Hutchmed announced that China’s NMPA accepted the NDA for fanregratinib (HMPL‑453), an FGFR‑targeted therapy, and granted the submission priority review for intrahepatic cholangiocarcinoma. The filing is backed by a single‑arm, multicenter phase II registration study conducted in China, reflecting a streamlined regulatory path for drugs addressing high unmet needs. Acceptance signals the NMPA’s continued openness to accelerated pathways for oncology agents and could position fanregratinib as one of China’s domestically developed targeted therapies in cholangiocarcinoma. For global companies and regional investors, the move underscores China’s growing regulatory influence in oncology commercialization strategies.