石药集团:重组全人源抗ACTRIIA / IIB单克隆抗体(JMT206) 在美国获临床试验批准

Core Viewpoint - The company, Stone Pharmaceutical Group, has received FDA approval for its recombinant fully human anti-ActRIIA/IIB monoclonal antibody (JMT206) to conduct clinical trials in the United States, and it has also been approved by the National Medical Products Administration of China for clinical trials in China by November 2025 [1] Group 1: Product Details - JMT206 specifically binds to Activin receptor type IIA (ActRIIA) and IIB (ActRIIB), blocking the binding of Activin A, Myostatin (GDF8), and Growth Differentiation Factor 11 (GDF11) to Activin receptor type II (ActRII) [1] - The product aims to inhibit downstream signaling pathways, reduce muscle loss, and promote skeletal muscle maintenance and growth, achieving muscle gain and fat loss [1] - It also assists GLP-1 receptor agonists in achieving higher quality weight loss effects [1] Group 2: Clinical Application - The approved clinical indication for JMT206 is weight management in obese or overweight individuals with at least one weight-related comorbidity [1] - Preclinical studies have shown that the product exhibits high bioavailability, good efficacy, and safety, indicating a high clinical development value [1]