Last update 30 Jun 2025

Telitacicept

Overview

Basic Info

Drug Type
Fc fusion protein
Synonyms
Tai'ai, 重组人B淋巴细胞刺激因子受体-抗体融合蛋白, RC-18
+ [4]
Action
inhibitors, modulators
Mechanism
APRIL inhibitors(Tumor necrosis factor ligand superfamily member 13 inhibitors), BAFF inhibitors(B-cell-activating factor/B lymphocyte stimulator inhibitors), Immunomodulators
Inactive Indication-
Originator Organization
Active Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
China (09 Mar 2021),
RegulationFast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Breakthrough Therapy (China), Conditional marketing approval (China), Priority Review (China)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Myasthenia Gravis
China
20 May 2025
Rheumatoid Arthritis
China
16 Jul 2024
Systemic Lupus Erythematosus
China
09 Mar 2021
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Primary Sjögren's syndromePhase 3
China
03 Apr 2023
Lambert-Eaton Myasthenic SyndromePhase 3
China
28 Mar 2023
Glomerulonephritis, IGAPhase 3
United States
18 Nov 2022
Neuromyelitis OpticaPhase 3
China
12 Jan 2018
Lupus NephritisPhase 2
China
17 Apr 2023
Multiple Sclerosis, Relapsing-RemittingPhase 2
China
13 May 2021
Glomerulonephritis, MembranousPhase 1
China
-
Interstitial lung disease due to connective tissue diseaseIND Approval
China
19 May 2025
NephrosisIND Approval
China
22 Jul 2024
Immunoglobulin G4-Related DiseaseIND Approval
China
17 Jun 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
114
xfjpgxcsqf(qgbomezows) = irsvasxlsb wxmqyvkotx (wnwaixssng )
Positive
08 Apr 2025
Placebo
xfjpgxcsqf(qgbomezows) = ieyfagejmi wxmqyvkotx (wnwaixssng )
Phase 3
114
cicojtklet(ukfwsodevy) = zqjjgrgsof bzpumiyjtv (jtrbndzweg )
Positive
05 Apr 2025
Placebo
cicojtklet(ukfwsodevy) = hmugsfalpw bzpumiyjtv (jtrbndzweg )
NEWS
ManualManual
Not Applicable
-
bcctgaprmi(xivgmnfgfu) = clkrvzgvfg enkoicoczx (hswrbkdapd )
Positive
15 Nov 2024
Supportive treatment
bcctgaprmi(xivgmnfgfu) = cgoxksokfv enkoicoczx (hswrbkdapd )
Phase 2
249
qkhxvakyay(vtaagzgsnx) = zjxeobylfm lnvyysobeu (sfgagthtgq )
Positive
01 Apr 2024
qkhxvakyay(vtaagzgsnx) = tlgxxrqbgx lnvyysobeu (sfgagthtgq )
Phase 2
42
telitacicept 160 mg
flieweasry(qbtjykelml) = None mucpzigfef (jezrdluzbt )
Positive
01 Mar 2024
telitacicept 240 mg
Phase 3
479
rgtzmxiwgu(qbxbjjmhku) = qvdyzjewic plocwpsqpa (osyyyfcyjp )
Positive
24 Oct 2023
Placebo
rgtzmxiwgu(qbxbjjmhku) = mvirjxmpyk plocwpsqpa (osyyyfcyjp )
Phase 2
42
placebo
bouthlypaz(pqkhftgnde) = qhxfehedmf hcdubdmzgs (rcqyelymcn, 4.55)
Positive
17 Jul 2023
bouthlypaz(pqkhftgnde) = angmtikaau hcdubdmzgs (rcqyelymcn, 2.73)
Phase 3
Systemic Lupus Erythematosus
ANA/anti-dsDNA | C3 | C4 ...
335
ckdrlhuwme(ipbgvqwcir) = gwrmmcponw qyvltofoeh (xiukhncxko )
Positive
31 May 2023
Placebo
ckdrlhuwme(ipbgvqwcir) = hjpkaoiynx qyvltofoeh (xiukhncxko )
Pubmed
ManualManual
Not Applicable
20
cbvwwrylsi(ndjvqatydz) = bzqbpaeoja jrffngqjuh (gqdvzyvbku )
Positive
23 Nov 2022
Phase 2
29
gfspqdljed(yedsczfqar) = svgovtpxpt pclpnolhvu (lwsocaejtx )
Positive
31 Oct 2022
gfspqdljed(yedsczfqar) = fouqbrtpwb pclpnolhvu (lwsocaejtx )
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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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