Jiangsu Hengrui Pharmaceuticals is one of China's largest drug developers and a growing presence in the global obesity race, often through out-licensing. Its oral small-molecule GLP-1 receptor agonist HRS-7535 (KAI-7535) and injectable GLP-1/GIP dual agonist ribupatide are both licensed to US-based Kailera Therapeutics outside Greater China, a deal that helped fuel Kailera's $625 million IPO in April 2026.
HRS-7535 has moved quickly through Chinese Phase 3 testing. Hengrui reported a Phase 3 win in Chinese type 2 diabetes in June 2026, and on July 7, 2026 Kailera and Hengrui announced topline data from two more Phase 3 trials: HARBOR-1 in obesity, with up to 10.9% weight loss at week 44, and OUTSTAND-2 in type 2 diabetes, showing non-inferiority versus dapagliflozin. China's drug regulator accepted marketing applications for both indications in September 2026, and on October 5 Nature Medicine published the full OUTSTAND-2 results under the drug's new name, safiglipron. Kailera runs parallel global trials.
On September 29, 2026, Hengrui licensed HRS-1596, a GLP-1/GIP dual agonist designed for once-weekly oral dosing, to Novo outside Greater China for $300 million upfront in a deal worth up to $2.6 billion.
Stories here follow Hengrui's metabolic readouts and the Kailera partnership. See #kailera, #oral-glp-1, and #obesity.
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.
A Phase 2 trial of ribupatide, the weekly GLP-1/GIP dual agonist injection that Hengrui licensed to Kailera Therapeutics outside Greater China, enrolled 158 Chinese women aged 18 to 40 with obesity or overweight and polyendocrine metabolic ovarian syndrome (PMOS). After 32 weeks, weight fell 10% on 1 mg, 15.1% on 2 mg, and 20.2% on 4 mg versus 2.6% on placebo, according to an EASD abstract reported by BioSpace on Friday, October 2, 2026. All three ribupatide groups had more frequent menstrual cycles, while cycles became less frequent on placebo, and there were no serious adverse events or adverse events that led to stopping the study.
Kailera Therapeutics said on Wednesday, September 30, 2026 that it has finished enrolling about 4,900 adults in the three-trial KaiNETIC Phase 3 program for ribupatide, a weekly GLP-1/GIP dual agonist licensed from Hengrui, including KaiNETIC-3, which compares ribupatide with semaglutide 2.4 mg in about 1,200 people with a BMI of 35 or higher. Each trial runs 76 weeks with titration up to 10 mg, and topline results are expected in mid-2028. At EASD on October 1, Kailera reported a 51-person Phase 1 study in which ribupatide exposure after injection in the upper arm or thigh was similar to abdominal injection, and early Phase 1 data for the triple agonist HRS-4729 showing 16.0% mean weight loss at week 12 on 12 mg in 10 participants.
Novo and Jiangsu Hengrui Pharmaceuticals announced on Tuesday, September 29, 2026 an exclusive license giving Novo global rights to HRS-1596, a GLP-1/GIP dual receptor agonist being developed for once-weekly oral dosing, outside mainland China, Hong Kong, Macao, and Taiwan, where Hengrui keeps the rights. Novo will pay $300 million upfront, and the deal is worth up to $2.6 billion including development, regulatory, and commercial milestones, plus royalties on sales. HRS-1596 is described as Phase 1-ready for weight management and type 2 diabetes; the deal requires Hart-Scott-Rodino clearance and is expected to close in the fourth quarter of 2026. Novo R&D chief Martin Holst Lange said the company wants to explore whether the drug can 'raise the bar for convenience.'
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.
Obesity biotech Kailera Therapeutics priced an upsized IPO of 39.06 million shares at $16, raising $625 million — the largest venture-backed biopharmaceutical IPO since Acelyrin in 2023. Lead candidate ribupatide (a GLP-1/GIP peptide dual agonist) drove 18% body weight loss at 48 weeks in a late-stage Chinese study; global Phase 3 readout expected in 2028.