科伦药业(002422):2025年环境、社会和公司治理报告（英文版）
原标题:科伦药业:2025年环境、社会和公司治理报告（英文版） abbreviations in this report, as set out below: Report Description Sichuan Kelun Pharmaceutical Co., Ltd. KELUN PHARMA, the Company, weThis report is the 14th publicly released Environmental, Social and Governance (ESG) Report of Sichuan Kelun Pharmaceutical Co., Ltd. (hereinafter referred to as "KELUN PHARMA", "the Company" or "we"). It systematically Sichuan Kelun Pharmaceutical Co., Ltd. Renshou Branch Renshou Branchelaborates on the Company's management objectives, practices and performance in the fields of governance, Sichuan Kelun Pharmaceutical Co.,Ltd. Guang'an Branch Guang'an Branchenvironment and society in 2025, aiming to fully respond to the concerns of all stakeholders and present our Sichuan Kelun Pharmaceutical Co., Ltd. Qionglai Branch Qionglai Branchcommitments and actions in advancing sustainable development.Sichuan Kelun Pharmaceutical Co., Ltd. Anyue Branch Anyue BranchReport Scope Sichuan Xinkaiyuan Pharmaceutical Co., Ltd. Xinkaiyuan Kunming Nanjiang Pharmaceutical Co.,Ltd. Kunming Nanjiang The report covers the period from January 1 to December 31, 2025, with certain contents retroactively reviewed or Hunan Kelun Pharmaceutical Co., Ltd. Hunan Kelun extended where appropriate. The report encompasses Sichuan Kelun Pharmaceutical Co., Ltd. and its subordinate Hunan Kelun Pharmaceutical Co., Ltd. Yueyang Branch Hunan Kelun Yueyang Branchsubsidiaries and branches. Hubei Kelun Pharmaceutical Co., Ltd. Hubei Kelun Jiangxi Kelun Pharmaceutical Co., Ltd. Jiangxi Kelun Data Source Guizhou Kelun Pharmaceutical Co., Ltd. Guizhou Kelun All information and data disclosed in this report are derived from the Company's internal official documents, annual Shandong Kelun Pharmaceutical Co., Ltd. Shandong Kelun reports and other public reports, raw operational data, public data released by government authorities, annual financial Henan Kelun Pharmaceutical Co., Ltd. Henan Kelun data, and third-party evaluation interviews, among others. Financial data in this report is denominated in RMB. In case of Guangxi Kelun Pharmaceutical Co., Ltd. Guangxi Kelun any inconsistency with the financial reports, the financial reports shall prevail. The Company warrants that there are no false records, misleading statements or material omissions in the contents of this report.Sichuan Kelun Pharmaceutical Research Institute Company Limited Kelun Pharmaceutical Research Institute Sichuan Kelun-Biotech Biopharmaceutical Company Limited Kelun-BiotechConfirmation and Approval Yili Chuanning Biotechnology Co., Ltd. CHUANNING BIOTECH Ili Jiangning Biotechnology Co., Ltd. JIANGNING BIOTECH This report has been confirmed by the management and approved by the Board of Directors on April 1, 2026. Ili Yongning Biopharmaceutical Co., Ltd. Yongning BiopharmaceuticalKhorgos Jinhe Biotechnology Co., Ltd. JINHE BIOTECH Compilation Basis Horgos Jinhe Biotechnology Co., Ltd. Jinhe Biotechnology Horgos BranchChengdu Qingshan Likang Pharmaceutical Co., Ltd. Qingshan LikangSelf-Regulatory Guidelines No. 17 for Companies Listed on Shenzhen Stock Exchange—Sustainability Report (For Trial Chongzhou Junjian Plastic Co., Ltd. Junjian Plastic Implementation) Sichuan Xindi Biopharmaceutical Co., Ltd. XINDI BIOTECH Self-Regulatory Guidelines No. 3 for Companies Listed on Shenzhen Stock Exchange—Compilation of Sustainability Report. Kelun-Kazpharm Co., Ltd. Kelun-Kazpharm GRI Sustainability Reporting Standards (GRI Standards) by Global Reporting Initiative (GRI)Celogen Lanka Co., Ltd. Celogen Lanka United Nations Sustainable Development Goals (UN SDGs) Morgan Stanley Capital International ESG ratings (MSCI ESG rating) Report AccessReport AccessReport Access The electronic version of this report is available for viewing and downloading on the Company's official website (Sichuan Not material Materiality to KELUN PHARMA's finance Highly materialrisks and opportunities results, and establish a mechanism faced by the Company, stakeholder interests. for continuous forming a list. monitoring and Environmental Social Governance dynamic optimization. No. Material Topic No. Material Topic No. Material Topic No. Material TopicEnvironmental Corporate governance ensuring that the R&D direction is consistent with the Company's strategy and social needs from the top level. Meanwhile, we have established a three-level intellectual property (IP) management structure with the General Manager as the top person in charge, including the "Intellectual Property Committee — Intellectual Property Management Office — Intellectual Property Working Group". We integrate IP management into the entire life cycle from R&D project initiation KELUN PHARMA's R&D and Innovation Governance Structure to product launch, building a solid technological barrier. The Intellectual Property Management Office reports to the Intellectual Property Committee on a quarterly basis, covering matters such as patent applications, acceptance and activities. Property Potential Core Strategies for R&D and Innovation of KELUN PHARMA Risk Type Risk Description of Impact Cycle Financial Impact Occurrence or time windows, leading to loss of market long-term and market timing share New Drug R&D May lead to a Address unmet clinical needs by developing decline in corporate Risk of inefficient R&D Insufficient R&D efficiency and failure to Short, innovative drugs with differentiated Medium, operating income operations and poor meet expected R&D progress, leading to medium, advantages and global potential high and an increase in project management reduced