上海医药:两款药品通过仿制药一致性评价
Cai Jing Wang·2025-11-11 05:24

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]