Contents
About BioKangtaiCompany OverviewValues and PhilosophyCompany MilestonesHonors and RecognitionESG Management Overview
Caring for Employees andHelping Them DevelopProtecting Employee Rights and InterestsCaring for Employee's GrowthSafeguarding Employees
Creative Products toBenefit Human Health
Continuous R&D and InnovationStrict Control of Quality and SafetyEnhancing Service EfficiencyResponsible Marketing
Giving Back to the Society andStaying True to the Original MissionImproving Products AccessibilityDevotion to Public Welfare
Future OutlookESG Key PerformanceESG Reporting Guide IndexGoverning Enterprise in Accordance with theLaw and Escorting Sustainable Development
Party Building LeadingNormative GovernanceCompliance Operations
Protecting Environment,Adhering to Green DevelopmentImproving EnvironmentalManagement SystemTackling Climate ChangeReducing the EnvironmentalImpact of Operations
About this Report
Data DescriptionIf not otherwise stated, the financial data disclosed in the report are derived from the audited financial report ofthe Company and other data are obtained from the Company’s internal statistics and relevant documents. The currencytype in the report is Chinese Yuan (CNY), and amounts covered in the report are in Chinese yuan.
Basis of the ReportThe report has been compiled in accordance with the Guidelines on the Content and Format of Information Disclo-sure by Companies Publicly Issuing Securities No. 2: Content and Format of Annual Reports by the China SecuritiesRegulatory Commission (CSRC), the Guidelines on Self-regulation of Listed Companies on Shenzhen Stock Exchange No.2: Standardized Operation of Listed Companies on the ChiNext Market by the Shenzhen Stock Exchange (SZSE) andother relevant regulations.
Scope of the Report
The report covers Shenzhen Kangtai Biological Products Co., Ltd. (BioKangtai, or the Company) and itswholly-owned subsidiary, which is in line with the scope of the Company’s annual consolidated financial statements.
From January 1, 2022, to December 31, 2022, with some representations and information traced back to previousyears as appropriate.
Full Name
Shenzhen Kangtai Biological Products Co., Ltd.
BioKangtai, the CompanyBeijing Minhai Biotechnology Co., Ltd.BioMinhai
Abbreviations
Reporting PrinciplesThe report is underpinned by following reporting principles:
Report LanguageThe report is written in two languages, Chinese and English. If there is any discrepancy between the two versions,the Chinese version shall prevail.
The report identifies and responds to substantive issues that are of concern to stakeholders and alsohave a significant influence on the Company, and provides focused reporting on these issues.
Materiality
Taking into account the characteristics of the industry, the report makes a detailed disclosure of theCompany’s active fulfillment of social responsibilities, possible problems and improvement plans andavoids selective disclosure.Balance
The report provides statistics on the Company’s quantitative ESG performance and discloses historicaldata for the past three years.Quantitative
The report provides detailed explanations of the meaning of the disclosed quantitative KPIs, as wellas the basis for their calculation and the assumed conditions. Meanwhile, indicators used in differentreporting periods are consistent to the extent possible to reflect trends in the performance levels.Comparability
Organizational scope
Time scope
2022 CORPORATE SOCIAL RESPONSIBILITY REPORT AND ENVIRONMENTAL, SOCIAL AND GOVERNANCE REPORTBIOKANGTAI
About BioKangtai
Company OverviewSince its inception in 1992, Shenzhen Kangtai Biological Products Co., Ltd. has been specialized in R&D, productionand sales of vaccines for human use. Listed on the ChiNext market of the Shenzhen Stock Exchange in February 2017(stock code: 300601), the Company is the first listed vaccine company in South China. Headquartered in Shenzhen, theCompany has five R&D centers and industrial bases in Shenzhen and Beijing. It is one of the major vaccine manufactur-ers in China. The Company’s main products include 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine,DTaP-Hib Combined Vaccine, 23-Valent Pneumococcal Polysaccharide Vaccine, Recombinant Hepatitis B Vaccine(Saccharomyces cerevisiae), Hib Conjugate Vaccine, Hib Conjugate Vaccine, Freeze-dried, etc. The Company’sSARS-CoV-2 Vaccine (Vero Cell), Inactivated was approved for emergency use in China in May 2021, and its Recombi-nant COVID-19 Vaccine (Y25 Adenovirus Vector) was authorized for emergency use by the National Agency of Drug andFood Control of Republic of Indonesia in October 2021. The Company’s product portfolio covers both vaccines for thenational immunization program vaccines and non-immunization program vaccines, with products reaching 31 provinc-es, municipalities and autonomous regions.
The Company is an industry leader in R&D innovation and has been engaged in the vaccine industry for over 30years, which has made it an innovative biopharmaceutical company with strong R&D strength, rich product offeringsand leading industrial scale. As one of the companies with the most comprehensive vaccine R&D platforms in China, theCompany has established the R&D and production capacity of virus vaccines, bacterial vaccines, genetically engineeredvaccines, conjugate vaccines, combination vaccines and other products. In addition, keeping abreast of internationalcutting-edge technology, the Company has been exploring the research on application of new vaccine technologies andthe establishment of new technology platforms, and has reserved product development platforms for, inter alia, mRNAtechnology, new adenovirus vector technology and new adjuvant technology, which could provide technical guaranteefor the Company to overcome the R&D barriers of a number of heavyweight vaccine varieties.The Company has more than 60 patents and over 30 vaccine varieties under development, basically covering thekey vaccine varieties in the world. Some vaccines out of them have entered registration process, including the Rabiesvaccine (human diploid cell) for human use, Freeze-dried, the Freeze-dried Live Attenuated Varicella Vaccine, the Inacti-vated Poliomyelitis Vaccine, Sabin Strains(Vero cell), the Diphtheria, Tetanus and Acellular Pertussis Combined Vaccine(component) , Adsorbed, Diphtheria, tetanus, pertussis (acellular, component), poliomyelitis (inactivated) vaccine(adsorbed) and Haemophilus influenzae type b conjugate vaccine, the Diphtheria, tetanus, acellular pertussis (compo-nent) Adsorbed Inactivated poliovirus vaccine, the Reassortant Rotavirus Vaccine, Live, Oral, Pentavalent (Vero Cell),the Influenza Vaccine (Split Virion), Inactivated, Quadrivalent and the MMR combined with live attenuated vaccine. TheCompany also made arrangements in the development of products such as the quadrivalent inactivated HFMD vaccine,the 20-valent pneumococcal polysaccharide conjugate vaccine, the zoster vaccine recombinant and the respiratorysyncytial virus vaccine recombinant (RSV). With the upcoming release of the vaccines, the Company’s product portfoliowill be g reatly enriched and its competitiveness will be further enhanced.
Based on a global strategy of "bring in" and "go abroad'. The Company has been working closely with severalinternationally renowned biopharmaceutical companies and R&D institutions, such as Merck (US), Sanofi-Pasteur(France), Intravacc (Netherlands) and AstraZeneca (UK), to import advanced vaccine technologies from abroad. Mean-while, the Company has been fostering the registration of its products overseas to boost the presence of its products onoverseas markets. In this regard, the Company has obtained export certificates in some countries for its DTaP-HibCombined Vaccine, 23-Valent Pneumococcal Polysaccharide Vaccine and Recombinant Hepatitis B Vaccine (Saccharo-myces cerevisiae). In addition, our Recombinant COVID-19 Vaccine (Y25 Adenovirus Vector) was authorized for emer-gency use by the National Agency of Drug and Food Control of Republic of Indonesia and exported in October 2021. InMarch 2022, the Company and its Philippine partner reached cooperation on the joint promotion of the registration,promotion, distribution, marketing and sales of the Company's 23-Valent Pneumococcal Polysaccharide Vaccine in thePhilippines; in May 2022, our Recombinant COVID-19 Vaccine (Y25 Adenovirus Vector) production site received a Decla-ration of Conformity issued by the European Union's qualified person, and in July 2022, the Company's vaccine produc-tion site in Guangming District, Shenzhen, received a GMP Declaration of Conformity issued by the Food and DrugAdministration, Philippines, marking the alignment of the Company's quality management system with internationalstandards; since August 2022, the Company has reached cooperation with its partners in the Philippines and Indonesiato jointly promote the registration, promotion, distribution, marketing and sales of the Company's 13-Valent Pneumo-coccal Polysaccharide Conjugate Vaccine in the Philippines and Indonesia; in February 2023, the Company entered intocooperation with Pakistani partners to jointly promote, among others, the registration, marketing and distributionlicense of the Company's 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine and 23-Valent PneumococcalPolysaccharide Vaccine in the Philippines in Pakistan; in March 2023, a memorandum of strategic cooperation wasentered into among the Company, AstraZeneca and Combiphar (an Indonesia Company) to jointly promote the localproduction and commercialization of our vaccines (including COVID-19 Vaccine and other vaccines) in Indonesia; and inApril 2023, BioMinhai signed a license and technology transfer agreement with Biotis of Indonesia for dual-vector 13-va-lent pneumococcal polysaccharide conjugate vaccine, whereby the two parties will jointly promote, among others, thelocal production, registration and commercial operation of this vaccine in Indonesia. Looking forward, the Company willcontinue to increase its efforts in international market expansion and actively explore diversified sales channels for itsproducts, so as to promote the Company's products to the international market and facilitate the realization of itsinternationalization strategy.
2022 CORPORATE SOCIAL RESPONSIBILITY REPORT AND ENVIRONMENTAL, SOCIAL AND GOVERNANCE REPORTBIOKANGTAI
2022 ESG Performance
99356R&D investment
30+R&D projects
10+Products marketed (includingthose approved for emergency use)
100%Complaint handling rate
No
product recall events
Products
14.65
Communityinvestment
2,018
Total workforce
39.05%
Percentage offemale employees
100%
Labor contractsigning rateSocial Performance
Business Operation
3,1574
Operating revenue
millionyuan
millionyuan
millionyuan
millionyuan
millionyuan13,786.35
Total assets
8,985.34Owner’s equity
517.63
Total tax payment
4.25
Total environmentalinvestment
Noaccidents relating to occupational
disease hazards100%
Three wastes emissioncompliance
production safety accidentsof average or aboveSafety and Environmental Protection
Values and Philosophy
BioKangtai has always adhered to the corporate purpose of “producing the best vaccine to benefit the mankind”and the core value of “dedication to people’s health”. With a focus on long-term exploration in the biopharmaceuticalsector, the Company aims to become a leading and world-renowned multinational company to contribute to the devel-opment of public health sciences. We take a market-oriented approach to enhance our R&D performance and productinnovation, continuously optimize our product mix, and to pursue high product quality, marginal efficiency, technologi-cal innovation, resource conservation and harmonious development.
Dedication to people's health
Core Value
Mission
Produce the best vaccines tobenefit mankind
Operation Principle
People orientation, excellence,honesty, efficiency, innovation
and cohesion
Vision
Become a leading and world-renowned biopharma-ceutical multinational company that pursue highproduct quality, high corporate efficiency, technolog-ical innovation, resource conservation and harmoni-ous development
Company Spirit
Diligent,perseverant,cohesive,en-terprising and self-empoweringmillionyuan
millionyuan
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Company Milestones
1992The Company was established.
1994The Companycompleted pilotproduction of 5μg Hepatitis BVaccine, whichwas laterapproved bythe Ministry ofHealth.
1998The vaccineacquired formalapproval numberfrom the ChinaFood and DrugAdministration.
2002The Companyintroduced its10μg Hepatitis BVaccine (1.0mlper dose) foradults.
2005The Company replacedits 10μg Hepatitis BVaccine (1.0ml per dose)with 10μg Hepatitis BVaccine (0.5ml perdose);And acquired its secondGMP certificate forhepatitis B vaccine.
2010
The Company introducedthe first 60μg Hepatitis BVaccine (1.0ml per dose)for adult hepatitis Bvaccine non-responders inChina;The Company acquired itsthird GMP certificate for itshepatitis B vaccine.
2012
The Company acquireda GMP certificate forits Hib ConjugateVaccine;
The Company acquireda GMP certificate forits DTaP-Hib CombinedVaccine.
2014
The Company acquired aGMP certificate (2010version) for its hepatitis Bvaccine;The Company acquired aGMP certificate for its HibConjugate Vaccine (pre-filled);The Company collaboratedwith INTRAVACC (Nether-lands) and WHO to importInactivated PoliomyelitisVaccine;BioMinhai established theBeijing Novel CombinationVaccine R&D Center, theBeijing AcademicianWorkstation, and theBeijing InternationalSci-Tech Cooperation Basefor Novel Vaccines
2017
The Company waslisted on the ChiNextMarket of ShenzhenStock Exchange.
2019
The Company’s 23-Va-lent PneumococcalPolysaccharide Vaccinereceived a GMP certifi-cate and was launched.
2021
The Company’sSARS-CoV-2 Vaccine,inactivated wasapproved for emergencyuse in China;The Company’s Recombi-nant COVID-19 Vaccine(Y25 Adenovirus Vector)was authorized foremergency use by theNational Agency of Drugand Food Control ofRepublic of Indonesia;The Company’s 13-Va-lent PneumococcalConjugate Vaccine waslaunched.
2022
The Company’s produc-tion site for RecombinantCOVID-19 Vaccine (Y25Adenovirus Vector)received a Declaration ofConformity issued by theEU's qualified person;The Company's vaccineproduction site in Guang-ming District, Shenzhen,received a GMP Declara-tion of Conformity issuedby the Food and DrugAdministration, Philip-pines.
1995
The Company’s 5μgHepatitis B Vaccine(0.5ml per dose)met the qualitystandards of Merck& Co., INC, and thevaccine acquiredapproval numberfor pilot productionfrom the Ministryof Health.
2000
BioKangtai acquiredits first GMPcertificate for itsHepatitis B Vaccine.
2004
The Companyintroduced HepatitisB Vaccine with threeyears’ effectiveness,which is the first ofits kind in China.
2011
The Company intro-duced its 20μgHepatitis B Vaccine(1.0ml per dose) forgrown-ups; theCompany introducedits 10μg Hepatitis BVaccine (0.5ml perdose) for children.
2013
The Company acquireda GMP certificate forits Measles, Mumpsand Rubella CombinedVaccine, live;BioMinhai establisheda postdoctoral R&Dcenter in Beijing.
2018
BioKangtai’s Guang-ming Base in Shen-zhen was officially putinto use.
2015
BioMinhai establishedthe National-Local JointEngineering Laboratoryfor Novel VaccineTechnologies.
2008
In a strategicreorganization,BioKangtai acquiredBeijing MinhaiBiotechnology Co.,Ltd. (BioMinhai) asits subsidiary.
2022 CORPORATE SOCIAL RESPONSIBILITY REPORT AND ENVIRONMENTAL, SOCIAL AND GOVERNANCE REPORTBIOKANGTAI
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Honors and Recognition
RecipientHonors and Special RecognitionAwarded by
First Prize of Shenzhen Science and
Technology Awards
Shenzhen Municipal People’s Government Science and
Technology Awards Committee
Guangdong Provincial Science and Technology Department,Guangdong Provincial Development and Reform Commission,Guangdong Provincial Economic and Information Commission,State-owned Assets Supervision and Administration Commission
of Guangdong Provincial People's Government, GuangdongProvincial Intellectual Property Bureau, Guangdong Provincial
Federation of Trade Unions
Innovative Enterprise of GuangdongKey High-tech Enterprise of China Torch Program
Torch High-tech Industry Development Center,
Ministry of Science and TechnologyMinistry of Science and Technology/Ministryof Environmental Protection/Ministry of Commerce, etc.Guangdong Provincial Economic and Information Commission/Guangdong Provincial Science and Technology Department, etc.Shenzhen National High-Tech Industry Innovation CenterShenzhen Association for Science and TechnologyQualified Person Committee of Guangdong
Pharmaceutical Association2021 Shenzhen Corporate Social Responsibility Conference
CPC Shenzhen Municipal Committee
Torreya, a global investment bankNational Business Daily
JRJSecurities TimesSecurities TimesRed Cross Society of China Jiangxi Branch,
Jiangxi Red Cross FoundationCPC Shenzhen Municipal Committee,Shenzhen Municipal GovernmentShenxin Communication ThinkJiangxi Red Cross FoundationTankof Shen Zhen PressGroup, Qingbo IntelligentTechnology Co., Ltd.Shenzhen Spiritual Civilization Construction CommitteeXinhuanet, China Enterprise Reform and Development Society
Science, Technology and Innovation Commission of ShenzhenMunicipality/Shenzhen Municipal Finance Committee/Shenzhen TaxService, State Taxation Administration/Shenzhen Local Taxation Bureau
China Key New Product CertificateLeading Enterprise of Guangdong Pilot
100 ProgramHigh-tech Enterprise Certificate2019 Top 20 Shenzhen Leading Biotech
CompaniesAcademician (expert) workstationPioneer of the Year in COVID-19 ReliefShenzhen Advanced Grassroots Party
Organization“Global Top 100 Pharmaceutical Enterprises”
in COVID-19 ReliefTop 10 Shenzhen Listed Companies with
Development Potential
Top 50 Most Promising Listed Companiesfor the 40th Anniversary of Shenzhen
Special Economic ZoneHonorary Certificate of Recognition for the Fight
Against the COVID-19 Pandemic in ShenzhenTop of the 2021 Brand Communication Power_istof Listed Companies in the Pharmaceutica andMedical Industry in the Greater Bay Area
2022 Enterprise ESG Outstanding SocialResponsibility Practice Case
WindAA Rating of"2022 Wind ESG Rating",
ranked in thetop 10 in the healthcare sector
"Top Ten Caring Enterprises"of the 19thShenzhen Care Action
Model Collective in Love Donation for COVID-19
Pandemic Prevention and Control in 2020
Top 10 Most Promising Listed Companies
in ChiNext at the 13th China Listed
Companies AwardsWinner in Pharmaceuticals Biology of the 10th
China JRJ Golden Intelligence Award
Guangdong “Excellent Group Member” forQualified Person in the Pharmaceutical Industry
BioKangtai
BioMinhai
China's Top 500 New Economy Enterprises China Enterprise Evaluation Association
Beijing Science and Technology AwardsBeijing Key Laboratory for Novel Conjugate
Vaccine Technology
Beijing Municipal People’s GovernmentBeijing 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 Novel Vaccines
Beijing Municipal Science and Technology CommissionBeijing Novel Combination Vaccine R&D CenterBeijing Municipal Science and Technology CommissionNational-Local Joint Engineering Laboratory for
Novel Vaccine Technologies.
