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(Alliance News) - Hutchmed (China) Ltd on Tuesday said the China National Medical Products Administration accepted its new drug application for fruquintinib in combination with paclitaxel.
The Hong Kong-based cancer and immunological diseases treatment developer said the drug combination was for the treatment of second-line advanced gastric or gastroesophageal junction adenocarcinoma in China.
The NDA was supported by data from the Frutiga study, which was a randomised, double-blind, phase 3 study in China to evaluate fruquintinib, combined with paclitaxel, compared with paclitaxel monotherapy, for second-line treatment of advanced gastric cancer.
Hutchmed said Fruquintinib has been approved under the brand name Elunate and is included in the China National Reimbursement Drug List.
It will market fruquintinib in China in partnership with Eli Lilly & Co.
Last month, Hutchmed and Takeda Pharmaceutical Co Ltd finalised an exclusive license agreement to further the global development, commercialisation and manufacturing of fruquintinib outside China.
"The NMPA acceptance of our NDA for fruquintinib is a positive step towards addressing the significant unmet medical need for gastric cancer patients. 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," said Hutchmed Head of Research & Development and Chief Medical Officer Michael Shi.
"Despite recent advancement in the first line setting, there are few treatments available for patients whose disease progressed on initial therapy. Fruquintinib has demonstrated clinically meaningful benefit for patients in the phase 3 Frutiga study, and we are excited by the possibility of providing a potential new oral treatment option for patients in China."
Earlier this month, Hutchmed said it will start registration phase enrolments for two of its prospective treatments under study, HMPL-453 and savolitinib.
This was after agreeing with the China NMPA to initiate the registration of the ongoing phase 2 trial of HMPL-453 for intrahepatic cholangiocarcinoma patients with fibroblast growth factor receptors 2 fusion.
If positive, it said the data from the registration phase may be used to support a future new drug application filing. The first patient received their first dose in March 2023.
Shares in Hutchmed were up 1.6% to 280.00 pence each in London on Tuesday morning.
By Greg Rosenvinge, Alliance News reporter
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