HUTCHMED Announces Takeda Submits New Drug Application in Japan for Fruquintinib in Heavily Pre-treated Metastatic Colorectal Cancer

Recently, HUTCHMED (China) Limited ("HUTCHMED") (NASDAQ/LSE: HCM; HKEX: 13) announced today that Takeda Pharmaceutical Company Limited has submitted a new drug application to Japan's Ministry of Health, Labour and Welfare for the use of fruquintinib in adult patients with previously treated metastatic colorectal cancer. Fruquintinib is a selective oral inhibitor of vascular endothelial growth factor receptors ("VEGFR")-1, -2, and -3, which play a key role in blocking tumor angiogenesis. In Japan, colorectal cancer has the highest incidence rate and the second-highest mortality rate among both men and women.1

The new drug application for Fruquintinib is based on the results of the FRESCO-2 global study (a Phase III international multicenter clinical trial conducted in the United States, Europe, Japan, and Australia) and the FRESCO China Phase III study. The FRESCO-2 and FRESCO studies explored Fruquintinib in combination with best supportive care versus placebo in combination with best supportive care for the treatment of patients with previously treated metastatic colorectal cancer. Both studies met their primary and key secondary endpoints, showing that Fruquintinib treatment achieved statistically significant and clinically meaningful improvements in both overall survival ("OS") and progression-free survival ("PFS"). Fruquintinib was generally well tolerated in patients.

Prior to the submission of this application, fruquintinib had already been submitted for the same indication in the United States and Europe. The U.S. Food and Drug Administration ("FDA") has granted priority review, with a Prescription Drug User Fee Act (PDUFA) target action date of November 30, 2023. The FDA’s regulatory review is proceeding in an orderly manner, and the inspection of HUTCHMED's manufacturing facility located in Suzhou, China, has been completed. The marketing authorization application submitted to the European Medicines Agency ("EMA") was confirmed and accepted in June 2023. The results of the FRESCO-2 global Phase III registration study were also published in The Lancet in June 2023 (NCT04322539).2

Takeda holds the global exclusive license to advance the development, commercialization, and production of fruquintinib for all indications outside of China. In China, fruquintinib was developed by HUTCHMED and is marketed under the brand name Elunate®. The pivotal Phase III registration study of fruquintinib, known as the FRESCO trial, which was conducted in 416 Chinese patients with metastatic colorectal cancer, supported the approval of fruquintinib in China and has been published in the Journal of the American Medical Association (JAMA) (NCT02314819).

About Fruquintinib

Fruquintinib is a selective oral VEGFR-1, -2, and -3 inhibitor. VEGFR inhibitors play a crucial role in inhibiting tumor angiogenesis. Fruquintinib is designed to have higher kinase selectivity, aiming to reduce off-target kinase activity, thereby achieving higher drug exposure, sustained target coverage, and greater flexibility when potentially used as part of combination therapy. To date, fruquintinib has generally been well tolerated in patients.

About the FRESCO-2 Study

FRESCO-2 is a global, multicenter clinical trial conducted in the United States, Europe, Japan, and Australia. It aims to explore fruquintinib plus best supportive care versus placebo plus best supportive care for the treatment of previously treated patients with metastatic colorectal cancer. As announced earlier, this study, which enrolled 691 patients, met its primary endpoint of overall survival (OS) in patients with metastatic colorectal cancer whose disease had progressed after standard chemotherapy and relevant biologic agents or who were intolerant to TAS-102 and/or regorafenib. In addition to OS, a statistically significant improvement was also observed in the key secondary endpoint, progression-free survival (PFS). To date, fruquintinib has generally been well tolerated in patients. The results were presented at the European Society for Medical Oncology (ESMO) Congress in September 2022 and subsequently published in The Lancet. For further details of this study, please visit clinicaltrials.gov and search for identifier NCT04322539.

Editor: Muyan

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