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Hutchmed Obtains Conditional Approval for Intrahepatic Cholangiocarcinoma Drug Atled in China
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11:31 PM EDT, 08/27/2026 (MT Newswires) -- Hutchmed (China) (HCM.L) said Friday it secured conditional approval from the China National Medical Products Administration for Atled as a treatment for intrahepatic cholangiocarcinoma in adults. Atled, or fanregratinib, is indicated for adult patients with advanced, metastatic or unresectable intrahepatic cholangiocarcinoma with fibroblast growth factor receptor 2 fusion or rearrangement who have previously undergone systemic therapy. The biopharmaceutical company said it used positive phase 2 results from a phase 2/3b clinical trial of Atled in China to support its new drug application. Hutchmed added that the phase 3b part of the study is designed to further validate the drug's clinical benefits and safety in the treatment setting.
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