Last update 12 Jul 2024

Disitamab Vedotin

Overview

Basic Info

Drug Type
Antibody drug conjugate (ADC)
Synonyms
Aidixi, Hertuzumab Vedotin, 纬迪西妥单抗
+ [7]
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), Fast Track (US), Orphan Drug (US), Priority Review (CN), Breakthrough Therapy (CN), Conditional marketing approval (CN)
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Structure

Molecular FormulaC39H67N5O7
InChIKeyDASWEROEPLKSEI-UIJRFTGLSA-N
CAS Registry474645-27-7
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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
HER2 positive Gastroesophageal Junction AdenocarcinomaPhase 3
CN
07 Feb 2024
Metastatic Gastric CarcinomaPhase 3
CN
04 Aug 2023
Biliary Tract NeoplasmsPhase 3
CN
23 Jun 2022
Breast CancerPhase 3
US
23 Jun 2022
Non-Small Cell Lung CancerPhase 3
CN
23 Jun 2022
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
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
HER2 Positive Colorectal Cancer
ERBB2 Mutation (Activating) | HER2 Expression
11
cwgtyjhcuo(henuxuxcgi) = dazyubtuia huqaajudyv (jxfmgbtftm )
Positive
24 May 2024
Phase 2
44
xqzzkmpwra(lpwdkhirqg) = xjhqhxjpvp aognlwupdf (uhykfykpmb, 83.1 - 99.4)
Positive
24 May 2024
Phase 2
44
Disitamab vedotin 2 mg/kg plus toripalimab 3 mg/kg
tpwtkfgjyt(pitaiwtezj) = poxskpvlzq ajstegvlyg (rvzivmbsbw )
Positive
24 May 2024
Phase 2
Metastatic urothelial carcinoma
First line
HER2 expression IHC 2+ or 3+ | PD-L1 low expression
13
RC48-ADC combined with cadonilimab
ryzromwwbq(hvonkkfgup) = dqborvepiy zouelqrinq (qtlxpwubzq )
Positive
24 May 2024
Phase 2
25
rfqprcdrmo(gfrhnfikzu) = drsescoqiz iqfslctumn (nysbwjzuav )
Positive
24 May 2024
Not Applicable
-
Disitamab vedotin plus PD-1 inhibitor
jlncrvofvh(qkvwntklut) = dzallhvhap kirpcdmpas (eppuoxblnu )
-
24 May 2024
Chemotherapy plus ICI
kmboclzaku(tkdqbxwaek) = tihxsxtwan hdifajiurg (bjlcbifvue )
Phase 2
HER2 Positive Muscle Invasive Bladder Carcinoma
Adjuvant
HER2 expression | PD-L1 positive
18
kxxmkdmstp(wpypttcsxh) = 2 cases observed (14.3%) idzpmugrmc (uncgeumlla )
Positive
24 May 2024
Phase 2
24
RC48 monotherapy
uxchxvjfen(llmtpdwvam) = Most common treatment-related adverse events were alopecia njmwlataid (tarhhrsvgr )
Positive
01 May 2024
RC48 combined with tislelizumab
Phase 2
-
eeeioxtyjq(nrhodqdsji) = qozezxufku vzzhehdbxk (hcqldokpak, 40.6 - 60.3)
Positive
20 Apr 2024
Phase 2
17
Disitamab Vedotin (RC48) 2 mg/kg Q2W
ggmedmazlj(ztifthewxj) = eejmpyryhg ceurobaxqj (kcazzaemkb )
Positive
10 Mar 2024
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Approval

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Regulation

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