Kailera Therapeutics (NASDAQ: KLRA) continues through September 2026 the ramp toward global ex-China Phase 3 initiation for ribupatide (a once-weekly subcutaneous injection GIP/GLP-1/glucagon triple agonist peptide licensed globally ex-China from Hengrui Pharma under the May 2024 up-to-$5+ billion collaboration). The China Phase 3 program is complete with mean weight loss of nearly 18% at 48 weeks in Chinese overweight and obese adults. Ribupatide oral formulation (HRS-7535, licensed as KAI-7535 to Kailera ex-China) had NMPA marketing authorization applications accepted in China September 2, 2026 for both obesity and type 2 diabetes based on the OUTSTAND-1 and OUTSTAND-2 Phase 3 trials. The global ex-China ribupatide Phase 3 program is designed to run against Eli Lilly's retatrutide (28.3% weight loss in TRIUMPH-1) as the second-in-class triple-agonist option, and Kailera has signaled ambition to file in the U.S. within 12-18 months of Phase 3 readout. Ribupatide would be the third Chinese-origin GLP-1-class asset to reach U.S. clinical development, following Innovent-Lilly mazdutide and Sciwind-Pfizer ecnoglutide.
Hengrui Pharma (SHA: 600276, HKEX: 1276) disclosed Wednesday September 2, 2026 that China's National Medical Products Administration (NMPA) accepted the marketing authorization application for HRS-7535 (an oral once-daily small-molecule GLP-1 receptor agonist) for long-term weight management in adults with obesity or overweight, plus a separate marketing authorization application for HRS-7535 in type 2 diabetes based on the Phase 3 OUTSTAND-1 and OUTSTAND-2 trials. The Chinese Phase 3 obesity trial delivered mean weight loss of up to 10.9% at Week 44 (11.1% at Week 50 with continued treatment) versus 2.5% for placebo in the 180 mg group. If approved, HRS-7535 would become the first oral small-molecule GLP-1 receptor agonist marketed in China. HRS-7535 is licensed to Kailera Therapeutics (NASDAQ: KLRA) for global rights outside Greater China; the U.S. Phase 3 program is planned to initiate imminently. HRS-7535 would compete with Novo Nordisk's Wegovy pill (oral semaglutide) and Eli Lilly's Foundayo (orforglipron) in oral obesity therapeutics.
On July 7, Kailera Therapeutics reported positive topline results from two Hengrui Pharma Phase 3 trials in China of HRS-7535/KAI-7535, a once-daily oral small-molecule GLP-1 receptor agonist licensed to Kailera outside Greater China. In HARBOR-1, 556 adults with obesity or overweight lost a mean 9.5% of body weight at 120 mg and 10.9% at 180 mg by week 44. OUTSTAND-2, in 810 adults with type 2 diabetes, showed HbA1c reductions of 1.50% to 1.68% and non-inferiority versus dapagliflozin. Hengrui plans China NDA filings; Kailera is running a parallel global Phase 2.
Kailera Therapeutics and Hengrui Pharma reported positive topline Phase 3 data from a Chinese T2D trial of HRS-7535, an oral small-molecule GLP-1 receptor agonist licensed to Kailera. Most adverse events were mild-to-moderate GI, with no Grade 3 hypoglycemic events and no liver-safety signal. Hengrui plans to submit a Chinese NDA for HRS-7535 in T2D and will share detailed efficacy data at an upcoming scientific conference. The readout extends the China-led oral-GLP-1 pipeline alongside ribupatide and aleniglipron.