Hengrui reports positive Phase 3 diabetes results for ribupatide in China
A GLP-1/GIP dual receptor agonist cleared a Phase 3 diabetes trial in China, but ribupatide is not approved in the US and was tested only against placebo.
Hengrui Pharma reported on July 20, 2026 that ribupatide, its once-weekly injectable GLP-1/GIP dual receptor agonist, met the primary endpoint and all key secondary endpoints in a Phase 3 trial in Chinese adults with type 2 diabetes who had not previously taken diabetes medication. Average HbA1c fell by as much as 2.67 percentage points at 36 weeks, depending on dose [1].
Ribupatide is also called HRS9531, and KAI-9531 outside Greater China. It is a different molecule from semaglutide (Ozempic, Wegovy, Rybelsus) and tirzepatide (Mounjaro, Zepbound) [1]. The trial, HRS9531-302 (NCT06650007), was multicenter, randomized, double-blind and placebo-controlled. It enrolled 218 participants whose blood sugar was not adequately controlled by diet and exercise, and assigned them in a 2:1:2:1 ratio to weekly ribupatide 2 mg, matching placebo for 2 mg, ribupatide 4 mg, or matching placebo for 4 mg. The core treatment period was 36 weeks, followed by a 16-week blinded extension [1].
Hengrui reported two sets of results that differ in how they account for participants who did not complete treatment. By the efficacy estimand, HbA1c fell 2.37 percentage points in the 2 mg group and 2.67 points in the 4 mg group, compared with 0.36 points for placebo. By the treatment policy estimand, the reductions were 2.19 points and 2.50 points, compared with 0.66 points for placebo [1].
The secondary results followed the same pattern. By the efficacy estimand, 87.7% of the 2 mg group and 94.5% of the 4 mg group reached HbA1c below 7%, compared with 16.7% on placebo. The shares reaching HbA1c below 5.7% were 39.7% and 63.0%, compared with 1.4% on placebo [1].
Hengrui said ribupatide was generally well tolerated, with a safety profile consistent with other GLP-1-based treatments and with previously reported Phase 2 data for the drug. Most treatment-emergent adverse events were mild to moderate and mainly gastrointestinal [1]. The announcement does not list rates for individual side effects or say how many participants stopped treatment. Hengrui said it intends to share further data from the trial at upcoming scientific conferences [1].
Why it matters for patients
Ribupatide is not approved for use in the United States, and the application Hengrui plans to file is with Chinese regulators for glycemic control in adults with type 2 diabetes [1]. Nothing about US prescriptions changes based on this readout.
The trial compared ribupatide with placebo only. It did not test the drug head-to-head against semaglutide, tirzepatide or any other approved GLP-1 or dual-agonist medicine, so there is no data showing how it compares with options already on the market [1].
The study enrolled only treatment-naive patients in China. Whether the results would carry over to people who are already taking other diabetes medications, or to US patient populations, has not been reported [1].
The numbers reported are topline results in a press release. Full safety data, including detailed side-effect rates and discontinuation rates, has not yet been published [1].
If ribupatide eventually reaches the US market, it would add another option in a category that has faced periodic supply and coverage questions. No US pricing, availability or launch timing has been disclosed [1].
What happens next
Hengrui plans to submit a New Drug Application in China for ribupatide injection for glycemic control in adults with type 2 diabetes. No filing date was given [1].
The company's separate application for ribupatide injection for long-term weight management in adults was accepted by China's National Medical Products Administration in September 2025 and is under review [1].
Outside Greater China, Kailera Therapeutics holds exclusive development and commercialization rights under a May 2024 agreement with Hengrui. Kailera is testing ribupatide injection for obesity in a global Phase 3 program called KaiNETIC [1].
An oral tablet version of ribupatide is in a Phase 3 trial in China for weight management and a Phase 2 trial for type 2 diabetes [1]. Timelines for any US diabetes trial or filing for ribupatide have not been disclosed.
Sources
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