Core Viewpoint - The company announced that its wholly-owned subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., has received FDA approval for the clinical trial application of the innovative drug HDM1002, which is a GLP-1 receptor agonist with potential for treating type 2 diabetes and weight management [1][2]. Group 1 - HDM1002 is an innovative small molecule drug developed by the company, possessing global intellectual property rights, and is characterized as a potent and selective GLP-1 receptor agonist [1]. - The drug has shown strong efficacy in improving glucose tolerance, reducing blood sugar levels, and aiding weight loss, along with good safety profiles [1]. - The clinical trial application for HDM1002 for treating adult type 2 diabetes was approved by both the National Medical Products Administration (NMPA) and the FDA in May 2023 [1]. Group 2 - The clinical trial application for HDM1002 for weight management in overweight or obese populations was approved by NMPA in September 2023, and the FDA approval followed in June 2025 [1]. - The product has entered the Phase III clinical research stage in China for both weight management and type 2 diabetes indications, with over 800 subjects enrolled in the Phase I and II trials, demonstrating significant efficacy in weight loss and blood sugar control [2].
华东医药:HDM1002临床试验申请已获美国FDA批准,具有改善糖耐受、降糖和减重作用