<div id="readability-page-1"><div>(Alliance News) - 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.By Eva Castanedo, Alliance News reporterComments and questions to newsroom@alliancenews.comCopyright 2025 Alliance News Ltd. All Rights Reserved.</div></div>

和黄医药

和黄医药（Hutchmed China Ltd）宣布，中国监管机构已接受其癌症治疗药物 fanregratinib 的新药申请，并授予其优先审评状态。该药物针对具有 FGFR2 基因改变的晚期肝内胆管癌患者。该申请得到了成功的二期研究的支持。和黄医药的股价下跌 1.1%，至 194.38 便士，2025 年累计下跌 16%

和黄医药的药物获得中国优先审评资格，用于治疗胆管癌