Peptide News Digest

#Hrs-7535

2 stories

Clinical Trials · View digest

Kailera and Hengrui Report Positive Phase 3 Topline for Oral GLP-1 HRS-7535/KAI-7535: Up to 10.9% Weight Loss in a Chinese Obesity Trial

On July 7, Kailera Therapeutics reported positive topline results from two Hengrui Pharma Phase 3 trials in China of HRS-7535/KAI-7535, a once-daily oral small-molecule GLP-1 receptor agonist licensed to Kailera outside Greater China. In HARBOR-1, 556 adults with obesity or overweight lost a mean 9.5% of body weight at 120 mg and 10.9% at 180 mg by week 44. OUTSTAND-2, in 810 adults with type 2 diabetes, showed HbA1c reductions of 1.50% to 1.68% and non-inferiority versus dapagliflozin. Hengrui plans China NDA filings; Kailera is running a parallel global Phase 2.

Clinical Trials · View digest

Hengrui's Oral GLP-1 HRS-7535 Clears Phase 3 in Chinese Type 2 Diabetes; NDA Filing Planned

Kailera Therapeutics and Hengrui Pharma reported positive topline Phase 3 data from a Chinese T2D trial of HRS-7535, an oral small-molecule GLP-1 receptor agonist licensed to Kailera. Most adverse events were mild-to-moderate GI, with no Grade 3 hypoglycemic events and no liver-safety signal. Hengrui plans to submit a Chinese NDA for HRS-7535 in T2D and will share detailed efficacy data at an upcoming scientific conference. The readout extends the China-led oral-GLP-1 pipeline alongside ribupatide and aleniglipron.