National Development and Reform Commission of ChinaBeijing Enterprise Technology Center
Beijing Municipal Bureau of Economy and
Information TechnologyScience and Technology Award of the Chinese
Pharmaceutical Association
Chinese Pharmaceutical AssociationAcademician (Expert) Workstation CertificationChina Association for Science and TechnologyWorker Pioneer AwardBeijing Intellectual Property Demonstration
Organization
All-China Federation of Trade UnionsBeijing Municipal Intellectual Property OfficeIPMS Certificate
Zhongzhi (Beijing) Certification Co., Ltd.Top 100 Beijing Private Enterprises in CSRBeijing Municipal Federation of Industry and CommerceTop 100 Beijing Private Enterprises in Science and
Technology Innovation
Beijing Municipal Federation of Industry and CommerceZhongguancun High-tech Enterprise CertificateZhongguancun Science Park Management CommitteeBeijing Model Worker's HomeBeijing Municipal Human Resources and Social Security BureauDemonstration Enterprise in Harmonious Labor
Relations in China
Daxing District Green Credit Five Star Enterprise
Joint Conference Office of Beijing Daxing District Green
Credit System
Beijing Municipal Human Resources and Social Security BureauPractice Site of Examiner Practice (Beijing
Zhongguancun) Base of China National
Intellectual Property Administration
Zhongguancun Intellectual Property Promotion Center, under the
supervision of Beijing Municipal Intellectual Property Office as
authorized by China National Intellectual Property Administration
High-tech Enterprise Certificate
Beijing Municipal Science and Technology Commission,
Beijing Municipal Finance Bureau, Beijing Municipal Tax Service
of State Taxation Administration
Beijing Municipal Science and Technology Commission, Beijing
Municipal Development and Reform Commission,Industrial Park Management Committee of Beijing Municipal
Bureau of Economy and Information TechnologyKey Innovation-driven Enterprise, Beijing G20
Project for Evolution of Biomedical Industry
RecipientHonors and Special RecognitionAwarded by
2022 CORPORATE SOCIAL RESPONSIBILITY REPORT AND ENVIRONMENTAL, SOCIAL AND GOVERNANCE REPORTBIOKANGTAI
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 corporate purpose of“producing the best vaccines to benefit the mankind”, core value of “dedication to people’s health”, as well as the operationprinciples of “people orientation, excellence, honesty, efficiency, innovation and cohesion”. The ESG philosophy focuses on theprotection of the rights and interests of stakeholders such as shareholders, employees, customers and suppliers, and placesemphasis on normative and honest operation with a view to promoting the sustainable and balanced development of theCompany, the society and the environment. In 2022, BioKangtai was selected as the "2022 Enterprise ESG Outstanding SocialResponsibility Practice Case" by Xinhuanet and won the AA rating of "2022 Wind ESG Rating", ranking among the top ten in thehealthcare industry.
ESG Approach
Sound GovernanceManage the Company in accordance with the law and regulations, pursuesound and stable development,strive to be a world-class company,and contin-ue to create value for our shareholders
High-Quality ProductsControl product quality strictly and provide better vaccinesthrough technological innovation
Win-win with EmployeesCreate a comprehensive development platform for employeesto help them grow together with the company and realize theirpersonal value
For Healthy CommunitySupport medical development and promote medical accessibility
For Green DevelopmentProactively address climate change and minimize the Company's carbonfootprint
Stakeholder 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-waycommunication through various channels with stakeholders such as shareholders, investors, governments and regulators,customers, suppliers, employees, industry associations, communities and the public. We listen and respond actively to thesuggestions and feedback from our stakeholders, and incorporate their concerns into our operations and decision-making,thereby satisfying their demands while improving our business management and achieving sustainable development.
Stakeholder Communication andMaterial Issue Identi?cation
Stakeholder Communication
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Referring to the latest policies of CSRC and SZSE and excellent practices of peers at home and abroad, the Company under-took the identification of material issues based on its own business and characteristics as well as expert opinions, with fullconsideration of stakeholders’ demands and priorities of concern. After identification, ranking and verification, we identified 18material issues as the focus of disclosure in the report, as shown in the chart below.
Material Issue Identi?cation
Customers
Government and Regulatory
Agencies
(e.g., National Medical Products Administration)
? Comply with appropriate lawsand regulations? Daily Policy Implementation? Regular Work Summary andOfficial Correspondence? Law Enforcement Supervisionand Inspection? Customer Satisfaction Survey? Customer Visits? Professional Communication? Customer Services and CustomerComplaints
? Product Quality? R&D Innovation? Customer Service? Data Security and Privacy Protection
? Compliance and Risk Management? Business Ethics? Occupational Health and Safety? Emissions Management? Responding to Climate Change? Use of Resources? Environmental Protection
Suppliers
Employees
Industry Associations
Community and Public
? Supplier Assessment and Audit? Supplier Training? Regular Meetings? Employee Activities? Labor Union and Staff Council? Complaints and Feedback? Industry Associations andOrganizations? Professional Communication? Project Cooperation? Community Activities and Services? Regular Communications? Media Communication? Popularization of VaccineKnowledge
? R&D Innovation? Intellectual Property Rights? Industry Development? Social Welfare? Access to Healthcare
? Employee Rights and Benefits? Employee Training and Development? Occupational Health and Safety
? Business Ethics? Supply Chain Management
Key StakeholdersCommunication ChannelsIssues of Interest
Shareholders and Investors
? General Meeting of Shareholders? Information Disclosure? SZSE’s Easy IR Platform? Investor Communication,Roadshows, Conference? Investor Hotline/Email
? Disclosure and Transparency? Compliance and Risk Management? Economic Performance
BioKangtai’s material issues matrix
High
High Importance to Stakeholders
Low Importance to the Company’s business
EconomicPerformance
ProductQualityR&D InnovationOccupational Health and SafetySupply Chain Management
Employee Rights and BenefitsAccess to Healthcare
Employee Training and DevelopmentBusiness EthicsInformationdisclosuretransparencyEmissionsManagementUse of ResourceResponding to Climate Change
Philanthropy
Customer Service
Data Security andPrivacy Protection
Compliance andRisk Management
Intellectual Property
High Material Issues
Moderate MaterialIssues
Economic IssuesEnvironmental IssuesSocial Issues
2022 CORPORATE SOCIAL RESPONSIBILITY REPORT AND ENVIRONMENTAL, SOCIAL AND GOVERNANCE REPORTBIOKANGTAI
Party Building Leading
Improving the constructionof Party organizationIn June 2022, the Company completed the re-election of the Party committee to further improve the organizationalstructure, enhance the organizational capacity, strengthen the organizational leadership and promote the construction work ofthe Party branch. The Party committee of BioKangtai is composed of five members, with one secretary and one deputy secretary.The Party committee of BioKangtai has 96 registered Party members and 2 branches under it. All Party members, under theleadership of the new Party committee, are concentrating their efforts and forging ahead for the steady development of theCompany.
Reinforcing the foundation of Party building
The Party committee of the Company insists on putting political construction in the first place, deeply promoting the studyand implementation of the spirit of the 20th CPC National Congress, the latest important speeches of General Secretary XiJinping and the spirit of important instructions and directives, learning around the construction of the Party conduct and of anhonest and clean government, and effectively strengthening the work of Party construction, ideology and the construction ofParty conduct and of an honest and clean government. It conscientiously implements "the Three Meetings and One Lecturesystem", the Thematic Party Day activities, organizes the life of the Party and democratic evaluation of the Party members,carries out the Party history study and education activities in a down-to-earth manner, guides the majority of Party members tofirmly establish the "red line" awareness with worst-case scenarios in mind. The Party committee also educates Party membersand cadres to practice in learning and learning in practice, in order to effectively improve the political quality of Party membersand cadres and their capabilities to solve practical problems, promote the harmony and stability of the enterprise, create a cleanand upright enterprise ecology, and build a solid foundation for the high-quality development of the Company.
Carrying out Party building activities
The Party committee of the Company insists on bringing the team building with the Party building and promoting the Partybuilding with the team building, strengthening and improving the work of the Party group under the new situation through aseries of Party building activities, maintaining and enhancing the political, advanced and mass nature, enhancing the vitality ofthe Party organization building, and promoting the deep integration of the Party building work and the central work.
2022 is the year for the 20th CPC National Congress which was convened by the Communist Party and the crucial year ofthe implementation of the “14th Five-Year Plan”. The Party committee of the Company always insists on the guidance of XiJinping Thought on Socialism with Chinese Characteristics for a New Era, deepens the study and implementation of the spirit ofthe 20th CPC National Congress, strengthens the ideological armament, carries out in-depth grass-roots Party building, gives fullplay to the political leadership of Party grass-roots organizations and the pioneering role of Party members, promotes the deepintegration of Party building work and corporate governance, production and operation, corporate culture and social responsibil-ity, and leads the high-quality development of our Company with high-quality Party building.
Committee
members
Secretary
Deputysecretary
RegisteredParty members
Party branches
In 2022, the Party committee of the Companyorganized a series of activities to celebratethe 30th anniversary of the establishment ofBioKangtaiPromoted the spirit of love and dedication to work andinspired the courage of employees to struggle and striveCreated an enterprise internal magazine"Guardian" (《守护》)To build a communication platform for the Partyand mass building and corporate culture
Set up "Kangxin Fund" (康馨基金)
To provide assistance to employees in difficulties
Opened a Party building book bar
Organized reading month activities and otherforms of Party building activities to promote therelationship of Party and masses, enhanced therole of the Party branch as a fighting base andcontinuously strengthened the centripetal forceof the Company.
PartybuildingactivitiesChoosing to set up advanced models
In order to give full play to the exemplary role of grass-roots Party organizations and the pioneering role of Party members,the Company has carried out the selection of advanced typical characters of "love the country, the post and the family" and theselection of "May Fourth Medal" of BioKangtai, actively transmitting the power of role models, promoting work in all areas bydrawing upon the experience gained on key points, creating a good atmosphere for learning and striving to be a model, andencouraging the active contribution to the cause of human immune health with the posture of a doer who strives for the first.
Construction of Party organization
Governing Enterprise in Accordance with the
Law and Escorting Sustainable Development
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Governance Structure
The Company strictly complies with the relevant provisions of the Company Law of the People’s Republic of China(hereinafter referred to as the “Company Law”), the Securities Law of the People’s Republic of China (hereinafterreferred to as the “Securities Law”), the Code of Corporate Governance for Listed Companies in China, the RulesGoverning the Listing of Shares on the ChiNext Market of Shenzhen Stock Exchange, the Guidelines on Self-regulationof Listed Companies on Shenzhen Stock Exchange No. 2: Standardized Operation of Listed Companies on the ChiNextMarket and other relevant laws and regulations. It has established a governance structure consisting of the generalmeeting, the Board of Directors, the board of supervisors and the management, formulated rules such as Rules of Proce-dure of the General Meeting of Shareholders, Rules of Procedure of the Board of Directors, Rules of Procedure of theSupervisory Board and Responsibilities of the President, clarifying the responsibilities and authority, rules of procedureand working procedures of the General Meeting of Shareholders, the Board of Directors and the management, forminga scientific and effective division of responsibilities and checks and balances mechanism, and standardizing operations.The "three meetings and one management" strictly follow the provisions of the Company Law, the Articles of Associa-tion and the Rules of Procedures, perform their own responsibilities with mutual constraints, and safeguard the legiti-mate rights and interests of the Company and all shareholders.
The Company's governance status was in compliance with the requirements issued by the CSRC and the SZSE inrelation to the governance of listed companies. The Company has been improving its corporate and standardized corporategovernance structure, optimizing its internal control management system, improving its risk prevention capability, andensuring its compliance and sound development.
Normative Governance
股东大会
公司监事会
The General Meeting of Shareholders isthe highest authority of the Company.
The Supervisory Board of the Company is the supervi-sory body of the Company, responsible for the supervi-sion and inspection of the Company's businessoperation and financial status, as well as the supervi-sion of the directors and senior management of theCompany in performing their duties in accordancewith the law, and responsible to the General Meetingof Shareholders.
The GeneralMeeting ofShareholders
The Board of Directors is the businessdecision-making body of the Company,and is responsible to the General Meetingof Shareholders.
TheSupervisoryBoard of theCompany
The President presides over the dailyproduction and operation managementof the Company within the authorizationof the Board of Directors.
The Boardof Directors ofthe Company
The
President
General Meeting of Shareholders
Board of Supervisors
Securities Affairs DepartmentHuman Resources DepartmentProject Management DepartmentInternational DivisionFinance CenterGeneral Manager’s OfficeBiosafety OfficeQuality Assurance Management CenterProduction & Operation CenterR&D CenterSales and Marketing CenterPharmacovigilance DepartmentSupply Chain Management DepartmentInternal Auditing Department
Secretary of theBoard of Directors
Board of Directors
President
Strategy CommitteeNomination CommitteeRemuneration andAssessment Committee
Audit CommitteeOffice of the
Chairman
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 the Articles of Association and the Rules of Procedure for General Meeting of Shareholders toregulate the convening, holding and voting procedures of shareholders’ meetings and treat all shareholders equally.The Company holds shareholders' meetings through a combination of on-site and online voting to ensure that share-holders can fully exercise their rights.
During the reporting period, the Company held one annual general meeting and one extraordinary generalmeeting, at whichnine motions were considered. The meetings were convened by the Board of Directors, and
lawyers were invited to witness the meetings and issue legal opinions on the convening and voting procedures ofthe shareholders' meetings. The convening and holding procedures of the shareholders’ meetings and the motionsconsidered were in compliance with the relevant laws and regulations and the Articles of Association.
BioKangtai’s governance structure
2022 CORPORATE SOCIAL RESPONSIBILITY REPORT AND ENVIRONMENTAL, SOCIAL AND GOVERNANCE REPORTBIOKANGTAI
The Company has formulated a sustainable profit distribution policy to continuously reward its shareholders. Sinceits listing, the Company has implemented its profit distribution plan in strict accordance with the relevant profit distribu-tion policy and deliberation procedures of the Articles of Association, with clear and explicit criteria for dividend distribu-tion and complete decision-making procedures and mechanisms. After consideration by the Board of Directors and theBoard of Supervisors and opinions by the independent directors, the relevant proposals are submitted to the GeneralMeeting of Shareholders for consideration to effectively protect the legitimate rights and interests of shareholders,especially the small and medium shareholders.
In June 2022, the Company implemented the 2021 Annual Equity Distribution Plan to distribute 8.5 yuan(tax-inclusive) cash dividends for every 10 shares to all shareholders from undistributed profits, and 6 shares forevery 10 shares to all shareholders from capital reserve, without bonus shares. Since its listing in 2017, the Companyhas paid cash dividends of 1,239 million yuan in total.
In 2022, the Company implemented share repurchases. According to Article 7 of the Guidelines on Self-regulationof Listed Companies on Shenzhen Stock Exchange No.9 – Share Repurchase, where the Company adopts a tender offeror the centralized bidding method to repurchase its shares using cash as consideration, the amount of shares repur-chased in the current year shall be deemed as the amount of cash dividends to be paid and shall be included in thecalculation of relevant proportions for the distribution of cash dividends for the year. The total amount of funds paid bythe Company to repurchase shares by way of centralized bidding during the period from September 21, 2022 to March13, 2023 was 120,967,842.86 yuan (excluding transaction fees), of which the total amount of funds paid during theyear 2022 was 19,993,586.45 yuan (excluding transaction fees), which was regarded as the amount of cashdividends for the year 2022.
