China Accepts HUTCHMED’s NDA For Fanregratinib And Grants Priority Review For FGFR2-Positive Advanced Intrahepatic Cholangiocarcinoma

HUTCHMED (China) Limited announced that the China National Medical Products Administration has accepted and granted priority review to its New Drug Application for fanregratinib (HMPL-453). The application seeks approval for the use of fanregratinib in adult patients with advanced, metastatic, or unresectable intrahepatic cholangiocarcinoma (ICC) who have tumors with FGFR2 fusion or rearrangement and who have previously received systemic therapy.

Fanregratinib is an oral, selective inhibitor targeting FGFR 1, 2, and 3. ICC is an aggressive cancer that originates in the bile ducts within the liver. It represents between 8.2% and 15% of primary liver cancers, making it the second most common type after hepatocellular carcinoma. The incidence of ICC has been rising in recent years, and the disease is associated with a poor prognosis, with a five-year overall survival rate of around 9%. Research shows that approximately 10–15% of ICC patients worldwide have tumors containing FGFR2 fusions or rearrangements.

The NDA submission is supported by results from a Phase II registration study conducted in China. This was a single-arm, multi-center, open-label trial that met its primary endpoint, demonstrating a positive objective response rate. Findings from key secondary endpoints—including progression-free survival, disease control rate, duration of response, and overall survival—also strengthened the overall evidence supporting fanregratinib’s potential benefit for this patient population.