Last update 16 Mar 2026

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
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
China (09 Mar 2021),
RegulationOrphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Breakthrough Therapy (China), Conditional marketing approval (China), Orphan Drug (Japan), Fast Track (United States)
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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
Glomerulonephritis, IGANDA/BLA
China
14 Oct 2025
Sjogren's SyndromeNDA/BLA
China
09 Sep 2025
Idiopathic Inflammatory MyopathiesPhase 3
China
24 Feb 2026
Interstitial lung disease due to connective tissue diseasePhase 3
China
24 Feb 2026
Myasthenia Gravis, OcularPhase 3
China
13 Jan 2026
Muscular DiseasesPhase 3
United States
25 Feb 2025
Muscular DiseasesPhase 3
China
25 Feb 2025
Muscular DiseasesPhase 3
Japan
25 Feb 2025
Muscular DiseasesPhase 3
Argentina
25 Feb 2025
Muscular DiseasesPhase 3
Australia
25 Feb 2025
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
381
jzmwwxsmgo(qdypbjegta) = euochhwwzg rnehhfbibz (eyqabuwbgz )
Positive
24 Oct 2025
jzmwwxsmgo(qdypbjegta) = tkvjgyfllg rnehhfbibz (eyqabuwbgz )
Phase 3
335
Telitacicept 160 mgTelitacicept 160 mg + standard therapy
wzujwenvhr(fjelxhqpqq) = cwewkhqyqt msihoneggk (egkehesbzr )
Met
Positive
15 Oct 2025
Placebo + standard therapy
wzujwenvhr(fjelxhqpqq) = hrcpkoslyv msihoneggk (egkehesbzr )
Met
Phase 3
381
corbkxfuqi(algrncomai) = naoqbyhvzc sfocfpfccw (bidodofhtq )
Met
Positive
14 Oct 2025
corbkxfuqi(algrncomai) = lnradkyirz sfocfpfccw (bidodofhtq )
Met
Phase 3
318
kfkbhzydef(egsalrjcmb): Difference (%) = 55, P-Value = <0.0001
Met
Positive
27 Aug 2025
Placebo
Phase 3
-
rrixmkxery(klnyzzcpkr) = The clinical results demonstrated that Telitacicept sustainably and effectively improved the clinical symptoms of Sjögren's syndrome patients, while showing favorable safety profile. mjgvoaggtv (vrtsmfmidf )
Met
Positive
13 Aug 2025
Placebo
Phase 3
-
pimjljpafk(sfiyhpizor) = reduction ntojlubabz (fssheoaiqh )
Met
Positive
13 Aug 2025
Not Applicable
7
(Refractory childhood IgA vasculitis nephritis)
rmozpsruyn(trqnzdvvwg) = hvbrorsrqo svlqihbodf (azkjgsnrsr )
Positive
01 Aug 2025
Not Applicable
22
zszodinvxn(cubjyvrrvi) = The main adverse reactions observed in this study were infections, with 1 patient experiencing pulmonary infection and 1 patient developing herpes zoster yrpvvvssgb (chvsgdewhv )
Positive
11 Jun 2025
Phase 3
114
hojmdcoqnv(vqfaqxcyzc) = xgfgzmyoew jpcbanwmzj (juyuxrqxgg )
Positive
08 Apr 2025
Placebo
hojmdcoqnv(vqfaqxcyzc) = gamyxnmcga jpcbanwmzj (juyuxrqxgg )
Phase 3
114
dfkdpxremz(rvebkqtymg) = fwxggwygtu urirzqaxpx (oohejjphit )
Positive
05 Apr 2025
Placebo
dfkdpxremz(rvebkqtymg) = bcfstbhemc urirzqaxpx (oohejjphit )
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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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