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HQP1351

Phase 2

Chronic Myeloid Leukemia, Chronic Phase | Small molecule | Oncology |Ascentage Pharma Group International - American Depository Shares|Last Updated: Mar 3, 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
RandomizedUNCONTROLLED
Total Trials2
Total Enrollment156
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04126681A Pivotal Study of HQP1351 in Patients With Chronic Myeloid Leukemia in Chronic PhasePHASE2 COMPLETED 144Oct 21, 2019Aug 1, 2024Mar 3, 202522 China, China +20
NCT03882281Pharmacokinetics Profiles of HQP1351 Under Fasting and High-fat Meals in Patients With Chronic Myeloid LeukemiaPHASE1 COMPLETED 12Mar 25, 2019Nov 16, 2019Jan 22, 20201 China
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
PurposeTREATMENT
Interventions
NameTypeDescription
HQP1351DRUGHQP1351 is a new, bioavailable inhibitor against BCRABLWT and a broad spectrum of BCR-ABL mutants including BCR-ABLT315I
Hydroxyurea or Interferon-based therapyDRUGPatients will receive BAT based on the Investigator's opinion, taking into account the manufacturer's instructions, labeling, subject's medical condition, and institutional guidelines.
HomoharringtonineDRUGPatients will receive BAT based on the Investigator's opinion, taking into account the manufacturer's instructions, labeling, subject's medical condition, and institutional guidelines.
Imatinib, Dasatinib or NilotinibDRUGPatients will receive BAT based on the Investigator's opinion, taking into account the manufacturer's instructions, labeling, subject's medical condition, and institutional guidelines.
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