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Plonmarlimab

Phase 3

Relapsed/Refractory Rheumatic and Immunologic Disease-associated Haemophagocytic Lymphohistiocytosis | Small molecule | Other |I-Mab Sponsored ADR|Last Updated: Dec 2, 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 Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07208058A Phase III Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of Plonmarlimab in Subjects With Relapsed/Refractory Rheumatic and Immunologic Disease-associated Haemophagocytic Lymphohistiocytosis (Also Known as Macrophage Activation Syndrome [MAS])PHASE3 RECRUITING 30Nov 21, 2025Nov 30, 2027Dec 2, 202515 China
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Study Endpoints
Primary Endpoints
Overall response rate (ORR)
at the end of Week 8
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PlonmarlimabEXPERIMENTAL -
Interventions
NameTypeDescription
PlonmarlimabDRUGSubjects will receive Plonmarlimab 10 mg/kg by intravenous injection once weekly from Week 1 to Week 3, and Plonmarlimab 6 mg/kg by intravenous injection once weekly from Week 4 to Week 8 (10 mg/kg QW×3 + 6 mg/kg QW×5).
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Eligibility Criteria
Age Range16 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites15

Inclusion Criteria: * Age: 16 to 80 years (inclusive), of any gender. * The subject is willing to participate in this study and voluntarily signs the informed consent form. For minor subjects aged 16 years (inclusive) to less than 18 years, written informed consent must be signed by both the subjec...

Countries:China
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07208058primaryCompletionDate: changed
LOWMay 24, 2026NCT07208058studyFirstPostDate: changed