China's NMPA has conditionally approved Atled (fanregratinib; HMPL-453), an oral selective fibroblast growth factor receptor (FGFR) 1/2/3 inhibitor developed by HutchMed (China) Limited (Nasdaq/AIM: HCM; HKEX: 13), for adult patients with advanced, metastatic, or unresectable intrahepatic cholangiocarcinoma (ICC) harboring FGFR2 fusions or rearrangements who have received prior systemic therapy.
The conditional approval requires HUTCHMED to complete a Phase IIIb confirmatory cohort — enrollment for which began in January 2026 — as a post-approval commitment. The drug blocks ATP binding at the FGFR active site, suppressing constitutively activated downstream signaling driven by FGFR2 gene fusions, which occur in approximately 10–15% of ICC cases globally, the company said.
HutchMed filed fanregratinib using the Phase II registration cohort of NCT04353375, a single-arm, multicenter, open-label Phase II/IIIb trial conducted in China. As previously reported, the study met its primary endpoint, with an Independent Review Committee-assessed objective response rate (ORR) of 42.5% (95% CI: 30.0%–53.6%) in pretreated patients. Median overall survival reached 16.6 months, disease control rate was 83.9%, and median time to response was 1.4 months.