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1、Pelcitoclax(APG-1252)APG-2449APG-5918Lisaftoclax(APG-2575)Alrizomadlin(APG-115)Olverembatinib(HQP1351)2024202420242024Environmental,Social Environmental,Social and Governance Reportand Governance ReportEnvironmental,Social Environmental,Social and Governance Reportand Governance Report(Incorporated
2、in the Cayman Islands with limited liability)Stock Code:HKEX:6855 NASDAQ:AAPGAscentage Pharma Group International 1Environmental,Social and Governance Report 2024 Ascentage Pharma Group InternationalPageAbout this Report2Highlights and Performance3Message from Management4About Ascentage Pharma61Corp
3、orate Governance and Solid Foundations71.1Corporate Governance71.2Business Ethics132Global Presence&R&D and Innovation152.1R&D and Innovation152.2Intellectual Property Rights252.3R&D Ethics and Morals263Strict Quality Control and Sustainable Supply283.1Quality and Safety283.2Service Excellence393.3S
4、upply Chain Management414Green Production,Safety Assurance494.1Environmental Management494.2Tackling Climate Change544.3Emission Management644.4Occupational Health and Safety675Empowering Talents to Create Warmth Together735.1Employment735.2Talent Development765.3Care and Welfare835.4Welcoming Commu
5、nity88Appendix I ESG Key Performance Indicators(KPIs)90Appendix II Hong Kong Stock Exchange Environmental,Social and Governance Reporting Code Content Index95Contents2Ascentage Pharma Group International Environmental,Social and Governance Report 2024Environmental,Social and Governance Report 2024Ab
6、out this ReportReport ReviewThis Report is the sixth Environmental,Social and Governance(hereinafter“ESG”)Report published by Ascentage Pharma Group International(hereinafter the“Company”or the“Group”)and its subsidiaries(hereinafter“Ascentage Pharma”or“Ascentage”or“we”or“us”).Reporting GuidelinesTh
7、e Report has been prepared in accordance with the Environmental,Social and Governance Reporting Code(hereinafter the“ESG Reporting Code”)under Appendix C2 to the Rules Governing the Listing of Securities issued by The Stock Exchange of Hong Kong Limited(hereinafter the“Hong Kong Stock Exchange”)effe
8、ctive from December 2023 onwards.Scope of ReportTimeframe:The Report covers the period between January 1,2024 and December 31,2024(hereinafter the“Reporting Period”or the“Year”or“2024”),whereas certain content would be in a retrospective or prospective basis(as appropriate)to enhance completeness of
9、 the Report.Scope of report:The content of the Report covers Ascentage Pharma Group International and its subsidiaries,including Ascentage Pharma(HK),Ascentage Jiangsu,Ascentage Suzhou,Ascentage Shanghai,Healthquest Pharma,Ascentage US,Ascentage Australia,Ascentage International and Ascentage Invest
10、ment.Data Source and DescriptionThe information and data used in this Report are collected from the official documents and statistical reports of the Group,which have been reviewed by relevant departments.Unless otherwise specified,the currency in this Report is Renminbi(RMB).Reliability Assurance a
11、nd ApprovalThe Group has not found any false record,misleading statement or material omission in this Report.This Report complies with all the“comply or explain”provisions in the ESG Reporting Code and prepared according to the reporting principles of materiality,quantitative and balance in the ESG
12、Reporting Code.This Report was approved by the Board of Directors on April 15,2025.Access and Response to the ReportThis Report is available in Traditional Chinese and English for readers reference.This Report can be found within the category of Financial Statements/ESG Information,on the HKEX news
13、website or the official website of Ascentage Pharma(https:/).We greatly value opinions from stakeholders and welcome your feedback via the following contact channels.Your opinion will facilitate us in further improving the Report and enhance the Groups overall ESG performance.Email:Address:68 Xinqin
14、g Road,Suzhou Industrial Park,Suzhou,JiangsuPhone number:86-21-619510883Environmental,Social and Governance Report 2024 Ascentage Pharma Group InternationalEnvironmental,Social and Governance Report 2024Highlights and PerformanceInnovation and Research and Development(R&D)Annual R&D investment amoun
15、ted to RMB947.2 millionWe have obtained a total of 16 Orphan Drug Designations(ODDs)from the FDA and 1 ODD from the EU for 4 of the Companys investigational drug candidates;we have also obtained 2 Fast Track Designations and 2 Rare Pediatric Disease(RPD)designations by the FDADuring the Reporting Pe
16、riod,olverembatinib was successfully included in the National Reimbursement Drug List(NRDL)for Basic Medical Insurance,Work-Related Injury Insurance,and Maternity Insurance(2024).All approved indications of olverembatinib are covered by the NRDLQuality and SafetyDuring the Reporting Period,Ascentage
17、 Pharma successfully obtained ISO 9001 quality management system certification,covering 100%of the Companys production facilitiesZero product recalls for safety and health reasonsEnvironment and HealthDuring the Reporting Period,Ascentage Pharma successfully obtained ISO 14001 environmental manageme
18、nt system certification,covering 100%of the Companys production facilitiesAdditionally,Ascentage Suzhou secured the approval to be a 2A-level Green Factory in Suzhou Industrial Park for 2024 along with obtaining the second batch of 3A-level Green Factory in SuzhouZero incidents of environmental poll
19、ution and environmental administrative penaltiesZero work-related fatality and injuryEmployee and CommunityEmployee training coverage reached 100%,with an average of 8.75 training hours per employeeEmployee coverage rate of the Employee Stock Ownership Plan reached 100%4Ascentage Pharma Group Intern
20、ational Environmental,Social and Governance Report 2024Environmental,Social and Governance Report 2024Message from ManagementIn 2024,the pharmaceutical industry forged ahead with unprecedented vitality and potential,riding the wave of innovation and transformation.Ascentage Pharma continued to execu
21、te its global patient-centric strategy,driving its growth through research and innovation.As we continue to advance our pipeline products and improve access to and affordability of our commercialized product,we are maximizing value of our stakeholders,particularly patients whose needs yet to be sati
22、sfied by existing therapies.Build a robust governance system and strengthen the foundation of corporate integrity.We are committed to establishing a robust corporate governance structure,clearly defining the roles and responsibilities of the Company and ESG management.We continue to deepen our focus
23、 on business ethics management,maintaining high ethical standards and a“zero-tolerance”policy.We continuously strengthen employees ethical awareness and encourage proactive reporting of any violations.Moreover,we place great emphasis on communication with stakeholders,establishing diverse communicat
24、ion channels to foster close connections with all parties.Pursue innovation-driven global expansion and join hands to build a healthier future.Upholding our core values of“Patients first;Science-based;Data-driven”,we remain steadfast in advancing our global strategy.We have made continuous progress
25、in product research and innovation,achieving significant milestones during the year,including the Exclusive Option Agreement with Takeda Pharmaceuticals International AG.Leveraging our exceptional R&D capabilities,we have also established a global intellectual property portfolio and formed strategic
26、 partnerships with leading biotech and pharmaceutical companies and academic institutions,building a global collaborative network.Additionally,we are steadily advancing global clinical trials,ensuring scientific rigor and precision at every step.Strengthen quality and safety management,and safeguard
27、ing the lifeline of pharmaceuticals.We recognize the paramount importance of product quality and safety.As such,we continue to optimize our quality management system and enhance our ability to manage the entire lifecycle of our products.We have also refined our product traceability and recall mechan
28、isms,and continually improved our customer service system to elevate service quality.In addition,we are committed to building a safe and sustainable supply chain,fostering mutually beneficial relationships with supply chain partners to create and share long-term value.5Environmental,Social and Gover
29、nance Report 2024 Ascentage Pharma Group InternationalEnvironmental,Social and Governance Report 2024Adhere to green development principles and enhance environmental management efficiency.We actively assume responsibility for environmental protection.Our efforts include continuously optimizing our e
30、nvironmental management system and establishing scientific and reasonable environmental goals.We strive to enhance the effectiveness of our environmental practices and integrate climate change considerations into our sustainability strategy to seize new business opportunities.In addition,we have str
31、engthened the management of pollutant emissions and actively explored and implemented effective pollution reduction measures.We are also dedicated to building a safety culture and fostering a safe and healthy research and development environment to ensure the health and safety of our employees.Foste
32、r talent development in a vibrant way and enhance workplace experience.We are dedicated to safeguarding employees rights and continuously enhance their workplace experience through a series of welfare policies.We prioritize communication and interaction with employees to increase their wellbeing and
33、 sense of belonging.We implement an international talent strategy,focusing on creating a diverse and inclusive corporate culture.Additionally,we are committed to giving back to society and making a positive impact.We actively uphold our social responsibilities by continuously supporting public welfa
34、re initiatives.Looking ahead to 2025,we will continue to advance sustainability and refine governance practices.We will also remain committed to our mission of“addressing unmet medical needs in China and around the world”.We will deepen our patient-centric global strategy,accelerate the global clini
35、cal development of our pipeline,and bring more innovative medicines from China to the world.With such efforts,we aim to benefit patients worldwide and illuminate the path to better health.Dr.Yang DajunChairman and CEO of Ascentage Pharma6Ascentage Pharma Group International Environmental,Social and
36、Governance Report 2024Environmental,Social and Governance Report 2024About Ascentage PharmaWe are a global,integrated biopharmaceutical company engaged in discovering,developing and commercializing therapies to address global unmet medical needs primarily in hematological malignancies.MissionTo addr
37、ess unmet clinical needs of patients in China and around the worldVisionTo become a global leading integrated biopharmaceutical companyValuePatients first;Science-based;Data-drivenCorporate Culture of Ascentage PharmaEstablished in 2009 and headquartered in Suzhou,China,Ascentage Pharma has offices
38、in Beijing,Shanghai,Guangzhou,Taizhou,China,and Rockville,Maryland in the United States.In October 2019,Ascentage Pharma was listed on the Main Board of Hong Kong Stock Exchange(6855.HK).Additionally,as of the release of this Report,Ascentage Pharma has been listed on the Nasdaq Stock Market(AAPG),m
39、aking it the first 18A company to achieve dual listing in the U.S.stock market.We always uphold and practice our mission of“addressing unmet clinical needs of patients in China and around the world”.To date,Ascentage Pharma has established a robust pipeline of innovative drug candidates,including in
40、hibitors targeting key proteins in apoptosis pathways such as Bcl-2,IAP,and MDM2-p53,as well as next generation inhibitors designed to combat kinase mutations emerging in cancer treatment,becoming the only innovative company globally with clinical-stage drug candidates covering all key apoptosis pat
