Key Takeaways:
Key Takeaways:
Hengrui Pharma and Kailera Therapeutics' oral GLP-1 drug HRS-7535 met its primary endpoint in two China-based Phase 3 trials, delivering 10.9% mean weight loss at week 44 in adults with obesity or overweight, according to data released Tuesday.
"The results validate the late-stage profile of HRS-7535 and pave the way for regulatory submission in China," the companies said in a joint statement. Hengrui plans to submit new drug applications for both obesity and type 2 diabetes in China this year.
In the HARBOR-1 obesity trial, patients receiving 180mg of HRS-7535 achieved 9.8% weight loss from baseline at week 44 using the treatment policy estimand, compared with 2.4% for placebo. An ad hoc analysis showed weight loss reached 11.1% at week 50. The 120mg dose produced 8% weight loss. In the OUTSTAND-2 diabetes trial, the highest 90mg dose reduced HbA1c by 1.68% at week 32, outperforming AstraZeneca's Farxiga (dapagliflozin), which achieved 1.28%.
Gastrointestinal side effects were pronounced. Nausea occurred in about 70% of HRS-7535 patients versus 16.2% on placebo, while vomiting affected up to 68.6% of treated patients compared with 4.5% on placebo. Treatment discontinuation rates due to adverse events were 4.1% for the 120mg group, 3.1% for the 180mg group and 2.7% for placebo. William Blair analysts said they were "particularly alarmed" by the nausea and vomiting rates, noting that reducing those to roughly 35% and 25%, respectively, would yield a competitive profile.
The data positions HRS-7535 as the potential third oral GLP-1 for obesity to reach the US market, behind Novo Nordisk's Wegovy pill and Eli Lilly's Foundayo (orforglipron). Lilly's Foundayo showed 11.1% weight loss at week 72, while Novo's oral semaglutide delivered 13.6% at week 64. Kailera, which raised $625 million in an April IPO, is running a global Phase 2 trial with a wider dose range and more gradual titration to address tolerability, with a readout expected next year.
UBS maintained a Buy rating on Hengrui with a HKD97.4 target price, forecasting the company's GLP-1 portfolio could generate RMB5.9 billion in China sales by 2035. The results are a positive signal for Kailera's broader pipeline, which includes four clinical candidates led by the injectable ribupatide. Kailera CEO Ronald Renaud said at a Jefferies event last month that most oral obesity drugs will deliver weight loss "in a very tight band, somewhere between 10% and 15%," making safety and tolerability the key differentiator.
This article is for informational purposes only and does not constitute investment advice.