1920
About the Company and thecontrolling shareholder
About supervisors and theBoard of Supervisors
About directors and Board of Directors
Rewarding Our Shareholders
The Company has independent and complete business and independent operation capability, and is independentof the controlling shareholder in terms of personnel, assets, finance, institutions and business, with separate account-ing an independent responsibility and risk. During the reporting period, major decisions of the Company were made bythe General 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 thedecision-making and operating activities of the Company beyond the General Meeting of Shareholders. There are nocircumstances such as appropriating the Company's funds or requesting guarantees for them or guaranteeing others.
The Board of Directors of the Company consists of eight directors, including three independent directors, and thenumber and composition of the Board of Directors are in compliance with the laws, regulations and the Articles of Associa-tion of 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 are fourspecialized committees under the Board, namely, the Strategy Committee, the Audit Committee, the Nomination Committeeand the Remuneration and Assessment Committee. Each committee carries out its functions in strict accordance with itsown working rules to promote scientific decision-making of the Board, improve the efficiency of the Board’s operation andplay an important role in the governance of the Company.
The Board of Supervisors of the Company is composed of three supervisors, including two employee representa-tives, and the number and composition of the Supervisory Board are in compliance with the laws, regulations and theArticles of Association of the Company. The supervisors of the Company strictly abide by the requirements of theCompany Law, Guidelines on Self-regulation of Listed Companies on Shenzhen Stock Exchange No. 2: StandardizedOperation of Listed Companies on the ChiNext Market, Articles of Association and Rules of Procedure of the Board ofSupervisors, and conscientiously perform their duties by attending the meetings of the Board of Supervisors, the meet-ings of the Board of Directors and the meetings of the General Meeting of Shareholders, and supervising the develop-ment strategy, financial activities, risk management, internal control and the performance of duties of the Board ofDirectors and senior management of the Company in accordance with the law for the benefit of the shareholders andthe overall interests of the Company.During the reporting period, the Company held 5 meetings of the Board of Supervisors with 25 motions consid-ered, all of which were convened and chaired by the chairman of the Board of Supervisors, and the convening,holding and voting procedures of the meetings were in compliance with the relevant provisions of the laws andregulations and the Articles of Association and the Rules of Procedure of the Board of Supervisors.
During the reporting period, the Company held 6 meetings of the Board of Directors with 35 motions considered.The meetings were all convened and chaired by the Chairman of the Company, and the convening, holding andvoting procedures of the meetings were in compliance with the relevant provisions of laws and regulations and theArticles of Association and the Rules of Procedure of the Board of Directors.
2022 CORPORATE SOCIAL RESPONSIBILITY REPORT AND ENVIRONMENTAL, SOCIAL AND GOVERNANCE REPORTBIOKANGTAI
Enhancing commu-nication withinvestors andpotential investors
2122
Continuous Strengthening of InvestorRelations Management
The Company strictly complies with the Guidelines on Self-regulation of Listed Companies on Shenzhen Stock Exchange No.2: Standardized Operation of Listed Companies on the ChiNext Market, Guidelines for Investor Relations Management of ListedCompanies, and Rules on Investor Relations Management. It has clearly defined the investor relations management mechanism,with the Secretary of the Board of Directors as the person in charge of investor relations management and the Securities AffairsDepartment as the functional department of investor relations management, led by the Secretary of the Board of Directors, anddedicated personnel in charge of investor reception. Through diversified methods such as shareholders' meetings, online perfor-mance briefings, road shows, analyst meetings, visiting receptions, SZSE’s Easy IR Platform, investor hotline, investor relationsmailbox, etc., the Company strengthens communication with investors and potential investors, sincerely listens to investors'opinions and suggestions, in order to convey new developments of the Company, enhance investors’ understanding and recog-nition of the Company, and maintain a good relationship between the Company and investors.
Regulating Information Disclosure
With great emphasis on information disclosure, the Company has strengthened its management of information disclosureaffairs in accordance with the provisions and requirements of the Company Law, the Measures for the Administration of Informa-tion Disclosure of Listed Companies, the Rules Governing the Listing of Shares on the ChiNext Market of Shenzhen StockExchange and the Guidelines on Self-regulation of Listed Companies on Shenzhen Stock Exchange No. 2: Standardized Operationof Listed Companies on the ChiNext Market. We have formulated the Regulations on the Management of Information DisclosureMatters 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 2022, the Company disclosed a total of147 periodic reports and temporary announcements, which provided true, accurate, complete and timely disclosure of theCompany’s business activities and material matters, ensuring that all investors had fair access to our information and effectivelyprotecting the legitimate rights and interests of investors.
Shareholders' meetingsSZSE’s Easy IR PlatformOnline performance briefingsRoad showsInvestor hotlineAnalyst meetingsInvestor relations mailboxVisiting receptions
Compliance Operations
Internal Control Management andCompliance Operations
The Company attaches great importance to the construction of standardized governance and internal control system, and inaccordance with the provisions of the Basic Standards for Enterprise Internal Control and its supporting guidelines, and on the basisof standardized corporate governance framework, it has continuously optimized the compliance management system by improvingthe compliance organization structure, establishing a sound compliance system and enhancing compliance awareness, and hasestablished clear internal controls and necessary internal supervision mechanisms from the corporate management level to the levelof each business process to guarantee operation in accordance with the law and standardized operation.
A compliance management team has been established under the Audit Committee of the Board of Directors of the Compa-ny. The compliance management team consists of full-time and part-time team member, where full-time team members arefrom the internal audit department and part-time team members are senior staff from each functional department, who collabo-rate with the full-time team members to carry out compliance reviews in their respective sectors.
Full-time personnel ofInternal Audit Department
Audit Committee
ComplianceManagement TeamPart-time personnel offunctional departmentsR&D Center
Quality AssuranceManagement Center
Sales andMarketing CenterSupply Chain Manage-
ment Department
Finance Center
Human Resources
DepartmentSecurities Affairs
Department
Biosafety DepartmentGeneral Manager’s Office
Improving the organizational structure of compliance management
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Risk Identi?cation and ManagementThe Company identifies and systematically analyzes potential internal and external risks in its business activities in a timelymanner, and constantly improves its risk management and internal control systems. In terms of risk identification, each departmentcarries out risk identification in its daily work according to the regulations, establishes risk database and Risk Identification List, andregularly conducts self-inspection on 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 the Audit Law ofthe People’s Republic of China, Guidelines on Self-regulation of Listed Companies on Shenzhen Stock Exchange No. 2: StandardizedOperation of Listed Companies on the ChiNext Market and the Company’s Internal Audit Regulations and Management Measures ofInternal Audit Practice, the Internal Audit Department audits, supervises and inspects the production and operation activities,economic efficiency, asset security, business ethics and anti-corruption, and the establishment and implementation of the internalcontrol system of the Company and its subsidiary, and makes suggestions and comments on the existing problems. The Internal AuditDepartment is independent and reports directly to the Audit Committee of the Board of Directors.In 2022, 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 on riskcontrol related laws and regulations and policy interpretation to employees through internal communication network from time totime to enhance their awareness of risk control.Internal auditing procedure
Establishing a sound compliance system and enhancing compliance awareness
In terms of compliance management regulations, the Company has formulated the Regulations on Compliance Management,which is applicable to the compliance management for all departments, subsidiary and employees of the Company, coveringbusiness areas such as transactions, safety and environmental protection, product quality, labor employment, finance, taxation,business partners, business innovation, asset management and intellectual property rights. Meanwhile, the Company starts from theguidance of the concept, improves the compliance awareness of all employees through compliance promotion, strengthens compli-ance supervision, promotes the effective implementation of compliance management, and continuously strengthens internal controland compliance management to escort the Company's stable operation.
Develop audit plans andimplement them after approvalby the Audit Committee.
Develop audit plan andaudit program for projects.
Deliver the audit notice tothe audited units.
Settlement of objections toaudit results and review andconfirmation of matters.
Follow up and supervise theimplementation ofcorrectivemeasures of the audited units.Conduct audit tasks, form auditconclusions and recommendations,reviewed by the person in charge.
010203040506
Anti-corruption and Business EthicsThe Company insists on honest and corruption-free operation and strictly abides by the relevant laws and regulations such asthe Law of the People’s Republic of China on Anti-Unfair Competition, the Law of the People’s Republic of China on Anti-MoneyLaundering, the Law of the People’s Republic of China on Protection of Consumer Rights and Interests and relevant standards suchas ISO37001 Requirements and Implementation Guide for Anti-Bribery Management System. The Company adopts a zero-tolerancepolicy for unethical business practices, improves the long-term mechanism for business ethics management by formulating theEmployee Handbook, Code of Professional Ethics, Rules for Integrity in Workplace, and Whistleblowing Management Regulations,implements control measures to enhance the ethical level of employees, requires employees to strictly comply with the relevantregulations on integrity office and anti-bribery, strengthens targeted management of key links, creates a culture of integrity, andbuilds a monitoring and reporting mechanism to encourage the employees of the Company to supervise the implementation ofintegrity governance, as well as to report suspected violations. Meanwhile, the Company requires employees in key positions to signthe Integrity Commitment. In 2022, all employees in key positions of the Company signed the Integrity Commitment.In terms of external integrity cooperation, the Company attaches importance to the prevention of business ethics risks in theprocurement process. In addition to establishing an integrity standardization mechanism with suppliers, the Company's internal auditdepartment conducts annual audits on business ethics in the supply chain and organizes training on business ethics for supply chainemployees.In external cooperation such as cooperation with external promoters, clear requirements on business ethical practices are alsoput forward, and the behavior of all parties involved in the cooperation is regulated by signing Integrity Agreements or agreeing onanti-bribery clauses in the cooperation agreements.
? Shall not use their authority toaccept bribes;? Shall not obtain trade secrets byimproper means;? Shall not undermine competitors byfalse advertising.
BusinessEthics Code and
Requirements
All employees
? Comply with the law, work withintegrity, sign the Integrity Commit-ment；? Never disseminate confidentialinformation in violation of relevantregulations.
Middle and seniormanagement andkey position personnel
? Strictly abide by laws and regulations,stipulate compliance terms in agreements,conduct market activities in accordancewith the law, and avoid paying bribes torelevant departments or employees of theCompany in any form to obtain improperbenefits.
External co-promoters
? Contracts signed with suppliers/part-ners must contain an integrity agreementor related clauses, and overseeing imple-mentation of the integrity agreement.
All departments
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The Company has formulated the Whistleblower Management System, which specifies the reporting mechanism, managementorganization, reporting channels and acceptance procedures, and handling measures, etc. The Company has also established aninternal whistleblower management leading group, headed by the Chairman. The Company encourages employees and partners toreport suspected violations and crimes, which can be reported anonymously or in real names, and rewards for truthful reporting.The Company keeps the personal information of the whistleblowers and the reporting information provided strictly confidentialthrough the confidentiality management measures such as dedicated management of the reporting information and minimizing thenumber of informants to prevent the whistleblowers from being treated unfairly and to protect the legitimate rights and interests ofthe whistleblowers. For personnel who violate the confidentiality provisions and retaliate against whistleblowers, the Company takesa zero-tolerance attitude, the violators will be dismissed, terminated from the labor contract, or transferred to judicial organs ifsuspected of breaking the law according to the severity of the circumstances.
Compliance reporting and whistleblower protection
Procedures for handling whistleblowing
BioKangtai’s Whistleblowing Channels
Director of the Office ofInternal WhistleblowingManagement LeadershipGroup 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.
Receive Whistleblower
Complaints
Investigate and Collect
Evidence
Handel Whistleblowing
WhistleblowerComplaint ReceiverHotlineEmailChannels
Director of the Office of Internal Whistleblowing Management Leadership Group0755-26988630shenjibu@biokangtai.comLetters, phone calls, emails, WeChat and visits, etc. We support anonymous reporting.
Creative Products to Bene?t Human Health
Continuous R&D and Innovation
The Company has been deeply engaged in the field of human vaccines for over 30 years, and always insisted on the R&D modewhich is mainly of independent R&D, supplemented by cooperative R&D and secondary innovation of imported technologies. Whilestrengthening the independent R&D and innovation ability, we pay attention to the cooperative relations with well-known enterpris-es and institutions in domestic and overseas, introduce advanced technology for absorption and use, enabling the Company tocontinuously improve its R&D ability. At present, we have mastered a number of core technologies such as engineered strainconstruction, cell culture, virus culture, exotoxin detoxification, polysaccharide purification, protein purification and polysaccha-ride-protein conjugation. We have R&D and production capability for viral vaccines, bacterial vaccines, genetically engineered proteinvaccines, conjugate vaccines and combination vaccines. In particular, we are at the leading edge of the development of combinationvaccines. At the same time, the Company has been keeping up with the international cutting-edge technology, continuously explor-ing the research and application of novel vaccine technologies and the establishment of new technology platforms, and reservedmRNA technology, adenovirus vector technology, new adjuvant technology and other product development platforms.Meanwhile, the Company has established a diversity of R&D platforms, which complement each other and form a strongsynergy effect, enabling the development of vaccine products and the construction of vaccine product portfolio in a more economicaland efficient way, so as to ensure the continuous upgrading of vaccines and the successful development of novel vaccines.
R&D Strategy
Platform forattenuated
vaccines
Platformfor virusattenuatedcombined
vaccine
Platform forinactivated
virusvaccines
Platform forGeneticallyEngineered
Vaccines
Platformfor bacterialpolysaccharide
vaccines
Platform forpolyvalentbacterialpolysaccharide
vaccinesPlatformfor bacterialpolysaccharide
conjugatevaccines
Platform forpolyvalentbacterialpolysaccharide
conjugatevaccines
Platform for
combinedvaccines
Platform forvirus vector
vaccines
Platform for
mRNAvaccines
Platform fornew adjuvant
technology
Well-developed R&D Bases
12 Diversified R&D Platforms
? Shenzhen Novel Vaccine Engineering Laboratory? Guangdong Therapeutic Hepatitis B Vaccine Laboratory? Beijing Key Laboratory for Novel Conjugate Vaccine Technology? Beijing Novel Vaccine Engineering Laboratory
? Postdoctoral R&D Center? Beijing International Sci-Tech Cooperation Base for Novel Vaccines? Beijing Novel Combination Vaccine R&D Center? Academician Workstation
In process
2022 CORPORATE SOCIAL RESPONSIBILITY REPORT AND ENVIRONMENTAL, SOCIAL AND GOVERNANCE REPORTBIOKANGTAI
Vaccine
The Company places emphasis on the introduction of international advanced technology to enrich its technologystrategies and reserves, and improves its independent innovation capability through introduction and absorption,promotes the achievement transformation of independent innovation technology, and develops itself from a one-waytechnology bringer to an overseas exporter of independent technology, so as to explore a way to transfer the indepen-dent innovation technology to overseas, and strive to improve the accessibility and affordability of vaccines worldwide.
PartnerCooperation Strategy
VaccinePartnerCooperation Strategy
Hepatitis B Vaccine
Rabies Vaccine
(MRC-5 cells)for Human Use,Freeze-dried
Merck, US
Sanofi Pasteur
Merck provides the Company with the Hepatitis B Vaccineproduction process, manufacturing know-how, technicaldocumentation, training, Recombinant Hepatitis BVaccine strains and detailed process plans, which will onlybe used to meet mainland China’s demand for hepatitis Bvaccine. After the contract has been in effect for ten years,the product can be exported or sold in Hong Kong SAR,Macao SAR and TaiwanSanofi Pasteur grants BioMinhai a nonexclusive,non-transferable and non-sub-licensable license to usethe materials and technology for the production of RabiesVaccine (MRC-5 cells) for Human Use, Freeze-dried todevelop, manufacture and market the vaccine inmainland China (excluding Hong Kong SAR, Macao SARand Taiwan)Inactivated
Poliomyelitis
Vaccine, SabinStrains (Vero cell)
INTRAVACC, the
Netherlands
INTRAVACC licenses to BioMinhai a non-exclusive,non-transferable technology for the production ofinactivated poliomyelitis vaccine from Sabin strains andrelated assays; BioMinhai can use this technology for theproduction in China and worldwide distribution ofinactivated poliomyelitis vaccine from Sabin strains andrelated combination vaccines
RecombinantCOVID-19 Vaccine(Y25 Adenovirus
Vector)
AstraZeneca
AstraZeneca has exclusively licensed BioKangtai todevelop, manufacture and commercialize the Recombi-nant COVID-19 Vaccine (Y25 Adenovirus Vector) in China(excluding Hong Kong SAR, Macao SAR and Taiwan); andto market the vaccine in Pakistan and Indonesia
Mumps Vaccine
Strains
IMUNA PHARM,A.S.