product competitiveness long-termR&D expenses Risk of Failure to achieve the expected commercial underperforming value of products, which may affect Medium, Medium-term, product commercial corporate strategic adjustments and market high long-termvalue layout KELUN PHARMA's Product R&D and Technological Innovation Opportunity ListLikelihood Potential Financial Opportunity Type Opportunity Description of Impact Cycle Impact Occurrence Opportunity of Technology Platform Construction AI-driven drug discovery acceleration Medium-term, applying cutting- High potentially speeding up R&D timelines long-term edge technologies of platforms such as ADC (Antibody-Drug Conjugate) and Opportunity of May lead to increased Policy and regulatory adjustments on raising new DC, and maintain and expand the leading advantages leveraging policy Short, medium, corporate operating industry entry barriers possibly reducing High and regulatory long-term in key technology fields such as ADC. Enhance the income and reduced excessive market competition changes R&D costs process of innovative drugs to improve R&D efficiency and Opportunity New technology platforms and management of upgrading Medium-term, transformation success rate practices adoption improving R&D quality Medium technology and long-term and efficiency management By comprehensively examining technological development trends, market dynamics, and changes in policies and Opportunity of regulations, and combining with the Company's R&D strategy and internal R&D capabilities, we continuously identify Global patent filing strategy for corporate May increase expanding globally Short, medium, products and innovation projects to secure IP Medium licensing and transfer potential risks and development opportunities in the process of product R&D and technological innovation, form a and growing long-term protection for international expansion income dynamic management list, and formulate and implement targeted management strategies to ensure the continuous and markets a high-quality domestic option for the first-line treatment of patients with Optimizing R&D a pipeline portfolio of Pipeline Portfolio metastatic colorectal cancer; Trastuzumab Botidotin (Trade Name: ?) was 舒泰莱 "innovation, improved successfully launched. innovation, and high-end generics", and allocate A New Drug Application (NDA) for Kelun-Biotech's A400 project has been Impact, Risk, and Opportunity Management resources rationally. accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China for the treatment of adult patients with RET fusion-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). To ensure the efficient and orderly conduct of scientific research activities, we have established a regular information ● reporting and decision-making mechanism, while assessing the potential impacts of relevant risks and opportunities on Progress in Biofermentation Products and Synthetic Biology Products R&D: the enterprise. Through regular and irregular strategic meetings, the project teams report project progress, key data and Ruikang Biotech completed the upgrading of the high-throughput strain breeding platform, the optimization of AI-enabled laboratory-scale fermentation achievements to the Project Approval Committee and Pipeline Committee of Kelun Pharmaceutical Research Institute. processes, the improvement of molecular modification of actinomycetes and After being collected and analyzed, this information ultimately supports the Group's Board of Directors in making streptomycetes, and the strain development of related amino acid products.strategic decisions. The Board of Directors comprehensively evaluates factors such as the scientific value and commercial value of projects, and conducts in-depth research and judgment on risks and opportunities to achieve the optimal Continuously increase balance between R&D input and output. Meanwhile, we focus on the continuous optimization of R&D processes. Project investment in and teams track indicators in real time, feed back and adjust R&D strategies timely, so as to ensure that R&D efficiency and construction of core elements, introduce achievements are at the leading level in the industry. leading scientists, and Strengthening the build a research team During the reporting period, the scale of the Company's R&D team continued to Construction of with high scientific expand, with a total of 2,799 R&D personnel, accounting for 13.91% of the total KELUN PHARMA's R&D and Innovation Risk and Opportunity Management ProcessR&D Talent Team research level and employees. international standards; and establish a sound internal training system to cultivate core R&D ● drug target discovery the fermentation output of antibiotic intermediates.An AI control model for Digital R&D Transformation biology. Optimize R&D processes In addition, we extend animal welfare and ethical requirements to the supply chain, and continuously improve the awareness and skills of all relevant personnel through training.Kelun-Biotech Conducts Audits on Laboratory Animal-Related Suppliers Anyue Branch Successfully Passes Acceptance of Sichuan Provincial Key Sci-Tech the patient-centered development philosophy, actively responds to the national medical and health system reform, Achievement Transformation and Demonstration Project Overseas Markets KELUN PHARMA's Strategy for Improving Healthcare AccessibilityWe continue to advance our internationalization strategy and actively expand into emerging markets and markets in developing countries, and have achieved remarkable progress in enhancing healthcare accessibility.
