Fapon Biopharma Receives FDA IND Approval for FP002, a Best-in-Class Anti-CD47 Monoclonal Antibody for Advanced Malignancies

On February 22, Fipen Pharma, a subsidiary of the Fipen Group, announced that its Investigational New Drug (IND) application for FP002, a self-developed monoclonal antibody candidate targeting CD47, had recently been approved by the U.S. Food and Drug Administration (FDA).

FP002 is a humanized IgG4 monoclonal antibody targeting the CD47 protein, independently developed and wholly owned by Fapon Biologics. This antibody maintains strong binding to CD47 on the surface of tumor cells while exhibiting negligible binding to CD47 on human red blood cells, thereby avoiding hemagglutination. It has demonstrated an excellent safety profile in preclinical safety assessments and superior efficacy compared to peer products across various preclinical tumor models. Based on current data, FP002 offers overall superior anti-tumor efficacy and a more pronounced safety advantage, holding the potential to become a global “best-in-class” therapeutic.

Fipeng Biopharma’s IND submission for this clinical study involves a single-arm dose-escalation trial designed to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of FP002 in patients with advanced malignant tumors. As a dual filing project in China and the United States, the company is simultaneously submitting its Investigational New Drug application in China.
 

Huo Yongting, President of Fapon Pharmaceuticals, stated, “FP002 is Fapon Pharmaceuticals’ first clinical program filed simultaneously in China and the United States. The approval of this project for clinical trials by the U.S. FDA marks a significant milestone in the company’s innovative drug development. After several years of organizational and platform development, Fapon Pharmaceuticals has established an innovation platform with international competitiveness and a project pipeline with differentiated competitive advantages. We are committed to driving progress through independent innovation, continuously improving the quality and accessibility of our medicines, with the aim of providing better and more affordable biologic innovative drugs to patients worldwide.”

Fipeng Biopharma is a company under the Fipeng Group, dedicated to the research and development of innovative biologic macromolecule drugs. It has established a comprehensive team and technological platform covering the entire process from target identification to early-stage clinical development. Leveraging its industry-leading innovative antibody discovery platform, the company has built an innovative R&D pipeline focused on oncology therapeutics. All projects possess fully independent intellectual property rights, with more than 10 candidates currently in development. In addition to the FP002 project, the company expects to identify two Preclinical Candidate Compounds (PCCs) and file Investigational New Drug (IND) applications annually in the future.