Core Viewpoint - The announcement indicates that the subsidiary of the company, Sai Er Biological, has received a notice of acceptance for the registration application of Dapagliflozin Metformin Extended-Release Tablets from the National Medical Products Administration, marking a significant step in the drug's approval process [1] Group 1 - The registration application involves four specifications (I, II, III, IV) for the drug [1] - The compound tablet was developed by AstraZeneca and was approved for marketing in the United States in 2014, with approval in China occurring in June 2023 [1] - The acceptance of the application means the product is entering the registration review stage, which is expected to have no significant impact on the company's recent performance [1] Group 2 - If the review is successfully passed, it will enrich the product pipeline of Sai Er Biological [1] - The timeline and outcome for drug registration approval remain uncertain [1]
赛升药业:子公司达格列净二甲双胍缓释片上市申请获受理