Hengrui Pharma(SH:600276) GLP1减重宝典·2025-09-01 09:59Core Viewpoint - The article discusses the recent acceptance of the HRS9531 injection application by the National Medical Products Administration of China, highlighting its potential for long-term weight management in adults with obesity or overweight conditions [2][3]. Group 1: Product Overview - HRS9531 is a dual receptor agonist for GLP-1 and GIP, developed by the company for the treatment of overweight/obesity and related comorbidities, as well as type 2 diabetes [3]. - The injection is intended for adults with a BMI of ≥28 kg/m² (obesity) or ≥24 kg/m² (overweight) with at least one weight-related comorbidity [2]. Group 2: Clinical Trial Results - The phase III clinical trial (HRS9531-301) showed positive topline results, with all dosage groups (2mg, 4mg, 6mg) achieving superior efficacy compared to the placebo [4]. - In the study involving 567 participants, the average baseline weight was 93 kg, and after 48 weeks of treatment, the maximum average weight reduction was 17.7% (adjusted for placebo) [4]. - The proportion of participants achieving a weight loss of ≥5% was 88.0%, with 44.4% of the high-dose group losing ≥20% of their weight [4]. Group 3: Safety and Tolerability - HRS9531 demonstrated good safety and tolerability, with most treatment-emergent adverse events being mild to moderate, primarily gastrointestinal in nature [6]. - Previous phase II trial results indicated an average weight reduction of 22.8% after 36 weeks of treatment with the 8mg dose, with no plateau effect observed [6]. Group 4: Future Developments - Complete results of the phase III clinical trial for HRS9531 will be presented at an upcoming academic conference [7].