Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a China-based biopharmaceutical company that develops and commercializes high quality drugs, announced today that its IND application for IBI101, a recombinant fully human anti-OX40 monoclonal antibody (mAb) drug candidate, has been approved by the US Food & Drug Administration (FDA). Innovent Biologics plans to initiate the US phase I clinical trial based on results from the China phase I study in patients with advanced solid tumors. Innovent was formed in 2011, and has raised over $500 million and floated an IPO in 2018.
IBI101 is the third molecule from Innovent approved for clinical trials by the FDA. The company also has received FDA IND approvals for IBI308 (Sintilimab, an anti-PD-1 antibody) in January, 2018 and IBI188 (an anti-CD47 antibody) in September, 2018 respectively. Innovent is the first Chinese biopharmaceutical company to receive clinical trial approval from FDA for an anti-OX40 monoclonal antibody. “Innovent was built according to international R&D and production standards and has been exploring the latest cutting-edge research in the area of biopharmaceutical development. The FDA IND approval of anti-OX40 monoclonal antibody once again demonstrates Innovent’s research and development capability. We hope that through our efforts, we can make more breakthroughs in the field of innovative biopharmaceuticals and benefit patients around the world,” said Michael Yu, Founder, Chief Executive Officer and Chairman.Source: PR Newswire