Core Points - Shanghai Pharmaceuticals announced on November 11 that it has released a plan for its controlling shareholder to increase shareholding, with details available in the announcement [2] Group 1 - The company confirmed that it will fulfill its information disclosure obligations in accordance with regulatory requirements [2]

Core Viewpoint - Shanghai Pharmaceuticals announced that its subsidiary, Shanghai Shiyuan 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: Drug Approvals - The injectable Cefuroxime Sodium is indicated for infections caused by specific sensitive strains of microorganisms, including respiratory, ENT, urinary tract, skin and soft tissue infections, sepsis, meningitis, gonorrhea, bone and joint infections, and postpartum and gynecological infections [1] - Cefuroxime Sodium was originally developed by GSK and launched in countries like the UK and Italy in 1978 [1] - The projected procurement amount for Cefuroxime Sodium injection in Chinese hospitals for 2024 is RMB 2.62 billion [1] Group 2: Aztreonam Details - 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 first launched in Italy in 1984 [1] - The projected procurement amount for Aztreonam injection in Chinese hospitals for 2024 is RMB 163 million [1]

Core Viewpoint - Shanghai Pharmaceuticals has received approval from the National Medical Products Administration for its generic drugs, injectable Cefuroxime Sodium and injectable Aztreonam, confirming their quality and efficacy consistency [1] Group 1: Company Developments - Shanghai Pharmaceuticals' subsidiary, Shanghai Shiyuan New Asia Pharmaceutical Co., Ltd., has been granted a Supplementary Drug Application Approval Notice [1] - The injectable Cefuroxime Sodium is indicated for treating infections caused by specific strains of microorganisms in respiratory, ENT, and urinary tract infections, first launched in 1978 in countries like the UK and Italy [1] - The injectable Aztreonam is used for treating urinary tract infections (both complex and uncomplicated) and lower respiratory tract infections caused by sensitive Gram-negative bacteria, first launched in Italy in 1984 [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, 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 ...