Biopharmaceutical company Takeda Pharmaceutical Company Limited (TSE:4502) (NYSE:TAK) disclosed on Monday that it has entered into an exclusive licensing agreement with commercial-stage, biopharmaceutical company HUTCHMED (China) Limited (Nasdaq/AIM: HCM) (HKEX: 13) and its subsidiary HUTCHMED Limited, to further develop and commercialise fruquintinib beyond China.

Fruquintinib is a highly selective and potent inhibitor of vascular endothelial growth factor receptors (VEGFR) -1, 2 and 3. It was approved in China in 2018 and the U.S. Food and Drug Administration (FDA) granted Fast Track designation for the development of fruquintinib for the treatment of patients with metastatic CRC in 2020. Fruquintinib is orally administered and may be potentially used across subtypes of refractory metastatic colorectal cancer (CRC), regardless of biomarker status, the company said.

Takeda said that under the terms of the agreement, it will receive an exclusive worldwide license to develop and commercialise fruquintinib in all indications and territories outside of mainland China, Hong Kong and Macau. Takeda will pay HUTCHMED USD400m upfront, up to USD730m in additional potential payments relating to regulatory, development and commercial sales milestones, as well as royalties on net sale, subject to the terms of the agreement. This deal is subject to customary closing conditions, including completion of antitrust reviews.

Takeda added that positive results of the Phase 3 multi-regional clinical trial of fruquintinib in refractory metastatic CRC, FRESCO-2, were presented at the European Society for Medical Oncology (ESMO) Congress in September 2022. FRESCO-2 met its primary endpoint of improving overall survival (OS) in patients with metastatic CRC and was generally well tolerated.