CD (Suzhou) Biopharma has secured clearance from the US Food and Drug Administration (FDA) for its Investigational New Drug (IND) application of CD-001, entering a Phase I first-in-human trial.

CD-001, the company's clinical candidate, is built on its proprietary Bispecific Fusion Protein (BsFP) platform.

This potential therapy, designed to target PD-1 positive CD8+ T cells using an anti-PD-1 antibody and an engineered IL-21 mutant, aims to address unmet medical needs in oncology and viral infections.

"The FDA's clearance of this IND reinforces our unwavering commitment to advancing groundbreaking immunotherapies," said Dr. Jian Xu, CEO of CD Biopharma.

"CD-001 shows promise as a first-in-class and best-in-class treatment and preclinical studies have demonstrated its effectiveness in various mouse tumor models, with excellent tolerance observed in non-human primates. We are excited to move forward with patient enrollment and expect initial clinical data in the upcoming months," Dr. Jian Xu added.