Medium and Long-Term Enhancing 2025 Progress Countries Sustainable Development Goal2 Program In Kazakhstan and Sri Lanka: We have deployed R&D in overseas We attach great importance to the advancement of medical and health undertakings in developing countries. Relying subsidiaries including Kelun-Kazpharm and Celogen Lanka, and on the Group's international development strategy, we closely cooperate with local partners and actively participate launched R&D projects based on investigations into local drug Launch R&D projects continuously, in various programs for enhancing local medical and health service capabilities. We formulate and continuously track Participating in regulatory authorities, hospitals and local market medication provide technical guidance to Public-Private demands. Overseas subsidiaries recruited local personnel who medium and long-term sustainable development goals, and jointly promote the improvement of medical service levels in R&D, quality and other personnel Partnerships to were arranged to receive guidance from Kelun Pharmaceutical developing countries. at overseas bases in the process, Enhance Local R&D Research Institute to enhance the local R&D capabilities in low and continuously improve local Capabilities in Low and middle-income countries. As of the end of the reporting personnel's R&D capabilities and the local level of pharmaceutical R&D Countries projects overseas. Among them, in Sri Lanka, two products Capacity through projects Medium and Long-Term (Metformin Hydrochloride Tablets and Omeprazole Capsules) and Enhancing 2025 Progress two small-volume liquid production lines have obtained EU GMP Sustainable Development Goal2 Program certification. In Kazakhstan: Kelun-Kazpharm has adopted an innovative Assisting Local cooperation model, established strategic cooperative relations Pharmaceutical In Sri Lanka: Celogen Lanka, invested by KELUN PHARMA in Cooperate with local regulatory Invest in building overseas factories in all local states, and realized the fast and accurate delivery of Enterprises in Low Sri Lanka, has become the first pharmaceutical enterprise in authorities such as drug to reduce medication costs and lead successful bid products to local hospitals by virtue of the local and Middle-income Sri Lanka to obtain EU GMP certification, which has greatly administrations to provide consulting times in low and middle-income distribution agent network; In Sri Lanka: Kelun Lifesciences Pvt. Countries in Meeting promoted the local pharmaceutical manufacturing level to meet and guidance for enterprises, countries, and shorten overseas Ltd. (Sri Lanka) directly distributed drugs to end-user institutions International international pharmaceutical production standards. In 2025, two enabling more products to obtain EU supply chains through local organizations, greatly cutting down intermediate Pharmaceutical newly added small-volume liquid production lines obtained EU GMP certification links and ensuring that drugs can serve patients in a timely and Production Quality GMP certification. effective manner. Standards Pharmaceutical Two newly added small-volume liquid production lines in the Supply Chains in Assist overseas production lines in two factories invested and constructed by us in Sri Lanka have Conduct continuous annual training Low and Middle- Providing Training obtaining EU GMP certification to successfully obtained EU GMP certification, further enriching the In Vietnam and Kazakhstan: We conducted irregular annual for local medical and nursing staff in income Countries for Local Health raise the level of medication in low product matrix with EU certification and effectively improving training and promotion of new products for local medical low and middle-income countries; to Improve Drug Workers in Low and middle-income countries local drug accessibility and pharmaceutical manufacturing and nursing staff to ensure proper usage and timely market Accessibility for and Middle-income Provide training on the use of 100% capacity. availability upon launch. Patients Countries of new products Assist overseas customers in Building the optimizing their own warehouse Capacity of storage capacity; plan to cover 60% We have assisted overseas customers in optimizing their own Establish a long-term communication Public Health of customers' warehouses in the warehouse storage capacity. mechanism with local governments We have established long-term cooperative mechanisms through Infrastructure, next 3-5 years and improve the "last and official institutions, and provide cooperation with local schools, and reserved professional talents Information Systems mile" drug supply assistance within our capacity with solid pharmaceutical knowledge for the local area.or Health Projects according to real-time needs income Countries Overseas Markets |