IMUNA PHARM, A.S. provides Mumps Vaccine Strains toBioMinhai for use in the production and sale of single ormultiple doses of vaccine and monovalent or multivalentcombination vaccines in mainland China for the purposeof preventing or treating human disease
13-valent pneumococcalpolysaccharide conjugate
vaccine
Biotis, Indonesia
BioMinhai supplies dual-vector 13-valent pneumoniavaccine solution to Biotis, and transfers the technology ofvaccine preparation, packaging, product verification, etc;subsequently, the two sides will jointly promote the localproduction, registration and commercial operation of thedual-vector 13-valent pneumonia vaccine in Indonesia.
Relying on its R&D platforms and core technologies, the Company has overcome the barriers to the developmentof several heavyweight vaccines, and completed the development of several world-leading vaccines with independentintellectual property rights, to contribute for immunization health of the people.
R&D Achievements
60μg Recombinant Hepatitis B Vaccine (Saccharomyces cerevisiae): The world's firstvaccine.
DTaP-Hib Combined Vaccine: The first domestically developed vaccine with the largest
number of combined vaccines, and a major achievement of the National Hi-tech R&DProgram (or 863 Program).
13-Valent Pneumococcal Polysaccharide Conjugate Vaccine: The world’s first dual-vector
13-valent pneumococcal polysaccharide conjugate vaccine; it is also a global best-sellingvaccine.
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 in?uenzae type b DTaP-HiB-IPV conjugate vaccine: The only
domestic quintuple vaccine that has obtained the Notice of Approval for Drug ClinicalTrials issued by the China National Medical Products Administration.
Technology import & cooperation
Technology export & cooperation
2827
Some important R&D achievements
2022 CORPORATE SOCIAL RESPONSIBILITY REPORT AND ENVIRONMENTAL, SOCIAL AND GOVERNANCE REPORTBIOKANGTAI
At present, the Company has more than 30 projects under development, basically covering key vaccine types inthe world. The major projects that have entered the registration procedures are as follows:
Extensive projects under research
SerialNo.
Registration StageVaccine NameCurrent Process
Rabies vaccine (human diploid cell)for human use, Freeze-dried
Completed on-site verification forregistration and GMP compliance
inspectionNDA under reviewLive Attenuated Varicella Vaccine
Completed on-site verification forregistration and GMP compliance
inspectionNDA under reviewInactivated PoliomyelitisVaccine, Sabin Strains (Vero cell)Group ACYW135 MeningococcalPolysaccharide VaccineInactivated Hepatitis A VaccineIn the summary stage of clinical phase
Completed the on-site job of Phase
III clinical researchSARS-CoV-2 Vaccine (Vero Cell),
Inactivated
Approved for emergency use in China
Obtained Phase III clinical trial
critical dataRecombinant enterovirus A71vaccine (Hansenula)
IND obtained, clinical phase in progressCompleted Phase I and II clinical trialsRecombinant Hepatitis BVaccine (Hansenula)
IND obtained, clinical phase in progressCompleted Phase I clinical trialDiphtheria, Tetanus and AcellularPertussis Combined Vaccine (component), Adsorbed
IND obtained, clinical phase in progressPhase I clinical trial in progressReassortant Rotavirus Vaccine, Live,
Oral, Pentavalent (Vero Cell)
IND obtained, clinical phase in progressPhase I clinical trial in progressQuadrivalent influenza virus
split vaccine
IND obtained, clinical phase in progressPhase I clinical trial in progress
Diphtheria, tetanus, pertussis (acellular,component), poliomyelitis (inactivated)
combined vaccine (adsorbed)
IND obtained
Obtained notification of clinical
trial approvalMMR combined with live attenuated
vaccine
IND obtained
Obtained notification of clinical
trial approvalAdsorbed tetanus vaccineIND obtained
Obtained notification of clinical
trial approval60μg Recombinant HepatitisB Vaccine (Saccharomycescerevisiae) (immunomodulator)
Has withdrawn the applicationfor vaccine registration approval, currentlyin the clinical data self-examination phase
Clinical data self-examination in
progress
Diphtheria, tetanus, pertussis (acellular,component), poliomyelitis (inactivated)vaccine (adsorbed) and Haemophilus
influenzae type b conjugate vaccine
IND obtained
Obtained notification of clinical
trial approval
Obtained Phase III clinical trial
summary reportObtained Phase III clinical trialsummary reportIn the summary stage of clinical phase
Completed the on-site job of Phase
III clinical research
The Company attaches importance to the improvement of R&D and innovation system, and integrates researchand innovation into its development strategy. In accordance with the Drug Administration Law of the People’s Republicof China, Vaccine Administration Law of the People’s Republic of China and Measures for the Administration of DrugRegistration, the Company has established and improved R&D and innovation system, and provided continuousimpetus for technology development and product innovation through various effects, including creating an innovativeenvironment, perfecting the incentive mechanism for innovation and promoting the transformation of R&D results, soas to create its core competitiveness with innovation.
Improvement of R&D and Innovation System
Environmentfor Innovation
IncentiveMechanism forInnovation
InnovationTransformation
? Implement innovation-driven strategy and incorporate innovation into the Compa-ny’s medium- and long-term strategy? Encourage innovative approach, tolerance for failure, courage to expose defectsand self-transcendence, to create a sound innovation culture? Set out clear targets and executable plans for innovation? Continuously increase investment in R&D. In 2022, the Company’s R&D investmentaccounted for 31.47% of its operating revenue? Formulation of R&D Center Project Management Regulations, BioKangtai’sReward and Punishment System, etc., which stipulates the incentive system andmeasures for innovation? Encourage technological innovation, benchmark with international standards,promote heavyweight products, and forster innovation projects? Prioritize the allocation of resources required for innovation, including increas-ing investment in scientific research, information technology, and strengtheningthe recruitment of leading talents? Establish mechanisms and capabilities to promote the transformation of innovationresults with commercial or social value? Form synergy between “product research and development” and “social needs”to achieve the virtuous cycle of “continuous innovation” by developing market-ori-ented products
2022 CORPORATE SOCIAL RESPONSIBILITY REPORT AND ENVIRONMENTAL, SOCIAL AND GOVERNANCE REPORTBIOKANGTAI
The Company strictly follows R&D ethics in research and innovation, and implements the ethical principlesof regulatory compliance, human and animal subject protection, integrity, data reliability, intellectual propertyprotection, and openness in its R&D practices.
R&D Ethics
We have attached great importance to the protection of intellectual property rights, strictly complied with thePatent Law of the People’s Republic of China, the Trademark Law of the People’s Republic of China and other relevantlaws and regulations, and secured our legal and effective intellectual property rights through patent application andtrademark registration to maintain our reputation and core competitiveness. BioMinhai, the subsidiary of the Company,has established an enterprise intellectual property management system in accordance with the national standardnamed Enterprise Intellectual Property Management Regulation (GB/T29490-2013) and successfully obtained thecertification of intellectual property management system.When engaging in external cooperation, the Company strictly abides by the legal procedures for technologyimportation and patent licensing, and signs technology licensing and R&D cooperation agreements with its partners,which clearly stipulate the rights and obligations of both parties and the ownership of R&D intellectual property rights.The Company promotes cooperation matters according to the agreements to avoid relevant disputes in respect ofintellectual property rights. During the reporting period, the Company did not have any incident related to the infringe-ment of others’ intellectual property rights, and there was no litigation case related to intellectual property rights.
Intellectual Property Protection
Adhering to the belief of “talent is the primary resource for corporate innovation”, the Company has accumulat-ed a large number of core technologies for vaccine R&D and production through nearly 30 years of R&D innovation andtechnology import and absorption, and has built up a crew with international vision, rich experience in vaccine develop-ment and management, as well as practical experience in industrialization. Among them, the key technicians havemore than 10 years of experience in vaccine R&D and have undertaken more than 60 national, provincial and municipalprojects; 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 correct development direction, technicalstandards, R&D progress and quality of vaccines.The Company has established comprehensive R&D talent incentive measures to promote product innovation andcontinuously recruit high-end R&D talents with both scientific and technical expertise.
1. Establish a long-term mechanism to motivate core R&D/key personnel. By the end of the reporting period, the Com-
pany has incentivized an aggregate of 913 core employees by implementation equity incentive plans (2017 restrict-ed stock incentive plan and 2019 stock option 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.
4. Provide housing subsidies for talents in Nanshan District, Shenzhen, and solve their problems in children’s enroll-
ment, application of Shenzhen household registration and dwellings.
5. Apply for Beijing household registration 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 an allowance for living expenses and preferential rental housing,
etc.
Stable R&D Team
R&D Talent Incentive Measures
Ethical principles for scientific research
RegulatoryCompliance
Human andAnimal Subjects
Protection
? The whole process of R&D should refer to and follow the relevant laws and regulations.
Integrity in
ScientificResearch
? Follow the scientific standards and the principle of honesty and trustworthiness.
? Clinical trials of drugs follow the principles of the Declaration of Helsinki of the WorldMedical Association and related ethical requirements, and the rights and safety ofsubjects are the primary consideration;? Follow the 3R principles (reduce, replace and refine) in the use of laboratory animalsand research, concern for the welfare of laboratory animals, and treat them well.
? The whole process of R&D should be recorded, and the records must be timely, true,standardized and complete.Reliable Data
? Respect for patents, copyrights and other forms of intellectual property rights.
Intellectual
Property
Protection
? Share research results and scientific resources openly within the permitted range.
Openness and
sharing
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Strict Control of Quality and Safety
The Company has always regarded product quality as the line of life since its establishment, and always gives toppriority to product quality. In accordance with the Drug Administration Law of the People’s Republic of China, theVaccine Administration Law of the People’s Republic of China, the Good Manufacture Practice of Medical Products andrelated laws and regulations, and standards for medical product registration, the Company has established a compre-hensive quality management system covering the whole life cycle of products, which sets strict quality controlstandards for each key part of R&D, production, storage and distribution of products, and formulated targeted qualitymanagement procedures to ensure that all requirements for safety, efficacy and quality control in medical productregulations and registration standards are systematically implemented in the process of vaccine R&D, production,quality control, product release, storage and transportation, and ensure that all procedures in raw material inspection,product R&D, production and distribution are in compliance with the intended use and registration standards, so as tostrictly ensure product quality in line with standards.
At the same time, the Company actively absorbs the cutting-edge technology and advanced quality managementconcepts from international organizations and well-known enterprises such as WHO, Sanofi-Pasteur and Merck, as wellas continuously improves and perfects the quality control system by benchmarking international advanced standardsto constantly enhance its quality control ability for ever-growing upgrade of product quality. During the reportingperiod, the Company has obtained declaration of compliance issued by the EU quality authority for recombinantCOVID-19 Vaccine (Y25 Adenovirus Vector) manufacturing base; the vaccine manufacturing base in GuangmingDistrict, Shenzhen of the Company has been granted declaration of compliance on GMP issued by the Philippine Foodand Drug Administration, indicating that the Company's quality management system is in line with internationalstandards.
To 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.
Quality Control System
Product lifecycle quality management system
Quality management policy
SourceManagement
? Material Management Regulations and Supplier Management Regulations havebeen formulated for standardized management.? Acceptance of materials according to the bill of materials and the requirements ofquality standards. The process includes procurement, acceptance, inspection,storage, release and use management.
QualityInspection
? Develop Sample Receipt, Inspection and Reporting Procedures, Quality ControlDepartment Standard Management Regulations, and Quality Control DepartmentReagent Management Regulations and strictly follow them.? Control product quality by conducting quality testing involving standards, reagents,sample retention and laboratory management, etc.
VaccineLabelingManagement
? Develop Printing and Packaging Materials Management Regulations and strictlyenforce the regulations.? The design samples of product labels need to be approved by the person incharge of production management and quality management, the person in chargeof quality management and the person authorized for quality. After the productlabels are purchased and printed according to the regulations, they need to beexamined by the quality management center before putting them into use.
ProductionMonitoring? Develop the Production Quality Control Management Regulations and implementproduction monitoring based on it.? In accordance with the regulations, process parameters are evaluated and continu-ously tracked to identify abnormal trends and achieve all-round data monitoring.
Release and
ProductTransportation
? Develop Assured Management Regulations, Sales Management Regulations, and ColdChain Transporter Management Regulations and strictly enforce these regulations.? Products are inspected and approved by the Quality Authorized Person before leavingthe factory. The products are transported according to the cold chain transportationrequirements, ensuring that they are delivered as required and well tracked in themarket.
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The Company has established an electronic system for vaccine traceability, which is connected with the nationalvaccine e-traceability platform to achieve full traceability and verifiability throughout the process of vaccine produc-tion, quality control and product release, storage and transportation. At the same time, the Company actively promotesthe construction of digital system for product production and inspection to accelerate the digital transformation ofvaccine production and achieve more efficient, real-time and traceable quality management. The Company's laborato-ry information management system, production and manufacturing execution system, group version of enterpriseresource management system, etc., have been launched in succession, and have gradually realized the whole link ofinformation management and control, whereby achieving accurate and reliable data management.
The Company attaches great importance to internal quality supervision and inspection, and carries out compre-hensive self-inspection every year. Through self-rectification and self-inspection of the whole process of qualitymanagement, the Company timely discovers the deviation and risk of quality management, and timely improves thequality management system to enhance the quality management level. Meanwhile, the Company accepts the audit ofregulatory authorities at national, provincial, municipal and district levels every year, and the audit results for 2022 areall satisfactory.
Digital construction of quality management
The Company has formulated regulatory documents such as Deviation Management Regulations, Regulations onChange Control, Regulations on Corrective and Preventive Measures and Regulations on Customer Complaint Handlingin accordance with the GMP management requirements to implement deviation and change management and riskcontrol in production to ensure that the products meet the intended use and vaccine registration requirements. More-over, we have established a GMP self-inspection team to conduct comprehensive self-inspection at least once a year,with comprehensive reports generated, corrective and preventive measures for defects formulated and implemented,and the effectiveness of the measures continuously tracked. By means of GMP self-inspection, the Company has madecontinuous improvement and refinement in quality control and management, keeping the product quality stable.
The Company has established a quality training system, covering new employee training, basic quality training,thematic training, external thematic training, and legal and regulatory training, to enhance the quality managementawareness of staff in each position. In 2022, the Company conducted more than 3,000 training sessions for employeeson product quality and safety, covering laws and regulations, personnel control, equipment management, materialcontrol, pollution control and aseptic assurance, quality assurance, data reliability, pharmacovigilance, and job-specificskills, with a 100% pass rate for those who participated in the training.
Corrective and preventive management
Quality training for staff
Examples of training sessions in 2022Quality audit, supervision and inspection
? The Company’s LIMS covers batch management, stability management, instrument management, standardsmanagement, reagent management, and laboratory survey management. The system enables efficient manage-ment of laboratory resources and more reliable laboratory data management.? The LIMS has been launched successfully.Laboratory InformationManagement System
LIMS
? 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 has been launched successfully.
ManufacturingExecution System
MES
Regular internalsupervision andinspection
? The Quality Assurance Department conducts quality supervision and inspections according to the prescribedfrequency, and checks the key control points of production batches. Meanwhile, annual self-inspection is carried outto cover the whole process of production and quality control (material management, production, quality control,continuous improvement, circulation, etc).? The Quality Assurance Department carried out at least one supervision and inspection to the production workshopsor departments once a week, and every batch of products was supervised and inspected in production. The Companycompleted the annual quality self-inspection audit as required, and the identified problems were rectified andimproved in a timely manner.
Quality auditsby government
departments
? At present, regulatory authorities supervise and monitor the quality of our vaccines by means of supervision andinspection, which are conducted by national, provincial and municipal medical product administrations. The Companyactively rectifies the problems raised by regulatory authorities in the process of supervision and inspection andimproves the quality system continuously.? In 2022, BioKangtai received vaccine inspections and GMP follow-up inspections from the National Medical ProductAdministration and Guangdong Provincial Medical Product Administration for three times, all of which were passed.? In 2022, BioMinhai received vaccine inspection, GMP compliance inspection, on-site verification of vaccine registra-tion and pharmacovigilance test from the National Medical Product Administration and the Beijing Municipal MedicalProduct Administration for five times, all of which were passed.
Deviations are reportedto the quality assurancedepartment in a timelymanner, and necessaryemergency measuresare taken.
Set up a deviationinvestigation team,conduct a deviationcause investigation,evaluate the impactcaused by deviation, andformulate corrective andpreventive measures.
Deviation reportingDeviation investigation
Complete corrective andpreventive measuresand evaluate theireffectiveness, and closethe deviation.
