• 文献检索
  • 文档翻译
  • 深度研究
  • 学术资讯
  • Suppr Zotero 插件Zotero 插件
  • 邀请有礼
  • 套餐&价格
  • 历史记录
应用&插件
Suppr Zotero 插件Zotero 插件浏览器插件Mac 客户端Windows 客户端微信小程序
定价
高级版会员购买积分包购买API积分包
服务
文献检索文档翻译深度研究API 文档MCP 服务
关于我们
关于 Suppr公司介绍联系我们用户协议隐私条款
关注我们

Suppr 超能文献

核心技术专利:CN118964589B侵权必究
粤ICP备2023148730 号-1Suppr @ 2026

文献检索

告别复杂PubMed语法,用中文像聊天一样搜索,搜遍4000万医学文献。AI智能推荐,让科研检索更轻松。

立即免费搜索

文件翻译

保留排版,准确专业,支持PDF/Word/PPT等文件格式,支持 12+语言互译。

免费翻译文档

深度研究

AI帮你快速写综述,25分钟生成高质量综述,智能提取关键信息,辅助科研写作。

立即免费体验

希利吉单抗:首次获批。

Xeligekimab: First Approval.

作者信息

Blair Hannah A

机构信息

Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.

出版信息

Drugs. 2025 Jan;85(1):97-101. doi: 10.1007/s40265-024-02125-1. Epub 2024 Dec 20.

DOI:10.1007/s40265-024-02125-1
PMID:39702866
Abstract

Xeligekimab (Jinlixi) is a recombinant human interleukin (IL)-17A-neutralizing immunoglobulin (Ig)G4 monoclonal antibody being developed by Genrix (Shanghai) Biopharmaceutical for the treatment of plaque psoriasis, axial spondyloarthritis and lupus nephritis. Xeligekimab binds to IL-17A and blocks its interaction with the IL-17A receptor, thereby inhibiting the release of C-X-C motif chemokine ligand 1 and IL-6. On 27 August 2024, xeligekimab received approval in China for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Xeligekimab is under regulatory review in China for the treatment of axial spondyloarthritis and is undergoing phase II development for the treatment of lupus nephritis. This article summarizes the milestones in the development of xeligekimab leading to this first approval for plaque psoriasis.

摘要

希立奇单抗(金礼西)是健适(上海)生物制药公司正在开发的一种重组人白细胞介素(IL)-17A中和免疫球蛋白(Ig)G4单克隆抗体,用于治疗斑块状银屑病、强直性脊柱炎和狼疮性肾炎。希立奇单抗与IL-17A结合并阻断其与IL-17A受体的相互作用,从而抑制C-X-C基序趋化因子配体1和IL-6的释放。2024年8月27日,希立奇单抗在中国获批用于治疗适合全身治疗或光疗的中度至重度斑块状银屑病成人患者。希立奇单抗在中国正接受强直性脊柱炎治疗的监管审查,并且正在进行狼疮性肾炎治疗的II期开发。本文总结了希立奇单抗开发过程中促成其首次获批用于斑块状银屑病的各个关键节点。

