG Reporting Guide IndexGuidelines on Self-regulation of Listed Companies on Shenzhen Stock Exchange No. 2:
Standardized Operation of Listed Companies on the ChiNext Market
Articales and DisclosuresChapters
9.1 Overview
ESG ApproachStakeholder Communication and MaterialIssue Identification
9.2 Business Principles
Corporate GovernanceCompliance ManagementDevelop High-quality ProductsResponsible Marketing
9.3 CSR Strategy and MechanismsESG Approach
9.4: (1)CSR system construction
Strict control of product qualityImprove Environmental ManagementProtect Employee Rights and BenefitsSafeguard EmployeesEconomic Performance
9.4: (2)Deficiencies and problems in fulfilling CSRIrrelevant
9.4: (3)Improvement measures and time scheduleAddressing climate change
9.5 Return to Shareholders
Corporate GovernanceEconomic Performance
9.6 Financial soundnessEconomic Performance
9.7 Protection of Employee Rights and BenefitsProtect Employee Rights and Benefits
9.8: (1)
Compliance with environmental protectionlaws, regulations and industry standards
Improve Environmental Management
9.8: (2)Environmental Protection PlanImprove Environmental Management
9.8: (3)Natural resource use
Improve Environmental ManagementAddress climate changeEnvironmental Performance
9.8: (4)Pollutant disposal
Reducing the Environmental Impact ofOperations
9.8: (5)Pollution prevention and control facilities
Reducing the Environmental Impact ofOperations
9.8: (6)
Payment of environmental protection-relatedtaxes and fees
Irrelevant
9.8: (7)Supply chain and environmental safetyStrict control of product quality
9.8: (8)
Other environmental protectionresponsibilities
Responding to climate change
9.9: (1)
Environmental protection policy, targets andeffectiveness
Improve Environmental Management
Articales and DisclosuresChapters
9.9: (2)Total annual resource consumptionEnvironmental performance
9.9: (3)
Environmental investment and environmentaltechnology development
Responding to climate change
9.9: (4)Pollutant discharge management
Reduce the environmental impact ofoperations
9.9: (5)
Construction and operation of environmentalprotection facilities
Reduce the environmental impact ofoperations
9.9: (6)
Waste treatment and disposal, comprehensiveutilization of recycled waste
Reduce the environmental impact ofoperations
9.9: (7)
Voluntary agreements with environmentalprotection departments
Improve environmental management
9.9: (8)
Rewarded by environmental protectiondepartments
Irrelevant
9.9: (9)Other voluntary disclosure ESG Key Performance
9.10 Environmental Protection Policy Implementation
Improve Environmental ManagementResponding to climate changeReduce the environmental impact ofoperations
9.11 Environmental Information DisclosureEnvironmental performance
9.12: (1)
Product safety laws, regulations and industrystandards
Strict control of product quality
9.12: (2)Production environment and processSafeguard Employees
9.12: (3)
Product quality and safety assurancemechanism and emergency response plan
Strict control of product quality
9.12: (4)Other quality and safety responsibilities
Strict control of product qualitySafeguard EmployeesSocial performance
9.13: (1)
Staff management system and violationhandling measures
Protect Employee Rights and Benefits
9.13: (2)
Prevention of occupational hazards andancillary safety measures
Safeguard Employees
9.13: (3)Employee trainingEmpowering Employee Development
9.13: (4)
Other responsibilities for employee rightsprotection
Protect Employee Rights and Benefits
9.14 Ethics of ScienceDevelop High-quality Products
9.15 Supervision and Monitoring
Compliance managementStrict control of product qualityResponding to climate changeSafeguard Employees
Shenzhen Kangtai Biological Products Co., Ltd.Contact Address: No.18, Shutianpu Road, GuangMing District, ShenZhenPostcode: 518106Tel:+86 755-26988558