Core Viewpoint - The application for the上市 of Shijiazhuang Pharmaceutical Group's innovative drug, Ploglitazone Metformin Sustained-Release Tablets, has been accepted by the National Medical Products Administration of the People's Republic of China, indicating a significant step in the company's product development pipeline [1] Group 1 - The product is a combination of the innovative drug Ploglitazone and Metformin, classified as a type 2.3 chemical drug registration, aimed at treating adult patients with type 2 diabetes mellitus (T2DM) [1] - Ploglitazone is a DPP-4 inhibitor that increases endogenous active GLP-1 levels, enhancing insulin secretion and suppressing glucagon secretion to improve hyperglycemia [1] - Metformin reduces hepatic glucose production and intestinal glucose absorption while increasing peripheral tissue sensitivity to insulin [1] Group 2 - Phase III clinical trials have confirmed that Ploglitazone demonstrates good efficacy and safety in T2DM patients, showing significant and sustained blood sugar reduction compared to Metformin monotherapy, with a lower incidence of hypoglycemia [2] - The combination of Ploglitazone and Metformin has a lower likelihood of drug interactions and does not require dosage adjustment for patients with mild to moderate renal impairment [2] - The combination formulation simplifies treatment regimens and significantly improves patient adherence, leading to more effective blood sugar control [2] - The company is actively advancing the clinical development of a three-drug combination formulation consisting of Ploglitazone, Dapagliflozin, and Metformin to benefit more patients [2]
石药集团(01093.HK)：普卢格列汀二甲双胍缓释片的上市申请获国家药监局受理