Hansoh Pharma Submits NDA for Orapeptide, a Once-Weekly GLP-1/GIP Dual Agonist for Chronic Weight Management in Adults with Obesity or Overweight

On June 4, Hansoh Pharma announced its independently developedGLP-1/GIP Receptor AgonistNew Drug Application (NDA) for Olepatide Injection Accepted by China’s National Medical Products Administration (NMPA) for Long-Term Weight Management in Adults with Obesity or Overweight. Olepatide is a once-weekly glucagon-like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) dual receptor agonist independently developed by the Group.

On March 7, Hansoh Pharma announced positive results from the Phase III clinical trial of olepatide (HS-20094) in adults with obesity or overweight. Olepatide is an investigational once-weekly subcutaneous GLP-1/GIP receptor dual agonist.

This randomized, double-blind, placebo-controlled study enrolled a total of 604 adult participants with overweight or obesity across 33 clinical centers, aiming to evaluate the efficacy and safety of once-weekly oleaglutide versus placebo over 48 weeks. The study met its co-primary endpoints: at 48 weeks, the reduction in body weight from baseline in the oleaglutide group was statistically significantly greater than that in the placebo group, and the proportion of participants achieving ≥5% weight loss was significantly higher in the oleaglutide group. After 48 weeks of treatment with oleaglutide, the mean percentage reduction in body weight from baseline reached up to 19.3%, and the proportion of participants achieving ≥5% weight loss reached up to 97.2%. These results demonstrate a high proportion of participants achieving clinically meaningful weight loss thresholds, with efficacy sustained through Week 48.

In this study, gastrointestinal tolerability during olezarsen treatment was significantly improved; compared with published Phase III trial data for GLP-1 receptor dual agonists, the incidence of gastrointestinal adverse events and the rate of treatment discontinuation were lower.

In June 2025, Hansoh Pharma and Regeneron Pharmaceuticals entered into a licensing agreement for olepatide. Under the agreement, Hansoh Pharma holds the rights to develop and commercialize olepatide in mainland China, Hong Kong, and Macau, while Regeneron Pharmaceuticals retains the development and commercialization rights for all other regions.$2.01 Billion! Regeneron Inlicenses Hansoh Pharma’s GLP-1/GIP Agonist HS-20094）