19.2% Weight Reduction! HENGRUI PHARMA (01276) Reports Positive Topline Results from China Phase III Obesity Trial of GLP-1/GIP Dual Agonist HRS9531

Stock Track
15 Jul

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.

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