Innovent Announces Mazdutide Received Approval from China's NMPA for Glycemic Control in Adults with Type 2 Diabetes

Core Insights - Innovent Biologics has received approval from China's National Medical Products Administration (NMPA) for mazdutide, a first-in-class dual glucagon (GCG)/glucagon-like peptide-1 (GLP-1) receptor agonist, aimed at glycemic control in adults with type 2 diabetes (T2D) [1][6][16] - Mazdutide is expected to provide comprehensive benefits in glycemic control, weight reduction, and improvements in hepato-cardio-renal metabolic indicators, addressing the urgent need for effective diabetes management in China [5][9][11] Industry Context - China has the highest prevalence of T2D globally, with approximately 140 million adults affected, representing 1 in 4 cases worldwide [2][12] - The treatment paradigm for diabetes is shifting towards a comprehensive, patient-centric management strategy that includes glycemic control, weight management, and cardiovascular risk factor mitigation [3][10] Clinical Evidence - The approval of mazdutide was based on two Phase 3 clinical trials (DREAMS-1 and DREAMS-2), which demonstrated its superiority over placebo and dulaglutide in glycemic control and weight reduction [6][7][11] - In DREAMS-1, at Week 24, the mean changes in HbA1c for the mazdutide 4 mg and 6 mg groups were -1.57% and -2.15%, respectively, compared to -0.14% for placebo [6] - In DREAMS-2, at Week 28, the mean changes in HbA1c for the mazdutide 4 mg and 6 mg groups were -1.69% and -1.73%, respectively, compared to -1.38% for dulaglutide [6] Safety and Administration - Mazdutide exhibited a safety profile consistent with previous GLP-1 receptor agonists, with no new safety signals identified [7] - The mazdutide injection device features significant improvements in convenience and safety, including a hidden needle design and single-use functionality, enhancing patient comfort and adherence [8] Future Implications - The approval of mazdutide aligns with the "Healthy China 2030" vision, aiming to improve disease management and reduce the burden of T2D in the population [5][11] - Innovent Biologics has plans for further clinical studies and potential new indications for mazdutide, indicating a commitment to advancing diabetes treatment options [14][15]