Hansoh ：Olatorepatide Phase III Study Meets Primary Endpoint
On June 4, Hansoh Pharma announced that the New Drug Application (NDA) for its innovative drug Olatorepatide Injection has been accepted by the NMPA for long-term weight management in adults who are obese or overweight. Olatorepatide is a glucagon-like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) dual receptor agonist independently developed by Hansoh Pharma, administered via once-weekly subcutaneous injection.
In March 2026, the first Phase III clinical study (HS-20094-301) of Olatorepatide in Chinese adults who are overweight or obese met its primary endpoint. HS-20094-301 (NCT06839664 / CTR20243973) was a multicenter, randomized, double-blind, placebo-controlled Phase III trial designed to evaluate the efficacy and safety of Olatorepatide in overweight or obese subjects. Enrolled subjects were randomized to receive Olatorepatide 5 mg, 10 mg, 15 mg, or placebo once weekly for 48 weeks. Results showed that at 48 weeks, the mean weight loss from baseline reached up to 19.3%, and the proportion of subjects achieving ≥5% weight loss reached up to 97.2%.
The Olatorepatide treatment group demonstrated excellent gastrointestinal tolerability, with mean nausea incidence <10% and mean vomiting incidence <5%. Compared with published Phase III data for other GLP-1-related dual agonist drugs, the incidence of gastrointestinal adverse events and treatment discontinuation rates were lower.
On June 2, 2025, Hansoh Pharma announced that it had entered into a license agreement with Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN), granting Regeneron an exclusive worldwide license (excluding mainland China, Hong Kong, and Macau) to develop, manufacture, and commercialize HS-20094.
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