Innovent Biologics Advances Novel Weight Management Drug Mazdutide with NDA Acceptance in China

08 February 2024 | Thursday | Regulatory


Innovent Biologics, Inc. (HKEX: 01801), a leading biopharmaceutical company, has announced a significant milestone with the acceptance of the New Drug Application (NDA) for mazdutide (Innovent R&D code: IBI362) by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China. Mazdutide, a dual agonist targeting glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR), is intended for chronic weight management in adults dealing with obesity or overweight.
Image Source : Public Domain

Image Source : Public Domain

 

This groundbreaking achievement marks mazdutide as the first GLP-1R/GCGR dual agonist to successfully complete Phase 3 trials in support of an NDA submission. As a next-generation weight-loss drug, mazdutide holds promise in offering an effective, safe, and user-friendly treatment option for the large population grappling with obesity or overweight in China.

The Phase 3 GLORY-1 (NCT05607680) clinical trial conducted in Chinese adults demonstrated mazdutide's superiority over placebo in reducing body weight and addressing various weight-related and cardiometabolic endpoints. The safety profile of mazdutide remained consistent with previous studies, showing no new safety concerns. Detailed results from the GLORY-1 study are expected to be unveiled later in 2024 through medical conferences or journals.

Professor Linong Ji from Peking University People's Hospital, the leading principal investigator of the study, emphasized the potential of mazdutide in mitigating the risks associated with chronic diseases linked to obesity or overweight. Dr. Lei Qian, Vice President of Clinical Development at Innovent, highlighted mazdutide's robust efficacy and cardiometabolic benefits, expressing optimism for its approval and potential to benefit millions in China.

Innovent Biologics remains committed to advancing its next-generation product pipeline, particularly in the cardiovascular and metabolic field, to address unmet medical needs and promote healthier lives.

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