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替莫泊珠单抗:首次批准。

Hetrombopag: First Approval.

机构信息

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

出版信息

Drugs. 2021 Sep;81(13):1581-1585. doi: 10.1007/s40265-021-01575-1.

DOI:10.1007/s40265-021-01575-1
PMID:34357499
Abstract

Hetrombopag (Hengqu), an oral nonpeptide thrombopoietin receptor agonist, is being developed by Jiangsu Hengrui Pharmaceutical for the treatment of thrombocytopenia and aplastic anaemia. On 16 June 2021, hetrombopag received its first approval in China as a second-line treatment for primary immune thrombocytopenia (ITP) and severe aplastic anaemia (SAA) in adults. The drug is also undergoing phase III development in China for the treatment of chemotherapy-induced thrombocytopenia. This article summarizes the milestones in the development of hetrombopag leading to this first approval for ITP and SAA.

摘要

恒格列净(Hengqu),一种口服非肽类血小板生成素受体激动剂,由江苏恒瑞医药公司开发,用于治疗血小板减少症和再生障碍性贫血。2021 年 6 月 16 日,恒格列净在中国首次获批,作为成人原发免疫性血小板减少症(ITP)和重型再生障碍性贫血(SAA)的二线治疗药物。该药还在中国进行 III 期临床试验,用于治疗化疗引起的血小板减少症。本文总结了恒格列净在开发过程中的重要里程碑,最终使其获得 ITP 和 SAA 的批准。

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