By Fineline Cube 
China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) and its US partner Kailera Therapeutics, Inc. jointly announced positive topline results from the Phase III clinical study (HRS9531-301) for HRS9531 in Chinese subjects with obesity or overweight.
Clinical Trial Results
Compared to placebo, all dose groups of HRS9531 (2mg, 4mg, 6mg) demonstrated superiority in both co-primary endpoints and all key secondary endpoints. After 48 weeks of treatment, the highest mean weight reduction reached 17.7% (16.3% after placebo adjustment), with 88.0% of subjects achieving ≥5% weight loss. Additionally, 44.4% of subjects in the high-dose group achieved ≥20% weight reduction. Supplementary analyses showed a maximum mean weight loss of 19.2% (17.7% after placebo adjustment).
Regulatory and Development Plans
Hengrui Pharma plans to submit a New Drug Application (NDA) in China for HRS9531 as a long-term weight management therapy. Kailera is advancing the global clinical development of HRS9531 (KAI-9531).
HRS9531 Mechanism and Development
HRS9531 is a dual agonist targeting the glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors. It is in-house developed by Hengrui for the treatment of overweight/obesity, related comorbidities, and type 2 diabetes. Multiple clinical trials involving over 2,000 Chinese subjects have been conducted.
Partnership Details
In May 2024, Hengrui licensed the global rights (excluding Greater China) for the development, production, and commercialization of HRS9531 to Kailera Therapeutics. The deal includes an upfront payment plus milestones totaling over USD 6 billion. Hengrui also acquired a 19.9% equity stake in Kailera.-Fineline Info & Tech