41、hway proteins.At the moment,we are conducting ten registrational trials,including two that were cleared by the FDA,for our three late-stage products,olverembatinib,lisaftoclax and APG-2449.7Environmental,Social and Governance Report 2024 Ascentage Pharma Group InternationalEnvironmental,Social and G
42、overnance Report 20241 Corporate Governance and Solid FoundationsAscentage Pharma acknowledges that corporate governance is crucial for the Company to achieve sustainable and steady growth.To this end,we continuously optimize our corporate governance structure,enhance the effectiveness of our compli
43、ance management system,and closely address the needs of all stakeholders,fostering a long-term brand image built on integrity.1.1 Corporate GovernanceAscentage Pharma is committed to establishing a robust corporate governance system while strictly adhering to relevant laws and regulations.By maintai
44、ning a diverse Board of Directors and implementing an efficient ESG management system,we continuously improve our corporate governance.Additionally,the Company actively promotes exchanges and cooperation with stakeholders,driving the Companys sustainable development.1.1.1 Corporate GovernanceRespons
45、ible governance is a crucial safeguard for the Company to achieve stable operations.Ascentage Pharma strictly complies with the Company Law of the Peoples Republic of China(中華人民共和國公司法)and the Listing Rules of the Hong Kong Stock Exchange(香港聯交所 上市規則),among other relevant laws and regulations.By formu
46、lating and rigorously implementing a series of rules and regulations,we continue to enhance management efficiency and quality,laying a solid foundation for the Companys long-term development.Ascentage Pharma has established a comprehensive and well-structured governance structure,The Board of Direct
47、ors has established an Audit Committee,a Remuneration Committee and a Nomination Committee,all in alignment with the governance principles that emphasize a clear division of responsibilities,efficiency,and transparency.Besides,our clinical development strategy is guided by our Scientific Advisory Bo
48、ard,which brings together global leading scientific scholars in the field of cancer research.This has ensured strong protection of all stakeholders interests,thereby promoting the Companys sustained and stable growth.Board ofDirectorsAuditCommitteeRemunerationCommitteeNominationCommitteeCorporate Go
49、vernance Structure of Ascentage PharmaThe Company actively implements a diversity strategy for the Board of Directors.To that end,we are striving to promote a diverse and well-balanced structure for the Board of Directors by comprehensively considering multiple aspects such as gender,professional sk
50、ills,age level,industry background,depth of knowledge,and educational qualifications of candidates for the Board.In particular,the Companys Nomination Committee is responsible for overseeing the implementation of the company polices relating to the diversity of the Board of Directors and conducting
51、regular assessments to optimize and adjust the diversity policy.We aim to ensure that the Company maintains a high level of independence and fairness in major decision-making.8Ascentage Pharma Group International Environmental,Social and Governance Report 2024Environmental,Social and Governance Repo
52、rt 2024As of March 31,2025,the Companys Board of Directors comprises 9 directors,including 6 directors who are independent non-executive directors(INEDs)according to the definition of the Hong Kong Stock Exchange.2 directors are female,6 directors have Ph.D.or Doctor of Medicine degrees and 3 direct
53、ors are non-ethnic Chinese.Each of the Audit Committee,Remuneration Committee and Nomination Committee is chaired by an independent director.The Company remains committed to risk management and control and compliance operations,with the Board of Directors taking the lead in overseeing the risk manag
54、ement and control system to ensure its ongoing effectiveness.Meanwhile,the Audit Committee and senior management jointly monitor the implementation of risk management policies to ensure their adequacy and effectiveness.Additionally,we actively conduct compliance training,incorporating practical case
55、 analyses and interactive sessions to provide guidance for identifying and mitigating potential compliance risks.This approach enhances employee engagement and strengthens their understanding of compliance.Compliance Management Training Activity:Legal Risk Analysis of Hot-spot EventsIn November 2024
56、,the Company organized a compliance education training session themed“Legal Risk Analysis of Hot-spot Events”in China,with Dr.Yang Dajun,Chairman and CEO,invited to attend.This training provided an in-depth legal analysis and education on anti-insurance fraud,highlighting the associated legal risks
57、and emphasizing the importance of strengthening internal controls and oversight to ensure that all employees act in accordance with compliance requirements.9Environmental,Social and Governance Report 2024 Ascentage Pharma Group InternationalEnvironmental,Social and Governance Report 20241.1.2 ESG Ma
58、nagement and ImplementationThe Company continues to advance our ESG practices by integrating ESG principles into corporate management.With a comprehensive ESG management system in place,we strive to achieve sustainable development while ensuring stable operations.ESG Management Structure and Respons
59、ibilitiesThe Company has established a comprehensive ESG management system with a three-tier organizational structure comprising“the Board of Directors the Audit Committee Functional Departments”.The Board of Directors serves as the highest responsible body,working together with departments at all l
60、evels to collaboratively drive the implementation of the ESG strategies.The ESG responsibilities of the Companys Audit Committee are as follows:Advise on the ESG strategies of the Company and identify material ESG risks and opportunities Identify material ESG issues,and determine the risks and oppor
61、tunities brought by such material ESG issues to the Company;Advise on and regularly review the ESG strategies of the Company for the Board of Directors approval;and Formulate goals based on the corresponding strategies and regularly review such goals.Approve and review ESG related policies Review ES
62、G related policies;and Review and supervise the policies related to material ESG issues to ensure their applicability.Review the annual ESG report of the Company Review the annual ESG report to ensure that ESG report has made comprehensive disclosure on the ESG risks,measures and progress toward goa
63、ls,while ensuring compliance with the requirements of related Listing Rules and applicable laws and regulations;and Recommend the Board of Directors to approve the ESG report.10Ascentage Pharma Group International Environmental,Social and Governance Report 2024Environmental,Social and Governance Rep
64、ort 2024Statement of the Board of DirectorsOverall responsibility of the Board of DirectorsThe Board of Directors is ultimately responsible for Ascentage Pharmas ESG management policies,target setting,progress review and ESG performance,and is responsible for evaluating and determining the Companys
65、ESG risks,ensuring that the Company has established a sound and effective ESG management and internal control system.In addition,the Board of Directors is responsible for approving the ESG report of the Company.ESG implementation and executionEach functional department is responsible for executing a
66、nd implementing ESG goals,rules and regulations,and policies approved by the Board of Directors,ensuring that ESG management is integrated into its daily operation.In addition,each functional department submits work reports to the Audit Committee regularly,providing strong support for the Board of D
67、irectors to review overall ESG strategies and develop related decisions on a regular basis.ESG risk managementAscentage Pharma attaches great importance to the identification and management of ESG risks and has established a comprehensive risk management framework and supervision mechanism of the pr
68、ogress towards goals.The Audit Committee is responsible for identifying and assessing risks and opportunities based on internal and external conditions of the Company.The Board of Directors is responsible for reviewing and determining risk mitigation strategy and risk management systems to effective
69、ly respond to the challenges that potential risks may pose to the Companys ESG management.Material ESG issuesThe Audit Committee is responsible for overseeing and maintaining the communication channels between the Company and our stakeholders.Through analyzing stakeholders concerns,the Audit Committ
70、ee identifies material ESG issues,thereby recommending specific ESG strategies and actions to the Board of Directors.11Environmental,Social and Governance Report 2024 Ascentage Pharma Group InternationalEnvironmental,Social and Governance Report 20241.1.3 Communication with StakeholdersWe value comm
71、unication with stakeholders and continuously optimize diversified communication platforms to deepen communication and cooperation with them.This approach supports the Companys efforts to advance ESG work.We pay close attention to and actively respond to the expectations and demands of stakeholders,i
72、ncluding government and regulatory authorities,shareholders and investors,patients and doctors,employees,suppliers and partners,and the media.By working together,we aim to drive the Companys growth and progress.Major StakeholdersCommunication ChannelsGovernment and regulatory authoritiesPolicy recom
73、mendations,work report,information submission,on-site inspectionShareholders and investorsGeneral meetings,investor meetings,industry summits,analyst meetings,road shows,information disclosure,day-to-day communication via telephone and emailPatients and doctorsClinical trials,physician visitsSupplie
74、rs and partnersBidding conference,suppliers review procedures,exchanges and communications,industry forumsEmployeesInternal communication platform,employees satisfaction survey,employee visits and careLocal communitiesCommunity activities,volunteer servicesMedia and members of the publicCompany webp
75、age,Companys WeChat official account,daily communication and feedback,public opinion monitoring,information disclosure,press conference12Ascentage Pharma Group International Environmental,Social and Governance Report 2024Environmental,Social and Governance Report 20241.1.4 Analysis of Material Issue
76、sIn 2024,Ascentage Pharma,in addition to the results of 2023 assessment of material ESG issues,integrated the requirements of ESG guidelines of the Hong Kong Stock Exchange,industry development trends,the Companys actual operational status in the current year,and strategic plans.On this basis,we ana
77、lyzed the key concerns of each stakeholder regarding the Companys ESG issues and accordingly developed the matrix of material ESG issues of Ascentage Pharma for 2024,providing a clear direction for the Companys future strategic plans.Management of chemicalsManagement of emissionEffective use of reso
78、urcesEnvironmental and natural resourcesIdentification and response of climate change risksOccupational health and safetyStaff and employment managementStaff development and trainingLabor standardsProtection of labor interestLabor communication and benefitDrug quality and safetySafety of clinical tr
79、ialsAvailability of drugsIntellectual property rights managementR&D and innovation of productsProtection of customers rights and privacySustainable management of supply chainResponsible marketingCommunity investment and charityProvision of customer servicesProduct inspections and recallsSustainable
80、development goals and strategiesCorporate governanceOperational complianceAnti-corruption and business ethicsMateriality to StakeholdersMateriality to Ascentage PharmaAnalysis of Material Issues of Ascentage PharmaImportantVery ImportantExtremely ImportantEnvironmental responsibility issuesLabor res
81、ponsibility issuesOperational responsibility issuesCorporate governance responsibility issues13Environmental,Social and Governance Report 2024 Ascentage Pharma Group InternationalEnvironmental,Social and Governance Report 20241.2 Business EthicsAscentage Pharma strictly abides by the Anti-Unfair Com
