上海医药集团股份有限公司关于盐酸曲马多注射液通过仿制药一致性评价的公告

Group 1 - Shanghai Pharmaceuticals Holding Co., Ltd. announced that its subsidiary, Shanghai Hefu Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for its Tramadol Hydrochloride Injection to pass the consistency evaluation of generic drugs [1][2] - The drug is primarily used for the treatment of moderate to severe pain and was originally developed by Grünenthal GmbH, first launched in Germany in 1977 [3] - As of the announcement date, the company has invested approximately RMB 1.52 million in research and development for this drug's consistency evaluation [3] Group 2 - According to the IQVIA database, the total procurement amount for Tramadol Hydrochloride Injection in hospitals across mainland China in 2024 was RMB 614.53 million [4] - The approval for consistency evaluation is expected to enhance the market competitiveness of Shanghai Hefu's Tramadol Hydrochloride Injection and expand its market share [5] - The company aims to leverage the experience gained from this evaluation for future product evaluations [5]