China’s NMPA accepts Hutchmed’s fanregratinib NDA: priority review for FGFR therapy

China’s National Medical Products Administration accepted Hutchmed’s NDA for fanregratinib (HMPL‑453), an FGFR‑targeted therapy for intrahepatic cholangiocarcinoma, and granted priority review. The submission is supported by a single‑arm, multicenter phase II registration study conducted in China, reflecting the regulator’s openness to streamlined oncology pathways for high‑unmet‑need cancers. An NMPA priority review could fast‑track first‑in‑China approvals for targeted oncology drugs and reinforces China’s evolving regulatory stance to promote domestic innovation in cancer therapeutics.