82、petition Law of the Peoples Republic of China(中華人民共和國反不正當競爭法),the Anti-Money Laundering Law of the Peoples Republic of China(中華人民共和國反洗錢法),Interim Provisions on Prohibiting Commercial Bribery(關於禁止商業賄賂行為的暫行規定)and other laws and regulations.The Company continuously strengthens its business ethics and a
83、nti-corruption control systems,by upholding“zero-tolerance policy”towards corruption,favoritism,improper competition and other violations of business ethics.To this end,we have developed the Code of Business Conduct and Ethics(商業行為與道德準則),which applies to the directors and all employees of the Compan
84、y(including full-time,part-time,and temporary employees)as well as stakeholders such as suppliers and contractors who have business relationships with the Company.This has ensured that all business activities are conducted in accordance with high standards of integrity and all applicable laws and re
85、gulations.The Board of Directors of the Company is responsible for supervising the implementation of the Code,while the Audit Committee is responsible for organizing and guiding its enforcement to ensure the effectiveness of its implementation.The Company conducts a full-scope audit of the implement
86、ation of the Code of Business Conduct and Ethics at least once every three years to verify whether business activities,meetings and events application,financial reimbursement processes,and other commercial behaviors comply with business ethics standards.Additionally,at the beginning of each month,we
87、 also conduct a compliance review on ethical business practices to ensure that employees engage with health care professionals(HCPs),health care organizations(HCOs),suppliers,and other partners without involvement in bribery,kickbacks,or other improper conduct.In doing this,we can ensure that both e
88、mployees and relevant stakeholders adhere to the business ethics code.During the Reporting Period,there were no lawsuits arising from corruption in the Company.The Company continuously conducts anti-corruption and business ethics training and publicity programs for the directors and all employees(in
89、cluding full-time,part-time,and temporary employees).We also have introduced online compliance courses for all employees to participate in.During the Reporting Period,in addition to implementing regular training plans,we organized 11 additional online compliance trainings regarding anti-corruption a
90、nd anti-commercial bribery,covering a total of 279 participants.This aimed to ensure that relevant business teams always adhere to compliance principles in their operational activities.Moreover,we also impose clear business ethics requirements on our contractor partners to ensure that they meet the
91、Companys business ethics and compliance standards.14Ascentage Pharma Group International Environmental,Social and Governance Report 2024Environmental,Social and Governance Report 2024Anti-Corruption and Anti-Bribery Compliance Training for New EmployeesEach new employee at Ascentage Pharma is requir
92、ed to complete the online course entitled Anti-Corruption and Anti-Bribery Compliance Training for New Employees upon joining.The training covers topics such as anti-corruption,anti-commercial bribery,and current compliance policy requirements.Furthermore,new employees in the commercial department a
93、re required to complete an additional Newcomer Training Camp Compliance Training course.This course provides a more comprehensive overview of anti-corruption and anti-bribery,anti-trust,anti-insider trading,as well as restrictions and requirements regarding compliance practice in various business in
94、teractions.In both the Employee Manual(員工手冊)and the Code of Business Conduct and Ethics,we have clearly outlined the reporting channels for compliance issues.Employees and contractors are encouraged to report any identified non-compliant behaviors such as corruption,bribery,extortion,fraud,and money
95、 laundering.At the same time,we have established a strict whistleblower protection policy,firmly prohibiting any form of retaliation against employees who report violations or potential violations in good faith.As of the end of the Reporting Period,the Company had not received any compliance reports
96、.Reporting Reporting websitehttps:/ hotline+1(833)200-3154(toll-free)15Environmental,Social and Governance Report 2024 Ascentage Pharma Group InternationalEnvironmental,Social and Governance Report 20242 Global Presence&R&D and InnovationPowered by technological innovation,Ascentage Pharma is dedica
97、ted to the mission of“addressing unmet clinical needs of patients in China and around the world”.Through our R&D activities,we have been advancing our pipeline products through clinical developments.We have very strong intellectual property protection with 541 issued patents globally as of December
98、31,2024,maintain the highest ethical standards in research,and ensure that scientific progress aligns with social responsibility.2.1 R&D and InnovationInnovation and R&D are the core driver of our growth.Through our global R&D capabilities,we aim to discover and develop both first-and best-in-class
99、therapies to address global unmet medical needs.To this end,we have built a high-performance R&D system powered by exceptional professionals to continuously promote product R&D and innovation.We also actively participate in R&D exchanges such as academic congresses and collaborations with academic i
100、nstitutes and other industry peers to deliver sustainable momentum for pharmaceutical industry advances.2.1.1 R&D ManagementWith over 400 employees in our R&D department,we have established an end-to-end drug development system spanning from discovery to clinical trials,significantly enriching our p
101、roduct pipeline.Concurrently,we have constructed worldwide manufacturing facilities compliant with international cGMP standards to accelerate innovation and global transformation.End-to-End R&D Management SystemNew-target small molecule targeted drugsDesignTranslationResearchScreeningDevelopmentOpti
102、mization16Ascentage Pharma Group International Environmental,Social and Governance Report 2024Environmental,Social and Governance Report 2024To continuously enhance efficiency in innovation and R&D,Ascentage Pharma has formed a comprehensive R&D management framework,based on which it systematically
103、manage various aspects of R&D functions including product candidates,project supervision,and clinical trials,thereby ensuring efficient and well-organized R&D operations.In addition,we have established a Scientific Advisory Board,chaired by Dr.Shaomeng Wang,the co-founder and non-executive Director
104、of the Group.Other members of the Scientific Advisory Board are independent members with extensive knowledge and experience in cancer research and drug discovery,providing all-round professional guidance for the Companys R&D strategies and planning.During the Reporting Period,Ascentage Pharma invest
105、ed a total of RMB947.2 million in R&D.R&D Management Structure and ResponsibilitiesR&D TeamProject CommitteeProject Management TeamResponsible for preclinical development and clinical trials on drug candidatesComprised of personnel from various functions,including the R&D,manufacturing,regulatory,cl
106、inical and commercialization departments,and is responsible for approving product development projects before their commencementResponsible for project management and coordination,including technical support,personnel management,budget monitoring,etc.17Environmental,Social and Governance Report 2024
107、 Ascentage Pharma Group InternationalEnvironmental,Social and Governance Report 2024During the Reporting Period,Ascentage Pharma received the following awards and honors in R&D and innovation.China New Drug Pioneer Award2024 Top 10 ESG-Competitiveness Pharmaceutical Listed Companies in China E-Pharm
108、a ManagerChinas Top 20 Blockbuster Drug Candidates(2015-2030)“Sunshine”Annual Award for Outstanding Innovative Drugs2024 Awards and Honors in R&D and Innovation18Ascentage Pharma Group International Environmental,Social and Governance Report 2024Environmental,Social and Governance Report 20242.1.2 P
109、roduct InnovationUpholding the principles of“original innovation”and“global innovation”,Ascentage Pharma maintains its global leadership in novel drug development that targets apoptosis pathways based on our proprietary protein-protein interaction targeted drug design platform.As of the end of the R
110、eporting Period,Ascentage Pharma had established a pipeline comprising six commercial and clinical-stage products.We have completed or are conducting numerous clinical trials on these product candidates globally including 13 registrational clinical trials.(1)Registrational Phase 2 trial completed,th
111、e NDA has been accepted with priority review designation by CDE of Chinas NMPA.(2)Registrational trials for ongoing CLL/SLL,AML and MDS;Phase 2 trials ongoing for MM.(3)Two registrational trials ongoing for NSCLC;Phase 2 trials ongoing for ovarian cancer.(4)The globe icon refers to trials that have
112、received clearance,or for which we plan to obtain clearance,in two or more countries or regions.The U.S.flag refers to trials for which we have received clearance from the FDA to conduct trials in the United States.The China flag refers to trials for which we have conducted,currently conduct or plan
113、 to conduct only in China.(5)The globe icon indicates having global development and commercialization rights.Our product candidates target clinical needs of“untreatable and unmet”conditions for patients in China and around the world.As of the end of the Reporting Period,we have received a total of 1
114、6 Orphan Drug Designations(ODDs)from the FDA and 1 ODD from the EU for 4 of our investigational drug candidates and also obtained 2 Fast Track Designations and 2 Rare Pediatric Disease(RPD)designations from the FDA.19Environmental,Social and Governance Report 2024 Ascentage Pharma Group Internationa
115、lEnvironmental,Social and Governance Report 2024 Core Product CandidateOlverembatinib(HQP1351)Our first lead asset,olverembatinib,is a novel,next-generation TKI.Olverembatinib is the first third generation BCR-ABL1 TKI approved in China for treatment of patients with CML-CP with T315I mutations,CML-
116、AP with T315I mutations and CML-CP that is resistant and/or intolerant to first and second-generation TKIs.Olverembatinib received support from the National Major New Drug Discovery and Manufacturing Program.Since January 2025,all approved indications of olverembatinib are covered by the Chinas NRDL
117、,which bolstered the affordability and accessibility of the drug in China.We entered into an exclusive option agreement in June 2024 with Takeda(Exclusive Option Agreement),pursuant to which Ascentage Pharma granted Takeda an exclusive option to enter into an exclusive license for olverembatinib.If
118、exercised,the Exclusive Option Agreement would allow Takeda to license global rights to develop and commercialize olverembatinib in all territories outside of the PRC,Hong Kong,Macau,Taiwan and Russia.We believe joining force with Takeda,a global biopharmaceutical company who has significant global
119、presence in hematological malignancies,will maximize global patients accessibility to olverembatinib.Olverembatinib was included as an Emerging Treatment Option in the 2024 National Comprehensive Cancer Network USA,or NCCN,guidelines for the management of CML and received recommendation from the Chi
120、nese Society of Clinical Oncology,or CSCO,guideline for the treatment of CML and Ph+ALL.As of the date of this announcement,the FDA has granted four ODDs to olverembatinib,including for CML,ALL,AML and GIST,and Fast-Track Designation for treatment of CML in patients with certain genetic markers who
121、have failed to respond to prior TKIs.Olverembatinib was also granted an Orphan Designation by the European Medicines Agency,or EMA,for the treatment of CML.Olverembatinib was accepted by the CDE breakthrough therapy designation,or BTD,for the treatment of patients with SDH-deficient GIST and Ph+ALL.
