Hengrui Pharmaceuticals has filed for Chinese approval of its dual GLP-1/GIP receptor agonist HRS9531 for weight management in adults with obesity or overweight with comorbidities. The submission follows positive Phase III results showing up to 19.2% weight reduction at 48 weeks, with 88% of patients achieving ≥5% weight loss and 44.4% reaching ≥20% reduction in high-dose groups. The therapy demonstrated favourable safety with predominantly mild-to-moderate gastrointestinal adverse events across over 2,000 Chinese subjects in clinical trials.

Hengrui licensed ex-China rights to US company Kailera Therapeutics for up to USD 6 billion in May 2024, retaining 19.9% equity stake. The candidate, renamed KAI-9531 internationally, represents China's first dual-incretin agonist submission, positioning Hengrui to compete in the global obesity market dominated by Novo Nordisk's semaglutide and Eli Lilly's tirzepatide. Previously, Phase II data showed 22.8% weight reduction at 36 weeks without plateauing.

PharmCube's NextBiopharm® database shows that HRS9531 is subleader of the GIPR/GLP-1R agonist race, only behind Lilly's tirzepatide as the first competitor to enter Phase III. Click here to request a free trial for NextBiopharm®.