Hengrui HRS-7535 Oral GLP-1 Receptor Agonist NMPA Marketing Authorization Application Accepted in China for Obesity and Type 2 Diabetes
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.