HENGRUI PHARMA (01276) and U.S. partner Kailera Therapeutics announced positive topline results on July 15, 2025, from the Phase III clinical trial (HRS9531-301) evaluating GLP-1/GIP dual agonist HRS9531 injection in Chinese subjects with obesity or overweight. Compared to placebo, all HRS9531 dosage groups (2mg, 4mg, 6mg) demonstrated superiority across co-primary endpoints and all key secondary endpoints.

The trial enrolled 567 participants with an average baseline weight of 93kg. Per the treatment policy strategy analysis, HRS9531 achieved up to 17.7% mean weight reduction after 48 weeks (16.3% placebo-adjusted), with 88.0% of subjects achieving ≥5% weight loss. Notably, 44.4% of high-dose group participants attained ≥20% weight reduction. Supplementary analysis under hypothetical strategy showed maximum mean weight loss of 19.2% (17.7% placebo-adjusted).

HRS9531 exhibited favorable safety and tolerability consistent with other GLP-1 therapies and prior Phase II data. Most treatment-emergent adverse events (TEAEs) were mild-to-moderate gastrointestinal incidents.

HENGRUI PHARMA plans imminent New Drug Application (NDA) submission in China for long-term weight management. Globally, Kailera advances clinical development of the compound (designated KAI-9531) outside Greater China.

Developed internally by HENGRUI PHARMA, HRS9531 targets GLP-1 and GIP receptors for treating overweight/obesity, related comorbidities, and type 2 diabetes. Over 2,000 Chinese subjects have received HRS9531 across multiple trials.

Notably, in May 2024, HENGRUI licensed global rights (excluding Greater China) for its proprietary GLP-1 portfolio including HRS9531 to Kailera. The deal includes up to $6 billion in upfront and milestone payments plus 19.9% equity stake in Kailera.