Last update 21 Nov 2024

Disitamab Vedotin

Overview

Basic Info

Drug Type
Antibody drug conjugate (ADC)
Synonyms
Aidixi, Hertuzumab Vedotin, 纬迪西妥单抗
+ [8]
Mechanism
HER2 antagonists(Receptor protein-tyrosine kinase erbB-2 antagonists), Tubulin inhibitors
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationConditional marketing approval (CN), Fast Track (US), Breakthrough Therapy (US), Orphan Drug (US), Priority Review (CN)
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Structure

Molecular FormulaC39H67N5O7
InChIKeyDASWEROEPLKSEI-UIJRFTGLSA-N
CAS Registry474645-27-7
View All Structures (2)
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External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
HER2 Positive Transitional Cell Carcinoma
CN
31 Dec 2021
HER2-positive gastric cancer
CN
08 Jun 2021
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Breast Carcinoma Metastatic in the LiverNDA/BLA
CN
15 Oct 2024
Metastatic urothelial carcinomaPhase 3
CN
14 Jun 2022
Urothelial Carcinoma of the Urinary BladderPhase 3
CN
14 Jun 2022
HER2-expressing Gastric AdenocarcinomaPhase 3
CN
24 Mar 2021
HER2 positive Gastrooesophageal junction cancerPhase 3
CN
06 Mar 2021
Locally advanced breast cancerPhase 3
CN
29 Sep 2020
HER2-Low Breast CarcinomaPhase 3
CN
22 Sep 2020
HER2 Positive Breast CancerPhase 3
CN
24 Apr 2018
Liver metastasesPhase 3
CN
24 Apr 2018
Metastatic human epidermal growth factor 2 positive carcinoma of breastPhase 3
CN
24 Apr 2018
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
127
(liicmbauid) = uiobelznlo yepblonfmh (opxsuyubgx, 11.8 - 25.9)
Positive
05 Oct 2024
(liicmbauid) = txepdqscoy yepblonfmh (opxsuyubgx )
Phase 2
HER2 Positive Breast Cancer
HER2-positive | PAM pathway activation
61
(HER2-expressing)
(cktdesktjl) = ucoeqmudfv yjtsuvirlk (vpjawyhlvm )
Positive
16 Sep 2024
(HER2-positive)
(cktdesktjl) = cdujhvhtya yjtsuvirlk (vpjawyhlvm )
Phase 1/2
Transitional Cell Carcinoma
HER-2 expressing | PD-L1 positive
41
Disitamab Vedotin+ Toripalimab
(eoksqurikv) = gamma-glutamyltransferase increased (12.2%), asthenia (9.8%), hypertriglyceridaemia (7.3%), and alanine aminotransferase increased (7.3%). kxwyqrpcbr (efolkjkaqq )
Positive
15 Sep 2024
Phase 2
20
(HER2 IHC ≥1+)
(ipdkfahwzq) = ynssvfyzhh wceguxwyre (vtsloymstx )
Positive
15 Sep 2024
(HER2-low pts (IHC 1+ or IHC2+/non-amplified))
(uictlhidxs) = lbburwmuzk tyauxdhcjb (cmosmiidlu, 46.2 - 95.0)
Not Applicable
Advanced gastric carcinoma
Second line | Last line | Third line
57
RC48 plus PD-1 inhibitor
(ymsgwrokmf) = mafjadtaaq vvuzfeqkdt (yudqbwixrv )
Positive
27 Jun 2024
(ymsgwrokmf) = yjxsnkhbxv vvuzfeqkdt (yudqbwixrv )
Phase 4
11
(ueoxomypiw) = cvkwijwlmm ywxskilxuw (muitmwytdx )
Positive
24 May 2024
Phase 1/2
18
(ripoctsclx) = nfljjexuvx ykkjkdglbi (zmcxcfsnqj )
Positive
24 May 2024
Phase 2
44
(gjrirdvkip) = lbzwgqwkgr txsfreoikt (rdrnglwwix, 83.1 - 99.4)
Positive
24 May 2024
Phase 2
44
Disitamab vedotin 2 mg/kg plus toripalimab 3 mg/kg
(loexkctqty) = ssabcdttej nzkdapxduw (umqhsafgwb )
Positive
24 May 2024
ASCO2024
ManualManual
Not Applicable
47
(lignqraypu) = wtypmnrgrp zsireawkjm (ivosbfebkf )
Positive
24 May 2024
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Core Patent

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Approval

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Regulation

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