China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) announced that it has received approval from the US Food and Drug Administration (FDA) to initiate a clinical study for its Category 1 drug JMT108, an anti-PD-1/IL-15 bi-functional fusion protein. This approval marks a significant milestone in the company’s global expansion and innovation in oncology treatments.
Drug Profile
JMT108 is a novel bi-functional fusion protein designed to target the PD-1 and IL-15 pathways, offering a dual mechanism of action to enhance anti-tumor immunity. Preclinical studies have demonstrated significant anti-tumor effects and a favorable safety profile across various malignant tumor models, underscoring its potential as a promising therapeutic candidate.
Clinical Trial Progress
The drug received clinical trial approval in China last month, and this latest FDA clearance further solidifies CSPC’s commitment to advancing its robust oncology pipeline on a global scale.-Fineline Info & Tech