Innovent Announces the Second Phase 3 Trial of Mazdutide in Chinese Patients with Type 2 Diabetes Met Study Endpoints, and Plans to Submit NDA of Mazdutide to the NMPA

Core Insights - Innovent Biologics announced that the Phase 3 clinical trial (DREAMS-1) of mazdutide for type 2 diabetes (T2D) met its primary and key secondary endpoints, demonstrating significant efficacy in glycemic control and weight loss [1][3][6] - The company plans to submit a new drug application (NDA) for mazdutide to the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) soon, following the acceptance of its first NDA for chronic weight management in February 2024 [1][10] Clinical Trial Results - DREAMS-1 was a randomized, double-blind, placebo-controlled trial involving 320 participants, showing a reduction in HbA1c of 1.57% for the 4 mg group and 2.15% for the 6 mg group compared to 0.14% for placebo at week 24 [2][3] - Key secondary endpoints indicated that mazdutide led to a higher proportion of patients achieving HbA1c < 7.0% and weight reduction ≥ 5% compared to placebo [3][4] Safety and Tolerability - The safety profile of mazdutide was favorable, with gastrointestinal adverse events being the most common, mostly mild to moderate, and no new safety signals identified [5][6] - The incidence of hypoglycemia was low, with no severe cases reported [5] Broader Implications - The results of the DREAMS-1 study provide significant medical evidence supporting the use of next-generation multi-target GLP-1R/GCGR drugs for T2D treatment, addressing the urgent need for innovative medications in China, where over 140 million people live with diabetes [7][8] - Mazdutide is positioned as a dual agonist that not only lowers blood glucose but also offers multiple cardiometabolic benefits, including weight loss and improved metabolic indicators [4][9] Company Overview - Innovent Biologics is a leading biopharmaceutical company focused on developing high-quality medicines for various diseases, with 10 products currently on the market and several new drug applications under review [11]