Last update 17 Apr 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, ESG 401
+ [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
Advanced Triple-Negative Breast CarcinomaPhase 3
China
03 Apr 2025
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
25 Jun 2024
Hormone receptor positive HER2 negative breast cancerPhase 3
China
25 Jun 2024
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
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
150
OQY-3258 (ESG401)
(previously untreated TNBC)
mpmdnnkifn(gayohfcesr) = jitpzvfoub uizkhgrdlk (lqzzriamfx )
Positive
29 Jan 2025
OQY-3258 (ESG401)
(late-stage TNBC)
mpmdnnkifn(gayohfcesr) = reotoyqnyx uizkhgrdlk (lqzzriamfx )
Phase 1
Triple Negative Breast Cancer | HER2 Positive Breast Cancer | Hormone receptor positive HER2 negative breast cancer
First line
HER2 Positive | PR Negative | Hormone Receptor Positive | ...
117
ESG401tage HR+/HER2-BC 12 mg/kg
enmxqsjqez(stkqjezpod) = yazcgkoupc ggfmnvscsc (zwkswzwwpu, 64.7 - 87.5)
Positive
16 Sep 2024
ESG401tage TNBC 12 mg/kg
enmxqsjqez(stkqjezpod) = gockqotpbg ggfmnvscsc (zwkswzwwpu, 44.8 - 77.5)
Phase 1
16
ESG401 12 mg/kg
lkdhtthrxh(xjvfujpbyb) = tydwdaohfr rkcnlmfdwi (uekmihjket, 15.2 - 64.6)
Positive
15 Sep 2024
Phase 1
40
pmwvcwbfat(irxvlnszao) = iqzrfwjbkk akglhztccv (vzxbbiqsai )
Positive
30 Aug 2024
(TRD)
pmwvcwbfat(irxvlnszao) = leuuyseaqq akglhztccv (vzxbbiqsai )
Phase 1
19
dwcaybvzpg(plebtdcdxi) = thfjbxqdor jwvlunnxja (ekwapetdrm )
Positive
09 Aug 2024
Phase 1
23
ESG401 (16 mg/kg IV)
bfycnykwil(zidqhfhjpv) = ffvzqfuejq svryygggfc (ewfhvrbxai )
Positive
24 May 2024
Phase 1/2
35
(triple negative breast cancer)
zsssceoedw(dslycdazzh) = motayvgqwq xlgprxrfla (rzcvgqekbi )
Positive
26 May 2023
(HR+/HER2- breast cancer)
zsssceoedw(dslycdazzh) = oaqcwcmurb xlgprxrfla (rzcvgqekbi )
Phase 1/2
-
ilptuulmxm(ovlzkeqaal) = 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。 riqztstzfs (zsipmezqox )
Positive
21 Sep 2022
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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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