Xeligekimab：首次批准。

IF 13 1区医学 Q1 PHARMACOLOGY & PHARMACY Drugs Pub Date : 2025-01-01 Epub Date: 2024-12-20 DOI:10.1007/s40265-024-02125-1

Hannah A Blair

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引用次数: 0

摘要

Xeligekimab （Jinlixi®）是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，由Genrix（上海）生物制药有限公司开发，用于治疗斑块型银屑病、轴性脊柱炎和狼疮性肾炎。Xeligekimab结合IL-17A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，xeligekimab在中国获得批准，用于治疗中度至重度斑块性银屑病成人患者，这些患者是全身治疗或光疗的候选人。Xeligekimab正在中国接受监管审查，用于治疗轴性脊柱炎，并正在进行治疗狼疮性肾炎的II期开发。本文总结了xeligekimab首次获批用于治疗斑块型银屑病的发展历程。

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Xeligekimab: First Approval.

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.

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来源期刊

Drugs 医学-毒理学

CiteScore

22.70

自引率

0.90%

发文量

134

审稿时长

3-8 weeks

期刊介绍： Drugs is a journal that aims to enhance pharmacotherapy by publishing review and original research articles on key aspects of clinical pharmacology and therapeutics. The journal includes: Leading/current opinion articles providing an overview of contentious or emerging issues. Definitive reviews of drugs and drug classes, and their place in disease management. Therapy in Practice articles including recommendations for specific clinical situations. High-quality, well designed, original clinical research. Adis Drug Evaluations reviewing the properties and place in therapy of both newer and established drugs. AdisInsight Reports summarising development at first global approval. Moreover, the journal offers additional digital features such as animated abstracts, video abstracts, instructional videos, and podcasts to increase visibility and educational value. Plain language summaries accompany articles to assist readers with some knowledge of the field in understanding important medical advances.