Core Viewpoint - The company has received a production registration approval notice from the National Medical Products Administration for its product, Dapagliflozin Metformin Extended-Release Tablets, indicating a significant step towards market entry in China [1] Group 1: Company Developments - Subsidiary Beijing Sair Biological Pharmaceutical Co., Ltd. has received the acceptance notice for the drug registration application [1] - The combination of SGLT-2 inhibitor Dapagliflozin and Metformin is expected to provide better glycemic control with fewer side effects [1] Group 2: Industry Context - Dapagliflozin and Metformin combination was developed by AstraZeneca and received FDA approval in 2014 [1] - The SGLT-2 inhibitors work through a non-insulin-dependent mechanism, reducing glucose reabsorption in the kidneys and promoting glucose excretion [1]
赛升药业(300485.SZ):达格列净二甲双胍缓释片药品注册上市许可申请获受理