Innovent Achieves Another Phase 3 Victory in China for Next-Generation Lilly GLP-1 Drug

1. Phase 3 Trial Success: Innovent Biologics has announced the successful completion of its Phase 3 trial (DREAMS-1) for mazdutide, a glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR) dual agonist, in Chinese adults with type 2 diabetes (T2D).
2. Superiority Over Dulaglutide: Mazdutide showed superiority to dulaglutide in terms of glycemic control, weight loss, and multiple cardiometabolic benefits in T2D patients.
3. Weight Loss and Cardiometabolic Benefits: The drug demonstrated significant weight loss and improved cardiometabolic endpoints compared to placebo.
4. NDA Submission: Innovent plans to submit a new drug application (NDA) for mazdutide to the Center for Drug Evaluation (CDE) for T2D treatment.
5. Licensing Agreement: Innovent entered into a licensing agreement with Eli Lilly to develop and commercialize mazdutide in China in 2019.
6. GLP-1 Mechanism: Mazdutide works by activating both the GLP-1 and glucagon receptors, boosting insulin secretion, cutting blood sugar levels, and promoting weight loss.
7. Chronic Weight Management: Innovent is also developing mazdutide for chronic weight management, with the NMPA accepting the drug application in February 2024.