29th Sep 2023 10:12
(Alliance News) - Hutchmed (China) Ltd on Friday said Takeda Pharmaceutical Co Ltd has submitted a new drug application for cancer treatment fruquintinib to the Ministry of Health, Labour & Welfare in Japan.
The Hong Kong-based cancer and immunological diseases treatment developer said that for approval is for the treatment of adult patients with previously treated metastatic colorectal cancer. Takeda, a Tokyo-based drugmaker, submitted the application.
Fruquintinib is a selective inhibitor of vascular endothelial growth factor receptors, which play a pivotal role in blocking tumour angiogenesis.
Hutchmed said CRC has the highest incidence and second-highest mortality rate among both men and women in Japan.
The application for fruquintinib is based on results from FRESCO-2, a global Phase III multi-regional clinical trial conducted in the US, Europe, Japan and Australia, as well as data from the Phase III FRESCO clinical trial conducted in China.
This submission follows prior submissions for fruquintinib in the US and Europe for the same indication.
"Alongside our partner Takeda, we are pleased to take this key step towards bringing fruquintinib to patients in Japan," said Michael Shi, head of Research & Development and chief medical officer.
"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."
Takeda shares closed down 0.7% to JPY4,641.00 each on Friday in Japan. Hutchmed shares fell 0.3% to 276.55 pence each in London on Friday morning.
By Sophie Rose, Alliance News reporter
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