法 律 意 见 书 江苏集萃药康生物科技股份有限公司: 根据《中华人民共和国公司法》(以下简称"《公司法》")、《中华人民共和国 证券法》《上市公司股东会规则》和《上海证券交易所科创板上市公司自律监管 指引第1号 -- 规范运作》等法律、法规和规范性文件以及《公司章程》的规定, 本所受公司委托,指派本所律师出席公司 2025年第二次临时股东大会,并就本 次股东大会的召集、召开程序、出席会议人员资格、召集人资格、表决程序以及 表决结果的合法有效性等事项出具法律意见。 为出具本法律意见书,本所律师对本次股东大会所涉及的有关事项进行了审 查,查阅了相关会议文件,并对有关问题进行了必要的核查和验证。 本所律师同意将本法律意见书随公司本次股东大会决议一并公告,并依法对 本法律意见书承担相应的责任。 本所律师根据相关法律、法规和规范性文件的要求,按照律师行业公认的业 务标准、道德规范和勤勉尽责精神,出具法律意见如下: 一、关于本次股东大会的召集、召开程序 江苏世纪同仁律师事务所 关于江苏集萃药康生物科技股份有限公司 2025 年第二次临时股东大会的 1、本次股东大会的召集 本次股东大会由董事会召集。 2025年8月21日 ...

证券代码：688046 证券简称：药康生物 公告编号：2025-064 江苏集萃药康生物科技股份有限公司 2025年第二次临时股东大会决议公告 本公司董事会及全体董事保证公告内容不存在任何虚假记载、误导性陈述或 者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 重要内容提示： 本次会议是否有被否决议案：无 一、 会议召开和出席情况 （一） 股东大会召开的时间：2025 年 9 月 25 日 （二） 股东大会召开的地点：南京市江北新区学府路 12 号 （三） 出席会议的普通股股东、特别表决权股东、恢复表决权的优先股股东及 其持有表决权数量的情况： | 1、出席会议的股东和代理人人数 | 60 | | --- | --- | | 普通股股东人数 | 60 | | 2、出席会议的股东所持有的表决权数量 | 264,824,992 | | 普通股股东所持有表决权数量 | 264,824,992 | | 3、出席会议的股东所持有表决权数量占公司表决权数量的比 | 64.8270 | | 例（%） | | | 普通股股东所持有表决权数量占公司表决权数量的比例（%） | 64.8270 | 二、 议案审议情 ...

Core Insights - The conference highlighted the growing global competitiveness of Chinese innovative drugs, particularly in areas like ADC and bispecific antibodies, while emphasizing the need for improvement in original innovation capabilities [1][5][6] - There is a consensus among industry leaders that "going global" is essential for the future of Chinese innovative drugs, with calls for more supportive policies to facilitate this process [1][7][9] Group 1: Current State of Chinese Innovative Drugs - Chinese innovative drugs have reached a global competitiveness level from "1 to 10," especially in engineering fields, but still need to enhance original innovation from "0 to 1" [1] - The quality of projects is crucial for international expansion, as highlighted by industry leaders who stress that strong data and comprehensive packages are essential for success [2][3] - The past decade has seen significant development in the Chinese innovative drug ecosystem, with a complete industrial chain now in place, particularly in cities like Shanghai [4] Group 2: Challenges and Opportunities - The domestic market's limitations are pushing companies to explore international markets, with a focus on countries involved in the Belt and Road Initiative [7] - There is a need for policy reforms regarding listing standards to support innovative drug companies that face long development cycles and high R&D costs [7][9] - The current pricing of innovative drugs in international markets is still influenced by domestic prices, which poses challenges for global competitiveness [9] Group 3: Future Directions and Innovations - The industry is witnessing a surge in various therapeutic areas, including small molecules, antibodies, peptides, RNA, and gene therapies, indicating a diverse landscape of innovation [10] - The potential for small nucleic acids and other novel therapies is recognized as a significant opportunity for Chinese companies to lead in the global market [10] - Industry leaders express confidence in the future of Chinese innovative drugs, anticipating that with time, more companies will emerge as global players [11]

