Innovent Biologics Inc. (HKG: 1801), a leading biopharmaceutical company in China, has announced that the Center for Drug Evaluation (CDE) in China has accepted for review the second New Drug Application (NDA) for its investigational drug mazdutide (IBI362). Mazdutide is a novel glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR) dual agonist developed for the blood sugar control of adult patients with type 2 diabetes.
The NDA filing is supported by the positive results from two Phase III clinical trials, DREAMS-1 (NCT05628311) and DREAMS-2 (NCT05606913), which evaluated the efficacy and safety of mazdutide as a monotherapy and in combination with oral hypoglycemic drugs, respectively. Both trials demonstrated that mazdutide outperformed placebo and dulaglutide 1.5 mg in blood glucose control and weight loss, with improvements in multiple cardiovascular, liver, and kidney-related indicators. The safety profile of mazdutide was consistent with previous clinical studies and other GLP-1R agonists, with no new safety risks identified.
Innovent has entered into an exclusive license agreement with Eli Lilly and Company (Lilly) for the development and potential commercialization of mazdutide in China. This GLP-1R and GCGR dual agonist, an OXM analogue, not only stimulates insulin secretion and lowers blood sugar but also enhances weight loss by increasing energy expenditure and improves liver fat metabolism. The molecule is currently under regulatory review in China for the treatment of obesity and chronic weight management, marking a significant step forward in the therapeutic landscape for metabolic diseases.- Flcube.com
