上海医药集团股份有限公司关于注射用头孢唑肟钠通过仿制药一致性评价的公告

Core Viewpoint - Shanghai Pharmaceuticals has announced that its subsidiary, Shanghai Shenyang Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the injection of Cefoperazone Sodium, indicating that the drug has passed the consistency evaluation for generic drugs [1][2]. Group 1: Drug Information - Drug Name: Cefoperazone Sodium Injection [2] - Dosage Form: Injection [2] - Applicant: Shanghai Shenyang Pharmaceutical Co., Ltd. [2] - Original Approval Number: National Drug Approval H20080085 [2] - Approval Conclusion: The drug has passed the consistency evaluation for quality and efficacy of generic drugs [2]. Group 2: Market Impact - The drug is primarily used for infections caused by sensitive bacteria, including lower respiratory tract infections, urinary tract infections, and sepsis [2]. - The estimated hospital procurement amount for the drug in 2024 is approximately RMB 360.877 million [3]. - The approval is expected to enhance the market share of the drug and improve competitive strength, while also providing valuable experience for future generic drug evaluations [4].