122、We are conducting 3 global registrational trials for patients with Ph+ALL(POLARIS-1 trial),CML(POLARIS-2 trial)and SDH-deficient GIST(POLARIS-3 trial).20Ascentage Pharma Group International Environmental,Social and Governance Report 2024Environmental,Social and Governance Report 2024In addition to t
123、he NRDL coverage,olverembatinib has been included in the special drug lists of Million Medical Insurance Plans for Commercial Healthcare Coverage,such as“Good Health Insurance Long-term Medical Coverage”and“Blue Health Insurance Long-term Medical Coverage”.Furthermore,both of its approved indication
124、s have been incorporated into the special drug list of the Cancer Prevention and Treatment Support Card Project for Employee Families,launched by the China Employee Development Foundation.This initiative aims to alleviate the financial burden of medical expenses for employee families across the coun
125、try.We are committed to fair pricing and enhancing drug accessibility,employing a value-based pricing approach that takes into account various factors,including regional economic development,patient needs,and affordability.To further improve the accessibility of the product globally,we have launched
126、 and advanced an innovative Named Patient Program(NPP).This program will allow access to olverembatinib on a named patient basis in over 130 countries and regions where the drug is not yet commercially accessible.Through the NPP model,we bring new hope to more patients by providing access to innovat
127、ive drugs of high clinical value to patients in urgent need around the world.R&D Progress of Other Selected Pipeline ProductsLisaftoclax(APG-2575)Lisaftoclax is a novel,oral Bcl-2 inhibitor developed to treat a variety of hematologic malignancies and solid tumors by selectively blocking Bcl-2 to res
128、tore the normal apoptosis process in cancer cells.In November 2024,the NDA for lisaftoclax for the treatment of r/r CLL/SLL has been accepted with priority review designation by the CDE of Chinas NMPA.According to an industry report commissioned by us and independently prepared by Frost&Sullivan,or
129、the F&S Report,this NDA is the second NDA filed in the world for a Bcl-2 inhibitor and the first in China for a Bcl-2 inhibitor for the treatment of patients with CLL/SLL that are resistant or intolerant to Brutons tyrosine kinase,or BTK,inhibitors.Currently,lisaftoclax has received clearances and a
130、pprovals for clinical studies in China,the United States,Australia,and Europe,with indications including CLL/SLL,non-Hodgkins lymphoma(NHL),AML,MM,Waldenstrms macroglobulinemia(WM),and certain solid tumors.Furthermore,FDA has granted five ODDs to lisaftoclax for the treatment of patients with follic
131、ular lymphoma(FL),WM,CLL,MM,or AML.We are conducting 4 global registrational trials for patients with CLL(GLORA and GLORA-2 trials),AML(GLORA-3 trial)and MDS(GLORA-4 trial).APG-2449APG-2449 is a novel,orally active,small-molecule FAK,the third generation of ALK and ROS1 triple ligase kinase inhibito
132、r(TKI)designed and developed by Ascentage Pharma.It is the first FAK inhibitor approved by CDE for clinical study in China.We are conducting 2 registrational Phase III clinical trials that will separately evaluate APG-2449 in patients with NSCLC who are resistant to or intolerant of second-generatio
133、n ALK TKIs;and treatment-nave patients with ALK-positive advanced or locally advanced NSCLC.21Environmental,Social and Governance Report 2024 Ascentage Pharma Group InternationalEnvironmental,Social and Governance Report 20242.1.3 Research Exchange and CollaborationWe have always adhered to the prin
134、ciple of open innovation and actively explored diverse cooperation opportunities.Through close collaboration with universities and research institutes both domestically and internationally,we continuously bring together cutting-edge scientific expertise,accelerating the development process of innova
135、tive drugs.We have established collaborations and other relationships with leading biotechnology and pharmaceutical companies around the world,including a collaboration and license agreement with Innovent and clinical collaboration agreements with AstraZeneca,Merck,and Pfizer,and research and develo
136、pment relationships with leading research institutions,such as Dana-Farber Cancer Institute,Mayo Clinic,MD Anderson Cancer Center,National Cancer Institute and the University of Michigan.Collaborating with China Pharmaceutical University on anti-tumor drugs R&D and jointly applying for two patentsPa
137、rtnering with the University of Michigan on R&D of novel anti-tumor PROTAC(Proteolysis Targeting Chimeras)Working with the Institute of Systems Medicine,Chinese Academy of Medical Sciences(CAMS)on the discovery of original tumor targets and jointly applying for a scientifc research project in Jiangs
138、u ProvinceAdditionally,Ascentage Pharma highly values industry exchange and collaboration,actively engaging in international academic conferences and industry forums.We share our latest research achievements,exchange cutting-edge technological insights,and proactively seek collaboration opportunitie
139、s.Selected examples of our collaboration activities with academic institutes22Ascentage Pharma Group International Environmental,Social and Governance Report 2024Environmental,Social and Governance Report 2024Ascentage Pharma participated in the first CBA-China annual conference in 2024Ascentage Pha
140、rma participated in the first CBA-China annual conference by Chinese American Biopharmaceutical Society in 2024.The conference,themed“Life and Health”,covered key topics such as investment and business development,vaccines,macromolecules and small molecules,antibody-drug conjugates(ADCs),and clinica
141、l research.At the event,olverembatinib,won the award of“China First-in-Class,a breakthrough target drug for Chinese Enterprises”.Ascentage Pharma presented multiple clinical advances at the 2024 AACR annual conferenceIn April 2024,Ascentage Pharma showcased three preclinical research findings at the
142、 American Association for Cancer Research(AACR)annual conference.These studies highlighted the Companys innovative drug pipeline,including olverembatinib,the MDM2-p53 inhibitor alrizomadlin(APG-115),and APG-2449.The findings provided support for the clinical development potential and combination the
143、rapy possibilities of these drugs in treating SDH-deficient tumors,prostate cancer,and ovarian cancer.23Environmental,Social and Governance Report 2024 Ascentage Pharma Group InternationalEnvironmental,Social and Governance Report 2024Ascentage Pharma presented multiple clinical advances at the CSCO
144、 annual conferenceIn September 2024,the 27th National Clinical Oncology Conference and the Chinese Society of Clinical Oncology(CSCO)annual conference were held in Xiamen,China.Ascentage Pharma presented three clinical advances for its three key drug candidates at the conference,with two selected fo
145、r oral presentations.The drug candidates included olverembatinib,the Bcl-2/Bcl-xL dual-target inhibitor pelcitoclax(APG-1252),and APG-2449.24Ascentage Pharma Group International Environmental,Social and Governance Report 2024Environmental,Social and Governance Report 2024Ascentage Pharma presented m
146、ultiple clinical and preclinical studies at the 66th American Society of Hematology(ASH)Annual MeetingAscentage Pharma Group presented results from multiple clinical and preclinical studies of the Companys four drug candidates(olverembatinib,lisaftoclax,APG-5918 and APG-2449)as presentations,includi
147、ng two Oral Reports,at the 66th American Society of Hematology(ASH)Annual Meeting.This is the seventh consecutive year for clinical data of olverembatinib to be selected for Oral Reports at the meeting,an achievement reflecting the strong recognition of olverembatinibs safety and efficacy profile by
148、 the international hematology community.This is also the third consecutive year for clinical results of lisaftoclax to be selected by the ASH Annual Meeting.In addition,the data of olverembatinib combined with lisaftoclax for pediatric and adolescent patients with relapsed/refractory(R/R)Ph+acute ly
149、mphoblastic leukemia(ALL).The study was recognized with the“Abstract Achievement Award”.Ascentage Pharma showcased multiple clinical advances at ASCO,demonstrating its global innovation and development strengthFour clinical studies have been selected for presentation at the 2024 American Society of
150、Clinical Oncology(ASCO)annual conference.Data from three key drug candidates:olverembatinib,lisaftoclax,and APG-2449 were presented for succinate dehydrogenase(SDH)-deficient gastrointestinal stromal tumor(GIST)and paraganglioma,acute myeloid leukemia(AML),Waldenstrm macroglobulinemia(WM)and non-sma
151、ll-cell lung cancer(NSCLC).25Environmental,Social and Governance Report 2024 Ascentage Pharma Group InternationalEnvironmental,Social and Governance Report 20242.2 Intellectual Property RightsIntellectual property rights are fundamental to our business.Through our robust research and development,or
152、R&D,platform and research collaborations,we have strategically developed a global intellectual property portfolio,which includes exclusive licenses to issued patents and patent applications worldwide with respect to olverembatinib,lisaftoclax and our other drug candidates.Our comprehensive and growi
153、ng intellectual property portfolio positions us to capture market potential globally.While actively advancing innovation and research,Ascentage Pharma places a strong emphasis on protecting the Companys intellectual property rights.We strictly follow the Patent Law of the Peoples Republic of China(中
154、華人民共和國專利法),the Rules for Implementation of the Patent Law of the Peoples Republic of China(中華人民共和國專利法實施細則)and other intellectual property laws and regulations and have established an internal intellectual property management system.This system drives the strategic layout of intellectual property,ens
155、uring its effective development,protection,and utilization,thereby fostering the Companys continuous pursuit of innovation.Ascentage Pharma actively responds to national and governmental initiatives by implementing the national standard of Enterprise Intellectual Property Management Standards(企業知識產權
156、管理規範)(GB/T29490-2013).During the Reporting Period,we successfully passed the intellectual property management system recertification which covers intellectual property management in targeted drug technologies,targeted drug R&D,and related procurement processes.On top of that,the Company has,to the e
157、xtent permitted by laws and regulations,refined its internal Employee Invention Reward System(職務發明獎酬制度)in order to increase incentive rewards for inventions and foster greater innovation enthusiasm among our employees.To further enhance intellectual property management,we have established a comprehe
158、nsive patent alert system,providing deep insights into industry patent application trends and landscapes.This system offers robust decision-making support for our project development.Simultaneously,we conduct thorough intellectual property due diligence for potential collaboration,project or technol
159、ogy introduction,and investment projects,therefore ensuring precise evaluations of ownership and infringement risks,allowing us to effectively mitigate potential intellectual property infringement pitfalls.National Intellectual Property Right Management System Certificate of Ascentage Suzhou26Ascent
160、age Pharma Group International Environmental,Social and Governance Report 2024Environmental,Social and Governance Report 2024Leveraging our outstanding innovative R&D capabilities,the Company has continued to advance its intellectual property layout globally.During the Reporting Period,we continued
161、to expand our patent portfolio and filed 63 invention patent applications,with a total of 43 invention patents granted.As of the end of the Reporting Period,we had 541 issued patents globally,among which 379 issued patents were issued outside of China.We regularly carry out intellectual property tra
162、ining to our employees,focusing on the knowledge of pharmaceutical patents,patent application and layout,and trade secret protection,etc.,so as to strengthen the intellectual property management capability of our employees.Trade secret protection trainingAscentage Pharma actively conducts trade secr
163、et protection training for new employees through an online course platform.The training focuses on sharing case studies of trade secrets in the medical field and uses videos to convey trade secret knowledge concerning intellectual property,making it easy to understand and effectively enhancing emplo
