BEIJING (dpa-AFX) - Hutchmed China Ltd. (HCM, HCM.L) announced Monday that the China National Medical Products Administration (NMPA) has accepted and granted priority review for New Drug Application or NDA for fanregratinib (HMPL-453) to treat adult patients with advanced, metastatic or unresectable intrahepatic cholangiocarcinoma (ICC) with fibroblast growth factor receptor (FGFR) 2 fusion/rearrangement who have previously received systemic therapy.
Fanregratinib (HMPL-453) is a novel, selective, oral inhibitor targeting FGFR 1/2/3. ICC, a highly aggressive malignancy arising from the intrahepatic biliary epithelium, accounts for 8.2-15.0% of primary liver cancers. It is cnsidered as the second most common type after hepatocellular carcinoma with generally poorer long-term survival in comparison.
The company noted that the NDA is supported by data from a single-arm, multi-center, open-label, Phase II registration studyin China, which met its primary endpoint of objective response rate. Results from the secondary endpoints including progression-free survival, disease control rate, duration of response and overall survival also support the primary endpoint findings.
The company plans to submit full results for presentation at an upcoming scientific conference.
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