— Approval based on results from global Phase III FRESCO-2 trial in patients with previously treated metastatic colorectal cancer —

— Fruquintinib already approved in several regions including the United States, Europe and China —

HUTCHMED (China) Limited (“HUTCHMED”)  announces that its partner Takeda (TSE:4502/NYSE:TAK) has received approval from the Japanese Ministry of Health, Labour and Welfare (“MHLW”) to manufacture and market FRUZAQLA^® (fruquintinib) for previously treated metastatic colorectal cancer (“CRC”). FRUZAQLA^® is the first novel targeted therapy in Japan to be approved for metastatic CRC, regardless of biomarker status, in over a decade. CRC is the most prevalent type of cancer in Japan, with an estimated 161,000 new cases and 54,000 deaths in 2023, according to the National Cancer Center’s statistics.

FRUZAQLA^® has been approved for the treatment of advanced or recurrent CRC that is neither curable nor resectable and that has progressed after chemotherapy.

“Takeda has now obtained approval in Japan for FRUZAQLA^®, demonstrating the strength of our global data package and the potential of this novel medicine to provide a much-needed treatment option to patients with metastatic CRC,” said Dr Weiguo Su, Chief Executive Officer and Chief Scientific Officer of HUTCHMED. “Takeda has been a leader in metastatic CRC treatment in Japan for over a decade and we are confident that it is well placed to bring FRUZAQLA^® to patients in Japan.”

Dr. Takayuki Yoshino, Deputy Director of Hospital, Head, Division for the Promotion of Drug and Diagnostic Development, and Chief, Department of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan, added: “The approval of FRUZAQLA^® in Japan is significant news for patients with metastatic colorectal cancer, who have long needed additional effective treatment options. The global FRESCO-2 study demonstrated the impact that this treatment can have on patients in the clinic. The increasing availability of screening and effective therapies in Japan has been driving patient outcomes in colorectal cancer, and we hope the introduction of FRUZAQLA^® will offer new hope to those with the condition.”

The approval by the Japanese MHLW was primarily based on results from the Phase III FRESCO-2 trial conducted in the US, Europe, Japan and Australia. Data from FRESCO-2 were published in The Lancet in June 2023. Takeda has the exclusive worldwide license to further develop, commercialize, and manufacture fruquintinib outside of mainland China, Hong Kong and Macau. FRUZAQLA^® was approved in the US in November 2023 and in Europe in June 2024.