China Accepts Hutchmed NDA — Priority Review for FGFR Inhibitor

China’s National Medical Products Administration accepted Hutchmed’s new drug application for fanregratinib (HMPL‑453), an FGFR‑targeted therapy for intrahepatic cholangiocarcinoma, and granted priority review. The NDA relies on a single‑arm, multicenter Phase II registration study conducted in China, reflecting the NMPA’s growing readiness to use streamlined pathways for high‑unmet‑need oncology drugs. Hutchmed moves closer to potentially delivering China’s first domestically developed FGFR therapy for this hard‑to‑treat liver cancer subtype.