Chinese drugmaker Hengrui Medicine and U.S. partner Kailera Therapeutics said their once‑daily oral GLP‑1/GIP dual receptor agonist, ripubopetide (HRS9531 / KAI‑9531‑T), produced encouraging top‑line results in a 166‑patient Phase II trial in China. By week 26, an estimand analysis showed mean weight reduction of up to 12.1% from baseline; investigators reported no clear weight‑loss plateau and vomiting rates no higher than 11.4%.
The study, registered as NCT06841445, used an analysis based on a hypothetical estimand strategy to gauge the treatment effect at 26 weeks. Hengrui intends to advance ripubopetide into a Phase III programme in China, while Kailera plans a global Phase II beginning in 2026. The asset is also being developed in a subcutaneous formulation, reflecting a dual approach to market entry and patient access.
The result matters because GLP‑1 and dual GLP‑1/GIP agonists have already rewritten expectations for pharmacological weight loss. Injectable therapies have delivered unprecedented mean reductions in body weight, but adherence, needle aversion and access have limited uptake. An effective, orally administered once‑daily GLP‑1/GIP agent would lower barriers for patients and payers, and could rapidly expand the addressable market for obesity treatment both in China and globally.
Caveats remain. The trial enrolled a modest number of participants and the published information is limited to top‑line figures. Short‑term tolerability, gastrointestinal side effects and the absence of a plateau are promising signals, but they do not substitute for larger, longer studies required to define durability, cardiovascular safety, metabolic benefits and real‑world tolerability. Regulators and clinicians will look for confirmatory Phase III data and detailed safety readouts before reassessing clinical guidance.
Commercially, the stakes are high. China is a high‑growth market for obesity medicines as prevalence climbs, and a homegrown oral GLP‑1/GIP could exert downward pressure on prices and reshape competitive dynamics with established Western players. Hengrui’s move to push a domestic Phase III while Kailera lines up a global study indicates a two‑track strategy: secure a Chinese regulatory lead and pursue international validation, licensing or co‑development depending on outcomes.
If the Phase III trials reproduce these findings, ripubopetide could accelerate the shift from injection‑dominant obesity care to more convenient oral regimens, broadening treatment uptake. For now, the announcement is a positive early signal that Chinese biopharma can advance sophisticated incretin biology into oral formats, but investors, clinicians and patients should await fuller data and regulatory milestones before drawing conclusions.