Core Viewpoint - The application for the上市 of the combination drug Ploglitazone Metformin extended-release tablets developed by the company has been accepted by the National Medical Products Administration of China [1] Group 1: Product Information - The product is a first-class innovative drug combining Ploglitazone and Metformin in a sustained-release formulation, aimed at treating adult patients with type 2 diabetes mellitus (T2DM) [1] - The proposed indication is for use in T2DM patients who have inadequate blood sugar control with Metformin monotherapy or are currently receiving a combination of Ploglitazone and Metformin [1] Group 2: Clinical Trial Results - Phase III clinical trials have confirmed that Ploglitazone demonstrates good efficacy and safety in initial treatment of T2DM patients and those with inadequate blood sugar control on Metformin monotherapy [2] - Compared to Metformin monotherapy, the combination of Ploglitazone and Metformin shows significant and sustained blood sugar-lowering effects with a lower incidence of hypoglycemia [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: Treatment Simplification - The combination formulation simplifies treatment regimens and significantly improves patient adherence, leading to more effective blood sugar control compared to the use of two separate formulations [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)：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