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HONG KONG - Hutchmed (China) Limited (Nasdaq/AIM:HCM; HKEX:13) has announced the completion of patient enrollment in a Phase II study for its drug candidate fanregratinib (HMPL-453), targeting intrahepatic cholangiocarcinoma (IHCC) in China. The study, which began dosing its first patient in March 2023, aims to evaluate the efficacy and safety of the drug in IHCC patients with fibroblast growth factor receptor (FGFR)2 fusion/rearrangement.
The single-arm, multi-center, open-label study has enrolled a total of 87 patients. It focuses on the objective response rate (ORR) as its primary endpoint, with secondary endpoints including progression-free survival (PFS), disease control rate (DCR), duration of response (DoR), and overall survival (OS). The results from the trial are expected to be released around the end of 2025 and could lead to a New Drug Application submission to China’s National Medical (TASE:BLWV) Products Administration (NMPA) if the outcomes are favorable.
Fanregratinib is a selective inhibitor targeting FGFR 1, 2, and 3. Abnormal FGFR gene alterations have been linked to tumor growth in several solid tumor types. Hutchmed retains global rights to fanregratinib.
IHCC, a subtype of primary bile duct cancer, has seen an increasing incidence in China, with 61,900 new cases estimated in 2015 and an annual increase of 9.2% from 2006 to 2015. FGFR2 fusion is present in 10-15% of IHCC patients.
Hutchmed is a biopharmaceutical company focused on the discovery, development, and commercialization of cancer and immunological disease therapies. It has successfully marketed three medicines in China, with one also approved in the US, Europe, and Japan.
This press release contains forward-looking statements regarding the therapeutic potential of fanregratinib, its clinical development, and the expectations of study outcomes. These statements are subject to risks and uncertainties, and actual results may differ. The information is based on a press release statement.
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