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上海医药集团股份有限公司关于子公司成为氨磺必利口崩片上市许可持有人的公告
Core Viewpoint - Shanghai Pharmaceuticals has received approval from the National Medical Products Administration to change the marketing authorization holder for Amisulpride Orally Disintegrating Tablets to its subsidiary, Shanghai Pharmaceutical Zhongxi Pharmaceutical Co., Ltd [1][2]. Group 1: Drug Information - Drug Name: Amisulpride Orally Disintegrating Tablets - Dosage Form: Tablet - Specifications: 50mg, 0.2g - Registration Classification: Chemical Drug - Approval Numbers: National Drug Approval Code H20250041, H20250042 - Approval Conclusion: Change of marketing authorization holder from "Shanghai Zezheng Pharmaceutical Technology Co., Ltd." to "Shanghai Pharmaceutical Zhongxi Pharmaceutical Co., Ltd." [2]. Group 2: Market Context - Amisulpride Orally Disintegrating Tablets is an improved formulation of Amisulpride Tablets, which was launched by Sanofi in France in 1986 for the treatment of adult schizophrenia [3]. - As of the date of the announcement, there are no other companies in China that have listed Amisulpride Orally Disintegrating Tablets [4]. - According to IQVIA data, the hospital procurement amount for Amisulpride oral formulations in 2024 is projected to be RMB 168.41 million [5]. Group 3: Company Impact - The change in marketing authorization holder for Amisulpride Orally Disintegrating Tablets enhances the product line of Shanghai Pharmaceuticals and is expected to improve the company's market competitiveness [6].