Takeda has entered into an exclusive licensing agreement with HUTCHMED (China) Ltd. and its subsidiary HUTCHMED Ltd., for the further development and commercialization of fruquintinib outside of mainland China, Hong Kong and Macau.
 
Approved in China in 2018, fruquintinib is a highly selective and potent inhibitor of vascular endothelial growth factor receptors (VEGFR) -1, 2 and 3. Fruquintinib is orally administered and has the potential to be used across subtypes of refractory metastatic colorectal cancer (CRC), regardless of biomarker status.
 
With a strong preclinical and clinical profile, fruquintinib offers a potential new treatment option for patients with refractory metastatic CRC, supporting the shared goal of Takeda and HUTCHMED to improve the lives of those living with cancer worldwide.
 
The Phase 3 multi-regional clinical trial of fruquintinib in refractory metastatic CRC, FRESCO-2, met its primary endpoint of improving overall survival (OS) in patients with metastatic CRC and was generally well tolerated.
 
The U.S. FDA granted Fast Track designation for the development of fruquintinib for the treatment of patients with metastatic CRC in 2020. In December 2022, HUTCHMED initiated a rolling submission of a New Drug Application (NDA) for fruquintinib with the FDA, which is planned to be completed in the first half of 2023. This will be followed by planned submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) and a JNDA to the Japan Pharmaceuticals and Medical Devices Agency (PMDA).
 
Under the agreement, Takeda will receive an exclusive worldwide license to develop and commercialize fruquintinib in all indications and territories outside of mainland China, Hong Kong and Macau. Takeda will pay HUTCHMED $400 million upfront, up to $730 million in additional potential payments relating to regulatory, development and commercial sales milestones, as well as royalties on sales. The deal is subject to customary closing conditions