CSPC drug JMT108 gains U.S. and China trial approvals

CSPC Pharmaceutical Group Limited (HKEX:1093) announced that its new Class I bi-functional fusion protein drug, JMT108, has been approved for clinical trials by the U.S. Food and Drug Administration (FDA) and the National Medical Products Administration of China. The approval in China was obtained in March 2025. JMT108 is a recombinant fully human anti-PD-1/IL-15 fusion protein designed to relieve immunosuppression on PD-1 positive tumor infiltrating immune cells and promote the proliferation and activation of related immune cells, achieving enhanced anti-tumor efficacy. The indication for this approval is advanced malignant tumors. Preclinical studies have demonstrated that JMT108 has a broad variety of indications with significant anti-tumor effects and a good safety profile.