Core Viewpoint - The announcement indicates that the application for the上市 of the combination drug Ploglitazone Metformin extended-release tablets has been accepted by the National Medical Products Administration of China, representing a significant step in the company's innovative drug development [1] Group 1: Product Development - The product is a Class 1 innovative drug combining Ploglitazone and Metformin in an extended-release formulation, aimed at treating adult patients with Type 2 Diabetes Mellitus (T2DM) [1] - The intended indication is for patients with inadequate blood sugar control on Metformin monotherapy or those currently receiving a combination of Ploglitazone and Metformin [1] Group 2: Clinical Trial Results - Phase III clinical trials have demonstrated that Ploglitazone shows good efficacy and safety in initial treatment of T2DM patients and those with inadequate control on Metformin monotherapy [2] - The combination of Ploglitazone and Metformin has shown significant and sustained blood sugar-lowering effects with a lower incidence of hypoglycemia compared to Metformin alone [2] - The product has a low potential for drug interactions and does not require dosage adjustment for patients with mild to moderate renal impairment [2] Group 3: Market Strategy - 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：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