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HMPL-453

Phase 3

Advanced Intrahepatic Cholangiocarcinoma | Small molecule | Oncology |HUTCHMED (China) Limited|Last Updated: Dec 30, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment235
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04353375HMPL-453 Tartrate in Advanced Intrahepatic CholangiocarcinomaPHASE2/PHASE3 RECRUITING 235Sep 1, 2020Feb 1, 2030Dec 30, 2025 -
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Study Design & Arms
Interventions
NameTypeDescription
HMPL-453DRUGCohort\_1:HMPL-453 150mg QD continuously in 21-day cycles; Cohort\_2, Cohort\_3 and Cohort\_4:HMPL-453 tartrate 300 mg QD orally (for 14 consecutive days \[Day 1 to 14\], followed by 7 days off \[Day 15 to 21\], 21 days as a treatment cycle)
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT04353375studyFirstPostDate: changed