164、yees expertise.Intellectual property themed sharing sessionTo enhance cross-departmental understanding of intellectual property-related knowledge,Ascentage Pharma has invited a U.S.patent attorney from an external partner law firm to conduct a themed sharing session.The session focused on how intell
165、ectual property can effectively empower drug R&D,covering key topics such as patent portfolio strategy,Orange Book Listing,patent term extension(PTE),regulatory data protection(RDP),and intellectual property due diligence.2.3 R&D Ethics and MoralsIn appreciation of the trust and contributions of eve
166、ry patient involved in our clinical researches,Ascentage Pharma upholds the highest standards and a rigorous approach in all our work.We strictly abide by the Drug Administration Law of the Peoples Republic of China(中華人民共和國藥品管理法),the Implementing Regulations of the Drug Administration Law of the Peo
167、ples Republic of China(中華人民共和國藥品管理法實施條例),the Good Clinical Practice(藥物臨床試驗質量管理規範)and other relevant laws and regulations,ensuring the standardization and scientific approach of clinical trials and fully protecting the rights and safety of participants.27Environmental,Social and Governance Report 202
168、4 Ascentage Pharma Group InternationalEnvironmental,Social and Governance Report 2024In the United States,the U.S.Food and Drug Administration(FDA)regulates drugs under the Federal Food,Drug,and Cosmetic Act of 1938(FDCA).Drugs also are subject to other federal,state and local statutes and regulatio
169、ns.Our product candidates are considered small molecule drugs and must be approved by the FDA through the new drug application,or NDA,process before they may be legally marketed in the United States.The process generally involves,among others,approval by an independent institutional review boards(IR
170、B)or ethics committee at each clinical trial site before each trial may be initiated.The clinical stage of development involves the administration of the investigational product to healthy volunteers or patients under the supervision of qualified investigators,generally physicians not employed by or
171、 under the trial sponsors control,in accordance with Good Clinical Practice(GCP)requirements,which include the requirement that all research subjects provide their informed consent for their participation in any clinical trial.Clinical trials are conducted under protocols detailing,among other thing
172、s,the objectives of the clinical trial,dosing procedures,subject selection and exclusion criteria and the parameters to be used to monitor subject safety and assess efficacy.Each protocol,and any subsequent amendments to the protocol,must be submitted to the FDA as part of the IND submission.Further
173、more,each clinical trial must be reviewed and approved by an IRB for each institution at which the clinical trial will be conducted to ensure that the risks to individuals participating in the clinical trials are minimized and are reasonable in relation to anticipated benefits.The IRB must also appr
174、ove the informed consent form that must be provided to each clinical trial subject or his or her legal representative,and must monitor the clinical trial until completed.We ask participants to sign the Consent Letter of Participants in Clinical Trials(受試者知情同意書)before the clinical trial to protect th
175、e participants rights to be informed,rights to choose and their privacy rights.We require clinical trial personnel to maintain strict confidentiality of participants personal information,and we expressly prohibit the collection of,or participation in,research on participants information in the cours
176、e of clinical trials.During clinical trials,participants information is identified by number and regular process reviews are conducted to ensure clinical trial compliance and avoid leakage of participants privacy.Participants Rights Protection Initiatives28Ascentage Pharma Group International Enviro
177、nmental,Social and Governance Report 2024Environmental,Social and Governance Report 20243 Strict Quality Control and Sustainable SupplyAscentage Pharma always places product quality and safety and customer service experience,at the core of corporate development.We have established a comprehensive an
178、d rigorous Quality Management System(QMS).We constantly enhance service quality and responsible marketing management and build a sustainable supply chain to ensure the high quality and supply stability of our products.3.1 Quality and SafetyProduct quality and safety serve as the cornerstone of Ascen
179、tage Pharmas stable operations and sustainable development.We have established a systematic quality management system,continuously strengthened our capabilities in managing the entire lifecycle of pharmaceutical products,fostered a culture of quality awareness across all employees,enhanced drug safe
180、ty traceability mechanisms,and improved product recall systems.In doing so,we aim to achieve comprehensive improvement in product quality and safety assurance.3.1.1 Quality ManagementAscentage Pharma strictly follows the Drug Administration Law of the Peoples Republic of China,the Implementing Regul
181、ations of the Drug Administration Law of the Peoples Republic of China,the Administrative Measures of Drug Registration(藥品註冊管理辦法),the Announcement of the NMPA on Strengthening the Supervision and Administration of the Entrusted Production of Holders of Drug Marketing Licenses 國家藥監局關於加強藥品上市許可持有人委託生產監
182、督管理工作的公告),the Supervision and Management Provisions on the Implementation of the Main Responsibility for the Quality and Safety of Pharmaceuticals by the Holders of Drug Marketing Licenses(藥品上市許可持有人落實藥品質量安全主體責任監督管理規定),and the Guidelines for On-site Inspection of Manufacturing Entrusted by Holders of
183、 Drug Marketing Licenses(藥品上市許可持有人委託生產現場檢查指南)and other laws and regulations.Based on GMP1,cGMP2,GCP3,GVP4 and other quality management standards,we have established a quality management system,implementing systematic quality control throughout the entire pharmaceutical product lifecycle from R&D and
184、 technology transfer through commercial production to product discontinuation.1 GMP:Good Manufacturing Practice2 cGMP:Current Good Manufacturing Practice3 GCP:Good Clinical Practice4 GVP:Good Pharmacovigilance Practice29Environmental,Social and Governance Report 2024 Ascentage Pharma Group Internati
185、onalEnvironmental,Social and Governance Report 2024We have formulated a set of comprehensive quality management systems including Quality Policy and Objectives(質量方針與目標),the Management Regulations on Changes during the Clinical Period(臨床期間變更管理規程),Release of Products from the Factory(產品出廠放行)and Releas
186、e of Products on the Market(產品上市放行).During the Reporting Period,we newly established new systems such as the Commercial Product Supply Risk and Business Continuity Management Protocols(商業化產品供應風險和業務連續性管理規程)and Product Process Parameter Controls(產品工藝參數管理).We also kept optimizing existing protocols inc
187、luding the Product Batch Number,Manufacturing Date and Expiry Date Management(產品批號,生產日期和有效期管理)and Corrective Action and Preventive Action(CAPA)Tracking System(糾正預防措施(CAPA)跟蹤系統管理).These continuous improvements to our quality management system framework serve to strengthen the awareness of primary res
188、ponsibility for drug quality and ensure the fulfillment of high-standard pharmaceutical quality requirements.To ensure the stable operation of our quality management system,we have established a GMP-compliant quality governance framework under the overall guidance of the Chairman and CEO,managed on
189、a daily basis by the Senior Vice President&CMC5 Head,and operating with active participation from key departments including Production Operations,Quality Assurance,Analytical&Quality Control,and Supply Chain departments.5 CMC:Chemistry,Manufacturing and Control30Ascentage Pharma Group International
190、Environmental,Social and Governance Report 2024Environmental,Social and Governance Report 2024We actively pursue the necessary pharmaceutical production qualifications and quality system certifications.During the Reporting Period,Ascentage Suzhou obtained both Drug Manufacturing License(Certificate
191、B)and Drug Manufacturing License(Certificate C),passed the GMP compliance inspection,and received an official notification confirming“Compliance”in January 2025.Additionally,during the Reporting Period,Ascentage Pharma successfully obtained ISO 9001 Quality Management System certification,with the c
192、ertification scope encompassing 100%of the Companys manufacturing sites.Drug Manufacturing License and System CertificationScope of CertificationDrug Manufacturing License(Certificate A)Ascentage SuzhouDrug Manufacturing License(Certificate B)Healthquest PharmaAscentage SuzhouDrug Manufacturing Lice
193、nse(Certificate C)Ascentage SuzhouPassed the annual inspection of the Biosafety Laboratory Certificate of Record(BSL-2 level)issued by the Suzhou Municipal Health Commission in 2024Ascentage Suzhou Microbiology LaboratoryEU QP GMP CertificationAscentage SuzhouPassed the GMP compliance inspection in
194、2024Ascentage SuzhouISO 9001 Quality Management System CertificationAscentage Suzhou31Environmental,Social and Governance Report 2024 Ascentage Pharma Group InternationalEnvironmental,Social and Governance Report 2024Ascentage Suzhou passed the GMP compliance inspectionAscentage Suzhou ISO 9001 Qual
195、ity Management System Certificate Quality TestingWe have formulated and implemented internal drug quality inspection practices such as physical,chemical and microbiological testing,and quality standards for raw and auxiliary materials as well as finished products in accordance with the Good Manufact
196、uring Practice of Medical Products(藥品生產質量管理規範)and other laws and regulations,as well as the current pharmacopoeia standards of China,the United States,and Europe.We have established in-house analytical and quality control laboratories at both our R&D center and production bases,and performed quality
197、 tests on all product batches in accordance with the relevant codes of practice and quality standards.Meanwhile,we follow the GDP6 for inspection records,reviewed in accordance to our internal QC Laboratory Analytical Data Audit(QC實驗室分析數據審核)process.Additionally,we engage certified third-party labora
198、tories to conduct quality testing for selected raw materials and excipients.6 GDP:Good Documentation Practice32Ascentage Pharma Group International Environmental,Social and Governance Report 2024Environmental,Social and Governance Report 2024Product TestingDuring the Reporting Period,we completed a
199、total of 156 raw and auxiliary materials quality testing,80 tests for intermediate products and finished goods,761 stability testing,and 931 testing items for packaging materials and clinical labels.The product testing achieved 100%batch coverage,with all testing items meeting quality standards and
200、a 100%compliance rate.Additionally,three batches of olverembatinib tablets produced by our Company underwent sampling inspection by the Suzhou Inspection Branch of Jiangsu Medical Products Administration in September 2024.The Suzhou Drug Inspection and Testing Research Center confirmed compliance wi
201、th drug registration standards and issued qualified inspection reports.Product Testing OptimizationTo further improve process control and internal testing capabilities,Ascentage Pharma keeps optimizing its product manufacturing processes,testing methods,and quality standards.During the Reporting Per
202、iod,we improved 6 manufacturing processes,upgraded 5 product quality standards,and refined 7 testing methodologies.Simultaneously,we expanded in-house testing capabilities by introducing advanced analytical instruments and optimization of internal resources.Notable enhancements included one gas chro
203、matography-mass spectrometry(GC-MS)system,one liquid chromatography-secondary mass spectrometry(LC-MS2)system,and one microwave digestion system for the quality control laboratory.33Environmental,Social and Governance Report 2024 Ascentage Pharma Group InternationalEnvironmental,Social and Governanc
204、e Report 2024Quality Risk AssessmentIn compliance with the ICH Q9 Quality Risk Management(質量風險管理)guideline,we have implemented comprehensive risk assessment,control,communication,and review throughout the drug product lifecycle.Also,precautionary testing and control measures are rigorously applied i
205、n critical areas including product stability studies and quality testing,thereby ensuring product quality and safety.During the Reporting Period,we completed 15 quality risk assessment reports,covering critical pharmaceutical stages including production,testing,storage,logistics,and computerized sys
206、tems.We also established precautionary testing and control measures targeting both critical quality risks and emerging quality and safety concerns.Quality risk management tools were applied to quality sensitive activities such as change control management,deviation handling,internal audits,and custo
