Hengrui HRS-7535 oral GLP-1: Phase 3 data

Hengrui Medicine and its US partner Kailera Therapeutics announced positive Phase 3 results for HRS-7535 (also designated KAI-7535) in July 2026, adding an oral small-molecule GLP-1 receptor agonist to the queue of drugs competing in the same space as oral semaglutide and orforglipron. The Phase 2 trial, published in Nature Communications on 22 June 2026, provides the peer-reviewed clinical baseline^[1]. The Phase 3 topline readout is an announcement, not yet a peer-reviewed publication, so the specific percentages are not independently verifiable in print at the time of writing.

What the Phase 2 trial showed

Gu and colleagues ran a randomized, double-blind, placebo-controlled Phase 2 trial of HRS-7535 in 235 Chinese adults with obesity and without diabetes across 29 centres in China^[1]. At 26 weeks, the 180 mg once-daily dose produced a 9.36 percent body-weight reduction from baseline, against 2.50 percent on placebo, a placebo-adjusted difference of 6.87 percent (P less than 0.0001). The 60 mg dose produced a 4.60 percent placebo-adjusted reduction. Gastrointestinal adverse events were the most common side effect and were predominantly mild to moderate, consistent with the wider GLP-1 class profile.

HRS-7535 is a non-peptide, orally active compound, which means it does not require refrigeration or injection. That is the same pharmacological class as orforglipron (Eli Lilly), and it addresses the same practical barrier that has constrained access to injectable GLP-1 agents: the requirement for a cold chain and a needle.

Where the DREAMS-2 trial fits

A second China-originated Phase 3 dataset published in April 2026 adds further context: the DREAMS-2 trial, appearing in Nature, tested mazdutide, a once-weekly glucagon and GLP-1 receptor dual agonist developed by Innovent Biologics^[2]. In 731 Chinese adults with type 2 diabetes, both the 4 mg and 6 mg mazdutide doses produced superior HbA1c reductions and significantly greater weight loss versus dulaglutide 1.5 mg weekly at 28 weeks. The 6 mg arm produced weight loss 5.76 percent greater than dulaglutide (P less than 0.0001), and significantly more participants in both mazdutide arms reached the composite endpoint of HbA1c below 7.0 percent with at least 5 percent body-weight reduction.

DREAMS-2 and the HRS-7535 programme represent different pharmacological strategies. Mazdutide is an injectable, weekly peptide with dual receptor activity; HRS-7535 is an oral, daily non-peptide compound acting solely at the GLP-1 receptor. Both were trialled exclusively in Chinese populations. That geographic specificity is material when considering how the data will be read by regulators outside China.

The Kailera licensing structure

Kailera, a US biotech headquartered in Waltham, Massachusetts, holds global ex-China rights to HRS-7535 under a licensing partnership with Hengrui. If Phase 3 data holds at submission quality, Kailera would file with the FDA while Hengrui separately pursues approval through China's NMPA. This in-licensing model, in which a Western company acquires ex-China commercial rights to a Chinese-developed asset while the Chinese developer retains domestic rights, has become a standard deal structure in the incretin class and broader obesity space over the past two years. AstraZeneca has been active in this market, though specific deal terms for recent licensing agreements with Chinese partners were not available from a primary source by the time this article was written.

What multi-regional trials require

One consistent challenge for Chinese-developed drugs seeking global approval is whether data from China-only trials is sufficient for non-Chinese regulatory agencies. The FDA's approach to multi-regional clinical trials expects data that includes populations representative of the US patient population. A trial run exclusively at Chinese sites in Chinese adults is not automatically transferable to a US or European label.

For HRS-7535, Kailera will need to run trials that satisfy FDA requirements independently of the Chinese Phase 3 data. The Hengrui Phase 3 results inform dose selection and signal validity, but the FDA filing will require a separate dataset. A parallel example: a Phase 2b trial of bofanglutide versus semaglutide in Chinese adults published in Annals of Internal Medicine in June 2026 was compelling science, but a China-only dataset is not a US registration package on its own.

What we do not yet know

For HRS-7535 the Phase 3 topline announcement from Kailera carries no peer-reviewed weight loss figures for the obesity indication, no safety discontinuation rates, and no comparison arm data that are independently citable at this stage. Until the trial appears in a peer-reviewed journal, specific numbers from the Phase 3 readout should be treated as company-reported claims.

For mazdutide the DREAMS-2 dataset is peer-reviewed but covers only 28 weeks in a Chinese type 2 diabetes population. Long-term cardiovascular outcomes, weight durability, and performance in non-Chinese populations are open questions. Innovent has not publicly confirmed a US or EU regulatory filing timeline for mazdutide as of this writing.

Why this matters for the oral GLP-1 pipeline

The oral GLP-1 pipeline is now larger than the injectable pipeline was five years ago. Orforglipron, from Eli Lilly, reported Phase 3 data in the Lancet^[3] covering obesity in type 2 diabetes (ATTAIN-2, December 2026): at 72 weeks the 36 mg dose cut body weight by 9.6 percent versus 2.5 percent on placebo. Oral semaglutide is already approved for type 2 diabetes in multiple markets. HRS-7535 and other Chinese-developed non-peptide GLP-1 agonists add further competition to a class that has faced sustained access constraints. Whether any of these compounds reaches approval outside China in the next three years depends on the multi-regional trial design decisions made now.

This article is for informational and educational purposes only. It is not medical advice. All compounds discussed except approved injectable and oral semaglutide formulations are investigational in most jurisdictions. Consult a qualified healthcare provider before making any treatment decision.