HRS-7535, now named safiglipron, is Jiangsu Hengrui's once-daily oral small-molecule GLP-1 receptor agonist, taken without fasting or food restrictions. Kailera Therapeutics develops it outside Greater China as KAI-7535, where a roughly 320-person Phase 2 trial in the U.S. and Australia is expected to report in 2027.
The drug finished Chinese Phase 3 testing in 2026. On July 7, the companies reported up to 10.9% weight loss at week 44 in the HARBOR-1 obesity trial, and China's drug regulator accepted marketing applications for obesity and type 2 diabetes in September. On October 5, Nature Medicine published the OUTSTAND-2 trial in 810 adults with type 2 diabetes: HbA1c fell 0.22 to 0.40 percentage points more than with dapagliflozin, and 3.9% to 4.0% stopped for side effects, versus 1.5%.
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Full results of OUTSTAND-2, published in Nature Medicine on Monday, October 5, 2026, come from 810 adults in China with type 2 diabetes not controlled on metformin, randomized to once-daily safiglipron (HRS-7535) 30, 60, or 90 mg or the SGLT2 inhibitor dapagliflozin 10 mg for 32 weeks. HbA1c fell 0.22 to 0.40 percentage points more on safiglipron, meeting the non-inferiority goal at every dose, and the 90 mg dose also passed the superiority test; weight loss was similar (2.35% to 4.17% on safiglipron versus 3.60% on dapagliflozin). Gastrointestinal side effects were more common on safiglipron, 3.9% to 4.0% stopped for adverse events versus 1.5% on dapagliflozin, Hengrui funded the trial, whose topline results were announced in July.
Kailera Therapeutics (NASDAQ: KLRA) holds rights outside Greater China to several Hengrui Pharma obesity drugs. Ribupatide (KAI-9531), a once-weekly injectable GLP-1/GIP dual agonist, is in the three-trial global KaiNETIC Phase 3 program, which had enrolled more than 4,700 participants as of August 12, 2026, testing doses up to 10 mg over 76 weeks with data expected in 2028. KAI-7535 (HRS-7535) is a separate drug, a once-daily oral small-molecule GLP-1 receptor agonist, now in a roughly 320-person global Phase 2 trial in the U.S. and Australia with data expected in 2027; Kailera's GLP-1/GIP/glucagon triple agonist is a third drug, HRS-4729.
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.