Hutchmed Says Chinese Regulator Granted Priority Review Status to New Drug Application for Fanregratinib

MT Newswires Live
Dec 29, 2025

Hutchmed (HCM) said Monday that the China National Medical Products Administration accepted the new drug application for fanregratinib as a potential treatment for adult patients with advanced, metastatic or unresectable intrahepatic cholangiocarcinoma and gave the application priority review status.

The company said the application is backed by data from a phase 2 study in China, which met its primary endpoint of objective response rate.

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