NEW DRUG APPLICATION FOR OLATOREPATIDE INJECTION ACCEPTED BY THE NATIONAL MEDICAL PRODUCTS ADMINISTRATION
SHANGHAI, June 4, 2026 — Hansoh Pharmaceutical Group Company Limited ("Hansoh Pharma", 3692.HK) today announced, ,the New Drug Application (NDA) for the Group’s innovative drug Olatorepatide Injection has been accepted by the National Medical Products Administration (NMPA) of China for chronic weight management in obese and overweight adult patients.
Olatorepatide is a proprietary dual GLP‑1/GIP receptor agonist discovered and developed in‑house by Hansoh Pharma. By selectively activating GLP‑1 and GIP receptors, the drug modulates metabolic pathways governing appetite suppression, glucose homeostasis, and energy balance to deliver glycemic control and weight reduction benefits. It is administered once weekly via subcutaneous injection.
In March 2026, the first Phase Ⅲ clinical study (HS-20094-301) of Olatorepatide in Chinese adults with obesity or overweight met its primary endpoint: Participants treated with olatorepatide achieved up to 19.3% mean weight loss from baseline at Week 48. Responder analyses showed that up to 97.2% of participants achieved ≥5% weight loss at Week 48. The study shows olatorepatide delivers robust weight-loss efficacy alongside improved gastrointestinal tolerability. Mean nausea incidence stood below 10%, with mean vomiting incidence under 5%. Compared with published Phase Ⅲ data from other GLP‑1 dual agonists, olatorepatide shows lower gastrointestinal adverse event rates and fewer treatment discontinuations.
Obesity is a complex chronic disease driven by multiple factors. According to a report in The Lancet Regional Health – Western Pacific, overweight and obesity prevalence among Chinese adults is projected to hit 72.2% by 2035[1], highlighting substantial unmet clinical need. Olatorepatide injection is poised to offer a novel therapeutic option for patients with obesity.
In June 2025, Hansoh Pharmaceutical entered into a licensing agreement with Regeneron Pharmaceuticals for olatorepatide. Per the agreement, Hansoh retains development and commercialization rights for Chinese mainland, Hong Kong, and Macau, while Regeneran secures all rights for the rest of the world.
References：
[1] Hu J, Xie J, Liu B, et al. Major risk factors of obesity in China and recommendations for future prevention and control efforts: a systematic review and meta-analysis. Lancet Reg Health West Pac. 2026 Mar 19;68:101833.
Hansoh Pharma is a leading innovation-driven pharmaceutical enterprise in China. With the mission of "continuous innovation for better life", the company focuses on major disease therapeutic areas such as oncology, anti-infectives, central nervous system (CNS), metabolism and immunology. Hansoh Pharma has launched 7 innovative medicines that generate product sales in China, with the revenue from innovative medicines and collaborative products exceeding 80%, forming a rich product pipeline. The company has consistently ranked among the top 100 global pharmaceutical companies and is recognized as one of the top 3 pharmaceutical R&D enterprises in China, and is designated as a National Key High-Tech Enterprise and a National Technology Innovation Demonstration Enterprise. Hansoh Pharma was listed on the Hong Kong Stock Exchange in June 2019 (stock code: 03692.HK).
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