Last update 27 Feb 2026

CN-201

Overview

Basic Info

Drug Type
Bispecific T-cell Engager (BiTE)
Synonyms
CN 201, CN201, MK-1045
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

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Precursor B-Cell Lymphoblastic Leukemia-LymphomaPhase 2
China
01 Nov 2022
Precursor B-Cell Lymphoblastic Leukemia-LymphomaPhase 2
China
01 Nov 2022
Rheumatoid ArthritisPhase 1
United States
17 Feb 2026
Rheumatoid ArthritisPhase 1
China
17 Feb 2026
Rheumatoid ArthritisPhase 1
Japan
17 Feb 2026
Rheumatoid ArthritisPhase 1
Belgium
17 Feb 2026
Rheumatoid ArthritisPhase 1
Colombia
17 Feb 2026
Rheumatoid ArthritisPhase 1
Italy
17 Feb 2026
Rheumatoid ArthritisPhase 1
Moldova
17 Feb 2026
Rheumatoid ArthritisPhase 1
Peru
17 Feb 2026
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
41
(relapsed or refractory follicular lymphoma)
crifxcuggb(nebjwocjsf) = No dose-limiting toxicities occurred, ixhpfkwcgv (kqyvsqjaii )
Positive
06 Dec 2025
Phase 1
49
pgvluvotyk(wuesrbipse) = mbccfswcwd xmmmyhxunx (hoqmubwwno )
Positive
06 Dec 2025
Phase 1/2
75
(target doses of ≥60 mg)
yzuxkyanja(nramwzfaom) = due to hemoptysis, which wasdetermined to be unrelated to MK-1045 aawehfltfe (ucmlbjiaic )
Positive
06 Dec 2025
(target dose ≥60 mg + prior exposure to blinatumomab or CAR T-cell therapy)
Phase 1
58
bkftnmamfu(wglmddwtej) = white blood cell decreased (32%), neutropenia (30%), lymphopenia (29%), anemia (29%), pyrexia (25%) and platelet decreased (23%). eglevrbanu (laqgrcyapl )
Positive
24 May 2024
(full doses ≥ 5mg)
Phase 1
42
CN201 600 μg
bcvhymlqnf(ymkyjdkqjq) = Not reached. uxvdcksnpm (uvmpgehliz )
Not Met
Positive
24 May 2024
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Deal

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Clinical Trial

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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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