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伏纳库珠单抗:首次获批

Vunakizumab: First Approval.

机构信息

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

出版信息

Drugs. 2024 Nov;84(11):1481-1485. doi: 10.1007/s40265-024-02110-8. Epub 2024 Nov 5.

Abstract

Vunakizumab () is a subcutaneous (SC) recombinant anti-interleukin (IL)-17A humanized monoclonal IgG1/κ antibody being developed by Suzhou Suncadia Biopharmaceutical Co., Ltd (a subsidiary of Jiangsu Hengrui Pharmaceuticals Co., Ltd) for the systemic treatment of autoimmune diseases related to the IL-17 pathway, including psoriasis, ankylosing spondylitis and psoriatic arthritis. In August 2024, vunakizumab was approved in China for the treatment of adult patients with moderate-to-severe plaque psoriasis who are suitable for systemic treatment or phototherapy. This article summarizes the milestones in the development of vunakizumab leading to this first approval for the systemic treatment of moderate-to-severe plaque psoriasis.

摘要

文尼单抗(Vunakizumab)是一种皮下(SC)重组抗白细胞介素(IL)-17A 人源化单克隆 IgG1/κ 抗体,由苏州盛迪亚生物医药有限公司(江苏恒瑞医药股份有限公司的子公司)开发,用于治疗与 IL-17 通路相关的自身免疫性疾病的全身治疗,包括银屑病、强直性脊柱炎和银屑病关节炎。2024 年 8 月,文尼单抗在中国获批用于治疗适合全身治疗或光疗的中重度斑块状银屑病成人患者。本文总结了文尼单抗的开发里程碑,这些里程碑促成了其在中重度斑块状银屑病全身治疗方面的首次获批。

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