China-headquartered Hengrui Pharmaceuticals announced positive topline results on 15 July from its Phase III trial (HRS9531-301) of GLP-1/GIP dual agonist HRS9531 in Chinese adults with obesity or overweight. All dose groups (2 mg, 4 mg, 6 mg) met primary and key secondary endpoints, with up to 19.2% mean weight reduction (17.7% placebo-adjusted) at 48 weeks. Notably, 44.4% of high-dose patients achieved ≥20% weight loss. The therapy demonstrated a safety profile consistent with GLP-1 class effects, with mostly mild-to-moderate gastrointestinal adverse events. Hengrui plans to submit a new drug application (NDA) in China for long-term weight management.

HRS9531, licensed to US-based Kailera Therapeutics for up to USD 6 billion in milestone payments excluding Greater China rights, is part of Hengrui's metabolic disease pipeline. The company also has oral GLP-1 agonist HRS-7535 and GLP-1/GIP/glucagon tri-agonist HRS-4729 in development. Kailera is advancing global trials of HRS9531 (rebranded KAI-9531), which previously showed 23.6% weight loss in Phase II studies. Hengrui's metabolism portfolio boasts four approved products, including SGLT2 inhibitor henagliflozin and DPP-4 inhibitor retagliptin.

According to PharmCube's NextBiopharm database, HRS9531 is one of seven Phase III GLP-1/GIP hopefuls aiming to challenge Eli Lilly's Zepbound (tirzepatide). Click here to request a free trial for NextBiopharm.