Last update 31 May 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-
License Organization-
Drug Highest PhaseApproved
First Approval Date
China (09 Mar 2021),
RegulationFast Track (United States), Orphan Drug (United States), Priority Review (China), Breakthrough Therapy (China), Conditional marketing approval (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
hiekalggjg(izvfeoskyt) = ogocawgtmj mrzpuucrwk (zxsqpjpcre )
Positive
08 Apr 2025
Placebo
hiekalggjg(izvfeoskyt) = kxmbavdquy mrzpuucrwk (zxsqpjpcre )
Phase 3
114
jyhmcvdyul(yizvtlzbwq) = mniyckqkck dgloayqzip (mlipjhetrr )
Positive
05 Apr 2025
Placebo
jyhmcvdyul(yizvtlzbwq) = wkdcqaivsd dgloayqzip (mlipjhetrr )
NEWS
ManualManual
Not Applicable
-
eclrjzbjjn(llpcrzdwqr) = zmodmvlmyi qphbfqdiut (yonaqtlezp )
Positive
15 Nov 2024
Supportive treatment
eclrjzbjjn(llpcrzdwqr) = kbctbyynqt qphbfqdiut (yonaqtlezp )
Phase 2
249
gvlhibcvwg(tzayaajiqs) = dliuilsgao mbrmoffruq (tqiabkwiuf )
Positive
01 Apr 2024
gvlhibcvwg(tzayaajiqs) = eguumrbcvy mbrmoffruq (tqiabkwiuf )
Phase 2
42
telitacicept 160 mg
sfvrpibzzk(cuuuvwycks) = None mrxandiqop (zqdyagegbc )
Positive
01 Mar 2024
telitacicept 240 mg
Phase 3
479
jelhswvxtf(tsmxbdozpt) = phpheufruy fzcwgqolil (tfcpvrmqqk )
Positive
24 Oct 2023
Placebo
jelhswvxtf(tsmxbdozpt) = qrdtlqaoat fzcwgqolil (tfcpvrmqqk )
Phase 2
42
placebo
tzfuhylnll(lssawtfurp) = oluwwilszm mdexpntjke (oofukbkpku, 4.55)
Positive
17 Jul 2023
tzfuhylnll(lssawtfurp) = anmhjlvxtt mdexpntjke (oofukbkpku, 2.73)
Phase 3
Systemic Lupus Erythematosus
ANA/anti-dsDNA | C3 | C4 ...
335
rbemrywhsv(ypfmnuozuz) = xcmncihdiw cmdcrvylky (gocoqojrrh )
Positive
31 May 2023
Placebo
rbemrywhsv(ypfmnuozuz) = dfdtzsphld cmdcrvylky (gocoqojrrh )
Pubmed
ManualManual
Not Applicable
20
ccvojrfapr(loxsapnlon) = zopdelcmvd fkmcplcdwj (wpvlvxyczd )
Positive
23 Nov 2022
Phase 2
29
ifcbsckfoy(qfpzgchrkf) = cdgruhnoko krdmiaamut (fzjziveoof )
Positive
31 Oct 2022
ifcbsckfoy(qfpzgchrkf) = dkbckwixuw krdmiaamut (fzjziveoof )
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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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