China-based HutchMed (HKG: 0013, NASDAQ: HCM) has announced that the National Medical Products Administration (NMPA) has accepted a market approval filing for the VEGFR inhibitor Elunate (fruquintinib) in China. The filing focuses on the use of Elunate in combination with paclitaxel as a second-line treatment for advanced gastric or gastroesophageal junction adenocarcinoma.
Supporting Data from FRUTIGA Study
The filing is supported by data from the FRUTIGA study, a randomized, double-blind, Phase III study conducted in China. The study evaluated Elunate plus paclitaxel compared with paclitaxel monotherapy as a second-line treatment for advanced gastric cancer. Approximately 700 patients were enrolled, with dual-primary endpoints of progression-free survival (PFS) and overall survival (OS). The trial successfully met the PFS endpoint at a statistically and clinically meaningful level. Additionally, fruquintinib demonstrated a statistically significant improvement in secondary endpoints, including objective response rate (ORR), disease control rate (DCR), and duration of response (DoR).
Elunate’s Profile and Market Presence
Elunate is a highly selective and potent oral inhibitor of vascular endothelial growth factor receptor (VEGFR) 1, 2, and 3. It was approved for marketing by the NMPA in September 2018 and commercially launched in China in November that year for the treatment of metastatic colorectal cancer (CRC) in patients previously treated with fluoropyrimidine, oxaliplatin, and irinotecan. The drug was included in the National Reimbursement Drug List (NRDL) in January 2020. In March 2023, HutchMed entered into a USD 1.13 billion licensing deal with Takeda Pharma, granting Takeda development, manufacturing, and commercialization rights globally, excluding mainland China, Hong Kong, and Macau. Eli Lilly holds exclusive commercialization rights to the drug in China.-Fineline Info & Tech
