HUTCHMED (NASDAQ:HCM) announced Monday that the China National Medical Products Administration (NMPA) has accepted its New Drug Application for fanregratinib and granted it priority review status.
The oral therapy is designed to treat adult patients with advanced intrahepatic cholangiocarcinoma (ICC) who harbor specific genetic alterations known as FGFR2 fusions or rearrangements.
The priority designation accelerates the regulatory timeline for fanregratinib (HMPL-453), a selective inhibitor targeting fibroblast growth factor receptors (FGFR) 1, 2, and 3.
ICC is a highly aggressive malignancy of the bile ducts and is the second most common primary liver cancer after hepatocellular carcinoma.
In China, where liver cancer rates are among the highest in the world, ICC represents roughly 8.2% to 15% of cases.
Patients with ICC face a grim prognosis, with an overall five-year survival rate of approximately 9%.
For the 10% to 15% of patients whose tumors are driven by FGFR2 fusions, fanregratinib offers a precision medicine approach that specifically disrupts the signaling pathways responsible for tumor growth and survival.
The application is supported by a multi-center Phase II registration study conducted in China.
The trial met its primary endpoint of objective response rate (ORR), with secondary endpoints—including progression-free survival (PFS) and overall survival (OS)—further validating the drug's clinical benefit in patients who have failed at least one prior line of systemic therapy.
HUTCHMED currently retains all global rights to fanregratinib.
The drug’s potential approval in China would mark the company’s fifth internally developed oncology medicine to reach the market, following the success of fruquintinib (Elunate), surufatinib (Sulanda), and savolitinib (Orpathys).
The priority review status typically reduces the NMPA review period to approximately six to nine months, potentially clearing the way for a commercial launch in late 2026.
Beyond ICC, HUTCHMED is investigating fanregratinib in other solid tumor settings, including mesothelioma and gastroesophageal junction adenocarcinoma, as part of a broader strategy to maximize the value of its FGFR platform.
The news comes as HUTCHMED continues to transition into a self-sustaining, commercial-stage biopharmaceutical powerhouse, bolstered by rising royalty income from global partner Takeda for the international sales of fruquintinib.