01 December 2018 | News
Global collaboration will initially evaluate Innovent's anti-PD-1 monoclonal antibody sintilimab in combination with Hutchison MediPharma's VEGFR inhibitor fruquintinib for solid tumors
Innovent Biologics, Inc. a world-class China-based biopharmaceutical company that develops and commercializes high quality drugs has announced that it through its wholly-owned subsidiary, Innovent Biologics Co., Ltd, has entered into a global collaboration agreement with Hutchison China MediTech Limited (Chi-Med), through its Innovation Platform subsidiary Hutchison MediPharma Limited, to evaluate the safety and tolerability of Innovent's sintilimab in combination with Hutchison MediPharma's fruquintinib in patients with advanced solid tumors.
Under the terms of the agreement, Innovent and Hutchison MediPharma will jointly explore potential application of this combination in solid tumors with global unmet medical needs through development efforts both in the US and in China.
"We are two leading China-based biopharmaceutical companies, one specialized in small molecules and another in large molecules; and we share the same vision of bringing China-originated mainstream anti-cancer therapies to global patients by combining our expertise and resources," said Dr. Michael Yu, Founder, Chief Executive Officer and Chairman of Innovent. "There is strong scientific evidence supporting synergistic effects of PD-1 therapy when used in combination with VEGFR inhibitor. In addition, we hope to benefit from recent regulatory changes in China that allow for the recognition of foreign clinical trial data to possibly expedite the path to a China launch. We are very pleased to partner with Chi-Med to co-develop this novel combination therapy for global patients".
Sintilimab (IBI308) is a fully human anti-PD-1 antibody. It binds to the PD-1 receptor on T cells, blocking the PD-1 ligand from interacting with PD-1 to help restore T-cell response and immune response, thus destroying the tumor cells. Sintilimab is jointly developed by Innovent and Eli Lilly and Company in China. National Medical Products Administration (NMPA, successor to 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.
Fruquintinib (brand name: Elunate) is a small molecule, selective and highly potent inhibitor of VEGFR 1, 2 and 3. VEGFR inhibitors play a pivotal role in tumor-related angiogenesis, cutting off the blood supply that a tumor needs to grow rapidly. It was first approved for CRC in China in September 2018. It is in late-stage clinical trials, including in combination with paclitaxel (Taxol®) in gastric cancer.
Elunate (fruquintinib capsules) is approved for use in China for the treatment of metastatic colorectal cancer ("CRC") with the approved dose in CRC being 5mg orally once per day, on a three-weeks-on / one-week-off cycle. It will be made available in the market in both 1mg and 5mg capsule packages. Pursuant to a collaboration agreement, Eli Lilly and Company ("Lilly") has full responsibility and authority for commercialization for Elunate in China.