替格瑞洛片用于急性冠脉综合征患者，包括接受药物治疗和经皮冠状动脉介 入治疗的患者，降低血栓性心血管事件的发生率。原研由 AstraZeneca 研发，于 2011 年在美国上市。2021 年 05 月，常州制药厂就该药品向美国 FDA 提出 ANDA 申请，并于近日获得最终批准上市。截至本公告日，公司针对该药品已投入研发 费用约人民币 967.13 万元。 证券代码：601607 证券简称：上海医药 公告编号：临2025-103 上海医药集团股份有限公司 关于替格瑞洛片获得美国 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。 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 属常州制药厂有限公司（以下简称"常州制药厂"） 收到美国食品药品监督管 理局（以下简称"美国 FDA"）的通知，其关于替格瑞洛片（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（"Final Approval"），现将相关情况公告如下： 一、该药品 ...

表决结果：赞成 3 票，反对 0 票，弃权 0 票 本议案尚需提交公司股东大会审议。 证券代码：601607 证券简称：上海医药 编号：临 2025-101 上海医药集团股份有限公司 第八届监事会第十五次会议决议公告 本公司监事会及全体监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。 上海医药集团股份有限公司（以下简称"本公司"或"上海医药"）第八届 监事会第十五次会议（以下简称"本次会议"）于 2025 年 11 月 6 日以通讯方式 召开。本次会议应到监事三名，实到监事三名，符合《中华人民共和国公司法》 和本公司章程关于监事会召开法定人数的规定。本次会议审议通过了以下议案： 一、《关于取消监事会并修订<公司章程>及其附件的议案》 为全面贯彻落实法律法规及监管要求，进一步提升公司治理水平， 根据《中 华人民共和国公司法》《中华人民共和国证券法》《上市公司章程指引》《上市公 司股东会规则》《上海证券交易所股票上市规则》等相关法律、法规、规范性文 件的规定，结合公司治理改革实际情况，公司拟取消监事会，由董事会审计委员 会行使《公司法》规定的监 ...

证券代码：601607 证券简称：上海医药 公告编号：临2025-100 二、《关于修订、新增公司部分制度的议案》 为进一步加强公司内部治理机制，完善治理体系，根据《中华人民共和国公 司法》《上市公司章程指引》《上市公司信息披露管理办法》《上市公司募集资金 监管规则》《上海证券交易所股票上市规则》《香港联合交易所有限公司证券上市 规则》等相关法律、法规、规范性文件的规定，在监事会改革及修订《公司章程》 的基础上，公司董事会同意对下列相关制度的修订及新增： 上海医药集团股份有限公司 第八届董事会第二十六次会议决议公告 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。 上海医药集团股份有限公司（以下简称"本公司"）第八届董事会第二十六 次会议（以下简称"本次会议"）于 2025 年 11 月 6 日以通讯方式召开。本次会 议应到董事 9 名，实到董事 9 名，符合《中华人民共和国公司法》和本公司章程 关于董事会召开法定人数的规定。本次会议审议并通过了以下议案： 一、《关于取消监事会并修订<公司章程>及其附件的议案》 详见本公司 ...

Core Insights - Shanghai Pharmaceuticals (601607) announced on November 6 that its subsidiary, Changzhou Pharmaceutical Factory, received final approval from the U.S. Food and Drug Administration (FDA) for the abbreviated new drug application of Ticagrelor tablets, which are intended for patients with acute coronary syndrome to reduce the incidence of thrombotic cardiovascular events [1] - Additionally, the subsidiary, Shanghai Pharmaceuticals Zhongxi, received a drug registration certificate from the National Medical Products Administration for the production of Tocilizumab sustained-release tablets, which are used to treat rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis [1] Group 1 - The FDA approval for Ticagrelor tablets marks a significant milestone for Shanghai Pharmaceuticals in the cardiovascular drug market [1] - The approval indicates the company's commitment to expanding its product offerings in critical therapeutic areas [1] - The registration of Tocilizumab sustained-release tablets further enhances the company's portfolio in the treatment of autoimmune diseases [1]

