Saturday, September 30, 2023
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.”
About HUTCHMED
HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has approximately 5,000 personnel across all its companies, at the center of which is a team of about 1,800 in oncology/immunology. Since inception it has focused on bringing cancer drug candidates from in-house discovery to patients around the world, with its first three oncology drugs now approved and marketed in China. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.
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