Innovent to Seek Approval for 9mg Xinermei in Obesity After Positive GLORY-2 Trial

Innovent Biologics plans to file for approval of 9mg Xinermei (mazdutide) for obesity in China following successful results from its Phase III GLORY-2 trial. In the 60-week study of 462 adults, participants receiving Xinermei 9mg achieved an average weight loss of 18.55%, versus 3.02% with placebo. Notably, 44% of patients lost ≥20% of body weight, rising to 48.7% among participants without type 2 diabetes. Secondary endpoints—including waist circumference, blood pressure, lipids, and liver fat—were also met, with MRI-PDFF showing a 71.9% reduction in liver fat among treated patients.

Xinermei, a dual GLP-1/glucagon receptor agonist, is already approved in China at 4mg and 6mg doses for obesity, and for type 2 diabetes. Innovent will submit its NDA to China’s NMPA. The company is also conducting Phase III trials GLORY-3 and GLORY-OSA, exploring metabolic-associated fatty liver disease and sleep apnea.

25-11-2025