Pharma Focus Asia

Innovent Receives an Approval from the US FDA to Initiate Clinical Trials for its Anti-CD47 Monoclonal Antibody IBI-188

Monday, October 01, 2018

Innovent Biologics, Inc. (Innovent), a world-class China-based biopharmaceutical company that develops high quality drugs, announced yesterday that its IND application for IBI-188, 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.

IBI-188 is the second Innovent molecule to be approved for clinical trials by the FDA. In January, 2018 the FDA IND for IBI308 (Sintilimab, an anti-PD-1 antibody) was also approved. Innovent is the first Chinese biopharmaceutical company to receive clinical trial approval for a CD47 monoclonal antibody from the FDA.

As one of the key targets in the field of anti-tumor immunotherapy, CD47 monoclonal antibody has become a highly researched therapeutic target across the world. Currently, a few CD47 advanced programs are in phase I and II clinical stage outside China. This IND approval demonstrates the significant progress Innovent has made to bring cancer treatments to global markets.

"Innovent, a China based company, was established with an ambition to serve global patient needs. We have been exploring the most advanced research areas and adhere to international innovative R&D and production standards. The FDA IND approval of anti-CD47 monoclonal antibody is an affirmation of our efforts and allow us to further advance Innovent's innovative programs. We hope that through our efforts, China's "smart" biologics will play a role on the international stage," said Michael Yu, Founder, Chief Executive Officer and Chairman.

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