HUTCHMED Announces NDA Acceptance in China for Fruquintinib in Second-Line Gastric Cancer
pharmafile | April 18, 2023 | News story | Business Services |
Hong Kong, Shanghai & Florham Park, NJ — Tuesday, April 18, 2023: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that its New Drug Application (“NDA”) for fruquintinib in combination with paclitaxel for the treatment of second-line advanced gastric or gastroesophageal junction adenocarcinoma in China has been accepted for review by the China National Medical Products Administration (“NMPA”).
Dr. Michael Shi, Head of R&D and Chief Medical Officer of HUTCHMED said, “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. 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 III FRUTIGA study, and we are excited by the possibility of providing a potential new oral treatment option for patients in China.”
The NDA is supported by data from the FRUTIGA study, a randomized, double-blind, Phase III study in China to evaluate fruquintinib combined with paclitaxel compared with paclitaxel monotherapy, for second-line treatment of advanced gastric cancer.
In China, fruquintinib is approved under the brand name ELUNATE® and is included in the China National Reimbursement Drug List (“NRDL”). HUTCHMED markets fruquintinib in China in partnership with Eli Lilly and Company.
In March 2023, HUTCHMED and Takeda Pharmaceutical Company Limited (TSE:4502, NYSE:TAK) closed an exclusive license agreement to further the global development, commercialization and manufacture of fruquintinib outside China.
