INNOVENT BIO (01801) announced that the New Drug Application (NDA) for Xinerui® (Mazdutide Injection, a glucagon "GCG"/glucagon-like peptide-1 "GLP-1" dual receptor agonist) in the high-dose 9mg formulation for long-term weight management in adults with moderate-to-severe obesity has been accepted by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA). Mazdutide is expected to provide a potent and safe new treatment option for China's moderate-to-severe obesity population beyond bariatric surgery.
This NDA is based on the outstanding results from the Phase III registration clinical trial GLORY-2 (NCT06164873) of Mazdutide 9mg in Chinese patients with moderate-to-severe obesity. The study recently met its primary endpoint and all key secondary endpoints.
Key findings include: - During the treatment period, the Mazdutide group showed continuous weight reduction, with no plateau reached by Week 60. At Week 60, the average weight loss was 18.55% in the Mazdutide 9mg group versus 3.02% in the placebo group. Additionally, 44.0% of Mazdutide 9mg subjects achieved ≥20% weight loss, compared to 2.6% in the placebo group (all P-values <0.0001). - In non-diabetic subjects, the Mazdutide 9mg group demonstrated an average weight loss of 20.08% at Week 60, versus 2.81% in the placebo group. Furthermore, 48.7% of Mazdutide 9mg subjects achieved ≥20% weight loss, compared to 3.1% in the placebo group (all P-values <0.0001). - Mazdutide 9mg also significantly reduced liver fat content in some subjects, with an average reduction of 71.9% from baseline, alongside notable improvements in key cardiometabolic indicators such as blood pressure, lipids, uric acid, and waist circumference. - The safety profile of Mazdutide 9mg was favorable, with no new safety signals identified. Detailed data from the GLORY-2 study will be presented at future international academic conferences or published in journals.
Xinerui® (Mazdutide Injection) 9mg is currently the only GLP-1-based therapy achieving over 20% weight loss after one year with just two-step dose titration. Its development provides evidence-based medical support for effective weight management in Chinese patients with moderate-to-severe obesity, beyond surgical options.
The acceptance of the 9mg NDA expands INNOVENT's portfolio from 2-4-6mg for the broader overweight/obesity population to 3-6-9mg for moderate-to-severe obesity, reflecting deep scientific insight and clear market demand. This strategy aims to deliver personalized, tiered solutions tailored to patients' severity levels and clinical needs. The company will collaborate closely with regulators to expedite approval and serve patients.
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