Innovent’s Mazdutide 9mg accepted for review by China’s NMPA

Innovent Biologics’ supplementary application for the 9 mg dosage of mazdutide, an innovative glucagon (GCG)/ glucagon-like peptide-1 (GLP-1) dual receptor agonist, for the long-term weight management in adults with moderate to severe obesity has been accepted for review by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA).

This application of mazdutide 9 mg aims to address a pressing unmet clinical need in China by offering a highly effective and safe new treatment option for adults with moderate-to-severe obesity, beyond current standard-of care metabolic and bariatrics surgery. The application is based on the encouraging results from the Phase 3 registration clinical study GLORY-2 (NCT06164873) of mazdutide 9 mg in Chinese adults with moderate to severe obesity. The study met its primary endpoints and all key secondary endpoints.

At Week 60, participants in the mazdutide group exhibited continuous weight loss, with no plateau observed. The mazdutide 9 mg group achieved a mean weight reduction of 18.55%, compared to 3.02% in the placebo group. 44.0% of participants in the mazdutide 9 mg group achieved a weight reduction of 20% or more, versus 2.6% in the placebo group (p<0.0001 for all comparisons).

The key secondary endpoints also demonstrated that mazdutide 9 mg achieved a weight loss of up to 20.08% at Week 60 among participants without type 2 diabetes, with the weight loss trend not yet reaching a plateau by the end of the study. Furthermore, nearly half (48.7%) of the non-diabetic participants achieved weight loss exceeding 20% (placebo: 3.1%; p<0.0001).

Additionally, the study observed that mazdutide 9 mg significantly reduced liver fat content, with a mean percent reduction from baseline of 71.9%, and also demonstrated significant improvements in other key cardiometabolic endpoints, including blood pressure, blood lipids, and serum uric acid, as well as significant reduction in waist circumference.

Mazdutide 9 mg exhibited a favorable safety profile, with no new safety signals identified. Detailed data from the GLORY-2 study, which met all its endpoints, are planned for disclosure at future international academic conferences or in scientific publications.

"In China, individuals with severe obesity (BMI > 32.5 kg/m²) face a substantial disease burden but have very limited treatment options. According to current Chinese clinical guidelines, metabolic surgery is recommended as a first-line treatment for such patients. However, the invasiveness of the procedure and patient apprehension significantly limit its widespread clinical application,” said Professor Linong Ji, the leading principal investigator of the study, Peking University People's Hospital. “The potent weight loss efficacy demonstrated by mazdutide 9 mg in the GLORY-2 study positions it as a highly promising alternative to metabolic surgery, potentially filling a major clinical gap. Its benefits across multiple metabolic parameters highlight the unique advantages of dual GCG/GLP-1 activation. The acceptance of this application marks the potential addition of another breakthrough therapy for the management of moderate to severe obesity in China, bringing new hope for improving the health of this population."

Innovent entered into an exclusive license agreement with Eli Lilly and Company (Lilly) for the development and potential commercialization of mazdutide, a dual GCG/GLP-1 receptor agonist, in China.