香港交易及結算所有限公司和香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部分內容而產生或因依賴 該等內容而引致的任何損失承擔任何責任。 Shanghai Pharmaceuticals Holding Co., Ltd. * （於中華人民共和國註冊成立的股份有限公司） （股份代碼：02607） 海外監管公告 上 海 醫 藥 集 團 股 份 有 限 公 司 於本公告日期，本公司的執行董事為楊秋華先生、沈波先生、李永忠先生及董明 先生；非執行董事為張文學先生；以及獨立非執行董事為顧朝陽先生、霍文遜先 生、王忠先生及萬鈞女士。 * 僅供識別 证券代码：601607 证券简称：上海医药 公告编号：临2025-105 上海医药集团股份有限公司 本公告乃根據香港聯合交易所有限公司證券上市規則第 13.10B 條而作出。 茲載列上海醫藥集團股份有限公司（「本公司」）在上海證券交易所網站(http://www.sse.com.cn) 刊登的《上海醫藥集團股份有限公司關於醋酸艾司利卡西平片獲得美國 FDA 批准文號的公 告》、《上海醫藥集團股份有限公司關 ...

证券代码：601607 证券简称：上海医药 公告编号：临2025-105 近日，上海医药集团股份有限公司（以下简称"上海医药"或"公司"）下 属上海上药中西制药有限公司（以下简称"上药中西"） 收到美国食品药品监 督管理局（以下简称"美国 FDA"）的通知，其关于醋酸艾司利卡西平片（基 本情况详阅正文，以下简称"该药品"）的简略新药申请（"ANDA"，即美国 仿制药申请）已获得最终批准上市，现将相关情况公告如下： 上海医药集团股份有限公司 关于醋酸艾司利卡西平片获得美国 FDA 批准文号的公告 本公司董事会及全体董事保证本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、准确性和完整性承担个别及连带责任。 根据 IMS 数据库显示，2024 年该药品原研与仿制药在美国的销售额约 3.82 亿美元。 四、对上市公司影响及风险提示 本次上海上药中西制药有限公司关于醋酸艾司利卡西平片的 ANDA 获得美 国 FDA 批准，对公司进一步拓展海外市场具有积极意义，并积累宝贵经验。 制剂出口业务因受海外市场法规政策及市场环境的变化、汇率波动、市场竞 争等不确定性因素影响，该药品可能存在销售不达预期 ...

证券代码：601607 证券简称：上海医药 编号：临 2025-106 上海医药集团股份有限公司 关于注射用头孢呋辛钠及注射用氨曲南通过仿制药一致性 评价的公告 本公司董事会及全体董事保证本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、准确性和完整性承担个别及连带责任。 近日，上海医药集团股份有限公司（以下简称"公司"）下属上海上药新亚 药业有限公司（以下简称"上药新亚"）的注射用头孢呋辛钠、注射用氨曲南收 到国家药品监督管理局（以下简称"国家药监局"）颁发的《药品补充申请批准 通知书》（通知书编号：2025B05069、2025B05110、2025B05111），前述药品 通过仿制药质量和疗效一致性评价。 一、药品基本情况 药品名称：注射用头孢呋辛钠 剂型：注射剂 规格：0.75g（按 C₁₆H₁₆N₄O₈S 计） 注册分类：化学药品 药品批准文号：国药准字 H20013214 申请人：上海上药新亚药业有限公司 审批结论：本品通过仿制药质量和疗效一致性评价。 规格：0.5g、1.0g 注册分类：化学药品 药品批准文号：国药准字 H20055839、国药准字 H20258235 ...

Core Viewpoint - Shanghai Pharmaceuticals (601607.SH) announced that its subsidiary, Shanghai Shiyou Zhongxi Pharmaceutical Co., Ltd., received notification from the U.S. Food and Drug Administration (FDA) that its Abbreviated New Drug Application (ANDA) for Eslicarbazepine Acetate Tablets has been approved for marketing [1] Group 1 - The approved drug, Eslicarbazepine Acetate Tablets, is indicated for the treatment of partial-onset seizures in patients aged 4 years and older [1]

Core Viewpoint - Shanghai Pharmaceuticals (601607.SH) announced that its subsidiary, Shanghai Shenyang Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for its injectable drugs, Cefuroxime Sodium and Aztreonam, which passed the consistency evaluation of generic drug quality and efficacy [1] Group 1: Drug Approvals - The injectable Cefuroxime Sodium is indicated for infections caused by specific sensitive strains of microorganisms, including respiratory infections, ENT infections, urinary tract infections, skin and soft tissue infections, sepsis, meningitis, gonorrhea, bone and joint infections, as well as postpartum and gynecological infections [1] - The injectable Aztreonam is indicated for infections caused by sensitive Gram-negative bacteria, including urinary tract infections (both complicated and uncomplicated), lower respiratory tract infections, sepsis, skin and skin structure infections, intra-abdominal infections, and gynecological infections [1]

