Last update 28 Mar 2025

CN-201

Overview

Basic Info

Drug Type
Bispecific T-cell Engager (BiTE)
Synonyms
CN 201, CN201
Action
inhibitors, stimulants
Mechanism
CD19 inhibitors(B-lymphocyte antigen CD19 inhibitors), CD3 stimulants(T cell surface glycoprotein CD3 stimulants)
Inactive Indication
Originator Organization
Inactive Organization-
Drug Highest PhasePhase 1/2
First Approval Date-
RegulationOrphan Drug (United States)
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R&D Status

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IndicationHighest PhaseCountry/LocationOrganizationDate
Pre B-cell acute lymphoblastic leukemiaPhase 2
China
30 Sep 2022
B-cell lymphoma recurrentPhase 1
China
16 Mar 2021
B-cell lymphoma refractoryPhase 1
China
16 Mar 2021
B-Cell LymphomaPhase 1
China
04 Mar 2021
B-Cell LeukemiaIND Approval
China
09 Nov 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
58
omkscpatth(gtewpjganz) = white blood cell decreased (32%), neutropenia (30%), lymphopenia (29%), anemia (29%), pyrexia (25%) and platelet decreased (23%). rqstgwobzc (tjnwbtgnio )
Positive
24 May 2024
CN201
(full doses ≥ 5mg)
Phase 1
42
CN201 600 μg
nbmanosxng(yddjskrexy) = Not reached. wnhkzfrcle (gsdupczgsw )
Not Met
Positive
24 May 2024
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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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