Hutchmed confirms new drug application for fruquintinib in Japan

Hutchmed China announced on Friday that its partner Takeda has officially submitted a new drug application (NDA) for fruquintinib to the Ministry of Health, Labour and Welfare (MHLW) in Japan.

The AIM-traded firm said the application seeks approval for using fruquintinib in treating adult patients who have previously undergone metastatic colorectal cancer (CRC) treatment.

CRC holds the distinction of having the highest incidence rate and the second-highest mortality rate among both genders in Japan.

Fruquintinib was recognised as a selective inhibitor targeting vascular endothelial growth factor receptors, crucial in obstructing tumour angiogenesis.

The evidence backing the NDA for fruquintinib stemmed from the results of two significant trials: FRESCO-2, a global phase three multi-regional clinical trial held across the US, Europe, Japan, and Australia, and the phase three FRESCO clinical trial which took place in China.

In those studies, fruquintinib combined with best supportive care (BSC) was pitted against a placebo with BSC in patients previously treated for metastatic CRC.

Both trials successfully met their primary and secondary objectives, significantly improving overall survival (OS) and progression-free survival (PFS) for the patients.

Furthermore, fruquintinib was shown to be generally well-accepted by patients.

In earlier developments, the US Food and Drug Administration (FDA) granted priority review status to fruquintinib with a set goal date for a decision by 30 November.

The FDA's review process was well underway, with Hutchmed’s manufacturing facility in Suzhou, China, already inspected.

Simultaneously, the European Medicines Agency (EMA) accepted a marketing authorisation application for fruquintinib in June, following data publication from the global registrational FRESCO-2 clinical trial in the Lancet the same month.

While Takeda held the exclusive global licence for the further development, commercialisation, and production of fruquintinib outside China, Hutchmed took the lead within China.

It markets fruquintinib under the brand name Elunate, with its approval rooted in the results of the FRESCO study.

That phase three pivotal registration trial included 416 patients with metastatic CRC in China, and its findings were published in the Journal of the American Medical Association (JAMA).

“Alongside our partner Takeda, we are pleased to take this key step towards bringing fruquintinib to patients in Japan,” said Hutchmed’s chief medical officer and head of research and development, Dr Michael Shi.

“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.”

At 1012 BST, shares in Hutchmed China were up 1.05% at 280.4p.

Reporting by Josh White for Sharecast.com.