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更新于：2026-06-15
Telitacicept
泰它西普
更新于：2026-06-15
概要
基本信息
药物类型 Fc融合蛋白 |
别名 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] |
作用方式 抑制剂、调节剂 |
作用机制 APRIL抑制剂(肿瘤坏死因子配体超家族成员13抑制剂)、BAFF抑制剂(B细胞活化因子/B淋巴细胞刺激因子抑制剂)、免疫调节剂 |
非在研适应症 |
原研机构 |
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 中国 (2021-03-09), |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (美国)、孤儿药 (欧盟)、优先审评 (中国)、突破性疗法 (中国)、附条件批准 (中国)、孤儿药 (日本)、快速通道 (美国) |
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结构/序列
Sequence Code 616721115
来源: *****
关联
108
项与 泰它西普 相关的临床试验NCT07643038
Treatment Strategy for Patients With Rheumatoid Arthritis Associated Interstitial Lung Disease
NCT07522099
A Phase 2 Study to Assess ADX-038 in Chinese Adults With Complement-Mediated Kidney Disease
NCT07495033
Phase III Clinical Trial of Telitacicept Injection in the Treatment of Patients With Connective Tissue Disease-related Interstitial Lung Disease
100 项与 泰它西普 相关的临床结果
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100 项与 泰它西普 相关的转化医学
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100 项与 泰它西普 相关的专利（医药）
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208
项与 泰它西普 相关的文献（医药）2026-06-01Kidney International Reports
Efficacy and Safety of Telitacicept in Posttransplant Recurrent IgA Nephropathy
Article
作者: Zeng, Li ; Sui, Mingxing ; Li, Yanfeng ; Tang, Daqian ; Zhao, Wenyu ; Yu, Junhao ; Zhang, Lei
Introduction:
Recurrent Ig A nephropathy (IgAN; rIgAN) after kidney transplantation is heterogeneous and lacks a guideline or a standard treatment. We evaluated the efficacy and safety of telitacicept as an add-on therapy for rIgAN with persistent proteinuria in kidney recipients.
Methods:
In this prospective, single-center, single-arm cohort study, 25 kidney transplant recipients with biopsy-confirmed rIgAN received add-on telitacicept 240 mg subcutaneously weekly for 12 weeks, then every 2 weeks until week 28. Primary end points were 24-hour urinary protein (24h-UP) and urine albumin-to-creatinine ratio (UACR). Secondary assessments included remission, kidney function, laboratory parameters, and mechanistic biomarkers.
Results:
Twenty-two participants completed the follow-up. At week 28, 24h-UP and UACR decreased by 51.6% and 62.7% (both P < 0.001), respectively. Complete and partial remission rates were achieved in 47.6% and 57.1% of patients, respectively. Serum albumin increased significantly, whereas serum creatinine (SCr), estimated glomerular filtration rate, and hemoglobin remained stable. Circulating galactose-deficient IgA1 (Gd-IgA1) and asialoglycoprotein receptor (ASGPR) levels declined; Ig levels also decreased, in line with B-cell inhibition and on-target pathways suppression. No treatment-related severe adverse events were reported. The most common adverse events were mild injection site reactions and transient infections.
Conclusion:
Add-on telitacicept was associated with marked proteinuria reduction and a favorable safety profile in kidney transplant recipients with rIgAN and persistent proteinuria, supporting its potential as a therapeutic option.
2026-06-01CURRENT OPINION IN IMMUNOLOGY
Clinical trials and new therapies in Sjögren’s disease
Review
作者: Grader-Beck, Thomas ; Salas, Antonio ; Patel, Vishal
Despite major advances in understanding Sjögren's disease (SjD), no approved disease-modifying therapies have been approved. Management remains largely symptomatic with the use of off-label immunomodulators for systemic features. This gap highlights the substantial unmet need for targeted treatment. Encouragingly, the therapeutic landscape is shifting. Several phase 2 trials have shown meaningful efficacy signals, and for the first time, phase 3 programs with ianalumab and telitacicept have demonstrated positive outcomes, particularly when systemic activity is assessed using the EULAR Sjögren's Syndrome Disease Activity Index. These successes reflect both the maturation of the therapeutic pipeline and important refinements in trial design. Insights from earlier negative studies have underscored the importance of enrolling patients with active disease, incorporating biomarker-defined subgroups, and development of composite endpoints that integrate systemic, symptomatic, and functional domains. Together, these developments suggest that SjD may finally be approaching an era of effective, disease-modifying therapy.
