Innovent Biologics, Inc. announced that the New Drug Application (NDA) for mazdutide (Innovent R&D code: IBI362), a glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR) dual agonist, has been accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China, for chronic weight management in adults with obesity or overweight. Mazdutide is the first GLP-1R/GCGR dual agonist to successfully complete Phase 3 trials in support of a NDA submission. As a new generation of weight-loss drugs activating both GLP-1 and glucagon receptors, mazdutide could bring an efficacious, safe and easy-to-use treatment option to the vast and ever-growing population with overweight or obesity in China.

In January 2024, the Phase 3 GLORY-1 (NCT05607680) clinical trial of mazdutide in Chinese adults with overweight or obesity met the primary endpoints and all key secondary endpoints. Mazdutide 4 mg and 6 mg showed superiority over placebo in terms of body weight reduction and multiple weight-related and cardiometabolic endpoints. The safety profile was similar to that observed in previous clinical studies of mazdutide, with no new safety signals observed.

Innovent will release detailed results from the GLORY-1 study in medical conferences or journals later in 2024.