Huadong Medicine Co.,Ltd. (000963.SZ) has announced that its wholly-owned subsidiary Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. has obtained positive topline results from the Phase III clinical study (HDM1002-301) in China of HDM1002 tablets, a Class 1 innovative drug and orally administered small molecule GLP-1 receptor agonist independently developed for weight management in overweight or obese populations.
The study showed that all dose groups of HDM1002 tablets met all primary endpoints and key secondary endpoints at Week 44; the weight loss effect continued with further reduction at Week 52, with no weight loss plateau observed; significant improvements in multiple cardiometabolic indicators, substantial reduction in liver fat content, and optimization of body composition were also observed; the safety and tolerability data were consistent with those of GLP-1 receptor agonist drugs, with no new safety signals observed.
The company has completed Pre-NDA communication and is about to formally submit a marketing application in China for HDM1002 tablets for weight management.