相似文献

1
Xeligekimab: First Approval.希利吉单抗:首次获批。
Drugs. 2025 Jan;85(1):97-101. doi: 10.1007/s40265-024-02125-1. Epub 2024 Dec 20.
2
Vunakizumab: First Approval.伏纳库珠单抗:首次获批
Drugs. 2024 Nov;84(11):1481-1485. doi: 10.1007/s40265-024-02110-8. Epub 2024 Nov 5.
3
A multicentre randomized double-blind placebo-controlled phase III study of the efficacy and safety of xeligekimab (GR1501) in patients with moderate-to-severe plaque psoriasis.一项关于 xeligekimab(GR1501)在中重度斑块状银屑病患者中的疗效和安全性的多中心、随机、双盲、安慰剂对照 III 期研究。
Br J Dermatol. 2024 Aug 14;191(3):336-343. doi: 10.1093/bjd/ljae062.
4
Ixekizumab: First Global Approval.依奇珠单抗:全球首次获批。
Drugs. 2016 May;76(8):901-5. doi: 10.1007/s40265-016-0579-y.
5
Population Pharmacokinetics of Xeligekimab: An Anti-IL-17A Monoclonal Antibody, in Patients with Moderate to Severe Plaque Psoriasis.Xeligekimab(一种抗白细胞介素-17A单克隆抗体)在中度至重度斑块状银屑病患者中的群体药代动力学
J Clin Pharmacol. 2024 Sep 10. doi: 10.1002/jcph.6129.
6
Ixekizumab for treatment of psoriasis.司库奇尤单抗治疗银屑病。
Expert Rev Clin Immunol. 2015 Apr;11(4):435-42. doi: 10.1586/1744666X.2015.1023295. Epub 2015 Mar 8.
7
The Role of IL-17 in the Pathogenesis of Psoriasis and Update on IL-17 Inhibitors for the Treatment of Plaque Psoriasis.白细胞介素-17在银屑病发病机制中的作用及斑块状银屑病白细胞介素-17抑制剂治疗进展
J Cutan Med Surg. 2016 Nov;20(6):509-516. doi: 10.1177/1203475416651605. Epub 2016 May 20.
8
Tildrakizumab: First Global Approval.替度鲁单抗:全球首次获批。
Drugs. 2018 Jun;78(8):845-849. doi: 10.1007/s40265-018-0917-3.
9
Ixekizumab: a new anti-IL-17A monoclonal antibody therapy for moderate-to severe plaque psoriasis.司库奇尤单抗:一种用于治疗中度至重度斑块状银屑病的新型抗白细胞介素-17A单克隆抗体疗法。
Expert Opin Biol Ther. 2016;16(2):255-63. doi: 10.1517/14712598.2016.1132695. Epub 2016 Jan 25.
10
Interleukin-17 (IL-17) inhibitors in the treatment of plaque psoriasis: a review.白细胞介素-17(IL-17)抑制剂治疗斑块状银屑病的综述
Skin Therapy Lett. 2015 Jan-Feb;20(1):1-5.

引用本文的文献

1
IL-17A Induces Circadian Disruptions Through the Epigenetic Repression of BMAL1 in Mice With Alzheimer's Disease.白细胞介素-17A通过对阿尔茨海默病小鼠中BMAL1的表观遗传抑制诱导昼夜节律紊乱。
J Cell Mol Med. 2025 Apr;29(7):e70546. doi: 10.1111/jcmm.70546.
2
Topical Therapy in Psoriasis: Clinical Benefits, Advances in Novel Drug Delivery Strategies, and Gene Therapy Regimen.银屑病的局部治疗:临床益处、新型药物递送策略的进展及基因治疗方案
Pharmaceutics. 2025 Feb 20;17(3):283. doi: 10.3390/pharmaceutics17030283.

本文引用的文献

1
Population Pharmacokinetics of Xeligekimab: An Anti-IL-17A Monoclonal Antibody, in Patients with Moderate to Severe Plaque Psoriasis.Xeligekimab(一种抗白细胞介素-17A单克隆抗体)在中度至重度斑块状银屑病患者中的群体药代动力学
J Clin Pharmacol. 2024 Sep 10. doi: 10.1002/jcph.6129.
2
Sequencing of Targeted Therapy in Psoriasis: Does it Matter?靶向治疗药物在银屑病中的测序:这有关系吗?
Am J Clin Dermatol. 2024 Sep;25(5):795-810. doi: 10.1007/s40257-024-00874-z. Epub 2024 Jul 13.
3
A multicentre randomized double-blind placebo-controlled phase III study of the efficacy and safety of xeligekimab (GR1501) in patients with moderate-to-severe plaque psoriasis.
一项关于 xeligekimab(GR1501)在中重度斑块状银屑病患者中的疗效和安全性的多中心、随机、双盲、安慰剂对照 III 期研究。
Br J Dermatol. 2024 Aug 14;191(3):336-343. doi: 10.1093/bjd/ljae062.
4
Preclinical development of GR1501, a human monoclonal antibody that neutralizes interleukin-17A.GR1501 的临床前开发,一种人源化单克隆抗体,能中和白细胞介素-17A。
Biochem Biophys Res Commun. 2019 Sep 17;517(2):303-309. doi: 10.1016/j.bbrc.2019.07.078. Epub 2019 Jul 25.