The molecule, developed in collaboration with Massachusetts-based Kailera Therapeutics, is headed for a new drug application in China and global clinical trials.
Hengrui Pharma’s dual GLP-1/GIP receptor agonist elicited 17.7% average weight loss in Chinese patients who are overweight or have obesity compared to placebo in a Phase III trial.
The topline data, from a trial comprising 567 patients in Shanghai, are the first late-stage readout for the novel injectable, dubbed HRS9531 in China. The drug, developed in partnership with Massachusetts-based Kailera Therapeutics, achieved at least 5% weight loss in 88% of patients who received it, and 20% weight loss in 44.4% of participants.
The trial met its primary endpoint—with HRS9531 eliciting “superior weight loss” across three different doses, 2 mg, 4 mg and 6 mg, in comparison to placebo at 48 weeks, according to the Tuesday announcement. The companies did not share differentiated data for each dose.
Safety and tolerability was “consistent with GLP-1 based treatments” and previously reported Phase II clinical data, according to Hengrui’s press release. The companies previously announced Phase II data in January, showing 21.1% placebo adjusted average weight loss after 36 weeks. Adverse events in that trial were “mild,” with gastrointestinal-related events related to dose escalation.
“This is a huge step forward in providing innovative solutions to meet the needs of people living with obesity,” Hong Chen, head of the metabolism department at Hengrui, said in the company’s statement. “Based on these robust and encouraging clinical results, we are accelerating our efforts to advance this highly promising candidate.”
Hengrui is planning to submit a new drug application for the drug in chronic weight management in China, while Kailera plans to study both higher doses and longer duration of treatment in global clinical trials.
Hengrui will present full data from the Phase III trial at an upcoming scientific meeting.
With this readout, Kailera is seeing the fruits of a novel strategy. The biotech launched in October 2024 with $400 million in financing. The initial portfolio consisted of four drugs from Hengrui, to which it acquired global development and commercialization rights for the entire world outside of greater China. One of those molecules is HRS9531, called KAI-9531 outside of China.
Kailera’s other molecules include KAI-4729, an injectable GLP-1/GIP/glucagon receptor triple-agonist, KAI-7535, a clinical-stage oral small molecule GLP-1 receptor agonist and KAI-9531 in an oral formulation, all intended to treat obesity.
