CSPC PHARMA (01093) announced that its self-developed recombinant fully human anti-ActRIIA/IIB monoclonal antibody (JMT206) has received clinical trial approval from the US Food and Drug Administration (FDA). The product had also obtained approval from China's National Medical Products Administration in November 2025 for clinical trials in China.
JMT206 can simultaneously and specifically bind to activin receptor type IIA (ActRIIA) and type IIB (ActRIIB), blocking the binding of activin A, myostatin (GDF8), and growth differentiation factor 11 (GDF11) to activin type II receptors (ActRII). This mechanism inhibits downstream signaling pathway activation, reduces muscle loss, and promotes skeletal muscle maintenance and growth to achieve muscle gain and fat reduction effects. Additionally, the product may enhance the weight-loss efficacy of GLP-1 receptor agonists.
The approved clinical indication targets weight management for obese or overweight individuals with at least one weight-related complication. Preclinical studies have demonstrated JMT206's high bioavailability, promising efficacy, and favorable safety profile, indicating significant clinical development potential.
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