CSPC Pharmaceutical gets US FDA nod for JMT206 obesity drug trials

CSPC Pharmaceutical Group Limited announced that its recombinant fully human anti-ActRIIA/IIB monoclonal antibody, JMT206, has obtained approval from the U.S. Food and Drug Administration (FDA) to commence clinical trials in the U.S. This milestone was revealed in a voluntary announcement dated December 10, 2025. The product also received approval from China's National Medical Products Administration in November 2025 for clinical trials in China.

JMT206 is designed to address weight management in individuals with obesity or overweight and at least one weight-related comorbidity. The antibody works by simultaneously binding to activin receptor type IIA and IIB, blocking factors like activin A and myostatin, to inhibit downstream signaling and promote skeletal muscle growth while reducing fat. Preclinical studies indicate JMT206 offers high bioavailability and promising efficacy and safety profiles.

The company's board of directors, led by chairman Cai Dong Chen, highlighted the potential for JMT206 to enhance weight loss outcomes when used with GLP-1 receptor agonists. This approval marks a key step in the clinical development of JMT206, underscoring its potential in the therapeutic landscape for weight management.