LONDON (ShareCast) - (Sharecast News) - Hutchmed China announced on Tuesday that its new drug application (NDA) for fruquintinib, in combination with paclitaxel has been accepted for review by the National Medical Products Administration (NMPA) in China.
The AIM-traded firm said the NDA was being evaluated for the treatment of second-line advanced gastric or gastroesophageal junction adenocarcinoma.

It said the application was supported by data from the 'FRUTIGA' study - a phase three study conducted in China to evaluate fruquintinib combined with paclitaxel, compared with paclitaxel alone, for the second-line treatment of advanced gastric cancer.

Fruquintinib is currently approved in China under the brand name 'Elunate', and was included in the China National Reimbursement Drug List (NRDL).

Hutchmed markets fruquintinib in China in partnership with Eli Lilly.

In March, Hutchmed and Takeda Pharmaceutical Company closed an exclusive licence agreement to further the global development, commercialisation, and manufacture of fruquintinib outside of China.

"The NMPA acceptance of our NDA for fruquintinib is a positive step towards addressing the significant unmet medical need for gastric cancer patients," said Dr Michael Shi, Hutchmed's head of research and development and chief medical officer.

"Gastric cancer is one of the most common cancers globally, with the highest incidence and mortality rates found in Asian populations.

"China alone accounts for over 40% of all new gastric cancer cases in the world."

Dr Shi said that, despite recent advancement in the first-line setting, there were few treatments available for patients whose disease progressed on initial therapy.

"Fruquintinib has demonstrated clinically meaningful benefit for patients in the phase three 'FRUTIGA' study, and we are excited by the possibility of providing a potential new oral treatment option for patients in China."

At 1209 BST, shares in Hutchmed China were up 2.11% in London at 281.3p.

Reporting by Josh White for Sharecast.com.

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