Deviation closureDeviation Handling Process
Thematic Training on Quality Management ModuleIn December 2022, BioKangtai organized a thematic training session on the QM module, mainly facing the manage-ment staff at the primary level. The training session allowed staff from all departments to further consolidate theirknowledge on quality management and promoted the effective implementation and continuous improvement ofquality management.Training on Contamination Control StrategyIn June 2022, BioKangtai participated in the training on interpretation of the Technical Guide for Electronic Recordingof Vaccine Production and Inspection (draft) held by China Association for Vaccines. The organizer of this traininginvited many industry experts. Through this training, the Company had a precise understanding of relevant laws andregulations, and further promoted the standardization, scientificity and forward-looking of its information construc-tion with a positive effect.
One-to-one Training on MicrobiologyIn August 2022, BioMinhai invited experts to conduct one-to-one training on microbial identification, microbial datadeviation investigation and microbial pollution control for relevant departments. Through targeted training, theunderstanding of microbial knowledge and relevant regulations and requirements was deepened.Thematic Training on Clean and Disinfect in Clean AreasIn November 2022, BioMinhai organized training on environmental monitoring, use of disinfectant and verification tostandardize the disinfection of cleaning agents in clean areas, effectively reduce the risk of microbial contamination,and promote the effective implementation and continuous improvement of quality management.
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The Company has established a Committee on Safety of Medicines (CSM), set up a Pharmacovigilance Depart-ment, and applied the full-time pharmacovigilance staff and pharmacovigilance system (PVMS) to form a whole-pro-cess and three-dimensional drug safety risk monitoring mode, which helps ensure the smooth development of pharma-covigilance activities, timely deal with and solve the problems with risks, and guarantee the safe use of drugs forconsumers. The Company accepts the pharmacovigilance inspection of the national government regulatory depart-ment every year, all of which were passed.
Key links of pharmacoviligance
In order to regulate the management of pharmacovigilance and enhance the awareness of all staff, the Companyformulated the Training Procedures for Pharmacovigilance Management, and included the training into the AnnualTraining Plan of the Company, focusing on the special training of staff, including the pharmacovigilance training of newstaff and the annual pharmacovigilance training of all staff. For the staff of our marketing center, the Company willconduct at least one adverse reaction information collection and processing training every year. In 2022, the Companyorganized more than 54 internal and external trainings on pharmacovigilance, and all related trainings and examina-tions were incorporated into the Company’s GVP training management system.
Training to improve pharmacovigilance awareness
Establishment of special pharmacovigilance administration departments
In terms of system construction, according to the new regulations issued by the national regulatory authorities,the Company has actively improved the construction of the pharmacovigilance related document system. At present,the Company has developed 39 procedures related to pharmacovigilance, fully covering the requirements for allpharmacovigilance management procedures such as post-marketing pharmacovigilance and pharmacovigilanceduring the clinical trial; at the same time, in response to the requirements of Guangdong Provincial Drug Administra-tion, we assisted Guangdong Provincial Adverse Drug Reaction Center in drafting and completing the Pharmacovigi-lance Inspection Manual of Guangdong Province, which was unanimously praised by the regulatory authorities.
Improvement of the phamacovigilance system construction
Pharmacovigilance Management
Department
Committee on Safety
of Medicines (CSM)
Functions
The Committee on Safety of Medicines (CSM), as the decision-making body forpharmacovigilance activities, is responsible for major risk identification, disposalof major or emergency adverse events, risk control decisions, and other majormatters related to pharmacovigilance.
Pharmacovigilance
Department
The Pharmacovigilance Department, as an independent functional department,has the following main responsibilities:
? Daily operation and management of the pharmacovigilance system, includingthe establishment 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 annualreports for marketing licensees, etc;? Preparation and submission of periodic safety updates for vaccines and annualreports for marketing licensees, etc;? Pharmacovigilance management and coordination with internal audits;? Organize pharmacovigilance-related education and training, etc.
Key Links
Clinical ResearchPharmacovigilance
Measures and ActionsQuality ProceduresStrictly comply with theGuidelines for Good ClinicalPractices and related regula-tions to fully protect therights and interests ofsubjects.
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 ofVaccines beforelaunch
AEFI Monitoringand Reporting
Procedures such as theVaccine Risk ManagementPlan were established forregulating the pre-market-ing risk assessment.
Documents such as Monitor-ing and Handling Proceduresfor Suspected Post-market-ing AEFI and Procedures forHandling PharmacovigilanceData are formulated for themonitoring and handling ofAEFI and data management.
The Company has formulated the Risk ManagementPlan for SARS-CoV-2 Vaccine, the Work Plan for Emer-gency Use of SARS-CoV-2 Vaccine, the AEFI MonitoringPlan for Emergency Use of SARS-CoV-2 Vaccine andthe Work Plan for Post-Emergency Use of SARS-CoV-2Vaccine to regulate the pharmacovigilance effortsafter emergency use of SARS-CoV-2 vaccine.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.The Company has launched and completed validationof a pharmacovigilance data management system formanaging safety-related data, which is a web-basedapplication for collecting AEFI reports during theclinical trial phase and post-marketing AEFI reports.
Risk Assessmentand Control
Formulate the OperationalProcedures for Vaccine RiskAssessment and Control andOperational Procedures forVaccine Risk Communicationfor 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.
Drug safety is a major livelihood and public safety issue, related to people's health and social harmony and stabili-ty. The company attaches great importance to the product lifecycle pharmacovigilance management. According to theprovisions of the Drug Administration Law of the People's Republic of China, the Vaccine Administration Law of thePeople's Republic of China, the Measures for the Administration of Adverse Drug Reaction Reporting and Monitoring,and the Guidelines for Good Pharmacovigilance Practices, the Company has continuously improved the pharmacovigi-lance system, and monitors, identifies, evaluates and controls suspected adverse events following immunization (AEFI)through its effective operation and maintenance.
2022 CORPORATE SOCIAL RESPONSIBILITY REPORT AND ENVIRONMENTAL, SOCIAL AND GOVERNANCE REPORTBIOKANGTAI
Product recall process of the Company
The Company has formulated the Product Recall Management Regulations, detailing the recall procedure flow andthe requirements of each link. Since its establishment, the Company has not experienced any recall ordered by themedical product administrations or active recalls. The Company conducts a mock recall at least once every two yearsto evaluate and ensure the effectiveness of the product recall system.
Supply chain quality management is an important part of product quality management. The Company continuesto carry out regular quality management on suppliers to ensure the quality of products and solutions from the source.The Company has formulated the Supplier Management Regulations and the Material Management Regulations, whichclearly stipulate the requirements and standards for supplier audit, new admission, changes, auditing, quality assess-ment and file management and ensure the selection of qualified suppliers to satisfy the quality requirements of theCompany. In daily management, the Company conducts regular quality audit of suppliers, dynamically tracks theirquality situation, assists suppliers to find problems and urges them to continuously improve their quality managementsystem and promote their efforts for the improvement of quality management so as to ensure product quality. For keyraw and auxiliary material suppliers, the Company reserves 2 or 3 backup suppliers to ensure proper market supplyunder unexpected circumstances.Based on the materials to be used for production provided by suppliers, the Company classifies materials into sixgrades of quality risk control: A1, A2, B1, B2, C1 and C2, and implements different quality control strategies accordingly.
Product Recall Management
Supply Chain Management and Audit
Supplier Onboarding
? Strict management of suppliers, set general qualification requirements and qualification require-ments for certain materials, strictly audit the business qualification of suppliers and quality ofmaterials to ensure compliance with the quality and technical standards of production;? The Supplier Management Regulations specifies procedures including initial supplier selectionand data review, sample evaluation, process verification, product stability research, data compila-tion and 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, produc-tion safety management measures, and production equipment conditions;? The Company signs Quality Assurance Agreement with suppliers of A1, A2 and B1 grades toensure that the products provided by them meet the Company’s quality standards and require-ments.
Quality IncidentsReport to the Committee on Safety of
MedicinesInitiate investigation and assessment of
vaccine safety risksDecide whether to recall
Develop and implement correctiveand preventive measures
Track the effectRecallDevelop and implement corrective and
preventive measuresTrack the effect
Close the recall action
Documentation
Mandatory recall by NMPA
relevant departments
Not meet therequirements
Not meet therequirements
Meet the requirementsMeet the requirements
Mandatory recall
NoYes
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Customer ServicesThe Company has built perfect customer communication channels and complaint management procedures, andcollects customer feedback through 400 customer service hotline and other ways, thus providing timely and effectivecommunication access and solutions for customers. The Company has formulated the Customer Feedback andComplaint Management Procedures to standardize the workflow of solving customer feedback. After receiving custom-er feedback, the Company first carries out internal communication and investigation for the issues, and organizesrelevant departments to formulate corrective measures and preventive measures to ensure timely and proper resolu-tion of the issues raised by customers.
Customer satisfaction is one of the indicators to measure the performance of product and service quality. TheCompany continuously conducts annual customer satisfaction surveys and obtains feedback from customers on itsproducts and services through the Customer Feedback Collection Form, so as to fully understand customer opinionsand suggestions and constantly improve the quality of service. In 2022, the Company conducted satisfaction surveyswith disease control and prevention organizations as customers with generally high satisfaction scores.
Information Security and Customer Privacy ProtectionThe Company strictly abides by the Personal Information Protection Law of the People’s Republic of China, the DataSecurity Law of the People’s Republic of China and other relevant laws and regulations, and has formulated theIT-01-001-Information Management Regulations and the C-00-I-0-009 Personal Information Security ManagementRegulations, which provide strict data security management and personal information security. In 2022, the Companycarried out an assessment on information security multi-level protection in accordance with the Information SecurityMulti-Level Protection Management Rules, which provides support for information security.In terms of customer privacy protection, the Company implements a strict confidentiality agreement system and setsexclusive permissions for customer information. The information department will regularly check the permissions, andmake timely corrections to any discovered problems. We attach great importance to cybersecurity and privacy protec-tion, and has added security measures for the server to enhance privacy protection. In 2022, the Company did not haveany incidents of customer information or privacy leakage.The Company invites external experts to conduct relevant training to improve employees’ awareness and recognitionof information protection. In April 2022, the Company invited Guangming Internet police and technical staff of Shen-zhen NST Technology to conduct information security training for all employees, mainly including knowledge onnetwork security prevention, ransomware prevention, personal information protection, and anti-telecommunicationsfraud, to improve employees’ awareness of cybersecurity and personal information protection.Enhancing Service Ef?ciency
Quality Management Centerorganizes relevant departmentsto carry out investigation anddevelop corrective and preven-tive measures.Collect customer feedbackand receive complaints.
Sales and Marketing CenterRelated Departments
Assist in the investigation,re-ply to customers and closecomplaint
Sales and Marketing CenterCustomer feedback management procedure
Supplier Evaluation and Audit
? The Company formulates an audit program every year to carry out audits and evaluations accordingto the classification of suppliers;? Audit types and frequency: there are regular on-site audits, written audits and remote video audits;the frequency is once a year or once every two years according to the importance of the suppliers; thesuppliers of the auxiliary materials and internal packaging materials in A1 complete at least one auditper year;? Audit coverage: supplier qualifications, quality management systems and regulatory measures;? Enhancement measures for suppliers: regularly evaluate the quality management system of suppli-ers, supervise the improvement of deficiencies, and discontinue or revoke the qualification of supplierswho do not meet the requirements.
2022 CORPORATE SOCIAL RESPONSIBILITY REPORT AND ENVIRONMENTAL, SOCIAL AND GOVERNANCE REPORTBIOKANGTAI
Responsible Academic Promotion
As for the marketing, the Company strictly abides by the Advertising Law of the People’s Republic of China, theTrademark Law of the People’s Republic of China and other relevant laws and regulations, and industry norms. TheCompany actively carries out diversified academic exchanges and promotion activities about product knowledge,disease prevention, vaccine immunization schedule, and always insists on ethical, scientific and objective promotion toensure that regulatory authorities, medical professionals and customers receive product and academic information ina timely, truthful and rigorous way.
With strictly adhering to the principles of accuracy, clarity and transparency of marketing, the research results,clinical practice information and vaccination prevention of the Company is delivered to the public through variousmeans, such as academic conferences, expert lectures, online and offline knowledge promotion, enabling the public tobetter obtain information about vaccine products and better understand the knowledge of vaccine-related diseases. Inaddition, the information published on professional pharmaceutical magazines by the Company is in compliance withthe requirements of the Pharmaceutical Advertising Laws of Guangdong Provincial Food and Drug Supervision Adminis-tration, and has obtained relevant advertising approvals.
Strict Review of Promotion MaterialsIn order to standardize the compliance review of promotional materials, the Company has formulated the Regula-tions on the Production, Collection and Management of Promotional Materials and Items, which specifies the produc-tion process and approval procedures for promotional materials. The promotional materials for products were preparedby product division, and reviewed by medical department, then jointly re-checked by marketing and medical director. Itcan be only put into use after the approval by the head of marketing center. Review and check at stages are placed forensuring the accuracy, clarity and transparency of promotional materials or declarative information.
As focusing on strengthening the responsible marketing awareness of the sales staff, through online and offlineapproaches, the Company organizes trainings on responsible marketing and related compliance matters for employeesin the sales positions in accordance with the requirements of the Sales Management Regulations, in respect withrelated laws and regulations, internal regulatory, compliance and integrity, product related knowledge, etc. Withregard to product information, the sales staff shall not disseminate functions and information beyond the productdescription, and should never exaggerate the functions of products and technologies or conceal their potential risks.
Establish Vaccine Science Popularization Base
In December 2019, the first vaccine science popularization base of Chinese Preventive Medicine Association wasofficially inaugurated in BioKangtai, which was jointly built by BioKangtai and Chinese Preventive Medicine Associationas a leading, authoritative and professional vaccine science popularization base in domestic to integrate vaccinescience resources, give full play to professional advantages, carry out academic exchanges, and popularize vaccinetechnology and knowledge scientifically, deepen the public's scientific understanding of vaccines, as well as protectthe healthy development of China's vaccination.
Three principles of responsible marketing
Responsible Marketing
Trainings on Responsible Marketing
Promotional or stated informationis consistent with approved labels,with no advertising or promotionalmaterials that have not beenapproved by compliance andmarketing departments.
Accuracy
Product information used ordisseminated to the public isomplete and clear, with no falseor misleading statements.
Clarity
The products’ performance andsafety information is describedcomprehensively, withoutconcealing its potential risks,so as not to cause any formof information inequality ormisinterpretation of information.
Transparency
TheCompany's
productdivision draftspromotionalmaterials forproducts
The medicaldepartmentis responsiblefor reviewingthe contentof thematerials
The finaldraft is jointlyreviewed bythe productdivision andthe medicaldepartment
Approval bymarketingand medicaldirector
Approval bythe head ofmarketingcenter
Printing foruse
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2022 CORPORATE SOCIAL RESPONSIBILITY REPORT AND ENVIRONMENTAL, SOCIAL AND GOVERNANCE REPORTBIOKANGTAI
Improving Environmental Management SystemEnvironmental ManagementThe Company takes “strict pollution control, scientific management, energy conservation and emission reduction, and continuousimprovement of energy efficiency” as its management principles and has established an environmental management structure withwell-defined responsibilities. The Environmental Health & Safety (EHS) committee is the Company’s environmental management body, andits Office of Safety, Health and Environmental Management is responsible for the regular environmental management. We require allemployees to sign a letter of responsibility for EHS targets, and associate environmental management performance with the quarterlyperformance appraisal of middle and senior management.
Environmental Management ProceduresThe Company strictly abides by relevant laws and regulations on environmental protection, and has formulated aseries of environmental management systems and procedures, such as Environmental Protection Management Regula-tions, Solid Waste Management Regulations, Operating Procedures for Wastewater Treatment System, and Manage-ment Procedures for Water Quality Monitoring in Wastewater Treatment Stations, to standardize 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 environ-mental protection facilities, so as to ensure the effective operation of environmental management.
Environmental Impact Analysis
The main business of BioKangtai is the R&D, production and sales of vaccines for human use. Through the use ofbiological and 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, andgenerating waste water, waste gas, harmless waste and hazardous waste. The Company complies with the provisionsof the Pollutant Discharge Permit, monitors and records pollutants by manual and automatic methods, and properlydisposes of all types of solid waste to strictly control the impact of production discharges on the environment.Pursuant to the Implementation Measures of Shenzhen Compulsory Liability Insurance for Environmental Pollution,BioKangtai has proactively responded to the compulsory liability insurance system for environmental pollution manage-ment, accepted a third-party assessment and purchased compulsory liability insurance for environmental pollution toavoid environmental incidents by means of third-party risk management and environmental management.
