China's regulator accepts Hengrui's ribupatide filing for type 2 diabetes
The acceptance starts a regulatory review in China but is not an approval, and no human trial results for ribupatide have been released. [1]
China's National Medical Products Administration (NMPA) has accepted a new drug application from Jiangsu Hengrui Pharmaceuticals for ribupatide injection, a dual GLP-1/GIP receptor agonist, for glycemic control in adults with type 2 diabetes [1]. Hengrui announced the acceptance on September 9, 2026, and the filing is now in formal review [1].
Ribupatide is also known as HRS9531, and as KAI-9531 in markets outside Greater China [1]. Hengrui describes it as a self-developed Class 1 innovative drug that activates both the GLP-1 and GIP incretin receptors, an approach meant to drive glucose-dependent insulin secretion, suppress glucagon and regulate appetite [1]. The company is developing two versions: a once-weekly subcutaneous injection and a once-daily oral tablet [1]. Only the injection and only the diabetes use are covered by the filing the NMPA accepted [1].
China has the world's largest population of people with type 2 diabetes, and the agency's move puts a domestically developed dual agonist into the queue alongside imported competitors [1]. Hengrui frames the asset as a possible homegrown alternative on price and supply; no pricing or reimbursement plans have been disclosed [1]. No figures for how many patients the diabetes indication would cover were released either [1].
Hengrui's China studies of the injection list a wide set of conditions: weight management in adults and adolescents, type 2 diabetes, obstructive sleep apnea with obesity, metabolic dysfunction-associated steatohepatitis (MASH), reduction of major adverse cardiovascular events in people with atherosclerotic cardiovascular disease, and obesity with knee osteoarthritis [1]. Trial readouts, effect sizes and any head-to-head comparisons with marketed incretin drugs have not been disclosed [1].
In May 2024, Hengrui gave Kailera Therapeutics exclusive rights to develop, make and sell its GLP-1 portfolio, ribupatide included, outside Greater China [1]. Kailera is running the global Phase 3 KaiNETIC trial of the injection in obesity, and intends to open a global Phase 3 study of the oral form in obesity in the first half of 2027 [1]. The two companies have not announced any US or European regulatory submission for ribupatide [1].
Ribupatide should not be confused with HRS-7535, a separate oral small-molecule GLP-1 receptor agonist from Hengrui that is also partnered with Kailera. China's regulator accepted a marketing application for HRS-7535 tablets for long-term weight management in adults with obesity or overweight in September 2026 [2].
Why it matters for patients
An accepted filing is not an approval, and acceptance of an application does not guarantee a drug will be cleared [1]. No approval timeline has been disclosed [1].
Nothing about this filing changes what is available in the United States today. No US filing for ribupatide has been reported, and the global program led by Kailera is in Phase 3 for obesity [1]. Any eventual US availability would require separate trials and a separate review.
Because no efficacy or safety results from the ribupatide trials have been released, how it compares with currently marketed GLP-1 and dual-agonist medicines is not yet known [1].
The uses being studied differ by country: the Chinese filing covers type 2 diabetes, while the global Phase 3 program under way is in obesity [1]. A drug can be cleared in one country and for one condition long before, or without, being cleared in another.
Patients who inject a GLP-1 weekly or take an oral GLP-1 should also note that the oral form of ribupatide is at an earlier stage than the injection, with the first global Phase 3 in obesity planned for the first half of 2027 [1].
What happens next
NMPA technical review of the ribupatide injection filing is under way, with no stated decision date [1]. Kailera's KaiNETIC global Phase 3 trial in obesity continues, and the company plans to begin a global Phase 3 trial of oral ribupatide in obesity in the first half of 2027 [1].
Sources
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