Hutchmed (China) Ltd. secured National Medical Products Administration acceptance and priority review for an NDA for fanregratinib (HMPL‑453), an FGFR‑targeted therapy for intrahepatic cholangiocarcinoma, based on a single‑arm phase II registration study in China. The move advances one of the country’s potential first domestically developed FGFR inhibitors toward approval. The NMPA’s acceptance underlines Beijing’s willingness to expedite oncology agents addressing high unmet need and to consider streamlined single‑arm submissions for rare tumor types. If approved, fanregratinib would strengthen China’s homegrown oncology portfolio and influence global FGFR development strategies.