Adhering to the concept of resource conservation and economic and environmental sustainable development, BioKangtai hasdeveloped a number of management systems and procedures in accordance with the Environmental Protection Law of the People's Repub-lic of China, the Law of the People's Republic of China on the Prevention and Control of Atmospheric Pollution, the Law of the People'sRepublic of China on the Prevention and Control of Environmental Pollution by Solid Waste, the Law of the People's Republic of China onthe Prevention and Control of Water Pollution and local laws and regulations, to continue to build and improve the environmental manage-ment system, strengthen the policy guarantee of environmental management, give priority to the comprehensive utilization of resources,energy conservation and emission reduction, and strictly implement environmental protection requirements such as emission permits andpollutant discharge standards. With the aim to save resources, reduce energy consumption, pollution and carbon, improves quality andefficiency, BioKangtai actively fulfills the social responsibility of environmental protection and adheres to green development throughupgrading equipment and facilities, energy conservation and consumption reduction, rational use of resources and effective wastemanagement measures. In 2022, BioMinhai was underwent a comprehensive green credit evaluation by Ecological Environment Bureau ofBeijing Daxing District on the environmental compliance, pollution control and emission reduction, low-carbon cycle, scientific managementand social contribution, and was honored as the "Five-star Green Enterprise in Daxing District".
Person in Charge
Director of EHS Committee? Responsible for the approval of the Company’s annual environmental targets and related policiesDeputy Director of
EHS Committee
? Responsible for the approval of environmental protection issues within the scope of responsibility? Responsible for the approval of environmental protection evaluation results
Heads of Departments
? Responsible for organizing and supervising the implementation of environmental protection efforts in all teams and departments of the Company? Responsible for the evaluation of the environmental protection efforts by teams and departments
Office of Safety, Healthand Environmental Management
? Responsible for the implementation of the departmental environmental protection efforts, and break down the department’s annual environmental protection goals to each team? Responsible for supervising the implementation of environmental management in the department, and organizing self-assessmentHeads of Teams
? Responsible for the implementation of the annual environmental protection efforts of the team? Responsible for the self-assessment of the completion of the team's annual environmental pro- tection goals
Main Responsibilities
Protecting EnvironmentAdhering to Green Development
Tackling Climate Change
Emission Source Identi?cationand Carbon Accounting
The main types of energy consumed by the Company in production are electricity, steam, natural gas and minoramounts of gasoline, diesel and liquefied petroleum gas (LPG). Electricity for production is provided by the city’s publicpower grid, mainly used for production equipment; steam are used mainly for utilities and equipment supportingproduction; natural gas is used mainly for boilers; gasoline and diesel are used for vehicles of the Company, and dieselis also used for emergency power generation and regular maintenance of generators; LPG is used for the Companycanteens. We identified the carbon emissions for Scope I and Scope II as follows:
Energy Management
The Company attaches importance to energy management. Through the establishment and improvement ofenergy management 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 2022, the Company commissioned Greem Industrial (ShenZhen) Co., Ltd. to conduct an energy audit, formulatingan energy audit report, an energy planning report, an energy saving diagnosis report and an energy efficiency bench-marking report. Through the energy audit, we have further understood our own energy efficiency and improvementpotential in production, thus laying the foundation for improving energy efficiency.
Improve Energy Ef?ciency,Reduce Cost and Increase Ef?ciencyThe Company has established a multi-dimensional system of energy saving and emission reduction measures,involving the purchase of energy-saving equipment, renovation of equipment for energy saving and equipment opera-tion with intelligent frequency to meet the requirements for sustainable development. In addition, the Company carriesout leakage inspection in daily equipment management and regularly maintains the equipment and facilities to ensuretheir integrity and avoid energy waste.
Scope of GHG Emissions
Scope I
Scope II
SourceProcessNatural gas
Diesel
GasolineLPG
Boilers and canteensThe Company’s transportation vehicles and generators
The Company’s passenger vehicles
The Company’s canteensPurchased electricitySteamPublic works and equipmentIn 2022, to further understand the main sources of carbon emissions and emission data, BioKangtai and BioMinhaicommissioned Shenzhen Carbonet Technology Development Co., Ltd. and China Quality Certification Centre, respective-ly, to conduct a carbon accounting, which determined their organizational boundaries and carbon emissions.
Energy management system
EnergyManagement Team
The Company has an energy management team, headed by the production manager, with membersfrom different departments. There is an energy consumption statistician in the team responsible forthe Company’s energy consumption statistics, which are archived in the energy utilization and man-agement platform. Meanwhile, the Company has carried out energy audit and clean production tocontinuously improve its energy management level.
Energy Statistics
Energy statistics is an important aspect of the Company’s energy management. To this end, we haveset up statistical units at three levels: company, area and workshop. Energy statisticians have beenset up at each level for energy statistics and reporting to the energy management team. By estab-lishing a statistical account of energy consumption, we have realized IT-based management ofenergy consumption at all levels, which is conducive to statistical analysis of energy consumption.
Energy-savingPerformance Assessment
The Company has established an accountability system for energy-saving targets and an energysaving evaluation system, taking the annual energy-saving target and the monthly energy consump-tion data as the energy consumption pointer. Meanwhile, the Company has collected the energy-sav-ing management measures of each workshop, set up projects, make modifications and evaluate theireffectiveness; each energy-using department is assessed, and the assessment results are directlyrelated to the monthly performance and annual assessment performance of the responsible person.
Energy Saving
Training
The Company actively carries out publicity and training on energy saving, and holds quarterly energyconsumption analysis meetings to discuss problems in the Company’s energy consumption and man-agement, as well as the orientation for energy saving and clean production.
EnergySupervision System
The Company strengthens energy control based on its energy management system and conductsregular supervision, inspection and assessment.
Production department,auxiliary production
department and other departments
2022 CORPORATE SOCIAL RESPONSIBILITY REPORT AND ENVIRONMENTAL, SOCIAL AND GOVERNANCE REPORTBIOKANGTAI
Reducing the EnvironmentalImpact of Operations
The Company strictly complies with the relevant laws and regulations, such as the Measures on the Administrationof Pollutant Discharge Permits, and applies for Pollutant Discharge Permit. We conduct regular pollution dischargeinspection and fill in quarterly and annual implementation reports on the National Management Platform for PollutantDischarge Permits in accordance with relevant regulations. In 2022, the Company did not receive any relevant adminis-trative penalties for excessive pollutant discharge.
Waste Management
The waste produced by the Company includes general waste and hazardous waste. We strictly abide by the Law of the People’sRepublic of China on the Prevention and Control of Environmental Pollution by Solid Waste, Management Measures for Hazardous WasteTransfer and other relevant laws and regulations. We manage and store hazardous waste such as medical waste, waste organic solvents,waste alcohol, waste hazardous chemicals, and waste reagents in accordance with the regulations, and hand them over to qualified organi-zations for disposal through the Company’s EHS department. For domestic waste, general industrial solid waste and other non-hazardouswaste, we comply with the Measures of Shenzhen Municipality on the Classification and Reduction of Domestic Garbage and the BeijingMunicipal Regulations on Management of Domestic Waste and 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 regulations related to wastedisposal.Use of Water ResourcesThe Company consumes water from the municipal water supply, which is not a major resource in production, leading to a low risk ofwater shortage. We have developed a water conservation management system and have taken active action to drive the achievement ofrelated targets. By improving the utilization of circulating and recycling water from boiler steam condensate process and cooling tower, theCompany achieved water conservation effectively.
Wastewater ManagementAs a vaccine manufacturer, wastewater treatment and discharge in compliance is the focus of our environmental protection efforts.The main pollution indicators for wastewater produced by the Company include pH, chemical oxygen demand (COD), suspended solids,ammonia nitrogen (NH3-N), total nitrogen, volatile phenols, and total phosphorus.The Company strictly complies with the provisions of relevant laws, regulations and normative documents, such as Law of the People'sRepublic of China on Prevention and Control of Pollution from Water Pollution, Discharge Standards for Bioengineering PharmaceuticalWastewater and Integrated Wastewater Discharge Standard, and has formulated management documents such as Operating Proceduresfor Wastewater Treatment System, Management Procedures for Water Quality Monitoring in Wastewater Treatment Stations and OperatingProcedures for Wastewater Discharge, which provide guidance on the Company’s wastewater treatment, monitoring and operation.The Company has wastewater treatment stations, which are operated in strict accordance with the requirements of relevant environ-mental protection regulations of the country. Industrial wastewater is discharged into the public sewerage network after treatment at thewastewater treatment stations. We have established an online monitoring system to monitor COD, ammonia nitrogen, pH, total phosphorusand other pollution indicators in wastewater on a daily basis, and commissioned a third party to conduct regular sampling and testing ofwastewater to ensure compliance with wastewater discharge standards. In 2022, a 600-ton treatment capacity upgrade project of theCompany's wastewater station in Guangming base passed completion and acceptance of environmental protection. In 2022, BioMinhaicompleted the environmental protection upgrade of ammonium sulfate wastewater transformation, PH adjustment transformation ofwastewater station, Parshall flume transformation and other projects to further ensure compliance with wastewater discharge standards.During the reporting period, the Company did not have any incidents of excessive or illegal discharge of wastewater.Air Emission Management
The main pollutants in the air emission produced by the Company are volatile organic compounds. We strictly abide by the provisionsof relevant laws, regulations and normative documents such as Law of the People’s Republic of China on Prevention and Control of AirPollution, Discharge Standards for Odorous Pollutants, Discharge Standards for Air Pollutants for the Pharmaceutical Industry, and EmissionControl Standard for Industrial Enterprises Volatile Organic Compounds, and have formulated the Environmental Protection ManagementRegulations to clarify the management requirements for air emission.
All our air emission vents are designed and installed in accordance with national standards; production waste gas and odorous airfrom animal rooms are treated by high-efficiency filters and activated carbon adsorption before discharge; fumes from canteens aretreated by fume purifiers before discharge. Meanwhile, we have commissioned a third party to conduct regular air emission testing toensure that the emission concentrations of pollutants in waste gas comply with national standards. During the reporting period, the Compa-ny did not have any incidents of excessive or illegal emission of waste gas.
Purchase ofEnergy-saving
Equipment
The Company considers the brand, efficiency and capacity of the equipment in itsprocurement. Equipment with energy-saving inverter and intelligent centralizedcontrol system, such as air conditioners, pumps and refrigeration equipment, areselected for higher energy efficiency.
EquipmentRenovation forEnergy-saving
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? Replace all lights to LED lights, renovate smart sensor lights and increase solar lights onthe roof? Design RO system for wastewater recycling for cooling towers? Replace the cooling towers, chillers and humidifiers? Renovate the power station for heat recycling? Replace insulation material for 2A water injection station pipeline? Replace low temperature coolers for 2B power station? Install intelligent centralized control energy saving system for the chilled-water system
For integrated energy management, the Company adjusts the operation of somepublic engineering equipment to intelligent frequency, reasonably distributes theload, and reduces energy waste on the premise of meeting the needs for production,R&D, storage and inspection.Equipment Runn-ing with Intelligent
Frequency
Measures for energy efficiency improvement
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Our Talent Philosophy? Talent is the core force of company development and the cornerstone for sustainable development. We believe thatwe should let capable staff take up important positions, mediocre employees be laid off and those with average abilityengage in general work.? The employees with good moral character, healthy body and mind, excellent performance and innovative spirit arethe most valuable assets of the Company.
Protection of Employees’ Basic InterestsThe Company adheres to the principle of equal employment and provides equal opportunities for employees. Bystrictly complying with the requirements of the Labor Law of the People’s Republic of China, the Labor Contract Law ofthe People’s Republic of China and 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, place oforigin, religious beliefs and other factors, and that child labor or forced labor is strictly prohibited. Meanwhile, theCompany has formulated the Labor Contract Management Measures, Compensation and Welfare Management Rules,Attendance and Leave Management Measures, Performance Management Rules, Work-related Injury ManagementRules, and other regulations to protect the legitimate rights and benefits of employees.
The Company always adheres to the core values of "dedication to people’s health", has developed a series ofhuman resource management systems such as employee employment, training, promotion, welfare, rights andinterests protection, and is committed to creating a safe, warm and harmonious office environment, building harmoni-ous and stable labor relations, effectively safeguarding the legitimate rights and interests of employees, and realizingthe common growth of employees and the enterprise.
Protecting Employee Rights and Interests
RecruitmentManagement
CompensationManagement
Working Hoursand LeaveTreatment ofWork-relatedInjuries
Recruitment: We insist on fair employment and prohibit the employment of child labor or forcedlabor.Dismissal: We terminate labor contracts of different types in accordance with our LaborContract Management Measures to protect the legitimate rights and interests of employees.
Compensation: We provide competitive compensation and benefits based on the principle ofequity. Our compensation system is based on the value of positions, and we reward employeesfairly according to their performance, taking into account the continuous and indirect contribu-tions of each position. We adhere to the performance-oriented principle and encourage valuecreation.Commercial insurance: We provide supplementary medical insurance services for employees,and our retired employees and interns are covered by accident insurance policies.Overtime: Overtime pay is paid according to the Labor Law of People’s Republic of China.Leave: Legal holidays and paid leave such as wedding leave, maternity leave, sick leave, andpaternity leave are implemented according to national laws and regulations; employees areentitled to annual leave as stipulated by the Company.Employees are entitled to leave for work-related injuries. The Company has formulated theManagement Measures for Work-Related Injuries in accordance with the Regulations onWork-Related Injury Insurance of Guangdong, which stipulates details of work-related injuryidentification, declaration, and treatment, as well as matters such as labor relations anddispute handling.
Overview of BioKangtai’s employee recruitment and basic rights policies
Caring for Employees
and Helping Them Develop
2022 CORPORATE SOCIAL RESPONSIBILITY REPORT AND ENVIRONMENTAL, SOCIAL AND GOVERNANCE REPORTBIOKANGTAI
Employee Welfare System
The Company has established a perfect welfare management system and providingdiversified benefits for different kinds of employees. We have formulated Welfare Mea-sures for Workers and Implementation Measures for Special Funds for Trade UnionEmployees to ensure the transparency and effective implementation of our welfare poli-cies.
Employee Communication MechanismThe Company attaches importance to the communication among employees, cares about the physical and mentalhealth of employees and advocates a work-life balance lifestyle. Employees can feedback problems or give suggestionsto the department head or other responsible persons through face to face or communication; as a platform for commu-nication with employees, the Company’s labor union takes the initiative to listen to employees’ voices and respond totheir demands. Meanwhile, the Company carries out various activities as humanistic care to create conditions foremployees to maintain a work-life balance and a friendly and energetic working atmosphere, enhancing the sense ofbelonging and cohesion of employees in the Company.
Welfarematters
Seniorityallowance
Maternity leave,
maternity
Holiday bonus
Benefits forfemale employees
Employee sympathygift and welfare forneedy employees
Annual healthcheckups
Academicallowance
HousingallowanceAllowance foroccupational safetyand positions ofspecialresponsibility
Meal allowance,high temperature/heating allowance
Caring for Employee's Growth
Employee Development and Training
In order to continuously improve the know-how knowledge, professional level and comprehensive quality ofemployees and cultivate an excellent staff team, the Company has formulated the Training and Development Systemand established a sound staff training system. Through post knowledge and skills training, corporate culture trainingand core staff career improvement training, the comprehensive quality and professional ability of employees are contin-uously improved, and employees' recognition of corporate culture is strengthened, so as to realize the common growthand mutual achievement of employees and the Company.
Training for New EmployeeAfter new employees join the company,they must receive induction training; theycan start working only after they arequalified.
Management TrainingDevelop Eagle Training Camps and advancedworkshop training programs to nurture thecompany's management staff and supportthem to realize their potential at all levels.
Professional and Technical TrainingFor the staff responsible for equipment,technology, R&D, and testing, we providesystematic training on relevant profes-sional knowledge and the ability to solveregular problems.External and Outsourced TrainingParticipate in external training, academicexchanges and visits, or outsource seniorexperts and professional trainers to thecompany to provide professional trainingto employees.
Employee
Training
System
Employee welfare
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Performance and Promotion
In order to stimulate the work enthusiasm of employees and meet its strategic development needs for talentsecurity and employees' own career development needs, the Company has formulated the Promotion ManagementRules, Performance Management Measures, Monthly Employee Bonus Plan and Annual Performance Evaluation & MeritPay System to standardize the career development of employees and ensure the rationality, objectivity and justice ofemployee promotion.
In terms of standardizing promotion management, the Company has gradually established a sound promotionsystem and career development channel for employees, carried out promotion evaluation in the form of professionalknowledge written test, 360-degree talent evaluation, promotion defense and continued to carry out professionaltechnical review and management personnel evaluation system, so that the multi-channel development mode is furtherclosely related to employee development. Competition for the job, trial, evaluation and recruitment is operated at levels;leveraging established BioKangtai 678 leadership model, clear standards are put forward for different managements.According to business and personnel characteristics of each technical department, promotion standard is establishedat technical sequence. At the same time, we will constantly standardize the promotion process, and carry out trackingand support for promotion.
In terms of performance management, we can provide basis for human resource decisions such as salary adjust-ment or grading, job change, talent cultivation and employee motivation through scientific and reasonable evaluationof employees' performance; the Company regularly conducts performance evaluations for middle and senior staff aswell as junior staff, where the performance evaluation for junior staff is carried out monthly with a performance-basedbonus system. In addition, the Company has set up awards and rewards system to recognize advanced employees andmotivate all employees to strive for excellence.
