贵州百灵(002424.SZ):糖宁通络片获得药物临床试验批准通知书

Core Viewpoint - Guizhou Bailing (002424.SZ) announced that its wholly-owned subsidiary, Bailing Yuxiu (Zhuhai) Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration (NMPA) for the clinical trial of its drug, Tangning Tongluo Tablets, aimed at treating type 2 diabetes [1] Group 1 - The clinical trial application for Tangning Tongluo Tablets has been approved, allowing the drug to enter clinical trials for type 2 diabetes [1] - Tangning Tongluo Tablets is a Class 1 new traditional Chinese medicine that has been in development for over ten years and has been used in clinical settings since 2014 as a hospital preparation [1] - The drug has accumulated significant human usage experience and has shown good efficacy in improving symptoms and reversing biochemical indicators in both treated and untreated type 2 diabetes patients [1] Group 2 - The approval for the clinical trial of Tangning Tongluo Tablets is based on prior clinical research, and it is noteworthy that it is the first traditional Chinese medicine to transition from a hospital preparation to a new drug, bypassing Phase I and II trials to directly enter Phase III trials [1] - The drug is designed to adjust the body's endocrine functions, demonstrating its pharmacological effects in treating type 2 diabetes [1]