ICP-248

Phase 3Small molecule

ICP-248 is one of 21 small molecule programs targeting Refractory Mantle Cell Lymphoma (MCL). It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Refractory Mantle Cell Lymphoma (MCL)Not yet recruiting

Acute Myelogenous LeukemiaRecruiting

Mature B-Cell MalignanciesRecruiting

Chronic Lymphocytic Leukemia/small Lymphocytic LymphomaRecruiting

Anti-CD20 Monoclonal AntibodyRecruiting

Refractory Mantle Cell Lymphoma (MCL)Phase 3

Not yet recruiting

Acute Myelogenous LeukemiaPhase 1

Recruiting

Mature B-Cell MalignanciesPhase 1

Recruiting

Chronic Lymphocytic Leukemia/small Lymphocytic LymphomaPhase 3

Recruiting

Anti-CD20 Monoclonal AntibodyPhase 1

Recruiting

Competition

Competitive Landscape

17 competitors in Chronic Lymphocytic Leukemia/small Lymphocytic Lymphoma

#DrugCompanyPhaseTrials

Jaypirca

Eli Lilly

Approved

5 2

Zydelig

Rituxan

5 4

Venclexta

AbbVie

Phase 3

4 5

Treanda

AAzurity Pharmaceuticals

Phase 3

2 6

Cytoxan

BBaxter Healthcare Corporation

Phase 3

2 7

Nublexa

BBeijing InnoCare Pharma Tech Co., Ltd.

Phase 3

1 8

Nemtabrutinib

Merck & Co.

Phase 3

2 9

Gazyva

Roche

Phase 2

4 10

Fludara

Sanofi

Phase 2

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 1Recruiting

Mature B-Cell Malignancies

NCT05728658

Q4 2027

Phase 1Recruiting

Anti-CD20 Monoclonal Antibody

NCT06351527

Q1 2028

Phase 1Recruiting

Acute Myelogenous Leukemia

NCT06656494

Q3 2028

Phase 2Recruiting

Refractory Mantle Cell Lymphoma (MCL)

NCT07082686

Clinical

Trials by Indication[1]

Refractory Mantle Cell Lymphoma (MCL)2 trials

A Randomized, Multicenter, Open-label, Phase 3 Study to Compare ICP-248 in Combination With Orelabrutinib Versus Pirtobrutinib in Participants With Relapsed or Refractory Mantle Cell Lymphoma (r/r MCL)

Not yet recruiting·BBeijing InnoCare Pharma Tech Co., Ltd.·Phase 3·NCT07784101·280 enrolled

A Single-arm, Multi-center, Open-label, Phase 2 Study to Evaluate the Efficacy and Safety of ICP-248 in Subjects With Relapsed or Refractory Mantle Cell Lymphoma

Recruiting·BBeijing InnoCare Pharma Tech Co., Ltd.·Phase 2·NCT07082686·75 enrolled

Mature B-cell Malignancies1 trial

The Study of ICP-248 in Patients With Mature B-cell Malignancies

Recruiting·BBeijing InnoCare Pharma Tech Co., Ltd.·Phase 1·NCT05728658·191 enrolled

Anti-CD20 Monoclonal Antibody1 trial

Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ICP-248 as Monotherapy or in Combination With Anti-CD20 Monoclonal Antibody in Mature B-cell Malignancies

Recruiting·IInnoCare Pharma Inc.·Phase 1·NCT06351527·78 enrolled

Chronic Lymphocytic Leukemia/small Lymphocytic Lymphoma1 trial

ICP-248 in Combination With Orelabrutinib in Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (APEX-03)

Recruiting·BBeijing InnoCare Pharma Tech Co., Ltd.·Phase 2/3·NCT06378138·226 enrolled

Acute Myelogenous Leukemia1 trial

A Phase 1 Study of ICP-248 in Combination With Azacitidine for the Treatment in Patients With Myeloid Malignancies.

Recruiting·BBeijing InnoCare Pharma Tech Co., Ltd.·Phase 1·NCT06656494·266 enrolled

Sources

References

[1]
ClinicalTrials.gov — 6 trial records for ICP-248. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — ICP-248 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for ICP-248. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Beijing InnoCare Pharma Tech Co., Ltd. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: BBeijing InnoCare Pharma Tech Co., Ltd.

ICP-248

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q4 2027

Q1 2028

Q3 2028

Trials by Indication[1]

Refractory Mantle Cell Lymphoma (MCL)2 trials

Mature B-cell Malignancies1 trial

Anti-CD20 Monoclonal Antibody1 trial

Chronic Lymphocytic Leukemia/small Lymphocytic Lymphoma1 trial

Acute Myelogenous Leukemia1 trial

References

Drug Info

Quick Facts

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