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上海医药(02607)子公司成为氨磺必利口崩片上市许可持有人
智通财经网· 2025-10-24 08:42
Core Viewpoint - Shanghai Pharmaceuticals has received approval from the National Medical Products Administration for the change of marketing authorization holder for Amisulpride Orally Disintegrating Tablets to its subsidiary, Shanghai Shiyou Zhongxi Pharmaceutical Co., Ltd [1] Group 1: Company Developments - The marketing authorization holder for Amisulpride Orally Disintegrating Tablets has been officially changed to Shanghai Shiyou Zhongxi Pharmaceutical Co., Ltd [1] - The company submitted the registration application for the change of marketing authorization holder to the National Medical Products Administration in September 2025, which has been accepted [1] - The company has invested approximately 31.5 million yuan in the development of this drug as of the date of the announcement [1] Group 2: Market Context - Amisulpride Orally Disintegrating Tablets is a modified formulation of Amisulpride, originally launched by Sanofi in France in 1986, used for the treatment of adult schizophrenia [1] - As of the announcement date, there are no other companies in China that have listed Amisulpride Orally Disintegrating Tablets [1] - According to the IQVIA database, the hospital procurement amount for Amisulpride oral formulations in 2024 is projected to be 168 million yuan [1]