Sinotherapeutics (SH:688247) Zhong Guo Zheng Quan Bao - Zhong Zheng Wang·2025-09-27 00:47Core Viewpoint - Shanghai Xuantai Pharmaceutical Technology Co., Ltd. announced that its wholly-owned subsidiary, Jiangsu Xuantai Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for a supplemental application to increase the specification of its drug, Saxagliptin Metformin Extended-Release Tablets, to include a new dosage of 50mg Saxagliptin and 500mg Metformin per tablet [1][2]. Drug Basic Information - Drug Name: Saxagliptin Metformin Extended-Release Tablets [1] - Registration Category: Chemical Drug [1] - Application Matter: Addition of specification "each tablet contains 50mg Saxagliptin and 500mg Metformin" [1] - Drug Approval Number: Guoyao Zhunzi H20258134 [1] - Dosage Form: Tablet [1] - Specification: Each tablet contains 50mg Saxagliptin and 500mg Metformin [1] - Marketing Authorization Holder: Jiangsu Xuantai Pharmaceutical Co., Ltd. [1] - Approval Conclusion: The application meets the requirements for drug registration and a new drug approval number has been issued [1]. Other Relevant Information - Saxagliptin Metformin Extended-Release Tablets are indicated for adult patients with type 2 diabetes who are currently receiving combined treatment with Saxagliptin and Metformin Extended-Release Tablets [2]. - The drug was developed by Merck Sharp & Dohme and was first approved for marketing in the United States in February 2012 [2]. - It was first approved for sale in China in May 2023 and is classified as a Category B product under medical insurance [2]. Impact on the Company - The newly approved specification of 50mg Saxagliptin and 500mg Metformin per tablet is expected to better meet patient medication needs, enhance the company's product competitiveness, and increase market share [3]. - The specific sales performance of the product may be influenced by various factors such as market environment and channel expansion, which introduces uncertainty [3].