First in China! Innovent Biologics Receives an Approval from the US FDA to Initiate Clinical Trials for its Anti-CD47 Monoclonal Antibody IBI188

  • 2018-10-02

Innovent Biologics, Inc. (Innovent Biologics) recently announced that its IND application for IBI188, a fully human anti-CD47 monoclonal antibody (mAb) drug candidate, has been approved by the US Food & Drug Administration (FDA) to initiate clinical trials for patients with advanced malignancies and lymphomas.

IBI188 is the second Innovent molecule to be approved for clinical trials by the FDA. In January, IBI308 (sintilimab, a type of anti-PD-1 monoclonal antibody) was also approved for clinical research by the FDA. It is worth mentioning that Innovent Biologics is the first Chinese biopharmaceutical company to get FDA approval for CD47 monoclonal antibody included into clinical research. On September 10 this year, IBI188 was also granted the clinical trial approval issued by China Drug Administration, which meant that the research on the target CD47 by Innovent Biologics had entered the clinical research stage from early development and had been in a leading position in China.

Doctor Yu Dechao, the founder, chairman and president of Innovent Biologics, said: “Innovent Biologics is a biopharmaceutical company headquartered in China with ambitions to meet the medical needs of patients worldwide. We have been exploring cutting-edge research fields and striving to meet the standards for international innovation, development and production. The FDA’s approval of the IBI188 for clinical trial is an affirmation of our efforts and enables us to further advance the innovative projects of Innovent Biologics. We hope that the biological agents produced from wisdom in China will play a role on the international stage through the efforts of Innovent Biologics.”

About IBI188: IBI188 is an anti-CD47 IgG4 monoclonal antibody with independent intelligent property rights developed by Innovent Biologics. It is intended to treat a variety of hematological tumors and solid tumors including the non-Hodgkin’s lymphoma and ovarian cancer. Both in vivo and in vitro experiments showed that IBI188 could bind to CD47 antigen on the surface of tumor cells and block the CD47-SIRPα signaling pathway. It could inhibit the signal “don’t eat me” transmitted by CD47 to prompt macrophages to recognize the signal “eat me” transmitted by tumor cells, thus engulfing tumor cells and exerting the anti-tumor effect of the body. Preclinical data showed that IBI188 had stronger blocking capability compared with similar drugs.