By Fineline Cube 
China-based CSPC Pharmaceutical Group Limited (HKG: 1093) has obtained Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) for its first-in-class GFRAL-targeted monoclonal antibody JMT203. This approval marks the initiation of clinical development for cancer-related cachexia, a debilitating syndrome characterized by weight loss, anorexia, and muscle wasting in advanced malignancies.
JMT203: Mechanism and Innovation
JMT203 is a GDF15–GFRAL/RET signaling pathway antagonist designed to block the interaction between growth differentiation factor 15 (GDF15) and its cognate receptor GFRAL/RET complex. By modulating this critical appetite-metabolism axis, JMT203 demonstrates potential to ameliorate chemotherapy-induced cachexia, preserve lean body mass in preclinical models, and improve nutritional status without compensatory fat accumulation.
Clinical Development and Safety Profile
The FDA clearance enables Phase I trials to evaluate JMT203’s safety and pharmacokinetics in solid tumor patients with cachexia. This follows completed GLP-toxicology studies that showed favorable safety margins, paving the way for further clinical evaluation.-Fineline Info & Tech