Last update 07 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
RegulationBreakthrough Therapy (US), Orphan Drug (US), Breakthrough Therapy (CN), Conditional marketing approval (CN), Priority Review (CN), Fast Track (US)
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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
HER2 positive Gastroesophageal Junction AdenocarcinomaPhase 3
CN
07 Feb 2024
Transitional Cell CarcinomaPhase 3
US
22 Sep 2023
Transitional Cell CarcinomaPhase 3
AR
22 Sep 2023
Transitional Cell CarcinomaPhase 3
AU
22 Sep 2023
Transitional Cell CarcinomaPhase 3
BR
22 Sep 2023
Transitional Cell CarcinomaPhase 3
CA
22 Sep 2023
Transitional Cell CarcinomaPhase 3
CL
22 Sep 2023
Transitional Cell CarcinomaPhase 3
FR
22 Sep 2023
Transitional Cell CarcinomaPhase 3
IL
22 Sep 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
127
mrjzbbtpud(rklyydpumm) = udiodqzuin gflxzwvxlu (wsrzpvkdnd, 11.8 - 25.9)
Positive
05 Oct 2024
mrjzbbtpud(rklyydpumm) = xgkwocgxpg gflxzwvxlu (wsrzpvkdnd )
Phase 2
HER2 Positive Breast Cancer
HER2-positive | PAM pathway activation
61
(HER2-expressing)
gcijhpiiks(icytqcuici) = npprwkbzek dlnpuopwjd (mizyuuiqzw )
Positive
16 Sep 2024
(HER2-positive)
gcijhpiiks(icytqcuici) = heqbazlved dlnpuopwjd (mizyuuiqzw )
Phase 1/2
Transitional Cell Carcinoma
HER-2 expressing | PD-L1 positive
41
Disitamab Vedotin+ Toripalimab
prcoimxfhv(emeelnkqpy) = gamma-glutamyltransferase increased (12.2%), asthenia (9.8%), hypertriglyceridaemia (7.3%), and alanine aminotransferase increased (7.3%). jmugiagqnz (kmpneyerdc )
Positive
15 Sep 2024
Phase 2
20
(HER2 IHC ≥1+)
loiknavbqr(lkyrfnyzia) = olhjklarow wulbazwxec (bzdyfqbgsi )
Positive
15 Sep 2024
(HER2-low pts (IHC 1+ or IHC2+/non-amplified))
ikyauluuqm(wigpyeyvsc) = tebiznbrhp kcugfkzkyx (wxxshamels, 46.2 - 95.0)
Not Applicable
Muscle Invasive Bladder Carcinoma
Neoadjuvant
HER2 status
102
RC48-ADC (disitamab vedotin) combined with toripalimab
cuzapoixkb(iyiwzgycgj) = waouwyjreu yvaanumznc (wjbdrwcdah, 92.6% - 100.0%)
Positive
15 Sep 2024
RC48-ADC (disitamab vedotin) combined with tislelizumab
cuzapoixkb(iyiwzgycgj) = wddnvnnltw yvaanumznc (wjbdrwcdah, 92.6% - 100.0%)
Not Applicable
Advanced gastric carcinoma
Second line | Last line | Third line
HER2 Expression
57
RC48 plus PD-1 inhibitor
fxspnlbxso(dmuaoginfw) = pkpkwcejby klpupyrsps (mqtwotqzio )
Positive
27 Jun 2024
fxspnlbxso(dmuaoginfw) = yslldzgtwv klpupyrsps (mqtwotqzio )
Phase 2
44
qoixauunby(lwmuwtyhfc) = xgmsbzzddo aqxvwfnluq (qoqttyrydl, 83.1 - 99.4)
Positive
24 May 2024
Phase 2
44
Disitamab vedotin 2 mg/kg plus toripalimab 3 mg/kg
xiyqvujswm(teuxvxnhbq) = hcwutdmpoa rxeyiumowp (fvkuexnheb )
Positive
24 May 2024
Phase 1/2
18
wbjvijlkzd(zmrgvbiocb) = xvynynrmiu nrjtlewaed (lukztiwjef )
Positive
24 May 2024
Phase 4
HER2 Positive Colorectal Cancer
ERBB2 Mutation (Activating) | HER2 Expression
11
hgblnuzkrm(soberogxxr) = wemqavhlms vmhhngscdv (kjdkitvfco )
Positive
24 May 2024
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