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Hutchmed China Ltd on Thursday reported positive phase two data for fanregratinib in patients with intrahepatic cholangiocarcinoma, showing clinically meaningful and durable responses in a registration-enabling study. The Hong Kong-based biopharmaceutical firm said the ‘pivotal’ registration clinical trial was conducted across 53 sites in China to evaluate the efficacy, safety and pharmacokinetic of fanregratinib in treating advanced intrahepatic cholangiocarcinoma patients with fibroblast growth factor receptor two fusion/rearrangement. Fanregratinib is a novel, highly selective and potent inhibitor that targets FGFR one, two and three, said Hutchmed China. The company explained that FGFR signalling has been found to be a driving force in ‘tumor growth, promotion of angiogenesis and resistance to anti-tumor therapies’. Hutchmed China said the study met its primary endpoint, with it demonstrating an Independent Review Committee-assessed objective response rate of 42.5%. The company noted the study demonstrated ‘high clinically meaningful objective responses, achieving rapid and durable disease control’. Shares in Hutchmed China were down 2.1% at 156.63 pence on Thursday morning in London. ‘The clinical reality for this patient population with advanced FGFR2-fusion/rearrangement ICC is highly challenging, as the entire cohort had progressed on prior chemotherapy, and a significant majority had prior immunotherapy exposure,’ said Jianming Xu of the Chinese PLA General Hospital and leading principal investigator of the study. ‘The results from this registration-enabling trial represent an important milestone in the targeted treatment landscape for FGFR2altered ICC. The objective response rate and survival metrics achieved by fanregratinib clearly support its therapeutic value as a potent, selective oral treatment option. We are encouraged by these findings and hope to see this innovation translate into clinical practice to address a critical need in gastrointestinal oncology.’ Hutchmed China said the results from the study will be presented at the European Society for Medical Oncology Gastrointestinal Cancers Congress which takes place from Wednesday to Saturday next week in Munich. Copyright 2026 Alliance News Ltd. All Rights Reserved.
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