HUTCHMED (NASDAQ:HCM) on Friday announced that uncertainty over a potential approval prompted it to withdraw a marketing application in China for its anti-cancer drug fruquintinib, marketed with Takeda (NYSE:TAK).

The Hong Kong-based biopharma had submitted a supplemental new drug application for fruquintinib to expand its use in China for patients with gastric or gastroesophageal junction adenocarcinoma.

Fruquintinib, an oral inhibitor of vascular endothelial growth factor receptors, is already approved in China as a late-line option for patients with colorectal cancer.

After discussions with the country’s drug regulator, the National Medical Products Administration of China (“NMPA”), the company has decided that the sNDA is unlikely to support an approval based on data from its Phase III FRUTIGA study.

While the China-based trial indicated an improvement in progression-free survival (“PFS”), one of its two dual primary endpoints, the results were not statistically significant for the second primary endpoint of median overall survival.

In light of the setback, the company said it will look for a new path forward for the drug.