作为科创板迈向"新高地"暨"硬科硬客"2025年会的重要内容之一，9月10日，君实生物（688180.SH）、 皓元医药（688131.SH）、药康生物（688046.SH）、美迪西（688202.SH）、迈威生物（688062.SH） 等科创板创新药领域龙头上市公司高管，逾50家机构投资者参与了创新药产业链的高层次闭门研讨会。 会议围绕中国创新药出海的核心能力、国际竞争力现状及未来发展方向进行深入研讨。 与会嘉宾认为，中国创新药已具备从"1到10"的全球竞争力，尤其在ADC、双抗等工程化领域国际领 先，但在"0到1"的原始创新方面仍需努力。出海，成为行业共识，企业呼吁政策进一步支持破解"出 海"难题。 "君实生物是最早把国际化当作自己重要战略的本土企业之一，特瑞普利单抗也是第一个获得美国FDA 批准上市的中国自研自产PD-1产品，目前已经在40个国家和地区获批。"李鑫坦言，产品出海是高成本 的事情，需要满足国际上未被满足的需求，同时要应对FDA等海外监管机构的严格审评，包括临床和生 产端。 皓元医药董事长兼总经理郑保富从产业链角度分析："创新药是我们CRO（定制研发机构）、CDMO （医药合同定制研发生产企 ...

二〇二五年九月 1 2025年第二次临时股东大会会议资料 公司代码：688046 公司简称：药康生物 江苏集萃药康生物科技股份有限公司 2025 年第二次临时股东大会会议资料 2025年第二次临时股东大会会议资料 目录 | 2025 年第二次临时股东大会参会须知 | 3 | | --- | --- | | 2025 年第二次临时股东大会会议议程 | 5 | | 议案一：关于公司 2025 年半年度利润分配预案的议案 | 7 | | 议案二：关于取消公司监事会、修订《公司章程》并办理工商变更登记的议案8 | | | 议案三：关于新增及修订公司部分治理制度的议案 | 9 | | 议案四：关于选举董事的议案 10 | | 2 2025年第二次临时股东大会会议资料 2025 年第二次临时股东大会参会须知 尊敬的各位股东： 为维护投资者的合法权益，确保江苏集萃药康生物科技股份有限公司（以下 简称"公司"）2025 年第二次临时股东大会的顺利召开，依据中国证券监督管 理委员会《上市公司股东会规则》等有关规定，制定会议须知如下： 一、公司根据《公司法》《证券法》《公司章程》及《股东大会议事规则》的 规定，认真履行法定职责， ...

Core Insights - The medical services sector experienced a slight increase of 0.29% on September 16, with Chengda Pharmaceutical leading the gains [1] - The Shanghai Composite Index closed at 3861.87, up 0.04%, while the Shenzhen Component Index closed at 13063.97, up 0.45% [1] Medical Services Sector Performance - Chengda Pharmaceutical (301201) closed at 33.32, with a significant increase of 15.25% and a trading volume of 157,100 shares, amounting to a transaction value of 508 million yuan [1] - Haocen Medical (002622) saw a rise of 10.10%, closing at 4.25 with a trading volume of 993,200 shares, totaling 409 million yuan [1] - Aoyang Health (002172) increased by 10.00%, closing at 4.73 with a trading volume of 87,500 shares, amounting to 41.39 million yuan [1] - Bid Pharma (688073) rose by 6.48%, closing at 74.73 with a trading volume of 26,000 shares, totaling 192 million yuan [1] - Yikang Biological (688046) increased by 5.56%, closing at 19.75 with a trading volume of 79,600 shares, amounting to 158 million yuan [1] - Other notable performers include Haoyuan Pharmaceutical (688131) with a 4.44% increase, closing at 78.28, and Xinlicheng (002219) with a 3.46% increase, closing at 2.39 [1] Fund Flow Analysis - The medical services sector saw a net outflow of 228 million yuan from institutional investors, while retail investors contributed a net inflow of 59.64 million yuan [3] - Speculative funds recorded a net inflow of 168 million yuan into the sector [3]

Group 1 - Jiangsu Jicui Yaokang Biotechnology Co., Ltd. was established on December 29, 2017, and went public on April 25, 2022, with a current market capitalization of 7.934 billion yuan [1] - The company's main business involves the research, production, sales, and related technical services of laboratory mouse models, with revenue composition as follows: commercial mouse model sales 55.36%, functional efficacy 23.46%, custom breeding 11.32%, model creation 7.06%, and agency import/export and others 2.70% [1] Group 2 - Noan Fund's Noan Pioneer Mixed A (320003) is among the top ten circulating shareholders of Yaokang Biotechnology, having reduced its holdings by 1.0721 million shares in the second quarter, now holding 5.3339 million shares, which is 1.3% of circulating shares [2] - The fund has achieved a year-to-date return of 29.91% and a one-year return of 60.29%, ranking 2678 out of 8246 and 2184 out of 8054 respectively [2] Group 3 - The fund manager of Noan Pioneer Mixed A is Yang Gu, who has a cumulative tenure of 19 years and 211 days, with the fund's total asset size at 5.133 billion yuan [3] - During Yang Gu's tenure, the best fund return was 1033.17%, while the worst was 3.03% [3]

