fanregratinib - (HMPL-453)

June 25, 2026: HUTCHMED (China) Limited (Nasdaq/AIM:HCM; HKEX:13) announced that results from its pivotal single-arm, multi-center, open-label Phase II registration study of fanregratinib (HMPL-453) in pretreated advanced intrahepatic cholangiocarcinoma (ICC) with FGFR2 fusions/rearrangements (NCT04353375) will be presented at the ESMO Gastrointestinal Cancers Congress (Munich) on July 4, 2026 (Rapid oral session on innovation; presentation 343RO).

The trial (53 sites in China) met its primary endpoint with an IRC-assessed ORR of 42.5% (95% CI: 30.0%–53.6%). Secondary outcomes included median time to response 1.4 months, median DoR 6.9 months (95% CI: 5.6–8.5), DCR 83.9% (95% CI: 74.5%–90.9%), median PFS 6.9 months (95% CI: 4.1–8.2), and median OS 16.6 months (95% CI: 12.4–16.6). All patients had prior chemotherapy; 72% had prior immunotherapy.

Regulatory: Supported by these data, an NDA in China for adult advanced/metastatic/unresectable FGFR2 fusion/rearrangement ICC after systemic therapy was accepted and granted priority review by China’s NMPA in December 2025.

Safety: Grade ≥3 drug-related AEs occurred in 48.3%; discontinuations due to drug-related AEs were 2.2%, with no treatment-related deaths.