Fapon Biopharma’s FP008 Receives FDA Approval for Clinical Trials

China-based Fapon Biopharma announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its FP008, an anti-PD-1 × IL-10M fusion protein designed to target solid tumors refractory to anti-PD-1 therapy.

Drug Profile
FP008 is a first-in-class immunocytokine with a unique mechanism of action (MOA). It holds therapeutic potential for patients who are anti-PD-1 naïve or resistant. The drug features IL-10 monomer (IL-10M) engineering, which significantly reduces hematologic toxicity. Additionally, the anti-PD-1 antibody enhances IL-10M activity through PD-1 targeted enrichment and cis-activation.-Fineline Info & Tech