HUTCHMED Announces Submission of New Drug Application for Fruquintinib for Previously Treated Metastatic Colorectal Cancer in Japan

— Third major market authorization application based on data from the FRESCO-2 global Phase III trial —

HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., Sept. 29, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (Nasdaq/AIM:​HCM, HKEX:​13) (“HUTCHMED”) today announced that Takeda (TSE:4502/​NYSE:TAK) has submitted a New Drug Application (“NDA”) to the Ministry of Health, Labour and Welfare (“MHLW”) in Japan for the approval of fruquintinib for the treatment of adult patients with previously treated metastatic colorectal cancer (“CRC”). Fruquintinib is a selective inhibitor of vascular endothelial growth factor receptors (“VEGFR”) -1, -2 and -3, which play a pivotal role in blocking tumor angiogenesis. CRC has the highest incidence and second highest mortality rate among both men and women in Japan.¹

The NDA for fruquintinib is based on results from FRESCO-2, a global Phase III multi-regional clinical trial (MRCT) conducted in the U.S., Europe, Japan and Australia, as well as data from the Phase III FRESCO clinical trial conducted in China. The FRESCO-2 and FRESCO clinical trials compared fruquintinib plus best supportive care (“BSC”) with placebo plus BSC in patients with previously treated metastatic CRC. Both trials met their primary and key secondary endpoints, showing a statistically significant and clinically meaningful improvement in overall survival (“OS”) and progression-free survival (“PFS”). Fruquintinib has been generally well tolerated by patients.

“Alongside our partner Takeda, we are pleased to take this key step towards bringing fruquintinib to patients in Japan,” said Dr. Michael Shi, Head of R&D and Chief Medical Officer of HUTCHMED. “Supported by a strong clinical data set, and its success in China, we believe that fruquintinib is an important option for these patients and are optimistic about the impact it will have if approved in Japan. There is now real regulatory momentum behind fruquintinib, and we are excited to see this drug take to the global stage.”

This submission follows prior submissions for fruquintinib in the U.S. and Europe for the same indication. The U.S. Food and Drug Administration (“FDA”) granted Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of November 30, 2023. The FDA review is progressing and the inspection of HUTCHMED’s manufacturing facility in Suzhou, China has been completed. A Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) was validated and accepted for regulatory review in June 2023. Data from the global registrational FRESCO-2 clinical trial was published in The Lancet, also in June 2023 (NCT04322539).²