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(Sharecast News) - Hutchmed China announced on Tuesday that its partner Takeda has received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) to manufacture and market 'Fruzaqla', or fruquintinib, for the treatment of previously-treated metastatic colorectal cancer (CRC).
The AIM-traded firm said the approval was the first novel targeted therapy for metastatic CRC in Japan in over a decade, regardless of biomarker status.
It said CRC is the most common cancer in Japan, with an estimated 161,000 new cases and 54,000 deaths recorded in 2023.
The approval was based on results from the global phase three 'FRESCO-2' trial, which was conducted across the US, Europe, Japan, and Australia.
Hutchmed said the trial demonstrated the efficacy of fruquintinib in patients with advanced or recurrent CRC that was neither curable nor resectable and had progressed after chemotherapy.
The findings were published in the Lancet in June last year.
Fruzaqla was already approved in a number of other regions, including the United States in November 2023 and Europe in June 2024.
Takeda holds the exclusive global licence for the development, commercialisation and manufacturing of fruquintinib outside of mainland China, Hong Kong, and Macau.
"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 chief executive and chief scientific officer Dr Weiguo Su.
"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."
At 1214 BST, shares in Hutchmed China were up 2.77% at 260p.
Reporting by Josh White for Sharecast.com.
