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Hutchmed China Ltd on Monday said Chinese regulators have accepted a new drug application for its cancer treatment fanregratinib and granted it priority review status. The Hong Kong-based developer of treatments for cancer and immunological diseases said the China National Medical Products Administration has accepted the application for fanregratinib to treat adults with advanced, metastatic or unresectable intrahepatic cholangiocarcinoma who have previously received systemic therapy and whose tumours carry FGFR2 fusion or rearrangement. Fanregratinib, also known as HMPL-453, is a selective oral inhibitor targeting fibroblast growth factor receptors FGFR1, FGFR2 and FGFR3. The application is supported by results from a phase II registration study conducted in China. Hutchmed said the trial met its primary endpoint of objective response rate, with secondary endpoints also supporting the findings. Intrahepatic cholangiocarcinoma is the second most common form of liver cancer after hepatocellular carcinoma and is associated with poor long-term survival. Hutchmed said around 10% to 15% of patients globally have tumours with FGFR2 gene alterations. The company said full trial results will be submitted for presentation at a future scientific conference. Hutchmed shares were down 1.1% at 194.38 pence in London on Monday morning. The stock is down 16% in 2025. Copyright 2025 Alliance News Ltd. All Rights Reserved.
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