(Feb. 22, 2023, Shenzhen, China) Fapon Biopharma, an innovative biotech company, announced today that its Investigational New Drug (IND) application of FP002, an anti-CD47 monoclonal antibody drug candidate, has been approved by FDA for clinical trials.

FP002 is a humanized anti-CD47 IgG4 monoclonal antibody, developed and patented by Fapon Biopharma. It binds strongly to the CD47 protein on the surface of tumor cells, and weakly to human red blood cells. This novel antibody does not cause hemagglutination. It has proven to be safe, and in comparison with similar products, have shown better efficacy in multiple tumor models in preclinical research. In demonstrating stronger anti-tumor efficacy and higher reliability, FP002 shows great potential in becoming the best-in-class drug worldwide.

Under this IND, the Company intends to initiate a single-armed, dose escalation and dose expansion study to investigate the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) activity of FP002 in subjects with advanced malignancies. Apart from the FDA submission, it has also been submitted for IND application in China.

“The FDA approval to commence our clinical trial for FP002 is a significant milestone for Fapon Biopharma,” said Vincent Huo, President of Fapon Biopharma. “This is our first project that includes IND application in both China and the US. With our cutting-edge technology platform and a competitive pipeline, we are committed to enabling more reliable and affordable biologics for patients all over the world.”

About Fapon Biopharma

Fapon Biopharma, a subsidiary of Fapon, is an innovative and fast-growing company focusing on developing novel biological products. It has developed a fully-integrated platform and a talented team which enable the Company to span programs from discovery-stage to clinical research stage. With over 10 projects in the pipeline, Fapon Biopharma specializes in cancer therapy and its drug candidates are all covered under patent protection. Preclinical candidate compounds (PCC) in two projects are expected to be determined and submitted for IND application periodically each year.

About Fapon

Fapon is committed to the research and development of in-vitro diagnostics (IVD), bio-therapies and precision diagnostics, and the provision of related products and services. Guided by “anticipation and readiness", one of its core values, Fapon focuses on three lines of business: raw material solutions, the IVD ecosystem, and intelligent digital diagnosis & treatment. Supported by its strong global R&D, manufacturing, sales and service network, Fapon's products have established presence in 61 countries and regions, serving more than 1,500 business partners.