— Prescription Drug User Fee Act (PDUFA) Target Action Date set for November 30, 2023 —

— NDA includes results from the Phase III FRESCO-2 and FRESCO clinical trials —

Takeda (TSE:4502/NYSE:TAK) and HUTCHMED (China) Limited (Nasdaq/AIM:HCM, HKEX:13) (“HUTCHMED”) today announced that the U.S. Food and Drug Administration (“FDA”) has granted priority review of the New Drug Application (“NDA”) for fruquintinib, a highly selective and potent inhibitor of vascular endothelial growth factor receptors (“VEGFR”) -1, -2 and -3 for the treatment of adult patients with previously treated metastatic colorectal cancer (“CRC”). If approved, fruquintinib will be the first and only highly selective inhibitor of all three VEGF receptors approved in the U.S. for previously treated metastatic CRC.^1,2 The Prescription Drug User Fee Act (PDUFA) goal date assigned by the FDA for this NDA is November 30, 2023.

“We are confident that fruquintinib has the potential to transform the treatment landscape for those living with previously treated metastatic colorectal cancer, as demonstrated by its strong clinical profile,” said Awny Farajallah, M.D., head of Global Medical Affairs Oncology at Takeda. “There are significant needs for patients with this disease in the U.S., and we believe fruquintinib has the potential to address these needs regardless of patients’ biomarker status. We look forward to continuing conversations with the FDA with the goal to make this therapy available to patients as soon as possible.”

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

“The clinical benefit of fruquintinib has been confirmed in multiple ways, from global clinical studies to commercialization in China. We are pleased to have Takeda as our partner furthering development and commercialization of fruquintinib outside of China,” said Dr. Michael Shi, Head of R&D and Chief Medical Officer, HUTCHMED. “Today’s acceptance marks a significant advancement towards the goal of providing patients with previously treated metastatic colorectal cancer a much-needed therapeutic option, given the limited treatment options currently available to patients. This also supports our ongoing vision to design and develop differentiated molecules that help patients with high unmet needs globally.”

Fruquintinib is currently approved in China under the brand name ELUNATE^®. Approval in China was based on the results of the FRESCO study, a Phase III pivotal registration trial of fruquintinib in 416 patients with metastatic CRC in China, published in The Journal of the American Medical Association, JAMA, in June 2018 (NCT02314819).³ In March 2023, HUTCHMED and Takeda closed an exclusive licensing agreement to further the global development, commercialization and manufacture of fruquintinib outside of China.