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阿普西莫瑞林:美国首次批准

Aponermin: First Approval.

机构信息

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

出版信息

Drugs. 2024 Apr;84(4):459-466. doi: 10.1007/s40265-024-02004-9.

Abstract

Aponermin () is a recombinant circularly permuted human tumour necrosis factor-related apoptosis-inducing ligand (TRAIL) developed by Beijing Sunbio Biotech (a wholly owned subsidiary of Wuhan Hiteck Biological Pharma CO., LTD) for the treatment of multiple myeloma. Aponermin binds to and activates the death receptors 4 and/or 5 on tumour cells, triggering intracellular caspase reactions and inducing apoptosis, thereby exerting antitumor effects. In November 2023, aponermin in combination with thalidomide and dexamethasone received its first approval in China for the treatment of patients with relapsed or refractory multiple myeloma who have received at least two prior therapies. This article summarizes the milestones in the development of aponermin leading to this first approval for relapsed or refractory multiple myeloma.

摘要

阿泊替尼(aponermin)是一种由北京双鹭药业(武汉海特生物制药股份有限公司的全资子公司)开发的重组环形排列人肿瘤坏死因子相关凋亡诱导配体(TRAIL),用于治疗多发性骨髓瘤。阿泊替尼与肿瘤细胞表面的死亡受体 4 和/或 5 结合并激活它们,触发细胞内半胱天冬酶反应,诱导细胞凋亡,从而发挥抗肿瘤作用。2023 年 11 月,阿泊替尼与沙利度胺和地塞米松联合治疗至少接受过两种先前治疗的复发或难治性多发性骨髓瘤患者在中国获得首次批准。本文总结了导致阿泊替尼治疗复发或难治性多发性骨髓瘤首次获批的里程碑事件。

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