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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