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APG-5918

Phase 1

Anemia | Small molecule | Hematology |Ascentage Pharma Group International - American Depository Shares|Last Updated: Nov 24, 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
RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment105
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05773586A Study to Investigate the Safety, Pharmacokinetics and Efficacy of APG-5918 in Healthy Subjects or Anemic PatientsPHASE1 RECRUITING 105 — — Mar 13, 2023Jul 15, 2028Nov 24, 20252 China, China
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
PurposeTREATMENT
Interventions
NameTypeDescription
APG-5918DRUGoral tablets 10mg, 50mg, 200mg.
PlaceboDRUGMatching placebo
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Competitive Landscape -Anemia 17 trials
CompanyTickerTrialsLead PhaseDrugs
Bristol-Myers Squibb CompanyBMY2PHASE3ACE-536, Luspatercept
Akebia Therapeutics, Inc.AKBA3PHASE3Erythropoiesis-Stimulating Agent, Vadadustat, Erythropoiesis Stimulating Agent, Epoetin alga /vadadustat
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK1PHASE3Elritercept, Epoetin Alfa
Cerus CorporationCERS1PHASE3Undisclosed
Disc Medicine, Inc.IRON2PHASE2DISC-0974
Incyte CorporationINCY1PHASE1INCB000928, ruxolitinib
Ascentage Pharma Group International Unsponsored ADRAAPG1PHASE1APG-5918
Harvard Bioscience, Inc.HBIO1NAUndisclosed
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT05773586studyFirstPostDate: changed