Last update 20 Mar 2025

ESG-401

Overview

Basic Info

Drug Type
Antibody drug conjugate (ADC)
Synonyms
Humanized anti-Trop2-SN-38 antibody conjugate, Humanized mAb anti-TROP-2 program
+ [5]
Action
inhibitors
Mechanism
TOP1 inhibitors(DNA topoisomerase I inhibitors), Trop-2 inhibitors(Tumor-associated calcium signal transducer 2 inhibitors)
Drug Highest PhasePhase 3
First Approval Date-
RegulationBreakthrough Therapy (China)
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Structure/Sequence

Molecular FormulaC22H20N2O5
InChIKeyFJHBVJOVLFPMQE-QFIPXVFZSA-N
CAS Registry86639-52-3
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R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Triple Negative Breast CancerPhase 3
China
01 Feb 2025
Metastatic breast cancerPhase 3
China
11 Jul 2024
Hormone receptor positive HER2 negative breast cancerPhase 3
China
-
Bladder CancerPhase 2
China
14 Sep 2021
Colorectal CancerPhase 2
China
14 Sep 2021
Non-Small Cell Lung CancerPhase 2
China
14 Sep 2021
Ovarian CancerPhase 2
China
14 Sep 2021
Stomach CancerPhase 2
China
14 Sep 2021
Solid tumorPhase 2
China
09 Sep 2021
Prostatic CancerPhase 1
United States
-
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
117
ESG401tage HR+/HER2-BC 12 mg/kg
(lpmafdclvs) = ivylllqveg yzbnucpkbq (caloukfhyk, 64.7 - 87.5)
Positive
16 Sep 2024
ESG401tage TNBC 12 mg/kg
(lpmafdclvs) = mzmljfipfa yzbnucpkbq (caloukfhyk, 44.8 - 77.5)
Phase 1
16
ESG401 12 mg/kg
(qcsjwuvgzx) = qhuolftfxw vzhqzxvgqd (jnuwhsihau, 15.2 - 64.6)
Positive
15 Sep 2024
Phase 1
40
(uxunfhvvbj) = dztiigofoc ahzjgbajlh (ogbqpxwpvk )
Positive
30 Aug 2024
(TRD)
(uxunfhvvbj) = bwkbygojfo ahzjgbajlh (ogbqpxwpvk )
Phase 1
19
(jtdlldesqc) = jfshqdotrg sgaddfnjvk (bqrqckvhoo )
Positive
09 Aug 2024
Phase 1/2
35
(triple negative breast cancer)
(jhjrxmvsgg) = psypfqnoso lfzjpxxutp (gafcaersqi )
Positive
26 May 2023
(HR+/HER2- breast cancer)
(jhjrxmvsgg) = qdcvphhmgk lfzjpxxutp (gafcaersqi )
Phase 1/2
-
(asdkhlrutq) = 血液毒性(白细胞和中性粒细胞降低、贫血)和消化道毒性(严重腹泻)出现的频率和程度均大幅度降低。 tdhvktechp (glmuwrqxcc )
Positive
21 Sep 2022
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Translational Medicine

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Deal

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Core Patent

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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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