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TQB3473

Phase 2

Primary Immune Thrombocytopenia | Small molecule | Hematology |Co-Diagnostics, Inc.|Last Updated: Jul 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment320
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07083739A Study on the Safety and Efficacy of TQB3473 Tablets in the Treatment of Persistent or Chronic Primary Immune Thrombocytopenia (ITP) in AdultsPHASE2 NOT YET_RECRUITING 320 — — Aug 1, 2025Mar 1, 2028Jul 24, 202551 China
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Study Endpoints
Primary Endpoints
Sustained response rate
Weeks 13-24

During the last 12 weeks of treatment, at least 2 platelet counts were ≥50×10\^9/L in three protocol-determined visits (excluding rescue treatment).

Secondary Endpoints
Response rate at 12 weeks
Within 12 weeks of treatment
Response rate at 24 weeks
Within 24 weeks of treatment
Time to Onset
Within 24 weeks of treatment
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TQB3473 TabletsEXPERIMENTALTQB3473 Tablets 600 mg orally once daily for 24 consecutive weeks.
Interventions
NameTypeDescription
TQB3473 TabletsDRUGTQB3473 tablet is a selective Spleen tyrosine kinase (Syk) inhibitor.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites51

Inclusion Criteria: Cohort 1 : * Voluntarily participate in this study with signed informed consent form (ICF) and demonstrated good compliance. * Age ≥18 years (calculated from the date of ICF signing); no gender restrictions; Eastern Cooperative Oncology Group (ECOG) performance status 0-1. * Cl...

Countries:China
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