华泰联合证券有限责任公司 关于江苏集萃药康生物科技股份有限公司 2025 年半年度持续督导跟踪报告 | 保荐人名称：华泰联合证券有限责任公司 | 被保荐公司简称：江苏集萃药康生物科技股 | | --- | --- | | | 份有限公司 | | 保荐代表人姓名：季李华 | 联系电话：010-56839300 | | 保荐代表人姓名：李皓 | 联系电话：010-56839300 | 根据《证券法》《证券发行上市保荐业务管理办法》和《上海证券交易所科 创板股票上市规则》等有关法律、法规的规定，华泰联合证券有限责任公司（以 下简称"华泰联合证券"或"保荐人"）作为江苏集萃药康生物科技股份有限公 司（以下简称"药康生物"、"公司"或"发行人"）首次公开发行股票的保荐 人，对药康生物进行持续督导，并出具本 2025 年半年度（以下简称"报告期"） 持续督导跟踪报告： 一、保荐人和保荐代表人发现的问题及整改情况 保荐人核查发现，由于受内外部因素影响，报告期内公司募集资金投资项目 实施进度存在晚于预期情形。 公司已于2022年年度报告、2023年半年度报告、2023年年度报告、2024年半 年度报告、2024年年度报告、2 ...

强化海外一站式服务，共建全球客户生态 近日，江苏集萃药康生物科技股份有限公司（以下简称"药康生物"）与上海益诺思生物技术股份有限公 司（以下简称"益诺思"）正式签署战略合作协议。 药康生物作为国内模式动物领域的领军企业，深耕非临床安全性评价上游模型开发，也在致癌评价方向 积累多年小鼠模型应用数据，该模型对阳性致癌物的自发肿瘤响应率极高，益诺思作为国内头部的、符 合药物非临床研究质量管理规范（GLP）的非临床安全性评价机构，拥有完善的毒理学研究资质及国际 化服务能力，双方基于产业链协同需求，拟在模型开发—安评应用—海外拓展领域展开深度合作，共同 推动我国生物医药研发产业链的自主可控与全球化布局。 联合推进国产非临床致癌评价小鼠模型的规模化应用 药康生物依托自主研发的小鼠模型（已验证对阳性致癌物的高响应率及稳定性），益诺思依托在非临床 安全性评价领域的完善资质及丰富经验，双方深度合作，共同完成该模型在非临床致癌性研究中的标准 化应用验证，推动相关模型成为国内符合GLP规范的、行业领先的商业化致癌评价模型。 双方将共享模型在致癌评价中的实验数据（包括肿瘤发生率、潜伏期、组织病理学特征等），依托益诺 思符合GLP标准 ...

Group 1 - Jiangsu Jicui Yaokang Biotechnology Co., Ltd. (Yaokang Bio) and Shanghai Yinos Biotech Co., Ltd. (Yinos) have signed a strategic cooperation agreement to enhance collaboration in the field of non-clinical safety evaluation and model development [1] - Yaokang Bio is a leading company in the domestic model animal sector, focusing on non-clinical safety evaluation and has accumulated extensive data on mouse models for carcinogenic evaluation, which exhibit a high response rate to positive carcinogens [1][2] - Yinos is a top-tier non-clinical safety evaluation institution in China, compliant with Good Laboratory Practice (GLP) standards, possessing comprehensive toxicology research qualifications and international service capabilities [1][2] Group 2 - The collaboration aims to standardize the application of domestically developed non-clinical carcinogenic evaluation mouse models, enhancing their recognition in the industry and promoting their commercialization [2] - Both companies will share experimental data related to tumor incidence, latency, and histopathological characteristics to improve the model's industry acceptance [2] - The partnership will facilitate the large-scale application of these models in innovative drug development enterprises [2] Group 3 - Yaokang Bio will leverage its strengths in model construction and non-GLP pharmacology and toxicology evaluation to provide preliminary drug activity screening and mechanism research services for overseas clients [3] - Yinos will utilize its internationally certified GLP toxicology evaluation qualifications to conduct subsequent pharmacokinetic and safety evaluations [3] - The collaboration aims to create a comprehensive overseas customer service loop, integrating efficacy, pharmacokinetics, and safety evaluation [3] Group 4 - The partnership combines the resource advantages of both companies, facilitating the entry of Yaokang Bio's mouse models into the evaluation supply chain [4] - The collaboration will target key domestic and international clients, establishing a benchmark cooperation model for the biopharmaceutical industry [4] - A global service network will be developed, covering major pharmaceutical markets, promoting the "Chinese model animals + Chinese evaluation services" paradigm [4]