HUTCHMED (China) Limited announced that China’s National Medical Products Administration has granted conditional approval for ATLED® (fanregratinib, HMPL-453), a novel oral inhibitor of FGFR 1/2/3, for adults with advanced, metastatic or unresectable intrahepatic cholangiocarcinoma (ICC) harboring FGFR2 fusions or rearrangements who have previously received systemic therapy.
ICC accounts for 8.2–15.00% of primary liver cancers and has a five-year overall survival rate of roughly 9%. Globally, 10–15% of ICC patients carry FGFR2 alterations, making them eligible for targeted FGFR inhibition.
Regulatory clearance is based on the Phase II registration cohort of a single-arm, multi-center trial (NCT04353375). Key efficacy results in pretreated FGFR2-altered ICC patients were:
• Objective Response Rate (IRC-assessed): 42.50% (95% CI: 30.00%–53.60%) • Disease Control Rate: 83.90% (95% CI: 74.50%–90.90%) • Median Time to Response: 1.40 months • Median Duration of Response: 6.90 months (95% CI: 5.60–8.50) • Median Progression-Free Survival: 6.90 months (95% CI: 4.10–8.20) • Median Overall Survival: 16.60 months (95% CI: 12.40–16.60)
HUTCHMED retains global rights to fanregratinib and plans to leverage its existing commercial platform for the drug’s China launch. A Phase IIIb confirmatory study, initiated in January 2026, will further assess clinical benefit and safety.
Acting CEO and CFO Johnny Cheng highlighted that ATLED® fills “a critical therapeutic gap” for Chinese patients with advanced ICC and underscored the company’s readiness to expedite market availability.
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