The Company attaches great importance to school-enterprise collaboration, and sets up management trainingclasses, professional training classes, vaccine featured classes, etc. through collaboration with well-known universities,to provide educational opportunities for outstanding management and technical talents and encourage employees toimprove themselves. We fully support front-line employees to acquire academic certificates and professional andtechnical qualifications by taking examinations and further education, so as to connect employee learning and talentdevelopment closely to enable them grow.To improve the professional and management abilities of employees in a targeted manner, in 2022, we sent 13 Keyemployees to pursue part-time master’s degrees in colleges and universities, such as programs in MBA and Biochemis-try and Molecular Biology Technology at Jinan University, which provide opportunities for further education for staffwith bachelor’s degree. The Company provides programs for different staffing levels via an online learning platform toempower management and promotion personnel at all levels. The Company jointly plans and organizes check andtraining planning projects with external consulting agencies, and carries out more than 30 mentoring training anddiscussion activities to provide solutions for training and cultivation of key talents. At the same time, some key techni-cians were invited by relevant colleges and universities to teach students majoring in biotechnology and participate inthe cultivation of future talents in the industry.
In order to improve employees' enthusiasm, promote and set up exemplary models, the Company annually awardsand honors individuals and teams who have made outstanding contributions to its business development, efficiencyimprovement and compliance operation efficiency, to encourage employees to keep forging ahead.
Winners will behonored at theCompany’s annualmeeting and willreceive bonusesAwards
Outstanding Employees Special Contribution to Fight Against the Pandemic Special Contribution for the 30th Anniversary of BioKangtaiExcellent Management StaffAdvanced Collective
Presentation
of Awards
School-enterprise collaboration
Grant multiple awards
2022 CORPORATE SOCIAL RESPONSIBILITY REPORT AND ENVIRONMENTAL, SOCIAL AND GOVERNANCE REPORTBIOKANGTAI
Safeguarding Employees
Biosafety ManagementAs a vaccine manufacturer, ensuring biosafety during research and development and production is particularlyimportant. The Company strictly complies with the laws and regulations such as the Biosafety Law of the People’sRepublic of China, and has established a sound biosafety management system covering all procedures of vaccineproduction in accordance with the General Requirements for Biosafety in Vaccine Production Workshops based onsystematic and comprehensive identification and in-depth analysis of biosafety risks. In 2021, the Company establisheda biosafety management system applicable to workshops with high biosafety risks, and in 2022, the Company's biosafe-ty management system covered the BSL-2 laboratory. The normal operation of biosafety management system effective-ly prevents biosafety risks in vaccine production. Meanwhile, the Company has improved emergency plans, conductedemergency drills, created a strong culture of biosafety, and enhanced employees’ awareness of biosafety risk to ensurethe achievement of biosafety targets for vaccine production and fully guarantee the supply of vaccines.The Company has established two production workshops at its Xili base for the production of inactivatedSARS-CoV-2 vaccines. As the first production workshops with high biosafety risk in South China, the two productionworkshops passed the joint biosafety inspection organized by the National Health Commission in 2021. At the Guang-ming base, the Company has expanded and reconstructed the existing BSL-2 laboratories for better facilitating the R&Dand experimental activities for vaccine production.
Inactivated SARS-CoV-2 Vaccine Production Workshops
SecurityLevel
BSL-2 Laboratories
The production workshops are constructed andmanaged in accordance with the GeneralRequirements for Biosafety in Vaccine ProductionWorkshops, conforming with BSL-3 requirements.
The laboratories meet the require-ments for BSL-2 laboratories. Accord-ing to the latest policy suggestionsand requirements of the government,three laboratories will be consolidat-ed and filed as the QC laboratory inthe Quality Inspection Research andDevelopment Building for unifiedmanagement.
SystemConstruction
Audit andInspection
Based on the biosafety risk assessment, theCompany has established systematic documentson biosafety management in accordance with210 inspection items in the General Require-ments for Biosafety in Vaccine Production Work-shops, which cover the whole productionprocess in workshops with high biosafety riskand provide comprehensive control over thepersonnel, facilities and processes involved. Thesystem documents include biosafety risk report,emergency plan, management manual, second-ary procedure documents, tertiary operationprocedures and quaternary record forms.Considering the operation practice of high-riskworkshops, the management system optimiza-tion is continuously promoted, so that workshopbiosafety management system is becomingmore developed.
Based on the requirements of Labora-tory Biosafety Manual (GB19489), thebiosafety system documents for BSL-2laboratories have been prepared,including biosafety risk report, emer-gency plan, management manual,secondary procedure documents anda safety manual for personnel on site,to ensure the covering of all factorsabout biosafety management of thelaboratory.
In 2022, the two production workshops received11 biosafety inspections organized by govern-ment departments, all of which were passed. TheCompany also performs key biosafety inspec-tions. 1 management review, 1 internal Audits, 2annual biosafety inspection and 33 daily inspec-tions were completed in 2022.
In 2022, the BSL-2 laboratories receivedand passed 2 biosafety inspectionorganized by government departments,and revised and improved laboratory’sbiosafety system documents based onthe opinions and suggestions from theinspection team experts.In terms of internal audit, 1 annualbiosafety inspection organized by theBiosafety Office was completed.
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The Company actively participates in and organizes various biosafety forums in respect of the latest trends in theindustry, shares the management experience on high-biosafety risk workshop to makes progress together, broaden thevision and keep improving with good social benefits.
In addition, in 2022, the Company conducted 13 biosafety emergency drills with simulated scenarios includinginfectious material spill, broken isolator gloves, experimentalists’ hands stabbed by sharp objects, anti-terrorism drills,information security, fire extinguishing and escape. All employees in the guarded area participated in the drills.
In 2022, the Company conducted biosafety training on multiple topics, focusing on the learning of biosafety-relat-ed laws and regulations and the wearing of personal protective equipment to continuously improve the safety aware-ness and performance of employees.
Submit a monitoring plan
Report daily activities to the biosafety office for monitoring and supervision byfull-time and part-time biosafety staff; conduct weekly self-inspections in guardedareas; conduct monthly verifications; conduct annual reviews.
Daily Monitoringand Management
Laboratory facility safety
Ensure that the buildings and facilities meet national standards.Management system (covering all steps for production operations and control ofarticles)Strict control of personnel access; standardization of operations at each worksta-tion; strict control of article sterilization; waste disposal and regular monitoring ofthe environment; regular inspection of workshop personnel's nucleic acid testresults; implementation of annual psychological evaluation and physical examina-tion; precise pandemic prevention according to the policy dynamics.
Key Area RiskManagement
Graded training
Training is divided into company-level, department-level and job-level, and thetraining content of each job is clearly defined according to the job training matrix.Training assessmentThe frequency of training for positions in guarded areas is once every six months,and the frequency of training for positions in non-guarded areas is once a year,with a full score of 100 points, requiring a 100% training pass rate.Emergency drillsThe Company has formulated the Inactivated COVID-19 Vaccine Production Work-shop Biosafety Emergency Plan which is mainly for the employees in the guardedarea.
Enhancement ofSafety Awareness
Corporate biosafetytraining sessions
Department-level jobtraining sessions
External suppliertraining sessions
Attendancesaccumulative4000
Production Safety and Management
Adhering to the policy of "safety first, prevention first and comprehensive treatment", the Company attaches greatimportance to employees’ occupational health and safety production, and strictly abides by relevant laws and regula-tions such as the Law of the People’s Republic of China on Safety Production, the Law of the People’s Republic of Chinaon Fire Fighting, the Law of the People’s Republic of China on Safety of Special Equipment, and the Regulations onSafety Management of Dangerous Chemicals. The Company has established a series of production safety rules andregulations, fully implemented an accountability system, and also increased the investment in production safety, mate-rials, 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, devel-oping an accident emergency response system, strictly controlling hazardous chemicals, and strengthening manage-ment of firefighting and other special equipment. The Company has had no production safety accidents of average orabove in the past three years. In 2022, BioMinhai was honored as the winner of Ankang Cup in Daxing District, Beijing.
I’m responsible for the safety of myself, others, and the Company; all those responsible for safety problems mustbe held accountable.
Biosafety management systemBiosafety Training
BioKangtai’s safety philosophy
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Occupational Healthand Safety Management
The Company attaches importance to the occupational health of employees and strictly abides by the Law of thePeople’s Republic of China on the Prevention and Treatment of Occupational Diseases , the Regulations on the Manage-ment of Occupational Health in the Workplace and other laws and standards, and has formulated the OccupationalHealth Management Regulations and the Labor Protection Equipment Management Regulations, to prevent, control andeliminate occupational hazards and protect the employees.The occupational disease hazards involved in the Company’s production include high temperature, noise, ultravio-let radiation, 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 theend of the reporting period, the Company had no accidents related to occupational disease hazards.
Standardized Safety Production
Safety Production Culture ConstructionAccident Response? Develop Safety Risk Assessmentand Management Rules and HiddenDanger Identification and Manage-ment Rules;? Identify and evaluate all kinds ofworkplace hazards by carrying outsafety inspections.
? All new employees must attendthe three-level safety education andtraining and pass the examinationbefore starting work;? Conduct regular production safetytraining to enhance employees’awareness of safe operation andemergency response;? Actively carry out online andoffline safety knowledge competi-tion, fire skills competition, EHSimprovement activities and othersafety cultural activities.
? The Company has formulated theProduction Safety Accident Emer-gency Response and Rescue Plan,including comprehensive plan,special plan and on-site plan).
Hazardous Chemicals Management
? The Company has formulated the Dangerous Chemicals Management Procedures, Regulations on the Managementof Dangerous and Highly Toxic Chemicals, Regulations on the Management of Explosive and Hazardous Chemicals andother regulations to control the purchasing, transportation, storage, use and disposal of dangerous chemicals;? In 2022, the Company carried out special activities to improve the standardization of dangerous chemicals, continu-ously improving the storage and use safety of dangerous chemicals, and improving the operation safety and emergencydisposal ability of employees through adding storage facilities, increasing monitoring and early warning equipment,improving emergency disposal capacity and strengthening hidden danger detection.
? The Company formulated the Fire Safety Management Regulations, Regulations on the Management of Fire FightingEquipment and Facilities, Special Emergency Plan for Fire Accidents and other regulations, and regularly conductsinspections, maintenance and testing of firefighting systems；?In 2022, the Company conducted 27 fire emergency drills among nearly 2,000 employees, the main items of whichincluded fire escape drills and use of fire extinguishing equipment and fire hydrants.Special Equipment Fire Management? The Company has formulated the Special Equipment Safety Manual and Elevator Safety Manual, requiring theregistration of newly installed special equipment and regular supervision and inspection of existing special equipmentand safety accessories.
Fire Management
Safety management in production
Key elements in production safety management
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? Revise the Occupational Health Management System, and prepare the occupational health operating procedures forkey posts;? Strictly abide by the “Three Simultaneities” procedures: occupational disease prevention facilities are designed,constructed and put into production and use with the main project simultaneously；? Develop the emergency rescue plan against occupational disease hazards and conduct emergency drill for occupa-tional hazards.
Occupational Health Regulations
? Complete occupational health files and workers' health monitoring files;? Organize regular physical examinations for employees and equip them with protective equipment against occupationaldiseases；
Occupational Health Supervision
? Set up safety marks or warning marks in conspicuous places where operational risks arise or exist, workplaces whereoccupational disease hazards occur, jobs, equipment, materials (products) packaging and storage places;? Supervise the wearing of protective equipment in workplace and proper use of occupational hazard protectionfacilities;? Regular maintenance and checks on occupational hazard protection facilities.
On-site Management of Occupational Health
? Provide regular occupational health training for employees before and during their employment;? Carry out the training and assessment mode, and employees who have passed the assessment may be engaged in thecorresponding operations.Occupational Health Education and Training
? Engage qualified organizations to carry out workplace occupational hazards inspection with all inspection results meetingstandards;? Implement the reporting of occupational hazards, and obtain the Receipt of Occupational Hazards Reporting.The Company cares about the mental health of employees and provides them with regular mental health lectures,team building and exchange activities, etc. ln 2022, the Company invited experts from Shenzhen Health Commission togive special lecture on health, with 263 employees attending the lecture.
Detection and Reporting of Occupational Hazards
Occupational health management
? Carry out the PPE Standardized Equipment Improvement Activities to comprehensively investigate occupational hazardfactors of operation and assess occupational hazard risks, and formulate PPE Scope of Application and Replacement Require-ments according to the Personal Protective Equipment Specification (GB 39800-2020) in 2022, make the revision andimplementation of labor protective equipment standards and matrix.
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With the aim of“produce the best vaccines for mankind”, the Compa-ny is dedicated to R&D and manufacture of high-quality vaccines, andcommitted to human immunization health. While promoting the steadydevelopment of its main business, the Company actively participates insocial welfare activities to create shared values for the industry andsociety. In 2022, the Company invested a total of 14.65 million yuan insocial welfare, and was honored with "Top Ten Caring Enterprises" of the19th Shenzhen Care Action.
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 author-ities and the Ministry of Finance of the State Council; other EPI vaccines and non-EPI vaccines are procured throughprovincial public resource trading platforms under the guidance of provincial and municipal governments and autono-mous regions directly under the Central Government.
Improving Products AccessibilityVaccination is the most economical and effective measure for us to control and prevent infectious diseases. Withthe aim of “providing best vaccines for mankind”, the Company actively promotes the R&D and industrialization ofproducts in the prevention of hepatitis B, pneumonia, tDAP, novel coronavirus infection and other diseases. At present,the Company has 10 listed and approved products for emergency use, of which, hepatitis B vaccines has been producedand sold more than 1 billion doses in total, helping more than 400 million people protect themselves from hepatitis Bvirus. At the same time, the Company expands R&D and innovation on the basis of existing products, and activelylayouts the R&D of novel vaccines and multi-conjugate multi-valent vaccines with market demand-oriented to providemore quality vaccine products for the society.
Vaccine and Materials Donations
Devotion to Public Welfare
Since 2020, the Company has been devoted to fighting the epidemic and actively engaged in public welfare. It hastotally donated more than RMB100 million to society, including poverty-stricken areas, Red Cross societies at all levels andscientific research institutions, making contributions to building public immunity barriers, supporting medical developmentand helping rural revitalization.
The Company strictly abides by the requirements of the Vaccine Administration Law of the People’s Republic ofChina and sets reasonable vaccine prices with reference to the production costs and market research results. We arecommitted to providing the community with safe, effective and high-quality products at affordable prices.
Based on raw and auxiliary materials, labor, logistics, R&D, medical, overhead, insurance andother related costs, we set reasonable prices after scientific calculations.CorporateLevelBased on the research results of the current market situation (annual batch volume of similarproducts, end-market batch volume, market strategies, etc.) and the prices of other vaccines inthe market, reasonable prices are set based on the principles of increasing market share andbrand acceptance, product competitiveness, etc.
MarketLevel
Time
2022
Vaccine and Materials Donations
Donated 23-valent Pneumococcal Polysaccharide Vaccine to provinces includingJiangxi, Jilin, Xinjiang, Yunnan, Gansu and Jiangsu, which were used to vaccinaterelevant persons and protect the health of more people.
March, 2022
Donated 7,000 sets of protective suits and 7,000 pairs of medical isolation shoecovers to Nanshan District Health Bureau in Shenzhen for front-line pandemicprevention.
June, 2022
Donated 100,000 yuan to Anhui Province Red Cross Foundation for its develop-ment in Anhui Province.
July, 2022
Donated 13-valent Pneumococcal Polysaccharide Conjugate Vaccine to Anhui RedCross Foundation for development of medical and health services in AnhuiProvince.
Active efforts for R&D and industrialization of products
In 2022, the Company's major vaccine and materials donations are as follows:
Pricing policy
Giving Back to the Society andStaying True to the Original Mission
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While pursuing corporate growth, BioKangtai gives full support to medical research and the cultivation of talentsin public health, and works together with foundations, universities and research institutes to create a win-win situationand shared value for the industry and society.
BioKangtai not only supports the development of medical care by leveraging its own advantages, but alsoresponds to the national call for rural revitalization by supporting poverty alleviation and rural revitalization effortsthrough charitable donations and other means.The Company has been supporting the public welfare of Xingan County, Jiangxi Province for a long time and caringabout local disadvantaged groups. Since 2018, a total of 15 million yuan has been donated to the Civil Affairs Bureauof the county to help the elderly living in retirement homes (including the disabled), orphans and de facto unsupportedchildren.In 2022, the Company actively supported the Guangdong Poverty Relief Day activity by making donation to Shen-zhen Guangming District Charity Association for key poverty relief projects in Guangdong province; the Company madedonations to revitalization project of Bo 'e Village in Badu Yao Ethnic Township, Tianlin County, Baise City, Guangxi forsupporting the matching assistance of Guangming District in Shenzhen City.
