HUTCHMED (China) Ltd (HCM) Form 6-K — Aug 28, 2026
HUTCHMED announced that China's NMPA has granted conditional approval to its New Drug Application for fanregratinib (HMPL-453), to be marketed as ATLED, for adult patients with advanced, metastatic or unresectable intrahepatic cholangiocarcinoma harboring FGFR2 fusions or rearrangements who have previously received systemic therapy. The approval is supported by the pivotal Phase II cohort of trial NCT04353375, which met its primary endpoint with a 42.5% objective response rate, an 83.9% disease control rate, median progression-free survival of 6.9 months and median overall survival of 16.6 months in pretreated FGFR2-altered ICC patients.
Key figures
- Trial Registration
- NCT04353375
- Disease Control Rate
- 83.9% (95% CI: 74.5%-90.9%)
- Objective Response Rate
- 42.5% (95% CI: 30.0%-53.6%)
- Median Time To Response Months
- 1.4
- Median Overall Survival Months
- 16.6
- Icc Share Of Primary Liver Cancers
- 8.2-15.0%
- Fgfr2 Alteration Prevalence In Icc
- 10-15%
- Five Year Overall Survival Rate Icc
- ~9%
- Median Duration Of Response Months
- 6.9
- Median Progression Free Survival Months
- 6.9
- Confirmatory Phase IIIb Enrollment Start
- January 2026
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