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HUTCHMED (China) Limited received conditional approval from the China National Medical Products Administration for…
HCMHUTCHMED (China) Ltd
HUTCHMED (China) Limited received conditional approval from the China National Medical Products Administration for fanregratinib, marketed as ATLED®, to treat adult patients with advanced intrahepatic cholangiocarcinoma harboring FGFR2 fusions or rearrangements. Clinical data demonstrated an objective response rate of 42.5%, a median progression-free survival of 6.9 months, and a median overall survival of 16.6 months in the pivotal Phase II/IIIb trial. This regulatory milestone expands the company's commercial portfolio with a novel oral selective FGFR inhibitor targeting a high-unmet-need oncology indication. HUTCHMED is an innovative biopharmaceutical company focused on the discovery and global development of targeted therapies and immunotherapies for cancer and immunological diseases.