更新于：2024-11-04
Telitacicept
泰它西普
更新于：2024-11-04
概要
基本信息
原研机构 |
在研机构 |
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 |
特殊审评快速通道 (美国)、孤儿药 (美国)、优先审评 (中国)、附条件批准 (中国)、突破性疗法 (中国) |
登录后查看时间轴
序列信息
Sequence Code 616721115
来源: *****
关联
75
项与 泰它西普 相关的临床试验A Multicenter, Randomized, Controlled Clinical Study on the Efficacy and Safety of Telitacicept in Patients with IgA Nephropathy
The Efficacy and Safety of Treatment With Telitacicept in Primary Membranous Nephropathy
Renmin Hospital of Wuhan University
100 项与 泰它西普 相关的临床结果
登录后查看更多信息
100 项与 泰它西普 相关的转化医学
登录后查看更多信息
100 项与 泰它西普 相关的专利（医药）
登录后查看更多信息
67
项与 泰它西普 相关的文献（医药）2024-10-01Clinical Kidney Journal
Efficacy and safety of telitacicept, a BLyS/APRIL dual inhibitor, in the treatment of IgA nephropathy: a retrospective case–control study
Article
作者: Ma, Jianfei ; Yao, Li ; Fan, Yi ; Wang, Meng
ABSTRACT:
Background:
Telitacicept, a B lymphocyte stimulator/A proliferation-inducing ligand dual-target fusion protein, has recently been used in autoimmune diseases. We assessed the efficacy and safety of telitacicept in immunoglobulin A nephropathy (IgAN) patients.
Methods:
This study included 42 IgAN patients who received telitacicept treatment, forming the ‘whole telitacicept group’. Among them, 20 patients who had not previously received corticosteroid (CS) therapy or immunosuppressive (IS) agents were categorized as the ‘newly treated telitacicept subgroup’. Additionally, 28 patients who were selected to match historical controls received conventional IS therapy (CS therapy with/without IS agents) and were classified as the ‘conventional IS group’. Telitacicept was partially used in combination with conventional IS therapy, including initial CS in different doses. Various indicators were compared at 4-week intervals up to 24 weeks among the three groups.
Results:
After 24 weeks of treatment, the 24-hour proteinuria decreased from 1.70 g [interquartile range (IQR) 1.05–2.58] to 0.21 g (IQR 0.39–0.13) (P = .043) in the newly treated telitacicept subgroup, from 1.78 g (IQR 0.97–2.82) to 0.44 g (IQR 1.48–0.16) (P = .001) in the conventional IS group and from 1.07 g (IQR 0.66–1.99) to 0.26 g (IQR 0.59–0.17) (P = .028) in the whole telitacicept group. The estimated glomerular filtration rate (eGFR) increased from 76.58 ± 30.26 ml/min/1.73 m2 to 80.30 ± 26.76 ml/min/1.73 m2 (P = .016) in the newly treated telitacicept subgroup, from 72.73 ± 33.41 ml/min/1.73 m2 to 84.08 ± 26.81 ml/min/1.73 m2 (P = .011) in the conventional IS group and from 70.10 ± 32.88 ml/min/1.73 m2 to 71.21 ± 31.49 ml/min/1.73 m2 (P = .065) in the whole telitacicept group. During follow-up periods, the efficacy rates of the three groups did not show statistically significant differences and no serious adverse events were observed.
Conclusions:
Telitacicept may be a safe and effective treatment for IgAN, offering reductions in proteinuria and increases in eGFR similar to conventional IS therapy. After a 24-week follow-up, the incidence of adverse events was lower for telitacicept than for conventional IS therapy.
2024-09-01INTERNATIONAL JOURNAL OF DERMATOLOGY
Response to telitacicept in systemic lupus erythematosus patients: a real‐world, single‐center observational study in China
Letter
作者: Liu, Yidan ; Deng, Min ; Wu, Ruifang ; Zhou, Xiao ; Zhu, Yanshan ; Wang, Qiao ; Su, Yuwen ; Li, Siying ; Zhang, Peng
2024-09-01JOURNAL OF AUTOIMMUNITY
Telitacicept: A novel horizon in targeting autoimmunity and rheumatic diseases
Review
作者: Zeng, Liuting ; Song, Tian ; Sun, Lingyun ; Yan, Yexing ; Yang, Kailin ; Yu, Ganpeng ; Hao, Moujia ; Chen, Junpeng ; Li, Yuwei ; Wu, Yang
BLyS and APRIL have the capability to bind to B cells within the body, allowing these cells to evade elimination when they should naturally be removed. While BLyS primarily plays a role in B cell development and maturation, APRIL is linked to B cell activation and the secretion of antibodies. Thus, in theory, inhibiting BLyS or APRIL could diminish the population of aberrant B cells that contribute to SLE and reduce disease activity in patients. Telitacicept functions by binding to and neutralizing the activities of both BLyS and APRIL, thus hindering the maturation and survival of plasma cells and fully developed B cells. The design of telitacicept is distinctive; it is not a monoclonal antibody but a TACI-Fc fusion protein generated through recombinant DNA technology. This fusion involves merging gene segments of the TACI protein, which can target BLyS/APRIL simultaneously, with the Fc gene segment of the human IgG protein. The TACI-Fc fusion protein exhibits the combined characteristics of both proteins. Currently utilized for autoimmune disease treatment, telitacicept is undergoing clinical investigations globally to assess its efficacy in managing various autoimmune conditions. This review consolidates information on the mechanistic actions, dosing regimens, pharmacokinetics, efficacy, and safety profile of telitacicept-a dual-targeted biological agent. It integrates findings from prior experiments and pharmacokinetic analyses in the treatment of RA and SLE, striving to offer a comprehensive overview of telitacicept's research advancements.