上海醫藥集團股份有限公司 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) 香港交易及結算所有限公司及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。 建議修訂公司章程並取消監事會 及 建議修訂股東大會議事規則及董事會議事規則 上海醫藥集團股份有限公司（「本公司」）於2025年11月6日召開第八屆董事會（「董事會」）第 26次會議審議通過了《關於取消監事會並修訂<公司章程>及其附件的議案》。 根據《中華人民共和國公司法（2023年修訂）》、《中華人民共和國證券法（2019年修訂）》、 《上市公司章程指引（2025年修訂）》、《上市公司股東會規則（2025年修訂）》、《上海證券交 易所股票上市規則（2025年4月修訂）》等相關規定，結合自身實際情況，董事會建議(1)對 本公司的公司章程（「公司章程」）作出若干相應修訂（「建議修訂公司章程」），其內容包括 但不限於取消監事會並 ...

Core Viewpoint - Shanghai Pharmaceuticals has received approval from the National Medical Products Administration for the production of Tocilizumab Sustained-Release Tablets, which are used to treat rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis [1] Group 1: Company Developments - Shanghai Pharmaceuticals' subsidiary, Shanghai Shiyou Chinese and Western Medicine Co., Ltd., has been granted a drug registration certificate for Tocilizumab Sustained-Release Tablets [1] - The drug was originally developed by Pfizer and was launched in the United States in 2016 [1] - The company submitted a registration application for the drug to the National Medical Products Administration in January 2024, which has been accepted [1] - As of the announcement date, the company has invested approximately RMB 19.42 million in research and development for this drug [1]

Core Viewpoint - Shanghai Pharmaceuticals (601607.SH) announced that its subsidiary, Changzhou Pharmaceutical Factory, received final approval from the U.S. FDA for the abbreviated new drug application (ANDA) for Ticagrelor tablets, which are used to reduce the incidence of thrombotic cardiovascular events in patients with acute coronary syndrome [1] Company Summary - The ANDA for Ticagrelor tablets was submitted to the U.S. FDA in May 2021 and has now been approved for market launch [1] - The company has invested approximately RMB 9.6713 million in research and development for this drug as of the date of the announcement [1] Industry Summary - Ticagrelor is indicated for patients with acute coronary syndrome, including those undergoing medical therapy and percutaneous coronary intervention, to lower the risk of thrombotic cardiovascular events [1] - The original drug was developed by AstraZeneca and was launched in the U.S. in 2011 [1]

Core Viewpoint - Shanghai Pharmaceuticals' subsidiary, Changzhou Pharmaceutical Factory, has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Ticagrelor tablets, which are used to reduce the incidence of thrombotic cardiovascular events in patients with acute coronary syndrome [1] Company Summary - The approved drug, Ticagrelor, was originally developed by AstraZeneca and was launched in the U.S. in 2011 [1] - As of the date of the announcement, the company has invested approximately RMB 9.6713 million in research and development for this drug [1]

Core Viewpoint - Shanghai Pharmaceuticals' subsidiary, Shanghai Shiyou Zhongxi Pharmaceutical Co., Ltd., has received a drug registration certificate for Tocilizumab Sustained-Release Tablets from the National Medical Products Administration, allowing for production approval [1] Group 1: Product Approval - The drug Tocilizumab Sustained-Release Tablets is approved for the treatment of rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis [1] - The drug was originally developed by Pfizer and was launched in the United States in 2016 [1] Group 2: Regulatory Process - Shanghai Shiyou Zhongxi submitted the registration application for the drug to the National Medical Products Administration in January 2024, which has been accepted [1] - The drug registration certificate number is 2025S03257 [1] Group 3: Investment and R&D - The company has invested approximately RMB 19.42 million in research and development for this drug [1]

Core Viewpoint - Citigroup has raised the target price for Shanghai Pharmaceuticals from HKD 13.1 to HKD 14.2, citing that the market may underestimate the long-term value created by the company's manufacturing platform restructuring, the significant potential of the commercial insurance market, and clear progress in cost optimization [1] Group 1 - The revenue forecasts for Shanghai Pharmaceuticals for 2025 to 2027 have been lowered by 3% to 6% to reflect ongoing pressure on core business [1] - The earnings per share forecasts for the same period have been reduced by 12% to 14% [1] - Citigroup maintains a "Buy" rating for Shanghai Pharmaceuticals [1]