Hengrui reports a positive Phase 3 diabetes readout for ribupatide in China

Hengrui Pharma reported on July 20, 2026, that its GLP-1/GIP dual agonist ribupatide met its main goal and all key secondary goals in a Phase 3 trial of Chinese adults newly diagnosed with type 2 diabetes.^[1] The result adds a diabetes claim to a drug candidate whose global obesity development, outside Greater China, is being run by the US company Kailera Therapeutics.^[1]

The trial, called HRS9531-302, enrolled 218 treatment-naive patients with type 2 diabetes who had not achieved blood sugar control through diet and exercise alone.^[1] Participants were randomly assigned to weekly injections of ribupatide at 2 mg or 4 mg, or to matching placebo, over a 36-week core treatment period followed by a 16-week extension.^[1]

Using one statistical method (the efficacy estimand), the 2 mg dose lowered A1C by an average of 2.37 percentage points at week 36, and the 4 mg dose lowered it by 2.67 points, compared with 0.36 points for placebo.^[1] Using a second method (the treatment policy estimand), reductions were 2.19 and 2.50 points for the two doses, versus 0.66 for placebo.^[1] Nearly all patients on the higher dose, 94.5%, reached an A1C below 7%, compared with 16.7% on placebo; 63.0% on the 4 mg dose reached an A1C below 5.7%, a near-normal range, versus 1.4% on placebo.^[1] Hengrui said the safety profile was consistent with other GLP-1-based drugs, with most side effects mild to moderate and mainly gastrointestinal.^[1]

Hengrui, based in China, plans to file for regulatory approval of ribupatide for type 2 diabetes with China's National Medical Products Administration.^[1] The company already has a separate application pending with Chinese regulators for ribupatide as a weight-management treatment, accepted in September 2025.^[1] In May 2024, Hengrui licensed rights to develop and sell ribupatide outside Greater China to Kailera Therapeutics, which is running its own global Phase 3 obesity program for the drug, called KaiNETIC.^[1] Outside China, the drug is sometimes referred to as KAI-9531.^[1]

Why it matters for patients

This trial was conducted only in China and targeted people with type 2 diabetes, not obesity, and not in the United States.^[1] For US patients weighing GLP-1 options today, ribupatide is not an approved or available medication, and this news does not change anything about current access to Ozempic, Wegovy, Rybelsus, Mounjaro, Zepbound, or Foundayo.^[1]

Still, the data are relevant to the broader competitive landscape. Kailera's separate obesity program for the same molecule is the pathway most likely to eventually reach US patients, since it covers markets outside Greater China.^[1] A positive diabetes signal in China does not automatically predict results in Kailera's obesity trials, since obesity and diabetes trials measure different outcomes in different populations, and the sources here do not report any Kailera trial results.^[1]

What happens next

Hengrui said it plans to submit a New Drug Application in China for ribupatide as a diabetes treatment, though no filing or review date was given.^[1] The company also said it will share more Phase 3 diabetes data at future scientific conferences.^[1] Separately, ribupatide's China weight-management application, filed in September 2025, remains under review by Chinese regulators, with no decision date disclosed.^[1] An oral version of ribupatide is in Phase 3 testing in China for weight management and Phase 2 testing for diabetes, according to Hengrui, but no results for the oral form were included in this announcement.^[1] No timeline for US regulatory filings or Kailera trial results was provided in the available sources.