HUTCHMED (China) Limited (HUTCHMED) announced that its subsidiary, HUTCHMED Limited, has entered into an exclusive license agreement with a subsidiary of Takeda Pharmaceutical Company Limited to further the global development, commercialization and manufacture of fruquintinib outside of mainland China, Hong Kong and Macau, where it is marketed by HUTCHMED. HUTCHMED Limited will receive up to USD 1.13 billion including USD 400 million upfront on closing as well as potential regulatory, development and commercial sales milestone payments, plus royalties on net sales. 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 metastatic colorectal cancer (CRC), regardless of biomarker status.

Positive results of FRESCO-2, the global Phase III multi-regional clinical trial of fruquintinib in refractory metastatic colorectal cancer (CRC), were presented at the European Society for Medical Oncology Congress (ESMO) in September 2022. FRESCO-2 met its primary endpoint of improving overall survival (OS) in patients with metastatic CRC and was generally well tolerated. Under the terms of the agreement, Takeda will receive an exclusive worldwide license to develop and commercialize fruquintinib from HUTCHMED Limited in all indications and territories outside of mainland China, Hong Kong and Macau.

Subject to the terms of the agreement, HUTCHMED Limited will be eligible to receive up to USD 1.13 billion, including USD 400 million upfront on closing of the agreement, and up to USD 730 million in additional potential payments relating to regulatory, development and commercial sales milestones, as well as royalties on net sales. The deal is subject to customary closing conditions, including completion of antitrust regulatory reviews. Following these clearances, Takeda will become solely responsible for the development and commercialization of fruquintinib in all included territories worldwide excluding mainland China, Hong Kong and Macau.

As previously announced, marketing authorization submissions in the U.S., Europe and Japan are planned to complete in 2023, with the rolling submission to the U.S. Food and Drug Administration (FDA) planned to complete in the first half of 2023. HUTCHMED will continue to focus on progressing late-stage clinical trials and the commercialization of fruquintinib in mainland China in collaboration with Eli Lilly and Company, where it is approved under the brand name ELUNATE for the treatment of patients with metastatic CRC who have been previously treated with fluoropyrimidine, oxaliplatin and irinotecan, including those who have previously received anti-vascular endothelial growth factor therapy and/or anti-epidermal growth factor receptor (EGFR) therapy (RAS wild type). ELUNATE has been included in the China National Reimbursement Drug List (NRDL) since January 2020.