哈药集团股份有限公司关于所属企业药品通过仿制药一致性评价的公告

Core Viewpoint - Harbin Pharmaceutical Group Co., Ltd. has announced that its subsidiary, Harbin Pharmaceutical Group Pharmaceutical Factory, has received approval from the National Medical Products Administration for the injection of Cefoperazone Sodium, which has passed the consistency evaluation of quality and efficacy for generic drugs [1][2]. Group 1: Drug Information - The drug, Cefoperazone Sodium for injection, is available in two specifications: 1.0g and 0.5g [1]. - It is indicated for infections caused by sensitive bacteria, including lower respiratory tract infections, urogenital infections, gynecological infections, bacteremia/sepsis, skin and soft tissue infections, abdominal infections, bone and joint infections, and central nervous system infections [2]. - As of the announcement date, there are 239 production approvals for Cefoperazone Sodium in China, with 37 manufacturers having passed the consistency evaluation [2]. - The projected annual sales for Cefoperazone Sodium in domestic hospitals for 2024 is estimated at 1.55 billion yuan, with sales of 889 million yuan recorded in the first three quarters of 2025 [2]. - The company has invested approximately 8.16 million yuan in the research and development of this drug's consistency evaluation project [2]. Group 2: Impact on the Company - The approval of the drug through the consistency evaluation will likely lead to increased support in medical insurance payments and procurement by medical institutions, enhancing the market share and competitiveness of the product [3]. - The experience gained from this evaluation will benefit the company's future efforts in conducting similar evaluations for other products [3].