207、mer complaint management.These measures provided a solid foundation and robust safeguard to ensure the continuous supply of safe,effective,and quality-controlled pharmaceutical products.Moreover,we established a business continuity program for product supply based on the quality risk management,and
208、implemented systematic risk assessment and control measures to ensure stable and continuous supply operations within acceptable risk thresholds.Non-Conforming Products ControlWe have established and continuously improved the Procedures for Handling Non-Conforming or Waste Materials and Products(不合格或
209、廢棄物料和產品的處理)in compliance with applicable laws and regulations.This document specifies comprehensive handling protocols and workflows to ensure full-process control and traceability of non-conforming products,preventing unauthorized diversion or reuse.In addition,according to the Guidelines for Inves
210、tigating Unusual Events,Exceedances and Out-of-trend Results(異常事件、超標及超趨勢結果調查指南),we initiate investigations into non-conforming products.Through systematic analysis of investigation findings,we identify the root cause and recommend effective corrective actions and preventive measures,thereby driving
211、continuous improvement and upgrade in both process control capabilities and inspection performance.34Ascentage Pharma Group International Environmental,Social and Governance Report 2024Environmental,Social and Governance Report 2024 Quality AuditAscentage Pharma conducts regular quality audits and p
212、ractices demanding drug quality standards.During the Reporting Period,we keep on-going supervision of and made improvements to the quality management in clinical trials and manufacturing processes through both internal and external audits.Internal Audit Throughout the year,we organized 3 internal au
213、dits,covering the six GMP systems.These audits were performed in strict compliance with current GMP regulations and Marketing Authorization Holder(MAH)requirements,which resulted in the identification of over 30 improvement requirements and recommendations,all of which were effectively implemented.O
214、ur quality management system demonstrated robust performance with no material quality or compliance risks identified.External Audit We engaged a professional third-party audit team to conduct quality audits of our quality management system based on the standards of the Chinese,European Union and U.S
215、.Good Manufacturing Practice(GMP)to ensure compliance with the high standards of drug quality regulatory requirements.Internal and External Quality Audits Quality CultureAscentage Pharma appreciates the significance of quality culture development.We implement a professional e-learning system to deli
216、ver mandatory annual quality training for all employees,supported by dedicated training coordinators who utilize the systems tracking functionality to monitor individual training completion status,thereby ensuring the integrity and effectiveness of our quality management training program.In 2024,we
217、carried out comprehensive training programs on quality control and product safety,including the GMP and Pharmaceutical Regulatory Laws and Regulations,Quality Control Management Guidelines and General Testing Procedures for Product Samples.These initiatives aimed to strengthen all employees quality
218、management awareness and enhance our overall quality control capabilities.35Environmental,Social and Governance Report 2024 Ascentage Pharma Group InternationalEnvironmental,Social and Governance Report 2024During the Reporting Period,Ascentage Pharma delivered various quality management training pr
219、ograms with over 37,000 attendances,with an on-time completion rate exceeding 99%.“Quality Golden Idea”CampaignOur“Quality Golden Idea”campaign achieved significant recognition and achieved fruitful results in 2023.After revising evaluation criteria and widening the scope of subjects,we relaunched t
220、he program in 2024 to solicit outstanding suggestions from all employees on enhancing regulatory compliance,product quality,production efficiency,and other areas.During the Reporting Period,we collected over 30“Golden Ideas”proposals,evaluated them and selected those qualifying for awards.All awarde
221、d proposals were fully adopted and implemented,giving new impetus to the continuous improvement of quality management.3.1.2 Drug Safety and TraceabilityAscentage Pharma is committed to implementing drug safety lifecycle management,establishing multilayered health protection shields.With the objectiv
222、e of establishing a pharmacovigilance system compliant with high-quality standards,we strictly adhere to the Good Pharmacovigilance Practice(藥物警戒質量管理規範),the Good Manufacturing Practice of Medical Products(藥品生產質量管理規範),the Provisions on the Administration of Pharmaceutical Directions and Labels(藥品說明書和
223、標籤管理規定),and other relevant regulatory requirements and GMP standards.We have formulated and implemented management systems including the Monthly Pharmacovigilance Quality Management Procedures(藥物警戒月度質量管理規範),the Pharmacovigilance Business Continuity Plan(藥物警戒業務連續性計劃),the Drug Safety Incident Emergenc
224、y Response Plan(藥品安全事件應急預案),and the Labelling Control Procedures for Drug for Trial Use(試驗用藥品標籤控制規程).Furthermore,we have developed rigorous safety management plans to conduct safety assessments at all phases of the product lifecycle,establishing and improving our pharmacovigilance management system.
225、We have also established a Drug Safety Committee comprising experts in medicine,pharmacovigilance,preclinical development,and regulatory affairs.The committee holds regular annual meetings to oversee critical pharmacovigilance matters,including post-marketing safety surveillance,major risk assessmen
226、t,handling of significant or urgent drug-related incidents,and risk control decision-making.36Ascentage Pharma Group International Environmental,Social and Governance Report 2024Environmental,Social and Governance Report 2024We,along with our subsidiaries holding marketing authorization,have adopted
227、 a unified pharmacovigilance management model and implemented full-process digital management of Individual Case Safety Reports(ICSRs)through the global drug safety database(Argus system),which enables integrated analysis of multi-source data including clinical trials,real-world evidence,independent
228、ly initiated reports,and literature.Therefore,a comprehensive safety event information repository for our pharmaceutical products has been established.We also regularly conduct safety signal detection and management for drugs.During the Reporting Period,we intensified our efforts in pre-market and p
229、ost-market drug safety management.We have entered into a pharmacovigilance agreement with Healthquest Pharma(our subsidiary),under which we are entrusted to conduct comprehensive pharmacovigilance activities for Healthquest Pharma,including monitoring,reporting,evaluating,signal detection,data minin
230、g,and risk management and control of adverse drug reactions.Pre-marketing Phase:During clinical trials,we optimize study design to implement comprehensive and frequent follow-up and monitoring of participants,enabling timely detection and management of adverse events.Concurrently,we enhance communic
231、ation and collaboration with clinical trial institutions through regular training and knowledge-sharing initiatives to elevate investigators pharmacovigilance awareness and safety monitoring capabilities.Post-marketing Phase:We have established effective communication channels targeting healthcare p
232、rofessionals,pharmacists,patients,and regulatory authorities,including a dedicated customer service hotline in the product manual,and a dedicated pharmacovigilance reporting email address displayed on our website.Through these channels,we collect adverse reaction data from clinical practice,post-mar
233、keting studies,market research programs,scientific literature,regulatory feedback,and public websites/forums monitoring.Meanwhile,we actively conduct various post-marketing studies and market surveillance research and launch patient education programs to enhance drug safety awareness.In full complia
234、nce with regulatory requirements,we actively collaborate with local health authorities on drug safety monitoring initiatives,performing routine safety signal detection and management for marketed products.Pre-marketing and Post-marketing Drug Safety Management37Environmental,Social and Governance Re
235、port 2024 Ascentage Pharma Group InternationalEnvironmental,Social and Governance Report 2024To ensure public drug safety and achieve comprehensive drug traceability,Ascentage Pharma has developed a Drug Traceability System(藥品追溯體系)in compliance with regulatory requirements including the Guidelines f
236、or the Development of Drug Information Traceability System(藥品信息化追溯體系建設導則)and Drug Traceability Code Encoding Standards(藥品追溯碼編碼要求).This system clearly defines the roles and responsibilities for the use and maintenance of the drug traceability system and codes.We adopt Alibaba Healths“Ma Shang Fang Xi
237、n Drug Traceability System”to manage pharmaceutical data tracking,which enables the real-time and accurate capture of the related information of end-to-end drug distribution and utilization and submits the relevant data to regulatory authorities in full compliance with regulatory mandates.In drug tr
238、aceability data utilization,Ascentage Pharma provides traceability information to downstream pharmaceutical distributors and healthcare institutions for their verification and feedback.Concurrently,we offer drug traceability query services to consumers through our traceability system,with all query
239、content strictly compliant with the Basic Dataset Standards for Drug Traceability Consumer Inquiries(藥品追溯消費者查詢基本數據集).3.1.3 Product RecallIn China,Ascentage Pharma complies with the Good Manufacturing Practice of Medical Products(Revised in 2010)(藥品生產質量管理規範(2010年修訂)and the Measures for the Administra
240、tion of Drug Recalls(No.92 of 2022)(藥品召回管理辦法(2022年第92號),and optimized the Commercialized Product Recall Procedures(商業化產品召回程序)during the Reporting Period to further improve standardized drug recall procedures.We also carried out annual product recall drills to ensure a compliant and efficient product
241、 recalls.38Ascentage Pharma Group International Environmental,Social and Governance Report 2024Environmental,Social and Governance Report 2024 Recall reason and health hazard assessmentRecall case assessment First level recall:within one day Second level recall:within three days Third level recall:w
242、ithin seven daysDetermine recall level Submit recall plan and investigation report to relevant departments Publish product information and recall plans on the Companys official website and update them in a timely mannerRecall plan and investigation The person in charge of the recall follows up the r
243、ecall processExecute recall Report to the Company and relevant departments the recall progressProgress reporting Internal evaluation of recall effects Disposal of recalled products as required Prepare recall conclusion reportRecall conclusion reportNotice of recall Within the time specified in the r
244、ecall level to notify the relevant enterprises and users to stop shipping,sales and use of defective productsProduct Recall ProcessProduct Recall DrillsDuring the Reporting Period,we carried out two product recall drills to validate and strengthen the effectiveness of our product traceability and re
245、call processes.They were based on simulations of discovering quality defects in drug products and pharmaceutical raw materials,and promptly started the corresponding batch traceability,and both of them realized 100%effective traceability of the defective drugs and materials within the stipulated tim
246、e.This confirmed and improved our product recall capability.During the Reporting Period,Ascentage Pharma did not have any product recalls due to safety and quality reasons.39Environmental,Social and Governance Report 2024 Ascentage Pharma Group InternationalEnvironmental,Social and Governance Report
247、 20243.2 Service ExcellenceCustomer Complaint ManagementAscentage Pharma adheres to the value of“Patient first”and takes customer feedback as an important driving force for continuous improvement.We have established multi-dimensional customer communication and complaining channels to collect consult
248、ation,feedback and complaints,and conducted technical investigations and handling of product complaints in a timely manner in accordance with the Product Complaint Handling and Technical Investigation(產品投訴處理和技術調查),the Investigation of Product Quality Complaints(產品質量投訴調查),to continuously improve the