100 项与 泰它西普 相关的药物交易
登录后查看更多信息
外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | - | - |
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
登录
| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 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
登录
| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 重症肌无力 | 申请上市 | 中国 | 2024-10-26 | |
| 原发性干燥综合征 | 临床3期 | 中国 | 2023-04-03 | |
| 免疫球蛋白a肾病 | 临床3期 | 美国 | 2022-11-18 | |
| 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 | |
| 肾病 | 临床2期 | 美国 | 2022-06-23 | |
| 肾病 | 临床2期 | 中国 | 2022-06-23 | |
| 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1期 | 中国 | - | |
| 免疫球蛋白G4相关疾病 | 临床申请批准 | 中国 | 2024-06-17 |
登录后查看更多信息
临床结果
临床结果
适应症
分期
评价
查看全部结果
临床2期 | 249 | 網顧鏇窪築築糧網簾襯(網願觸製簾衊願艱鏇蓋) = 齋網餘鬱窪鏇願範艱遞 繭淵憲鑰製鑰遞糧醖窪 (鏇網網鹽艱鏇簾簾願繭 ) | 积极 | 2024-04-01 | |||
網顧鏇窪築築糧網簾襯(網願觸製簾衊願艱鏇蓋) = 獵鏇鬱艱鑰網鬱範網憲 繭淵憲鑰製鑰遞糧醖窪 (鏇網網鹽艱鏇簾簾願繭 ) | |||||||
临床3期 | 479 | Telitacicept 160 mg | 鬱鏇齋繭網網衊繭憲鹽(範襯膚遞網廠構築壓膚) = 憲範糧簾衊衊憲遞網糧 鬱蓋淵鹽夢醖網鏇顧簾 (鏇構範襯鏇網膚襯鹹窪 ) 更多 | 积极 | 2023-10-24 | ||
Placebo | 鬱鏇齋繭網網衊繭憲鹽(範襯膚遞網廠構築壓膚) = 顧簾觸獵壓夢範獵鬱鏇 鬱蓋淵鹽夢醖網鏇顧簾 (鏇構範襯鏇網膚襯鹹窪 ) 更多 | ||||||
临床2期 | 42 | placebo | 築網窪淵觸廠夢範廠憲(鏇醖願餘夢憲願鹹糧淵) = 艱鹹醖繭遞齋選衊獵膚 艱簾蓋憲壓鏇築鬱憲廠 (衊觸衊醖膚憲鹽願遞簾, 4.55) | 积极 | 2023-07-17 | ||
築網窪淵觸廠夢範廠憲(鏇醖願餘夢憲願鹹糧淵) = 餘鬱艱願糧製糧鹹壓齋 艱簾蓋憲壓鏇築鬱憲廠 (衊觸衊醖膚憲鹽願遞簾, 2.73) | |||||||
临床3期 | 335 | 醖齋蓋選選願觸範遞網(廠簾窪鑰廠製壓觸觸鬱) = 選構衊鏇壓鏇鑰窪獵顧 齋鹽餘憲膚壓顧遞遞醖 (蓋遞廠衊膚構壓簾鬱鏇 ) | 积极 | 2023-05-31 | |||
Placebo | 醖齋蓋選選願觸範遞網(廠簾窪鑰廠製壓觸觸鬱) = 積鹽夢醖鏇夢獵夢獵餘 齋鹽餘憲膚壓顧遞遞醖 (蓋遞廠衊膚構壓簾鬱鏇 ) | ||||||
Pubmed 人工标引  | N/A | 20 | 衊選窪網網鹽艱窪襯鏇(選壓繭膚積醖衊構範製) = 繭選淵衊蓋遞襯餘觸繭 夢夢憲觸淵襯憲鏇壓簾 (遞襯壓製鏇淵齋淵網遞 ) 更多 | 积极 | 2022-11-23 | ||
临床2期 | 29 | (160mg) | 選糧壓夢壓積憲鏇繭簾(簾觸鑰觸簾製築選鹽構) = 鏇鹹積壓夢餘蓋獵廠構 淵構醖範鹽壓蓋鹽糧顧 (蓋憲壓觸構衊積簾繭範 ) | 积极 | 2022-10-31 | ||
(240mg) | 選糧壓夢壓積憲鏇繭簾(簾觸鑰觸簾製築選鹽構) = 選簾範獵窪襯膚齋範鹽 淵構醖範鹽壓蓋鹽糧顧 (蓋憲壓觸構衊積簾繭範 ) | ||||||
临床3期 | 335 | Standard of Care+Telitacicept | 繭鏇鏇築構襯夢鹽網構(糧遞襯夢鹹淵鏇膚繭壓) = 積遞構鏇觸範窪襯願鹽 鏇鹹衊築窪選鬱衊繭構 (積壓構廠製艱築夢積齋 ) | 积极 | 2022-09-19 | ||
Standard of Care+Placebo | 繭鏇鏇築構襯夢鹽網構(糧遞襯夢鹹淵鏇膚繭壓) = 築鹽憲顧壓繭選獵鬱夢 鏇鹹衊築窪選鬱衊繭構 (積壓構廠製艱築夢積齋 ) |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
来和芽仔聊天吧
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用