Huadong Medicine gains FDA approval for diabetes drug trial

Huadong Medicine [SZSE:000963] announced that its wholly-owned subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., has received approval from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for HDM1010 tablets. The approval allows the company to conduct Phase I clinical trials in the United States for the treatment of type 2 diabetes. HDM1010 is a fixed-dose combination of HDM1002, a novel small molecule SGLT2 inhibitor independently developed by Zhongmei Huadong. The company already has an approved IND for HDM1002 (IND 164262) and is conducting Phase III trials in China for both diabetes and weight management indications. The company acknowledges the risks and uncertainties inherent in drug development.