249、quality of our products and services and customer satisfaction.During the Reporting Period,we received a total of 0 complaints about our products and services.Receiving and recording complains Internal complain channels:e-mail,telephone,oral complaint,etc.External complain channels:national service
250、hotline 400-168-1351 and third-party platforms Prepare Product Complaint Form（產品投訴表）and Product Complaint Tracking Log（產品投訴追蹤日誌）to record complaints Conduct product technical investigation based on product descriptions Formulate corrective and preventive measures based on fundamental reasons and inp
251、ut into the Corrective Action and Preventive Action(CAPA)Tracking System（糾正預防措施（CAPA）跟蹤系統）Notify complainants of the investigation results and relevant information Review and summarize complaint records and conduct management evaluation of products being complainedTechnical investigations on product
252、s being complainedClosure of complaint proceduresHandling Procedure of Product Complaints40Ascentage Pharma Group International Environmental,Social and Governance Report 2024Environmental,Social and Governance Report 2024Responsible MarketingAscentage Pharma attaches great importance to responsible
253、 marketing and has formulated the Responsible Marketing Policy(負責任營銷政策),which applies to all employees of the Company(including full-time employees,part-time employees,and temporary employees),and encourages suppliers and other business partners to comply with it.We have established and implemented
254、a mechanism for reviewing and supervising responsible marketing materials,requiring all marketing materials to be reviewed and approved by the Companys Medical Affairs Department and Marketing Department prior to release to avoid misleading information and omission of information.We also conduct reg
255、ular monitoring and inspection of our marketing and market practices to identify and correct potential non-compliance and mistakes in a timely manner and to ensure that our marketing materials and activities comply with laws and regulations,internal systems and ethical standards.In addition,we engag
256、e an external auditor to conduct audits on our sales and marketing practices on a semi-annual basis.The scope of the review covers the standardized management of the overall sales process,including the signing of sales contracts,the implementation of the sales system,and the substantive review of sa
257、les expenses,etc.,to ensure that the marketing activities and sales business processes are in compliance with the regulations.We have also formulated the Compliance and Expense Management System for Sales and Academic Activities(銷售與學術活動合規和費用管理制度)to safeguard the authenticity,reasonableness and compl
258、iance of the product promotion and sales process.To build a culture of responsible marketing,we formulate a responsible marketing training program and case study exercise covering all employees every year to ensure that employees are aware of and comply with the relevant systems and standards.During
259、 the Reporting Period,we organized 14 responsible marketing training and examinations for our marketing staff and conducted all-staff responsible marketing training and practical exercises to enhance their understanding of compliant marketing,academic knowledge of our products,principles and require
260、ments of interaction with patients,and protection of consumer rights and interests.In terms of customer privacy protection,we strictly comply with laws and regulations on information and privacy protection such as the Personal Information Protection Law of the Peoples Republic of China(中華人民共和國個人信息保護
261、法),to ensure that all patients personal data and privacy information are adequately protected and properly handled.We require all patient personal data and privacy information to be kept only in medical institutions and pharmacies by healthcare professionals,and the Company does not receive or store
262、 any patient personal data.41Environmental,Social and Governance Report 2024 Ascentage Pharma Group InternationalEnvironmental,Social and Governance Report 20243.3 Supply Chain ManagementAscentage Pharma builds a standardized supplier management system,implements the supplier full life-cycle managem
263、ent,ensures the safety and stability of the supply chain,and continuously improves the quality of suppliers products and services.At the same time,we focus on the sustainable development of the supply chain and are committed to establishing a fair and equitable supply chain partnership with mutual b
264、enefits and mutual prosperity,so that we can work together to realize long-term value creation.3.3.1 Supplier Management SystemAscentage Pharma has established and implemented a supplier management system comprising,among others,the Procurement and Supply Management Regulations(採購供應管理規程),the Regulat
265、ion for GMP Materials Procurement Management(GMP物料採購管理規程),the GMP Supplier Management Regulations(GMP供應商管理規程)and Tendering and Bidding Management Regulations(招投標管理規程).Also,during the Reporting Period,we established the Code of Conduct for Suppliers(供應商行為準則),which explicitly specified our expectation
266、s for suppliers in areas such as business ethics,quality,labor and employment,health and safety,and environmental protection.In addition,we optimized and upgraded the Procurement and Supply Management Regulations(採購供應管理規程)and other systems to continuously improve the standardized procurement process
267、.Additionally,we follow the procurement and supply principles of resource sharing,comprehensive assessment of procurement and planned procurement to ensure rational and efficient allocation of resources.We have applied digital tools such as the one-stop business travel and expense management platfor
268、m HELIOS system,the Office Automation(OA)system,the Good Supply Practice(GSP)system for pharmaceutical business management,and the ZKH Procurement Platform(a Chinese B2B procurement platform),and introduced inventory visualization management to achieve efficient tracking of inventory supply,thereby
269、improving supplier management efficiency.In 2024,we continued to conduct performance verification of the Warehouse Management System(WMS),and substantially completed the integration of GMP material procurement management into the WMS system,further enhancing our supply chain digital management capab
270、ility.42Ascentage Pharma Group International Environmental,Social and Governance Report 2024Environmental,Social and Governance Report 2024 Supplier Full Life-cycle ManagementWe have implemented a supplier full life-cycle management process covering supplier selection review,procurement review,coope
271、ration assessment,and elimination mechanism to guarantee standardized supplier management,effectively reduce supplier cooperation risks,and ensure the compliance and stability of our production operations.Selection review:Review the basic information of the supplier to ensure that it meets pharmaceu
272、tical standards in accordance with the Questionnaire for the Manufacturer or Dealer of GMP Materials(GMP物料製造商經銷售調查表)or the Questionnaire for the GMP Services Providers(GMP服務商調查表)Conduct supplier background and risk checks by downloading and reviewing corporate credit reports,etc.to assess their cred
273、it history and compliance Review due diligence reports prepared by third party due diligence vendors or the suppliers themselves.We conduct multi-channeled assessment and keep potential risks to manageable levels by understanding the detailed information of the suppliers operating entities,previous
274、and existing business relationships and experiences with us or our employees,the suppliers relationships with government,third party subcontracting and control and compliance eventsProcurement review:In key bidding projects,supplier information will be reviewed jointly by the legal department,EHS(En
275、vironmental,Health and Safety)department,infrastructure department,finance department,compliance department,marketing department and procurement department We engage professional third-party vendors to prepare compliance report and evaluate for suppliers in key procurement categories.In particular,a
276、 professional third party consultant will be engaged to conduct the professional construction audit at the settlement of key fixed assets procurements43Environmental,Social and Governance Report 2024 Ascentage Pharma Group InternationalEnvironmental,Social and Governance Report 2024Cooperation asses
277、sment:For GMP suppliers,the Company categorizes GMP suppliers into 3 levels(i.e.Risk Level III,Risk Level II,Risk Level I)according to risks in a descent order based on a comprehensive assessment of the likelihood,severity,and detectability of quality defects of the materials or services supplied by
278、 the suppliers,and ensures that activities such as the addition,change,removal,and disqualification of the materials or services supplied by the GMP suppliers follow the corresponding regulations in accordance with the strict protocolsRisk LevelType of Material SuppliedType of Service SuppliedIIISta
279、rting material for Active Pharmaceutical Ingredients(API)production,pharmaceutical excipients,internal packaging materialsCommissioned production of API,commissioned production/commissioned primary packaging of formulated products,commissioned inspectionIIOther materials for API production,printed o
280、verpack materials,key GMP consumables in direct contact with the productCommissioned production of starting material,commissioned secondary packaging of formulated products,commissioned storage,commissioned destruction of controlled waste,commissioned transport with temperature control requirementsI
281、Non-printed overpack materials,other key GMP consumablesCommissioned audits,preventive maintenance,calibration and metrology,validation and verification,commissioned transport without temperature control requirements,pest control,GMP consultancySupplier Risk Level Classification44Ascentage Pharma Gr
282、oup International Environmental,Social and Governance Report 2024Environmental,Social and Governance Report 2024 Develop an annual quality audit plan based on supplier levels and internal supplier risk levels,conduct on-site quality audits of suppliers and strengthen supply chain management and revi
283、ew to ensure supply quality and reliabilitySupplier audit initiativesOur supplier audits cover different categories of GMP material supply and GMP services such as commissioned production service of starting material,commissioned production service of chemical API,and pharmaceutical excipients.The a
284、udit dimensions include quality management,EHS management,qualification and credit,etc.On-site audits will be conducted at least once every two years for higher risk materials or GMP services,and once a year for commissioned production of preparations.We have also selected a professional third-party
285、 auditing company to conduct audits of the factories of overseas suppliers(mainly imported excipient suppliers),and to review the compliance status of the plants,facilities and quality systems of the excipient suppliers production sites.During the Reporting Period,we conducted quality audits of our
286、Tier 2 suppliers of starting material for olverembatinib to ensure that their qualifications and product quality met FDA regulatory requirements.During the Reporting Period,we completed a total of 21 supplier audits and signed 28 supplier quality agreements;in response to the problems identified in
287、the audits,we promptly urged our suppliers to make quality improvements,so as to build a strong supply chain quality defense for high-standard product quality.Elimination mechanism:Suppliers involved in quality incidents and suppliers who are identified with serious deficiencies in the audit and fai
288、l to rectify,or who seriously violate national laws and regulations or contract terms,will be blacklistedDuring the Reporting Period,we had a total of 1,075 suppliers,among which 978 were in Mainland China,Hong Kong,Macau and Taiwan,while 97 were from overseas.45Environmental,Social and Governance R
289、eport 2024 Ascentage Pharma Group InternationalEnvironmental,Social and Governance Report 2024 Supplier Support and CooperationAscentage Pharma conducts a number of supplier quality management training programs for different categories of suppliers every year.Meanwhile,we actively participate in var
290、ious industry exchanges and forums to discuss supplier relationship management and risk control,supply chain stability,digital empowerment,sustainable sourcing and certification,and other aspects of communication.Supplier quality communication and support After the quality audit,conduct annual speci
291、al quality training for all key API manufacturers and suppliers for commissioned production of preparations to help the suppliers correctly understand,thoroughly investigate and effectively rectify the problems identified in the audit process.Conduct training for pest control service providers on qu
