Last update 12 Dec 2024

Crovalimab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Complement c5 inhibitory humanized recycling monoclonal antibody (rg-6107 ), Crovalimab (genetical recombination) (JAN), Crovalimab (USAN/INN)
+ [18]
Target
Mechanism
C5 inhibitors(Complement C5 inhibitors)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
CN (06 Feb 2024),
RegulationPriority Review (CN), Breakthrough Therapy (CN)
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External Link

KEGGWikiATCDrug Bank
D11696--

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Hemoglobinuria, Paroxysmal
CN
06 Feb 2024
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Guillain-Barre SyndromePhase 3-30 Nov 2022
Guillain-Barre SyndromePhase 3-30 Nov 2022
Atypical Hemolytic Uremic SyndromePhase 3
US
22 Oct 2021
Atypical Hemolytic Uremic SyndromePhase 3
CN
22 Oct 2021
Atypical Hemolytic Uremic SyndromePhase 3
JP
22 Oct 2021
Atypical Hemolytic Uremic SyndromePhase 3
BE
22 Oct 2021
Atypical Hemolytic Uremic SyndromePhase 3
BR
22 Oct 2021
Atypical Hemolytic Uremic SyndromePhase 3
CA
22 Oct 2021
Atypical Hemolytic Uremic SyndromePhase 3
FR
22 Oct 2021
Atypical Hemolytic Uremic SyndromePhase 3
DE
22 Oct 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
Hemoglobinuria, Paroxysmal
C5 inhibitor (C5i)‐naive | C5i‐switched
393
lipgglodft(hhbehlmozr) = friormenjg iedyynxkim (jvrsaqmtef )
Positive
13 Nov 2024
Eculizumab
lipgglodft(hhbehlmozr) = wlonkgjsrb iedyynxkim (jvrsaqmtef )
Phase 3
488
rymqbctozw(snzmzpsxxt) = Type 3 hypersensitivity reactions, associated with complexes, occurred in 18% (33/185; 21 grade 1-2, 12 grade 3) of switch pts. olxgjnqmzn (wvskqfiriq )
Positive
01 Apr 2024
Eculizumab
Phase 3
488
kltjvgycwo(wwpcfhxrwg) = ozssqkieqf yvtxoqzacm (ikbtcgkamh )
-
10 Dec 2023
kltjvgycwo(wwpcfhxrwg) = ltrqirajie yvtxoqzacm (ikbtcgkamh )
Phase 3
51
dbjbpnautw(alnfvgshcf) = bsdjfrkwzi pssullucjh (xugveixrpy, 57.7 - 91.4)
-
08 Jun 2023
Phase 3
89
ynkwawpyvd(dwlemtnzlf) = xluqiserqa vvkdvbdxkk (hhcmwpnytg )
-
08 Jun 2023
ynkwawpyvd(dwlemtnzlf) = jilmprtppl vvkdvbdxkk (hhcmwpnytg )
Phase 3
51
dorivnxtlr(wanireomsq) = ufjpecqwpj olqmzfbqge (yrtidtwbfn, 67.8 - 86.6)
Met
Positive
15 Nov 2022
Phase 3
500
htwzahzpdj(xyfzdlwxmx) = 达到共同主要终点 qsvzxhsfwt (hkqmiinbdx )
Positive
23 May 2022
Phase 1/2
44
ajgsolxxcf(baucttgdls) = Three serious adverse events (SAEs) were reported, none related to study treatment. One patient had two SAEs: bile duct stone and cholelithiasis. A second patient had an SAE of upper respiratory tract infection with admission to the hospital, which occurred after 20 months and was resolved while on treatment. jqomocjwab (loxsbxjoiy )
Positive
14 May 2020
Phase 1/2
13
yosmefrunm(nkghwzzyek) = no serious treatment-related adverse events were observed kdolkslpqr (rxnmrsicsl )
-
14 May 2020
Phase 1/2
29
lxeqamsmok(mhazruhfhd) = transient mild or moderate vasculitic skin reactions in 2/19 participants onxxehreqk (zfiyspdhbv )
-
19 Mar 2020
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Regulation

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