HUTCHMED wins NMPA approval for ATLED in FGFR2-altered bile duct cancer

HUTCHMED (China) Limited announced on August 28, 2026 that the China National Medical Products Administration granted conditional approval of fanregratinib (HMPL-453), an oral inhibitor targeting FGFR 1/2/3, for adult patients with advanced, metastatic or unresectable intrahepatic cholangiocarcinoma with FGFR2 fusion or rearrangement who have already received systemic therapy.¹ The drug will be sold in China under the brand name ATLED.¹

Intrahepatic cholangiocarcinoma, the company noted, is an aggressive cancer of the bile duct lining that makes up 8.2 to 15.0 percent of primary liver cancers, ranking second behind hepatocellular carcinoma.¹ The company added that its five-year overall survival rate is around 9 percent, and roughly 10 to 15 percent of cases worldwide carry FGFR2 fusions or rearrangements.¹

The approval rests on findings from a registration cohort tied to a Chinese clinical trial registered as NCT04353375, described by the company as a single-arm, multi-center, open-label, pivotal Phase II/IIIb study¹, with data recently presented at the European Society for Medical Oncology Gastrointestinal Cancers Congress 2026.¹ The trial hit its primary endpoint, with an Independent Review Committee-assessed objective response rate of 42.5 percent (95% CI: 30.0%-53.6%) among pretreated advanced patients with FGFR2 fusions or rearrangements.¹

On secondary measures, median time to response was 1.4 months¹, median duration of response was 6.9 months (95% CI: 5.6-8.5) and disease control rate reached 83.9 percent (95% CI: 74.5%-90.9%)¹, while median progression-free survival was 6.9 months (95% CI: 4.1-8.2) and median overall survival was 16.6 months (95% CI: 12.4-16.6).¹

HUTCHMED said the Phase IIIb portion will act as a confirmatory study, with enrollment for that cohort beginning in January 2026.¹ The company said it retains all worldwide rights to fanregratinib.¹