Core Viewpoint - Shanghai Pharmaceuticals has received final approval from the U.S. FDA for its abbreviated new drug application (ANDA) for Acetate Eslicarbazepine Tablets, which are used to treat partial seizures in patients aged 4 and above [1] Company Summary - Shanghai Pharmaceuticals' subsidiary, Shanghai Shiyou Zhongxi Pharmaceutical Co., Ltd., is responsible for the ANDA application and has invested approximately RMB 15.9371 million in the research and development of this drug [1] - The drug was originally developed by Bial-Portela, Eisai, and Dainippon Sumitomo and was first launched in the U.S. in 2013 [1] - The ANDA application was submitted in January 2018, with temporary approval granted in June 2020, leading to the recent final approval [1] Industry Summary - The approval of Acetate Eslicarbazepine Tablets represents a significant milestone in the generic pharmaceutical market, particularly for epilepsy treatments [1] - The drug's approval may enhance competition in the market for epilepsy medications, potentially impacting pricing and availability for patients [1]

Core Viewpoint - Shanghai Pharmaceuticals has received final approval from the U.S. FDA for its abbreviated new drug application (ANDA) for Oxcarbazepine Tablets, marking a significant milestone for the company in the U.S. market [1] Company Summary - Shanghai Pharmaceuticals' subsidiary, Shanghai Shiyou Zhongxi Pharmaceutical Co., Ltd., has successfully obtained final approval for the ANDA of Oxcarbazepine Tablets [1] - The drug is indicated for the treatment of partial seizures in patients aged 4 years and older, originally developed by Bial-Portela, Eisai, and Dainippon Sumitomo [1] - The ANDA application was submitted to the U.S. FDA in January 2018, with temporary approval granted in June 2020 for four specifications, leading to the recent final approval [1] - The company has invested approximately RMB 15.9371 million in research and development for this drug [1]

Core Insights - Shanghai Pharmaceuticals' subsidiary, Shanghai Shenyang Pharmaceutical Co., has received approval from the National Medical Products Administration for its injectable drugs, Cefuroxime Sodium and Aztreonam, which have passed the consistency evaluation for generic drug quality and efficacy [1][2] Group 1: Cefuroxime Sodium - Cefuroxime Sodium is indicated for infections caused by specific sensitive strains of microorganisms, including respiratory, ENT, urinary, skin, and soft tissue infections, among others [1] - The drug was originally developed by GSK and launched in the UK and Italy in 1978 [1] - As of the announcement date, the company has invested approximately RMB 3.5343 million in the research and development of this drug [1] - The total procurement amount for Cefuroxime Sodium injection in mainland China hospitals in 2024 is projected to be RMB 2,621.73 million [1] Group 2: Aztreonam - Aztreonam is used to treat infections caused by sensitive Gram-negative bacteria, including urinary tract infections, lower respiratory tract infections, and skin infections [2] - The drug was developed by BMS and first launched in Italy in 1984 [2] - The company has invested approximately RMB 6.6794 million in the research and development of Aztreonam [2] - The total procurement amount for Aztreonam injection in mainland China hospitals in 2024 is projected to be RMB 162.7 million [2]

Core Viewpoint - Shanghai Pharmaceuticals has received final approval from the U.S. FDA for its abbreviated new drug application (ANDA) for Acetate Eslicarbazepine Tablets, which are used to treat partial seizures in patients aged 4 and above [1] Company Summary - The product was initially developed by Bial-Portela, Eisai, and Dainippon Sumitomo and was first launched in the U.S. in 2013 [1] - Shanghai Pharmaceuticals submitted the ANDA to the U.S. FDA in January 2018 and received temporary approval for four specifications in June 2020 [1] - The company has invested approximately RMB 15.9371 million in research and development for this product as of the announcement date [1]

Core Viewpoint - Shanghai Pharmaceuticals has received final approval from the U.S. FDA for its abbreviated new drug application (ANDA) for Acetate Eslicarbazepine Tablets, allowing the product to be marketed in the United States [1] Company Summary - Shanghai Pharmaceuticals' subsidiary, Shanghai Shiyou Zhongxi Pharmaceutical Co., Ltd., is the entity that received the FDA notification regarding the approval [1]

Core Viewpoint - Shanghai Pharmaceuticals announced the approval of its injectable drugs, Cefuroxime Sodium and Aztreonam, by the National Medical Products Administration, indicating successful consistency evaluation of generic drug quality and efficacy [1] Group 1 - Shanghai Pharmaceuticals' subsidiary, Shanghai Shiyuan New Asia Pharmaceutical Co., Ltd., received approval for injectable Cefuroxime Sodium and Aztreonam [1] - The approval was granted through the issuance of Supplementary Application Approval Notices with specific notification numbers [1] - The approved drugs have passed the consistency evaluation for generic drug quality and efficacy [1]

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]