Core Viewpoint - Shanghai Pharmaceuticals (601607.SH) announced that its subsidiary, Shanghai Shiyu New Asia Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for its injectable drugs, Cefuroxime Sodium and Aztreonam, which passed the consistency evaluation of quality and efficacy for generic drugs [1] Group 1: Product Approvals - The injectable Cefuroxime Sodium is indicated for treating infections caused by specific sensitive strains of microorganisms, including respiratory infections, ENT infections, urinary tract infections, skin and soft tissue infections, sepsis, meningitis, gonorrhea, bone and joint infections, as well as postpartum and gynecological infections [1] - Cefuroxime Sodium was originally developed by GSK and was first launched in countries like the UK and Italy in 1978 [1] - The injectable Aztreonam is indicated for infections caused by sensitive Gram-negative bacteria, including urinary tract infections (both complicated and uncomplicated), lower respiratory tract infections, sepsis, skin and skin structure infections, intra-abdominal infections, and gynecological infections [1] - Aztreonam was developed by BMS and was first launched in Italy in 1984 [1]

Core Viewpoint - Shanghai Pharmaceuticals announced that its subsidiary, Shanghai Pharmaceuticals Holding Co., Ltd., received notification from the U.S. FDA that its abbreviated new drug application for Eslicarbazepine Acetate Tablets has been approved for marketing [1] Group 1: Drug Approval and Market Potential - The drug is indicated for the treatment of partial seizures in patients aged 4 years and older, and it was originally launched in the U.S. in 2013 [1] - The application was submitted in January 2018 and received temporary approval in June 2020 [1] - The company has invested approximately 15.9371 million yuan in research and development for this drug [1] - The projected sales for both the original and generic versions of the drug in the U.S. for 2024 are approximately 382 million USD [1] Group 2: Export Business Uncertainty - There is uncertainty regarding the company's formulation export business [1]

Group 1 - BeiGene expects its 2025 revenue to be between 36.2 billion and 38.1 billion yuan, driven by the strong performance of its flagship product, Brukinsa, in the US and European markets [1] - The company's R&D, sales, and management expenses are projected to be between 29.5 billion and 30.9 billion yuan, with a gross margin maintained at a high level of 80% to 90% [1] - The revenue growth adjustment indicates that BeiGene is entering a new phase of self-sustainability, showcasing its strong potential for innovative drug commercialization and global competitiveness [1] Group 2 - Shanghai Pharmaceuticals received FDA approval for its Ticagrelor tablets, which will be used for patients with acute coronary syndrome, marking a significant step in its internationalization and innovative R&D efforts [2] - The approval reflects the product's quality and compliance with international standards, enhancing the company's position in the global market [2] - Additionally, the company received a drug registration certificate for tofacitinib extended-release tablets, which are used to treat rheumatoid arthritis and other conditions [2] Group 3 - A divorce case has led to a change in the actual controller of Wohuayi Pharmaceutical, with both parties now holding 50% equity in Beijing Zhongzheng Wanrong Investment Group [3] - This structural change may impact decision-making efficiency and strategic progress due to potential disagreements between the two parties [3] - However, it also presents an opportunity for the company to optimize its governance structure and reduce reliance on individual control [3] Group 4 - Yixin Pharmacy's chairman plans to transfer shares to his daughters through block trading, totaling no more than 11.712 million shares, which will not change the company's control [4] - This internal transfer is a stable family succession arrangement, allowing for wealth transfer while maintaining control through a concerted action agreement [4] - The move effectively mitigates risks associated with changes in control and governance structure [4] Group 5 - Sinovac Biotech has submitted an application for an H-share listing on the Hong Kong Stock Exchange, marking a key step in its internationalization strategy [5] - The listing is expected to provide significant capital support for the company's innovative drug development and global market expansion [5] - It will also enhance the company's international brand image and market influence [5]

Group 1: Approval of New Drugs - Shanghai Pharmaceuticals has received final approval from the FDA for its abbreviated new drug application (ANDA) for Ticagrelor tablets, which are indicated for patients with acute coronary syndrome [1][2] - The drug is available in dosages of 60mg and 90mg, and the original drug was developed by AstraZeneca and launched in the U.S. in 2011 [1][6] - The company has invested approximately RMB 9.67 million in the research and development of this drug [1] Group 2: Market Competition - As of the announcement date, there are already generic versions of Ticagrelor available in the U.S. from companies such as Apotex Inc., Alembic Pharmaceuticals Ltd, and Mylan Pharmaceuticals Inc. [2] - According to IMS data, the combined sales of the original and generic versions of the drug in the U.S. are projected to be approximately $1.284 billion in 2024 [3] Group 3: Impact on Company - The approval of Ticagrelor tablets is expected to positively impact Shanghai Pharmaceuticals' efforts to expand into overseas markets and accumulate valuable experience [4] - The company has also received approval for the production of Tofacitinib citrate extended-release tablets, which are used to treat rheumatoid arthritis and other conditions [7][8] - The company has invested approximately RMB 19.42 million in the research and development of Tofacitinib citrate extended-release tablets [8] Group 4: Regulatory Changes - The company plans to cancel its supervisory board and amend its articles of association to enhance corporate governance, with the audit committee of the board taking over the supervisory functions [13][23] - This decision is in line with regulatory requirements and aims to improve the company's governance structure [13][24]

Core Viewpoint - Shanghai Pharmaceuticals has decided to abolish its supervisory board and amend its articles of association to enhance corporate governance, transferring the supervisory functions to the audit committee of the board of directors [1]. Group 1: Corporate Governance Changes - The decision to cancel the supervisory board was made during the 26th meeting of the 8th board of directors on November 6, 2025 [1]. - The amendments to the articles of association include the removal of references to the supervisory board and supervisors, and the renaming of the "president's office meeting" to "administrative office meeting" [2]. - The company aims to align its governance structure with relevant laws and regulations, including the Company Law and Securities Law of the People's Republic of China [1].