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速递|恒瑞减重药实现近18%体重下降!拟加快在中国申报上市

Core Viewpoint - The injectable GLP-1/GIP dual agonist HRS9531 developed by Heng Rui Pharmaceutical has shown promising results in a 48-week Phase III clinical trial, achieving an average weight loss of nearly 18%, with plans to apply for market approval in China as soon as possible [2][6]. Group 1: Clinical Trial Results - The Phase III clinical study conducted in China evaluated doses of HRS9531 at 2 mg, 4 mg, and 6 mg weekly, involving 531 overweight or obese adults without diabetes, showing a maximum weight loss of 17.7%, with a placebo-adjusted weight loss of 16.3% [2]. - In a predefined supplementary analysis, the 6 mg dose group achieved a weight loss of 19.2% [2]. - Among participants receiving HRS9531, 88% achieved at least a 5% weight loss, and 44.4% achieved a weight loss of 20% or more, meeting the primary endpoint [3]. Group 2: Safety and Side Effects - Most adverse events reported were mild to moderate, primarily gastrointestinal reactions [3]. - The company emphasized the good safety and tolerability of HRS9531, suggesting its potential to help more obese patients achieve personalized weight loss goals [7]. Group 3: Competitive Landscape and Future Plans - HRS9531 is expected to compete with Eli Lilly's GLP-1/GIP dual agonist Tirzepatide (Zepbound), which previously demonstrated a 20.9% weight loss in a 36-week study [2]. - Kailera Therapeutics, Heng Rui's partner in the U.S., announced plans to explore higher doses and longer treatment durations in global clinical trials to expand the drug's potential [5][6]. - If approved, HRS9531 will be the second domestically approved weight loss drug following Innovent Biologics' dual agonist Mazdutide [6].