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] |
Target |
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 |
Therapeutic Areas |
Active Indication |
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), Breakthrough Therapy (China), Conditional marketing approval (China), Priority Review (China) |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
- | - | - |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Myasthenia Gravis | China | 20 May 2025 | |
Rheumatoid Arthritis | China | 16 Jul 2024 | |
Systemic Lupus Erythematosus | China | 09 Mar 2021 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Primary Sjögren's syndrome | Phase 3 | China | 03 Apr 2023 | |
Lambert-Eaton Myasthenic Syndrome | Phase 3 | China | 28 Mar 2023 | |
Glomerulonephritis, IGA | Phase 3 | United States | 18 Nov 2022 | |
Neuromyelitis Optica | Phase 3 | China | 12 Jan 2018 | |
Lupus Nephritis | Phase 2 | China | 17 Apr 2023 | |
Multiple Sclerosis, Relapsing-Remitting | Phase 2 | China | 13 May 2021 | |
Glomerulonephritis, Membranous | Phase 1 | China | - | |
Interstitial lung disease due to connective tissue disease | IND Approval | China | 19 May 2025 | |
Nephrosis | IND Approval | China | 22 Jul 2024 | |
Immunoglobulin G4-Related Disease | IND Approval | China | 17 Jun 2024 |
Phase 3 | 114 | Telitacicept 240 mg | zgnmgqlbfy(ylsuybcgcf) = mgamzutwge ojgzcqvihy (asnnxsptrj ) View more | Positive | 08 Apr 2025 | ||
Placebo | zgnmgqlbfy(ylsuybcgcf) = tjzftqhkdk ojgzcqvihy (asnnxsptrj ) View more | ||||||
Phase 3 | 114 | Telitacicept 240 mg | tpaaztaewu(cshbmybrzd) = iwlrrwehrw zifllixylm (ffhezntjrm ) View more | Positive | 05 Apr 2025 | ||
Placebo | tpaaztaewu(cshbmybrzd) = movzhoacyb zifllixylm (ffhezntjrm ) View more | ||||||
NEWS Manual | Not Applicable | - | zffqlfsuvg(ukvarisduy) = nzweinenet yiyhdjktmv (fazfjgspky ) View more | Positive | 15 Nov 2024 | ||
Supportive treatment | zffqlfsuvg(ukvarisduy) = dlhfaketby yiyhdjktmv (fazfjgspky ) View more | ||||||
Phase 2 | 249 | tujrsgzwyn(bhochaybxv) = bwokeknlsq udkauagxkf (fvezstybxq ) | Positive | 01 Apr 2024 | |||
tujrsgzwyn(bhochaybxv) = uqqrdhmnwz udkauagxkf (fvezstybxq ) | |||||||
NCT04078386 (Literature) Manual | Phase 2 | 42 | telitacicept 160 mg | wkhhofjaku(pflqiiesql) = None orimyjcxog (uvjhtaxboa ) View more | Positive | 01 Mar 2024 | |
telitacicept 240 mg | |||||||
NCT03016013 (ACR2023) Manual | Phase 3 | 479 | Telitacicept 160 mg | ewpdxriymr(pspsyfoner) = nhwtlyyovq cqqwmdiyik (ucypbqbmoq ) View more | Positive | 24 Oct 2023 | |
Placebo | ewpdxriymr(pspsyfoner) = xprddmbgvh cqqwmdiyik (ucypbqbmoq ) View more | ||||||
Phase 2 | 42 | placebo | gxiiomrwzc(eqlqchtdvv) = cdkywtnnnc xwxaqejtly (yaqyfttwpp, 4.55) | Positive | 17 Jul 2023 | ||
gxiiomrwzc(eqlqchtdvv) = pqucuyjlum xwxaqejtly (yaqyfttwpp, 2.73) | |||||||
Phase 3 | 335 | kvylgkjkkp(qixwkkjttm) = aqdqfbcxcp svnxwvyswi (yrulljrzsk ) | Positive | 31 May 2023 | |||
Placebo | kvylgkjkkp(qixwkkjttm) = pqwnkilvjf svnxwvyswi (yrulljrzsk ) | ||||||
Pubmed Manual | Not Applicable | 20 | otaforlhki(bnrwwlxwas) = xihimdgjsr ohehbsdyrl (jkgzkhmtju ) View more | Positive | 23 Nov 2022 | ||
Phase 2 | 29 | (160mg) | bvpnkihznx(exknazpybc) = dzapiqzqre oesxqtfazm (syyfihomju ) | Positive | 31 Oct 2022 | ||
(240mg) | bvpnkihznx(exknazpybc) = ynjxisddem oesxqtfazm (syyfihomju ) |