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

SUZHOU, China, Sept. 30, 2018 /PRNewswire/ — 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.

About IBI-188

IBI-188 is an anti-CD47 IgG4 monoclonal antibody developed by Innovent with independent intellectual property rights. Both in vitro and in vivo experiments showed that IBI-188 can bind to the CD47 antigen on the surface of tumor cells, block the CD47-SIRPα signaling pathway, inhibit the “Don’t Eat Me” signal, and promote the phagocytosis of tumor cells by macrophages, thereby exerting an anti-tumor effect. It has stronger receptor blocking ability than other investigational drugs against this target. Innovent will launch several clinical trials to assess its safety and efficacy for multiple tumor types, including non-Hodgkin’s lymphoma and ovarian cancer.

About IBI-308 (Sintilimab)

Sintilimab is a fully human anti-PD-1 antibody. It binds to the PD-1 receptor on T cells, blocking the PD-L1 ligand from interacting with PD-1 to help restore T-cell response and immune response, thus destroying the tumor cells. Sintilimab is an anti-PD-1 monoclonal antibody jointly developed by Innovent and Eli Lilly and Company in China. National Medical Products Administration (NMPA, formerly known as CFDA) accepted the New Drug Application (NDA) submitted by Innovent for sintilimab on April 16, 2018, and granted it priority review status on April 23, 2018. The indication for the first new drug application is relapsed/refractory classical Hodgkin’s Lymphoma.

About Innovent

Inspired by the spirit of “Start with Integrity, Succeed through Action”, Innovent’s mission is to develop and commercialize high quality biopharmaceutical products that are affordable to ordinary people. Since its establishment from 2011, Innovent has developed a fully-integrated platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities, and a pipeline of innovative and commercially promising monoclonal antibodies and other biologics in the fields of oncology, ophthalmology, autoimmune and metabolic diseases. Innovent has built up a pipeline of 17 antibody drug candidates, with four core products in late-stage clinical development in China and one that has a New Drug Application (NDA) accepted by the NMPA with priority review status.

Innovent has a highly talented international team, including many expert returnees with experience in innovative biopharmaceutical drug discovery, development, production and commercialization. The company has also entered into various key strategic alliances with Eli Lilly and Company, Adimab, and other biopharmaceutical companies. Innovent has raised 580 million USD in private financing from numerous world-renowned VC or PE firms, including Eight Roads and F-Prime Capital (which form part of the proprietary investment business of Fidelity), Lilly Asia Ventures, Capital Group, Legend Capital, Temasek, Rock Springs Capital, Cormorant Private Healthcare, Hillhouse Capital, China Life, Ally Bridge, Taikang Insurance Group, and State Development & Investment Corporation.

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Source: Innovent Biologics, Inc.

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