Chinese biopharmaceutical company Innovent Biologics Inc (HKEX:01801) announced on Tuesday that it has received Fast Track Designation from the US Food and Drug Administration (FDA) for its PD-1/IL-2 alpha Bispecific Antibody Fusion Protein (R&D code: IBI363) intended for the treatment of unresectable locally advanced or metastatic melanoma (except choroidal melanoma) in patients who have progressed after around one line of systemic therapy, which must include a PD-1/L1 inhibitor.

Phase 1/2 clinical trials are currently being conducted in China, the United States and Australia to evaluate IBI363's efficacy and safety in various advanced malignant tumours.

IBI363, a first-in-class drug candidate, has been independently developed by Innovent Biologics. The product's active ingredient is PD-1/IL-2 bispecific antibody fusion protein.

Dr. Hui Zhou, Innovent senior vice president, said: "As a First in-class PD-1/IL-2 alpha-bias bispecific antibody fusion protein, IBI363 monotherapy has shown encouraging efficacy and a favourable safety profile in melanoma subjects who have previously received immunotherapy. We will continue to explore the efficacy and safety of IBI363 in melanoma to provide more effective clinical treatment for patients with immune-resistant melanoma."