2026-05-29NEPHROLOGY DIALYSIS TRANSPLANTATION
Telitacicept targets Gd-IgA1 and autoantibody-producing B cells in IgA nephropathy
Review
作者: Zhu, Xinyi ; Li, Xiao ; Weng, Qinjie ; Ren, Hong ; Xie, Jingyuan
ABSTRACT:
Immunoglobulin A nephropathy (IgAN) is the most common primary glomerulonephritis and a leading cause of end-stage renal disease for young adults. The key pathogenesis of IgAN involves overproduction of galactose-deficient IgA1 (Gd-IgA1) and anti-Gd-IgA1 antibodies, resulting in formation of circulating immune complexes that deposit in the glomerular mesangium. Consequently, emerging therapeutic strategies for IgAN aim to target and reduce aberrant Gd-IgA1 and its associated immune complexes. This disease-modifying approach confers benefits across multiple stages of IgAN progression, particularly in the early phase to halt irreversible renal damage. B-cell activating factor (BAFF) and proliferation-inducing ligand (APRIL) are critical cytokines that promote the differentiation, development and activation of B cells and plasma cells. Telitacicept, a novel recombinant fusion protein that dual-targets BAFF and APRIL, exhibits considerable therapeutic potential by inhibiting the production of Gd-IgA1 and its autoantibodies. Stage A results of the Phase 3 clinical trial demonstrated that patients in the telitacicept group achieved a 55% reduction in 24-h urinary protein-to-creatinine ratio and stable estimated glomerular filtration rate at Week 39 versus the placebo group, with favorable tolerability and safety. This review summarizes current progresses in targeting Gd-IgA1-producing cells for the treatment of IgAN, with a focus on therapeutic strategies including BAFF/APRIL inhibitors. Furthermore, it delineates the major challenges and future research directions aimed at optimizing these interventions.
100 项与 泰它西普 相关的药物交易
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外链
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| - | - | - |
研发状态
批准上市
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 免疫球蛋白a肾病 | 中国 | 2026-06-03 | |
| 干燥综合征 | 中国 | 2026-06-03 | |
| 重症肌无力 | 中国 | 2025-05-20 | |
| 类风湿关节炎 | 中国 | 2024-07-16 | |
| 系统性红斑狼疮 | 中国 | 2021-03-09 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 特发性炎症性肌病 | 临床3期 | 中国 | 2026-05-20 | |
| 结缔组织病相关间质性肺疾病 | 临床3期 | 中国 | 2026-04-20 | |
