• Launch follows approval by Japanese Ministry of Health, Labour and Welfare in September 2024 —
• Milestone payment to be made to HUTCHMED from Takeda 
• Fruquintinib already launched in several regions including the United States, Europe and China 

HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that it will receive a milestone payment following the pricing approval and launch of FRUZAQLA^® (fruquintinib) 1mg/5mg capsules in Japan by its partner Takeda (TSE:4502/NYSE:TAK) for patients with previously treated metastatic colorectal cancer (“CRC”). This follows approval for the manufacturing and marketing of FRUZAQLA^® by the Japanese Ministry of Health, Labour and Welfare.

FRUZAQLA^® is the first novel oral targeted therapy in Japan to be approved for metastatic CRC, regardless of biomarker status, in over a decade. FRUZAQLA^® is indicated for the treatment of advanced or recurrent colorectal cancer that is neither curable nor resectable, and that has progressed after chemotherapy. 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 statistics from the National Cancer Center.¹

On the launch of FRUZAQLA^® in Japan by Takeda, Dr Weiguo Su, Chief Executive Officer and Chief Scientific Officer of HUTCHMED, said: “The launch of FRUZAQLA^® in Japan highlights the continued progress of our partnership with Takeda across the globe. Takeda is well positioned to build on more than a decade of leadership in the treatment of metastatic CRC in Japan and bring a differentiated treatment option in FRUZAQLA^® to patients.”

The launch of FRUZAQLA^® in Japan follows its approval in September 2024, 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, and markets under the FRUZAQLA^® brand name. It received approval in the US in November 2023, in the EU in June 2024, in Switzerland in August 2024, in Canada, Japan and the United Kingdom in September 2024 and in Argentina, Australia and Singapore in October 2024. Regulatory applications are progressing in many other jurisdictions.