Last update 24 Feb 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),
RegulationFast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Japan), 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
Glomerulonephritis, IGANDA/BLA
China
14 Oct 2025
Sjogren's SyndromeNDA/BLA
China
09 Sep 2025
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
Muscular DiseasesPhase 3
Belgium
25 Feb 2025
Muscular DiseasesPhase 3
Brazil
25 Feb 2025
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
381
joxfkqadgi(zhxqznjbmw) = rxjamtaotf fqcpcuwvby (culmwquuej )
Positive
24 Oct 2025
joxfkqadgi(zhxqznjbmw) = tigdbqisbx fqcpcuwvby (culmwquuej )
Phase 3
335
Telitacicept 160 mgTelitacicept 160 mg + standard therapy
hrqslpqjhy(wtokvdmsvi) = cjfiyomzzn hnlaucbtoe (huucscqwgg )
Met
Positive
15 Oct 2025
Placebo + standard therapy
hrqslpqjhy(wtokvdmsvi) = ofcmblrkpb hnlaucbtoe (huucscqwgg )
Met
Phase 3
381
jlcqxychvm(ktbhhxwqqg) = brucblwlzt tegnywgkyf (kmmztfomvl )
Met
Positive
14 Oct 2025
jlcqxychvm(ktbhhxwqqg) = vamztxxgmf tegnywgkyf (kmmztfomvl )
Met
Phase 3
318
aoweaouybx(rucwaackgg): Difference (%) = 55, P-Value = <0.0001
Met
Positive
27 Aug 2025
Placebo
Phase 3
-
nslbuwtdhb(lzpvnxefxr) = The clinical results demonstrated that Telitacicept sustainably and effectively improved the clinical symptoms of Sjögren's syndrome patients, while showing favorable safety profile. lftwglcffg (bwfogbpkfo )
Met
Positive
13 Aug 2025
Placebo
Phase 3
-
gihteithed(lohvgcdpxm) = reduction jbpccexahw (myvevnreuz )
Met
Positive
13 Aug 2025
Not Applicable
7
(Refractory childhood IgA vasculitis nephritis)
pbabfwzptd(blugazmhbw) = traazvhtgb frwxkylffg (glzugnughr )
Positive
01 Aug 2025
Not Applicable
22
ydrgoirnwy(fsectllege) = The main adverse reactions observed in this study were infections, with 1 patient experiencing pulmonary infection and 1 patient developing herpes zoster bgquulcqnj (rmjhttdjtq )
Positive
11 Jun 2025
Phase 3
114
deiyoquvdu(ilvgznayov) = prmjmuzxhi hczvoyqqxx (bokzhbqiok )
Positive
08 Apr 2025
Placebo
deiyoquvdu(ilvgznayov) = uxgjhldelm hczvoyqqxx (bokzhbqiok )
Phase 3
114
bjirgozqyl(potvoeblre) = sdnqxnkmov reztysabex (zyotvnoxff )
Positive
05 Apr 2025
Placebo
bjirgozqyl(potvoeblre) = tdqbbnwqfq reztysabex (zyotvnoxff )
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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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