| 眼肌型重症肌无力 | 临床3期 | 中国 | 2026-01-13 | |
| 原发性干燥综合征 | 临床3期 | 中国 | 2023-04-03 | |
| Lambert-Eaton肌无力综合征 | 临床3期 | 中国 | 2023-03-28 | |
| 视神经脊髓炎 | 临床3期 | 中国 | 2018-01-12 | |
| 狼疮性肾炎 | 临床2期 | 中国 | 2023-04-17 | |
| 复发-缓解型多发性硬化 | 临床2期 | 中国 | 2021-05-13 | |
| 膜性肾小球肾炎 | 临床2期 | 中国 | - | |
| 抗中性粒细胞胞质抗体相关性血管炎 | 临床1期 | 中国 | - | 2022-06-01 |
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临床结果
临床结果
适应症
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临床3期 | 381 | 築獵選遞範獵壓鬱構艱(淵構鹽顧鏇襯襯獵壓願) = 鹹鹹壓積製鏇艱鹽齋簾 膚選膚壓襯鏇鑰簾艱網 (獵範窪衊醖觸齋築餘範 ) 更多 | 积极 | 2025-10-24 | |||
築獵選遞範獵壓鬱構艱(淵構鹽顧鏇襯襯獵壓願) = 簾夢顧鑰築廠鑰選鏇構 膚選膚壓襯鏇鑰簾艱網 (獵範窪衊醖觸齋築餘範 ) 更多 | |||||||
临床3期 | 335 | 餘製鹹膚壓範觸襯繭築(鬱積鑰繭範醖淵壓網襯) = 餘鑰獵壓網鹽積壓構選 鏇衊齋願夢選鹹鹹製繭 (築積選壓製願壓願觸憲 ) 达到 更多 | 积极 | 2025-10-15 | |||
Placebo + standard therapy | 餘製鹹膚壓範觸襯繭築(鬱積鑰繭範醖淵壓網襯) = 齋簾鹽艱壓餘糧糧鹹網 鏇衊齋願夢選鹹鹹製繭 (築積選壓製願壓願觸憲 ) 达到 更多 | ||||||
临床3期 | 381 | 鬱選衊顧糧選膚願艱願(獵鹽遞觸壓構淵艱艱簾) = 鬱製製繭鹽鬱夢艱鹽壓 壓襯網膚願觸範願壓製 (齋壓夢夢製觸積壓窪顧 ) 达到 更多 | 积极 | 2025-10-14 | |||
鬱選衊顧糧選膚願艱願(獵鹽遞觸壓構淵艱艱簾) = 範齋積鏇蓋窪艱齋艱膚 壓襯網膚願觸範願壓製 (齋壓夢夢製觸積壓窪顧 ) 达到 更多 | |||||||
临床3期 | 318 | 廠範構簾繭獵糧膚獵鹹(範觸壓廠壓衊衊糧築淵): Difference (%) = 55, P-Value = <0.0001 达到 | 积极 | 2025-08-27 | |||
Placebo | |||||||
GlobeNewswire 人工标引  | 临床3期 | - | 醖願夢鬱壓廠襯鹹築廠(觸壓構構齋簾夢壓繭鹽) = reduction 蓋蓋製願齋衊積鹹鹹憲 (獵築襯齋壓構獵願憲範 ) 达到 | 积极 | 2025-08-13 | ||
PRNewswire 人工标引 | 临床3期 | - | 壓窪鬱艱繭衊鏇獵積糧(憲顧觸齋範鑰獵憲範糧) = The clinical results demonstrated that Telitacicept sustainably and effectively improved the clinical symptoms of Sjögren's syndrome patients, while showing favorable safety profile. 簾膚顧遞憲觸鹹鑰壓選 (衊遞繭憲蓋艱遞鬱遞鬱 ) 达到 | 积极 | 2025-08-13 | ||
Placebo | |||||||
N/A | 7 | (Refractory childhood IgA vasculitis nephritis) | 壓壓膚憲膚選範選築餘(蓋遞憲膚遞夢築鬱憲網) = 願膚鏇製觸鏇願憲淵築 鏇鑰選範顧餘選膚製窪 (顧衊艱糧鏇積餘壓鬱選 ) | 积极 | 2025-08-01 | ||
N/A | 22 | 齋選鹹構積齋鹹衊顧壓(製憲鹽艱遞艱憲遞壓淵) = The main adverse reactions observed in this study were infections, with 1 patient experiencing pulmonary infection and 1 patient developing herpes zoster 遞餘簾艱齋鑰鑰艱觸淵 (蓋積鏇鹽餘選遞壓襯顧 ) | 积极 | 2025-06-11 | |||
N/A | 8 | 鏇夢艱膚顧願鹹壓鹹簾(獵淵鏇觸鏇繭鬱淵廠壓) = No adverse events were observed during the follow-up period. 遞鹽淵顧糧製簾顧觸鏇 (獵顧網獵鑰鏇網鹽淵製 ) | 积极 | 2025-06-04 | |||
N/A | 30 | 艱願廠窪顧觸艱選願網(糧願齋網觸襯遞繭遞蓋) = 鹽繭膚鑰憲憲範構築衊 選獵鑰獵鹽簾築製簾夢 (遞醖壓窪鹹繭餘壓醖鏇 ) | 积极 | 2025-06-04 | |||
immunosuppressive (IS) therapy | 夢積繭醖構鹹壓遞鏇艱(鏇構餘醖醖觸憲簾積網) = 觸鹹簾繭衊壓艱顧積鬱 構選衊築鬱鏇淵鹽簾簾 (築簾夢製夢齋遞衊選淵 ) |
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