CSPC PHARMA (01093): Recombinant fully human anti-ACTRIIA / IIB monoclonal antibody (JMT206) approved for clinical trials in the United States.

CSPC PHARMA (01093) announced that the group's developed recombinant fully human anti-ActRIIA/IIB monoclonal antibody (JMT206) has been approved by the U.S. Food and Drug Administration (FDA) for clinical trials in the United States. The product has also been approved by the National Medical Products Administration of the People's Republic of China in November 2025 for clinical trials in China. This product can specifically bind to both Activin receptor type IIA (ActRIIA) and IIB type (ActRIIB), blocking the binding of Activin A, myostatin (GDF8), and growth differentiation factor 11 (GDF11) with Activin receptor type II (ActRII), thereby inhibiting the activation of downstream signaling pathways, reducing muscle loss, and promoting bone and muscle maintenance and growth, to achieve the effects of muscle building and fat reduction. Additionally, the product can assist GLP-1 receptor agonists in achieving higher quality weight loss effects. The approved clinical indication for this product is weight management in obese or overweight individuals with at least one weight-related comorbidity. Preclinical studies have shown that the product has high bioavailability, as well as good efficacy and safety, making it of high clinical development value.