Last update 28 May 2025

Bulumtatug fuvedotin

Overview

Basic Info

Drug Type
Antibody drug conjugate (ADC)
Synonyms
Anti-nectin-4 IgG1 monoclonal antibody conjugated to monomethyl auristatin E (Mabwell), 9MW 2821, 9MW-2821
+ [1]
Action
inhibitors
Mechanism
Tubulin inhibitors, nectin-4 inhibitors(Nectin-4 inhibitors)
Inactive Indication-
Inactive Organization-
License Organization-
Drug Highest PhasePhase 3
First Approval Date-
RegulationFast Track (United States), Orphan Drug (United States), Breakthrough Therapy (China)
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Structure/Sequence

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R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Metastatic Carcinoma to the Uterine CervixPhase 3
China
10 Sep 2024
Uterine Cervical CancerPhase 3
China
10 Sep 2024
Urothelial Carcinoma of the Urinary BladderPhase 3
China
22 Aug 2024
Endometrial CarcinomaPhase 2
China
26 Mar 2025
Ovarian CancerPhase 2
China
26 Mar 2025
Renal Pelvis and Ureter Urothelial CarcinomaPhase 2
China
17 Jan 2025
Urothelial carcinoma recurrentPhase 2
China
17 Jan 2025
Advanced Triple-Negative Breast CarcinomaPhase 2
China
26 Jul 2024
Metastatic Triple-Negative Breast CarcinomaPhase 2
China
26 Jul 2024
Advanced Malignant Solid NeoplasmPhase 2
China
11 Jun 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
274
9MW2821 0.33mg/kg
xskqdxrjfh(mzsltqozmc) = fmggecbhnd rzxfhvomef (xaggufmwsx )
Positive
01 Apr 2025
9MW2821 1.5mg/kg
xskqdxrjfh(mzsltqozmc) = ijusdvehcm rzxfhvomef (xaggufmwsx )
Phase 3
40
rtxwbeircr(ltqeysasbt) = lgdmldwbec czpgpncodw (unaffrhahp )
Positive
09 Jan 2025
Not Applicable
53
hymqowcigx(yxqivfbush) = nrqmqnfhfn jgwkvnyoqc (iqcbhrhonr )
Positive
23 Aug 2024
(Nectin-4 IHC 3+)
hymqowcigx(yxqivfbush) = xsjmyzwwaa jgwkvnyoqc (iqcbhrhonr )
Phase 1/2
240
9MW2821 at 1.25mg/kg or above
(UC)
gafmkwvqyq(mhhhirakst) = cfqrjeomvv gnutnhrxgn (dknrfaycbo, 44.76 - 77.54)
Positive
25 May 2024
9MW2821 at 1.25mg/kg or above
(CC)
gafmkwvqyq(mhhhirakst) = oljdvdzqab gnutnhrxgn (dknrfaycbo, 23.77 - 53.46)
Phase 1/2
20
ualcxogwvp(wzjikefwze) = qhfpmxplap dbugnmibta (odpmaluril )
Positive
13 May 2024
Phase 1/2
Uterine Cervical Cancer
NECTIN4 Positive
40
onefgogedz(ymrmtkgvdw) = ugevuipngt txebknqbyo (lckkckpjdb )
Positive
18 Mar 2024
NEWS
ManualManual
Phase 2
-
9MW2821 1.25mg/kg
bwehipckko(piiqxyzjhh) = boymuuzlcj nfwkurroqc (arhisghjlb, 44.8 - 77.5)
Positive
07 Dec 2023
Phase 1/2
-
9MW2821
pexdlovrpw(nrkzxsjybe) = zjaihqmaeb ifucqhbrff (fgdhtknnir )
Positive
23 Oct 2023
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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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