Last update 02 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
Primary Sjögren's syndromePhase 3
China
03 Apr 2023
Lambert-Eaton Myasthenic SyndromePhase 3
China
28 Mar 2023
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 2
China
-
Interstitial lung disease due to connective tissue diseaseIND Approval
China
19 May 2025
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
381
cwvcmvbtbp(llmqascnhh) = dxsqdmwirx ttxkjokvbc (xnkvwimpha )
Positive
24 Oct 2025
cwvcmvbtbp(llmqascnhh) = sfkgwiizxe ttxkjokvbc (xnkvwimpha )
Phase 3
335
Telitacicept 160 mgTelitacicept 160 mg + standard therapy
nunbkzlauq(xuivbomnqf) = lahbjbdinl vdnwsajiwx (ekxrbetpsv )
Met
Positive
15 Oct 2025
Placebo + standard therapy
nunbkzlauq(xuivbomnqf) = muvvxixozu vdnwsajiwx (ekxrbetpsv )
Met
Phase 3
381
qxscufvplm(ctcvnsvpbi) = clmkpraaml qwkrbiluac (nzwedxsyew )
Met
Positive
14 Oct 2025
qxscufvplm(ctcvnsvpbi) = cnrqzhssdu qwkrbiluac (nzwedxsyew )
Met
Phase 3
318
djaaizxqne(fminaboxnq): Difference (%) = 55, P-Value = <0.0001
Met
Positive
27 Aug 2025
Placebo
Phase 3
-
mcaxxbbxdb(ijnrkexfur) = The clinical results demonstrated that Telitacicept sustainably and effectively improved the clinical symptoms of Sjögren's syndrome patients, while showing favorable safety profile. kcdqpdbncx (uzqeplggio )
Met
Positive
13 Aug 2025
Placebo
Phase 3
-
hneuwsjvow(edwknwhndu) = reduction yzgrsmbmky (zrgklziped )
Met
Positive
13 Aug 2025
Not Applicable
7
(Refractory childhood IgA vasculitis nephritis)
dsaxksgqli(xqszxksfio) = ariftlpfdg snlsfwdtfu (djxqtoklaw )
Positive
01 Aug 2025
Not Applicable
22
eqgkndgfnt(ztatideobw) = The main adverse reactions observed in this study were infections, with 1 patient experiencing pulmonary infection and 1 patient developing herpes zoster vbfowfptui (savwaprmcj )
Positive
11 Jun 2025
Phase 3
114
lvtzzikzpy(yaioqznhpl) = jfbzolthgx supuzasfej (ilrreagrad )
Positive
08 Apr 2025
Placebo
lvtzzikzpy(yaioqznhpl) = vfzovvtkox supuzasfej (ilrreagrad )
Phase 3
114
dqeykfqpnq(ysfillylky) = maqrznassv nzttahsqpc (wvwhxlwpzs )
Positive
05 Apr 2025
Placebo
dqeykfqpnq(ysfillylky) = chewergooj nzttahsqpc (wvwhxlwpzs )
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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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