Hansoh Pharma's Novel Dual-Agonist Obesity Drug Olelpotide Receives NDA Acceptance, Targeting the $150 Billion Global Weight-Loss Market

　　【Pharmaceutical Network | Industry Trends] In recent years, the global race for weight-loss drugs has continued to intensify, with analysts predicting that the annual size of the global market for obesity medications could reach $150 billion by 2030. Faced with vast market demand, Chinese pharmaceutical companies are also actively strengthening innovative research and development, achieving continuous breakthroughs.
 

 

Data shows that olepatide is a once-weekly glucagon-like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) dual receptor agonist independently developed by Hansoh Pharma. It is reported that on March 7, 2026, Hansoh Pharma announced that the Phase III registration study of olepatide (HS-20094) in Chinese adults with overweight or obesity had met its primary endpoint. After 48 weeks of treatment, the mean weight reduction among subjects reached up to 19.3%, and the proportion of subjects achieving ≥5% weight loss was as high as 97.2%. Meanwhile, the drug demonstrated significant advantages in gastrointestinal tolerability.
 

In terms of safety, olepatide also demonstrates excellent gastrointestinal tolerability. Reportedly, owing to its innovative design featuring dual-target synergistic action, the incidence of nausea with olepatide averages less than 10%, and the incidence of vomiting averages less than 5%. These figures are significantly superior to the published Phase III clinical trial data for GLP-1-related dual agonists.
 

The National Medical Products Administration (NMPA) has accepted the marketing authorization application for olepatide injection, potentially offering patients a new therapeutic option. Obesity has become one of the most severe challenges among chronic diseases. Data indicate that over 650 million adults worldwide are affected by obesity, while the combined prevalence of overweight and obesity among Chinese adults has exceeded 50%. However, for a long time, there has been a lack of truly effective medications suitable for long-term use in obesity treatment. With domestic pharmaceutical companies making significant breakthroughs, the weight-loss drug market is poised to welcome more new options. It is reported that, in addition to Hansoh Pharma, other manufacturers of domestically produced GLP-1 novel drugs, including Innovent Bio, Sciwind, and Hengrui Medicine, are accelerating their strategic layouts in this field.
 

For instance, mazdutide, a natural dual-target weight-loss and glucose-lowering agent targeting GCG and GLP-1 independently developed by Innovent Bio, acts on the liver directly via the GCG target while GLP-1 suppresses appetite. In addition to achieving weight loss, it reduces hepatic fat content by up to 80%, promoting hepatic lipolysis and energy expenditure, thereby reducing intrahepatic fat accumulation. In June 2025, mazdutide received approval from the National Medical Products Administration for long-term weight management in adults with obesity or overweight, becoming the first approved dual GCG/GLP-1 targeted weight-loss medication.
 

In March this year, Sciwind also announced that the National Medical Products Administration had approved Enoglutide Injection (Xianweiying), a next-generation cAMP-biased GLP-1 receptor agonist, for long-term weight management in adults with overweight or obesity, in conjunction with a reduced-calorie diet and increased physical activity. Xianweiying is the first biased GLP-1 weight-loss drug to be approved and marketed globally.
 

In May this year, Hengrui Medicine and U.S.-based Kailera Therapeutics jointly announced that the Phase III clinical trial (OUTSTAND-1) of their independently developed oral small-molecule glucagon-like peptide-1 (GLP-1) receptor agonist, HRS-7535, had achieved positive top-line results in adult patients with type 2 diabetes in China. Based on this success, Hengrui Medicine plans to submit a marketing application in China for HRS-7535 for the treatment of type 2 diabetes. The product is expected to become the first domestically produced oral small-molecule GLP-1 receptor agonist to be submitted for market approval.
 

Currently, metabolic disorders such as obesity, diabetes, and fatty liver disease are widespread. According to data from the "Dietary Guidelines for Adult Obesity" released by the National Health Commission, the prevalence of overweight and obesity among Chinese adults is projected to reach 65.3% by 2030, with medical costs attributable to overweight and obesity potentially reaching RMB 418 billion. The large patient population and the substantial societal healthcare burden have made efficient, safe, and accessible weight-loss medications an urgent necessity, thereby opening up broad development opportunities for domestic innovative pharmaceutical companies.
 

As more domestically produced new drugs are launched and submitted for market approval, China’s weight-loss medication market will enter a dual transformation phase characterized by “domestic substitution plus technological upgrading.” Previously, the domestic weight-loss market relied heavily on imported drugs, which were prohibitively expensive, had limited accessibility, and exhibited significant side effects in some cases, thus failing to meet the demands of large-scale clinical treatment. The concentrated breakthrough of domestically developed innovative drugs not only matches imported originator drugs in core weight-loss efficacy but also optimizes treatment regimens to better align with the physiological characteristics of the Chinese population. Furthermore, by leveraging advantages in localized research and development and manufacturing, these drugs effectively reduce costs, promising to significantly lower the treatment threshold for obesity patients in China.
 

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