In 2022, several employees of the Company participated in epidemic prevention volunteer activities by helpingcommunity workers for registration, assisting medical workers to carry out nucleic acid testing, and assisting in theprevention and control of COVID-19 epidemic.
In December 2021, we donated 20 million yuan to China Foundation for Hepatitis Prevention and Control (in fouryears) for related academic activities, hepatitis B research projects, and hepatitis B prevention and control.
Support the Development of Healthcare
Support Rural Revitalization
Participate in Voluntary Public Welfare
Support Medical Research
Industry-Academia-Research Institute Collaboration
In July 2021, for deepening the cooperation between industry, academia and research institutes, the Company donated30 million yuan (over three years) to the Education Development Foundation of Jinan University in Guangdong for theestablishment of JNUBioKangtai Biomedical Development Fund to promote the high-quality development of thedisciplines of public health and the cultivation of public health talents；In September 2021, in order to support the development of education and scientific research of College of Pharmacy inShenzhen Technology University, the Company donated 1 million yuan (in five years) for the establishment of "BioKang-tai" Outstanding Freshman Scholarship.In November 2021, the Company donated 500,000 yuan (in five years) to Huizhou University for the establishmentof BioKangtai scholarship and fellowship.
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2022 CORPORATE SOCIAL RESPONSIBILITY REPORT AND ENVIRONMENTAL, SOCIAL AND GOVERNANCE REPORTBIOKANGTAI
8.1 Economic Performance
8.2 Environmental Performance
ESG Key Performance
Operating revenue
Total assetsOwners’ interests
Total tax
Net assets per share
RMB10,000RMB10,000RMB10,000RMB10,000
SharesRMB
IndicatorsUnit
365,2091,414,898
916,674
90,602687,093,526
13.34
2021315,7401,378,635898,53451,7631,120,493,735
8.02
2022
IndicatorsUnit
Energy UseTotal electricity consumption
Total natural gas consumptionTotal heat consumption
Diesel consumptionGasoline consumption
LPG consumption
MWhm?GJTonsTonsTons
226,118958,451746,34422,441684,927,132
10.90
2020
2020
48,8591,250,828
158,416
2021
78,1143,573,871
181,352
2022
74,0922,747,788230,389
Total number of sharesissued by the Company
Future Outlook
Looking forward to the future, with the aim of“providing bettervaccines for mankind”and adhering to the core values of"peo-ple-oriented, for people's health", the Company will continuously
focus on the field of biopharmaceutical and firmly grasp the develop-ment opportunities of the industry to activate its internal develop-ment power with scientific research and innovation, and drive newgrowth with heavyweight products and marketing, so as to steadilypromote its business operation; based on a global strategy of "bringin" and "go abroad", the Company will promote its vaccine productsto go abroad and to the world, and be committed to becoming aworld-class supplier of biological vaccines, making greater contribu-tion to protecting people's life and health.
While promoting the steady development of its own business,the Company will continue to strengthen its social responsibility,adhere to the social welfare activities, and wholeheartedly contributeto the society; leveraging integration the ESG theory with its develop-ment strategy and operation, the Company will conscientiously fulfillthe main responsibility of ecological and environmental protection,and firmly pursue the green development; the Company will alsostrengthen communication and exchanges with all stakeholders toenable them to pursue win-win cooperation for creating social valueand promoting high-quality sustainable development.
IndicatorsUnit
Total GHG EmissionsTotal GHG emissions in Scope I
Total GHG emissions in Scope IIGHG emissions per unit of revenue
Total air emissions
Total VOCsExhaust emissions per unit of revenueTotal industrial wastewater discharge
Ammonia nitrogen discharge
CODTotal nitrogenTotal phosphorus
Total hazardous waste
m?Tonsm?/RMB10,000
m?TonsTonsTonsTonsm?/RMB10,000Tons
Total waterWater consumption frompublic water supply
tCO2etCO2etCO2etCO2e/RMB10,000
m?m?m?
2020
98,882,171
0.22
393,813
1.45
29.20
0.13
0.01
1.74
50,3983,16347,235
0.22
581,494518,38063,114
2021
253,578,606
0.43
564,561
2.96
33.13
0.77
0.07
1.55
73,6598,32665,333
0.20
1,024,860952,44772,413
2022
266,618,494
0.1939
553,540
3.40
41.85
0.31
0.02
1.75
91,0156,76684,249
0.29
1,000,216
908,194122,471
7172
GHG Emissions
Water Use
Discharge Management
RMB10,000
TimesTimes
Hazardous waste generatedper unit of revenue
kg/RMB10,000
Tonskg/RMB10,000
0.37
0.78
1,700
0.67
0.54
1.10
0.65
Use of Resources for Production
Notes:
[1]. The statistical caliber of environmental performance covers Shenzhen Kangtai Biological Products Co., Ltd. and itswholly-owned subsidiary, which is consistent with the scope of the annual report and consolidated financial statements.The increase of air emissions, hazardous and non-hazardous waste discharge comes from the expansion of the compa-ny's production scale. In 2020, the Company’s Xili base was officially put into operation, so the environmental perfor-mance in 2020 includes the Xili base’s data after it was put into operation. The environmental performance data in 2021and 2022 includes that of the Xili base’s 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 ofcarbon emissions from natural gas, gasoline, diesel and LPG refers to the Guideline for Accounting and Reporting ofGreenhouse Gas Emissions from Enterprises: Power Generation Facilities (revised edition of 2022) by Ministry of Ecologyand 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 carbonemissions from electricity and heat refers to the Guideline for Accounting and Reporting of Greenhouse Gas Emissionsfrom Enterprises Power Generation Facilities (revised version of 2022) by the Ministry of Ecology and Environment of thePeople’s Republic of China and the Guideline for Accounting and Reporting of Greenhouse Gas Emissions from Enterpris-es in Other Industries (for Trial Implementation) by the National Development and Reform Commission of the People’sRepublic of China. In particular, the carbon emissions of purchased electricity are calculated based on the grid emissionfactor, which is obtained from the Ministry of Ecology and Environment and is taken as 0.6101 kg CO2 e/kWh in 2020and 0.5810 kg CO2 e/kWh in 2022.
Water from barrels andsteam conversionsBysource
Industrial wastewater dischargeper unit of revenue
IndicatorsUnit202020212022
Total general non-hazardous wastegeneral non-hazardous wastegenerated per unit of revenue
Annual environmental expenditureNumber of environmental aware-ness training sessionsNumber of Incidents punished forenvironmental law violations
2022 CORPORATE SOCIAL RESPONSIBILITY REPORT AND ENVIRONMENTAL, SOCIAL AND GOVERNANCE REPORTBIOKANGTAI
8.3 Social Performance
PeoplePeoplePeoplePeoplePeoplePeoplePeoplePeoplePeoplePeoplePeoplePeoplePeoplePeoplePeoplePeoplePeoplePeoplePeople
MaleFemaleFull-time contract workersFull-time dispatched workers
Part-timeOther types> 50 years old30 to 50 years old< 30 years oldMainland employees
Junior employeesMiddle managersSenior managers
Indicators
Total number of employees
Unit
2,0431,251
2,015
1,195
2,043
1,939
20202,4451,505
2,413
1,2881,0912,445
2,332
1,2001,018
20212,0181,230
1,994
1,154
2,018
1,903
1,036
2022
Notes:
[1]. The statistical caliber of employees covers Shenzhen Kangtai Biological Products Co., Ltd. and its wholly-ownedsubsidiary, which is consistent 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.
By employment type
By region?
By education
By gender
By age group?
By rank
%%%People
PeoplePeoplePeople
Days
Labor contract signing rateSocial insurance coverage rateCoverage rate of employee medical checkups
1,438
1,491
1,323
Employment and Employee Rights
Occupational Health and Safety
Liabilities to employees
Employees from Hong Kong Macao, Taiwan and overseas
Employees withDoctoral DegreeEmployees withMaster’s DegreeEmployees withBachelor’s DegreeEmployees with JuniorCollege Degree and below
Number of employees covered by collectivebargaining agreements (end of period)
IndicatorsUnit 2021 2022 2020
Number of employees in positions at risk of
occupational diseasesNumber of employees withoccupational diseaseNumber of employees who died due to
work-related injuriesNumber of workdays lost due to
work-related injuries
2022 CORPORATE SOCIAL RESPONSIBILITY REPORT AND ENVIRONMENTAL, SOCIAL AND GOVERNANCE REPORTBIOKANGTAI
DomainsLaws and Regulations
Compliance orNon-compliance
During the reporting period, the Company did not violate any laws and regulations related to product quality,customer service, intellectual property protection, environmental protection and employment. The main domainsand laws and，regulations that the Company is involved in are listed in the table below.
Compliance
Compliance
ComplianceComplianceCompliance
Product Quality
Product Researchand Development
Compliance
Compliance
ComplianceComplianceCompliance
%%PcsRMB10,000
%Person
%
Pcs
Pcs
Pcs
27,340
12.09
20.80
73,847
20.22
18.81
99,356
31.47
23.04
PcsPersonHours
Amount of community investmentOf which: Investment in educationInvestment in the medical and health careAmount of charitable donations
RMB10,000RMB10,000RMB10,000RMB10,000
930.87
1.80
585.35
343.72
1,891.301,011.80
648.38
231.12
1,464.64
31.80
579.47
853.37
Product liability
Anti-corruption
Community investment
8.4 Compliance Operations
IndicatorsUnit202120222020
Complaint handling rate
Percentage of sold products that had to betaken back due to safety and health issuesNumber of incidents involving violations oflaws and regulations on products and services
Percentage of R&D personnelNumber of trademarks approvedNumber of trademark applicationsNumber of patents grantedin the reporting periodNumber of patent applicationsin the reporting period
R&D InvestmentRatio of R&D investment to operating revenue
Number of R&D personnel
Pcs
Number of patent applicationsin the reporting periodNumber of employees participating in anti-cor-
ruption related trainingTotal hours of anti-corruption training received
by employees
IndicatorsUnit202120222020
IndicatorsUnit202120222020Amongthem
Drug Administration Law of the People’s Republic of China, Vaccine Admin-istration Law of the People’s Republic of China, Measures for the Adminis-tration of Drug Registration, Good Manufacture Practice of MedicalProducts, Guidelines for Good Clinical Practices, Measures for the Supervi-sion and Administration of Drug Production, etc.Drug Administration Law of the People’s Republic of China, Vaccine Admin-istration Law of the People’s Republic of China, Measures for the Adminis-tration of Drug Registration, Good Manufacture Practice of MedicalProducts, Guidelines for Good Clinical Practices, Measures for the Supervi-sion and Administration of Drug Production, etc.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.Law of the People's Republic of China on Consumer Rights and Interests,etc.
Intellectual PropertyProtectionCustomer Service
Law of the People's Republic of China on the Protection of PersonalInformationInformation security
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,Law of the People's Republic of China on Prevention and Control ofEnvironmental Pollution by Solid Waste, Law of the People's Republic ofChina on Prevention and Control of Pollution from Wastewater, Law of thePeople's Republic of China on Promotion of Cleaner Production, Law of thePeople's Republic of China on Energy Conservation, Guangdong Environ-mental Protection Regulations, etc.
Biosafety Law of the People's Republic of China, etc.
EnvironmentalProtection
Biosafety
Criminal Law of the People's Republic of China, Law of the People's Republicof China Against Unfair Competition, Interim Provisions on the Prohibition ofCommercial Bribery, China Internal Auditing Standards, Basic Standards forEnterprise Internal Control, Anti-Money Laundering Law of the People'sRepublic of China, etc.Business Ethics
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 Republicof China, Law of the People's Republic of China on Mediation andArbitration of Labor Disputes, Law of the People's Republic of China onTrade Unions, Law of the People's Republic of China on the Protection ofWomen's Rights and Interests, etc.Employment andLabor
Law of the People's Republic of China on Prevention and Control of Occupa-tional Diseases, etc.OccupationalHealth and Safety
Note:
[1]. The complaint handling rate in this report is calculated according to thisformula: complaint handling rate = number of complaints handled/totalnumber of complaints received × 100%.
2022 CORPORATE SOCIAL RESPONSIBILITY REPORT AND ENVIRONMENTAL, SOCIAL AND GOVERNANCE REPORTBIOKANGTAI
7778
ESG Reporting Guide Index
Clause and DisclosuresChapters
9.9: (7)
9.9: (8)
9.1 Overview
9.2 Business Principles
9.3 CSR Strategy and Mechanisms
Guide Index of Guidelines on Self-regulation of Listed Companies on Shenzhen Stock Exchange No. 2: Standard-ized Operation of Listed Company on the ChiNext Market.
1.5 ESG Approach
1.5 Stakeholder Communication and Material Issue
Identification
2.1 Party Building Leading
2.2 Normative Governance
2.3 Compliance Operations
3.1 Continuous R&D and Innovation
3.4 Responsible Marketing
1.5 ESG Approach
3.2 Strict Control of Quality and Safety
4.1 Improving Environmental Management
5.1 Protecting Employee Rights and Interests
5.3 Safeguarding Employees
8.4 ESG Key Performance - Compliance Operations
Irrelevant
4.2 Tackling climate change
2.2 Normative Governance
8.1 ESG Key Performance – Economic Performance
5.1 Protecting Employee Rights and Interests
4.1 Improving Environmental Management System
4.1 Improving Environmental Management System
4.1 Improving Environmental Management System
4.2 Tackling climate change
8.2 ESG Key Performance – Environmental Performance
4.3 Reducing the Environmental Impact of Operations
4.3 Reducing the Environmental Impact of Operations
Irrelevant
3.2 Strict control of quality and safety
4.2 Tackling climate change
4.1 Improving Environmental Management System
8.2 ESG Key Performance – Environmental Performance
4.2 Tackling climate change
4.3 Reducing the Environmental Impact of Operations
4.3 Reducing the Environmental Impact of Operations
9.4：（1）
9.4：（2）
9.4：（3）
9.8：（1）
9.8：（2）
9.8：（3）
9.8：（4）
9.8：（5）
9.8：（6）
9.8：（7）
9.8：（8）
9.9：（1）
9.9：（2）
9.9：（3）
9.9：（4）
9.9：（5）
9.9：（6）
9.5 Return to Shareholders
CSR system constructionDeficiencies and problems in fulfilling CSRImprovement measures and time schedule
Compliance with environmental protection laws,regulations and industry standardsEnvironmental Protection Plan
Use of natural resourcesPollutant disposalPollution prevention and control facilitiesPayment of environmental protection-related
taxes and feesSupply chain and environmental safetyOther environmental protection responsibilitiesEnvironmental protection policy,
targets and effectivenessTotal annual resource consumptionEnvironmental investment and environmental
technology developmenPollutant discharge managementConstruction and operation ofenvironmental protection facilities
9.6 Financial soundness
9.7 Protection of Employee Rights and Interests
Clause and DisclosuresChapters
Waste treatment and disposal,comprehensive utilization of recycled waste
Voluntary agreements with environmental protectiondepartmentsRewarded by environmental protection departmentsOther voluntary disclosure
Product safety laws, regulations and industry standardsProduction environment and processProduct quality and safety assurance mechanism andemergency response planOther quality and safety responsibilitiesStaff management system and violation handling measuresPrevention of occupational hazards and ancillary safetymeasuresEmployee trainingOther responsibilities for employee rightsprotection
9.9: (9)
9.12: (1)
9.12: (2)
9.12: (3)
9.12: (4)
9.13: (1)
9.13: (2)
9.13: (3)
9.13: (4)
9.14: Ethics of Science
9.15 Supervision and Monitoring
9.10 Environmental Protection Policy Implementation
9.11 Environmental Information Disclosure
4.3 Reducing the Environmental
Impact of Operations
4.1 Improving Environmental Management System
4.1 Improving Environmental Management System
8 ESG Key Performance
4.1 Improving Environmental Management System
4.2 Tackling Climate Change
4.3 Reducing the Environmental Impact of Operations
3.2 Strict control of quality and safety
8.2 ESG Key Performance – Environmental
Performance
5.3 Safeguarding Employees
3.2 Strict control of quality and safety
3.2 Strict control of quality and safety
5.3 Safeguarding Employees
8.3 ESG Key Performance – Social Performance
5.1 Protecting Employee Rights and Interests
5.3 Safeguarding Employees
5.2 Caring for Employee's Growth
5.1 Protecting Employee Rights and Interests
3.1 Continuous R&D and Innovation
2.3 Compliance Operations
3.2 Strict control of quality and safety
4.2 Tackling climate change
5.3 Safeguarding Employees
2022 CORPORATE SOCIAL RESPONSIBILITY REPORT AND ENVIRONMENTAL, SOCIAL AND GOVERNANCE REPORTBIOKANGTAI