292、ality management system and industry regulations and an in-depth look at GMP requirements and standards for pest control in pharmaceutical plants,to effectively empower pest control suppliers to improve their corporate quality management system and compliance with CMP requirements.Strength quality r
293、equirements for suppliers of high-density polyethylene(HDPE)bottles,prompting suppliers to upgrade quality control standards,add new on-site control equipment,and optimize HDPE production processes.Industry training and exchanges Participate in industry events such as the 2nd China ESG-Manufacturing
294、 Procurement Forum in 2024 to exchange industry development trends and excellent practices,and to promote communication and cooperation with upstream and downstream suppliers.46Ascentage Pharma Group International Environmental,Social and Governance Report 2024Environmental,Social and Governance Rep
295、ort 2024 Supply Chain Stability AssuranceStable supply of commercialized products is a key element that contributes to Ascentage Pharma overall supply chain stability.We have actively mobilized various internal functional departments to calculate and project the demand plans for long-cycle materials
296、 and maintain close communication with suppliers to secure the inventory of upstream supplies such as API,starting material,packages,reagents and consumables.During the Reporting Period,we planned to establish an inventory of over 12 months of supplies for olverembatinib API,taking into account the
297、existing inventory of olverembatinib API,the contracted volume to be delivered and the production plan for 2025.Furthermore,adequate year-round supply of production-related materials and excipients is a metric for the Procurement Departments performance appraisal as a way to strengthen the continuou
298、s supervision and control of supply stability.The Procurement Department of the Company also carries out the development and inspection of alternative suppliers from time to time,and implements the dual sourcing strategy to minimize risk of supply disruption.In order to ensure the stable supply of c
299、ommercialized product of olverembatinib tablets,during the Reporting Period,our subsidiary,Ascentage Suzhou,was added as a manufacturer to produce our commercialized product,olverembatinib tablets,internally.In order to ensure a stable drug supply,Ascentage Pharma has joined hands with its logistics
300、 partners to build a global clinical drug supply center.As at the end of the Reporting Period,we had conducted clinical product trials in 18 countries and established 15 distribution centers,which has ensured the access to drugs and their timely and intact delivery to patients in urgent need.47Envir
301、onmental,Social and Governance Report 2024 Ascentage Pharma Group InternationalEnvironmental,Social and Governance Report 2024Environmental considerations Green and environmental protection requirements for logistic suppliers:In terms of pharmaceutical cold chain logistics,we give priority to green
302、logistics service providers(such as Sinopharm Logistics that has obtained energy-saving product certifications)to promote energy conservation and emission reduction in the supply chain.Environmental protection considerations for supplies under the GMP category and printed packaging materials:We give
303、 priority to GMP suppliers that have established environmental protection systems such as those that have obtained relevant environment certifications.3.3.2 Sustainable Supply ChainAscentage Pharma is committed to building a high-quality,responsible and sustainable supply chain by comprehensively id
304、entifying,evaluating and controlling potential ESG risks in all aspects of the supply chain.During the Reporting Period,we optimized the Procurement and Supply Management Procedures(採購供應管理規程)by adding quality and environmental protection certifications,carbon neutrality and employment compliance to
305、the evaluation of supplier qualifications,as well as incorporating suppliers ESG competencies into the selection of evaluation items.In the course of cooperation with various suppliers,we have also taken into account ESG factors such as environmental protection,employment compliance,labor rights and
306、 interests,quality management and anti-corruption.48Ascentage Pharma Group International Environmental,Social and Governance Report 2024Environmental,Social and Governance Report 2024Social considerations Compliant employment requirements for outsourced suppliers:For the suppliers who provided contr
307、acted staff to us,we strictly require that their employment of the staff is in compliance with the relevant laws and regulations through bidding requirements and contract clauses to protect interests of employees at the outsourced suppliers,and we reserve the right to spot check the implementation f
308、rom time to time.Quality management system for suppliers under GMP categories:We require suppliers to have a mature and complete quality management system,and conduct ESG risk reviews on GMP material suppliers according to the Questionnaire for the Manufacturer or Dealer of GMP Materials(GMP物料製造商經銷售
309、調查表)or the Questionnaire for the GMP Services Providers(GMP服務商調查表)to prevent potential quality risks.Safety management requirements for suppliers of incoming construction services:We carry out safety management trainings quarterly,covering the safety management responsibilities for incoming construc
310、tion suppliers,basic construction site safety requirements,etc.We have conducted a total of 120 training sessions in 2024.Governance considerations Compliance and anti-corruption commitments and clauses:We set up due diligence questionnaires,request written commitments from our suppliers in relation
311、 to their business relationships and compliance events,and impose requirements on supplier integrity through anti-corruption clauses in our contracts.Anti-corruption review on the supply chain:Our legal and compliance departments review supply chain compliance and anti-corruption risks,incorporate b
312、usiness ethics requirements and hospitality and gift policies in our procurement processes,establish effective supervision and complaint channels,and strictly investigate and deal with anti-corruption related non-compliance matters and behaviors.49Environmental,Social and Governance Report 2024 Asce
313、ntage Pharma Group InternationalEnvironmental,Social and Governance Report 20244 Green Production,Safety AssuranceAscentage Pharma has always practised the concept of green development.To do that,it earnestly fulfills its environmental protection responsibilities,taking the initiative in addressing
314、climate change by strictly implementing the management of pollutant emission outputs,and committed to mitigating the negative impact on the environment.In addition,employee health and safety serve as the first line of monitoring on our production operations.We continue to improve the production safe
315、ty management system and strengthen the risk control mechanism to effectively improve occupational health and safety management.4.1 Environmental ManagementAscentage Pharma strictly abides by laws and regulations,continuously optimising its environmental management system by regularly carrying out i
316、nternal and external audits.We establish scientific environmental management objectives to guide the effective environmental work for better environmental management practices.4.1.1 Environmental Management SystemIn China,Ascentage Pharma strictly complies with the Environmental Protection Law of th
317、e Peoples Republic of China(中華人民共和國環境保護法),the Law of the Peoples Republic of China on Appraising of Environment Impacts(中華人民共和國環境影響評價法,and has formulated and continuously improved the Handbook for the Environment Management System(環境管理體系手冊),and a series of SOPs to clearly regulate environmental obje
318、ctives,performance and process management procedures and strictly prevent various environmental risks.We have developed the Environmental Management Policy(環境管理政策)to clearly stipulate the management practices in key environmental management areas such as environmental management,waste and emission m
319、anagement,and resource management.This policy is applied to production and operation activities of Ascentage Pharma and its subsidiaries.In addition,Ascentage Pharma has established a core environmental management structure composed of the Environment,Health and Safety(EHS)department and department
320、heads.The Board is responsible for regularly reviewing environmental management policies,performance related to environmental management and the achievement of objectives of the Company,supervising the implementation of environmental policies and ensuring the efficient operation of the environmental
321、 management system.We also strive to enhance the environmental protection awareness of all employees of the Company,and create a green development atmosphere through safety and environmental protection education for new employees and regular environmental protection trainings.50Ascentage Pharma Grou
322、p International Environmental,Social and Governance Report 2024Environmental,Social and Governance Report 2024During the Reporting Period,Ascentage Pharma has successfully obtained the ISO 14001 environmental management system certification,which covers 100%of the production bases of the Company,dem
323、onstrating our excellent environmental management performance.Environmental Management System CertificationWhile continuously strengthening the environmental management system,Ascentage Pharma regularly reviews the environmental management of all its operating sites through internal and third-party
324、audits in accordance with environmental protection regulations and relevant certification standards to ensure the effectiveness of the environmental management process.In response to the problems identified in the audit,we would require the relevant departments to correct the gaps and make improveme
325、nts in a timely manner to continuously improve the Companys environmental management performance.51Environmental,Social and Governance Report 2024 Ascentage Pharma Group InternationalEnvironmental,Social and Governance Report 2024Internal AuditExternal Audit In 2024,Ascentage Pharma conducted two in
326、ternal environmental audits on each department,including regular assessment on internal and external environmental pollution factors,effectiveness of environmental risk management mechanism,etc.In 2024,Ascentage Pharma conducted monthly environmental monitoring on all of its R&D and production sites
327、,covering a total of 21 testing items and 579 samples.The annual monitoring performance is normal,with all pollutants in compliance with national and local emission standards In 2024,Ascentage Pharma has undergone two external professional environmental compliance audits,including environmental mana
328、gement related to the research and development of oncology drugs,etc.In 2024,Ascentage Pharma has undergone a total of 8 environmental inspections and audits by external regulatory authorities,covering the storage and disposal of hazardous wastes,enforcement of pollution discharge permits,and treatm
329、ent of wastewater,waste gas and waste residue etc.Internal and external environmental auditExternal Environmental Compliance AuditIn 2024,Ascentage Pharma conducted a professional external environmental compliance audit on the management related to the research and development of antitumor drugs,wit
330、h a view to verifying the effectiveness of the environmental management system.The Phase I of the audit focused on reviewing the effectiveness of the hazard identification process,environmental factor assessment system and monitoring mechanism.Regarding the two identified management deficiencies,we
331、have implemented systematic rectification measures to enhance our management level and have successfully obtained the audit certification.The Phase II of the audit focused on the assessment mechanism of environmental objectives,risk management and control process,compliance evaluation system and eme
332、rgency response capabilities.The audit results showed that all the indicators satisfied the regulatory requirements.52Ascentage Pharma Group International Environmental,Social and Governance Report 2024Environmental,Social and Governance Report 2024During the Reporting Period,Ascentage Suzhou secure
333、d the approval to be a 2A-level green factory in Suzhou Industrial Park in 2024,along with obtaining the second batch of 3A-level green factories in Suzhou,and was conferred the“Advanced Unit of Eco-environmental Protection”,demonstrating the Companys remarkable achievements in environmental management.As at the end of the Reporting Period,Ascentage Pharma did not have any environmental pollution
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