China’s National Medical Products Administration accepted Hutchmed’s NDA for fanregratinib (HMPL‑453), granting priority review based on a single‑arm phase II registration study in intrahepatic cholangiocarcinoma. The acceptance exemplifies China’s willingness to use expedited pathways for oncology drugs addressing high unmet needs. The NDA comes as Asia — led by China — is increasingly shaping global biotech trends, with regulatory reforms, domestic capital and dealmaking altering where companies prioritize development and commercialization. Investors and global pharma partners will watch how China’s regulatory flexibility affects global development strategies and the appetite for regionally based registrations.