HUTCHMED (China) Limited (NASDAQ:HCM) on Thursday said results from its pivotal Phase 2 registration study evaluating fanregratinib (HMPL-453) in patients with intrahepatic cholangiocarcinoma (ICC) will be presented at the European Society for Medical Oncology (ESMO) Gastrointestinal Cancers Congress.
ICC is an aggressive cancer that forms in the small bile ducts inside the liver.
The company said the data underpin a New Drug Application for fanregratinib that was accepted for review and granted priority review by China's National Medical Products Administration (NMPA) in December 2025.
The NDA seeks approval for fanregratinib to treat adult patients with advanced, metastatic, or unresectable ICC harboring fibroblast growth factor receptor (FGFR)2 fusion or rearrangement whose disease progressed following prior systemic therapy.
Read Also: Positive China Trial Data Moves HUTCHMED Closer To Rare Blood Disorder Drug Filing In 2026 Phase II Study Meets Primary Endpoint The single-arm, multicenter, open-label Phase II trial enrolled patients across 53 sites in China to assess the efficacy, safety, and pharmacokinetics of fanregratinib in advanced ICC patients with FGFR2 fusion or rearrangement.
