信迪利单抗：全球首次获批。

Sintilimab: First Global Approval.

机构信息

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

出版信息

Drugs. 2019 Feb;79(3):341-346. doi: 10.1007/s40265-019-1066-z.

Abstract

Sintilimab (Tyvyt) is a fully human IgG4 monoclonal antibody that binds to programmed cell death receptor-1 (PD-1), thereby blocking the interaction of PD-1 with its ligands (PD-L1 and PL-L2) and consequently helping to restore the endogenous antitumour T-cell response. It has been co-developed by Innovent Biologics and Eli Lilly and Company, and was recently approved in China for the treatment of classical Hodgkin's lymphoma in patients who have relapsed or are refractory after ≥ 2 lines of systemic chemotherapy. Sintilimab is undergoing phase I, II and III development for use in various solid tumours, including non-small cell lung cancer and oesophageal cancer, in China. Phase I/II development of sintilimab for use in solid tumours is underway in the USA, with the US FDA accepting an Investigational New Drug application for sintilimab in January 2018. This article summarizes the milestones in the development of sintilimab leading to this first approval for the treatment of classical Hodgkin's lymphoma in patients who have relapsed or are refractory after ≥ 2 lines of systemic chemotherapy.

摘要

信迪利单抗（Tyvyt）是一种全人源 IgG4 单克隆抗体，与程序性死亡受体-1（PD-1）结合，从而阻断 PD-1 与其配体（PD-L1 和 PD-L2）的相互作用，进而有助于恢复内源性抗肿瘤 T 细胞反应。它是由信达生物和礼来公司共同开发的，最近在中国被批准用于治疗复发或难治性经典型霍奇金淋巴瘤患者，这些患者在接受≥2 线系统化疗后复发或难治。信迪利单抗正在中国进行 I 期、II 期和 III 期开发，用于治疗各种实体瘤，包括非小细胞肺癌和食管癌。信迪利单抗在实体瘤中的 I/II 期开发正在美国进行，美国 FDA 于 2018 年 1 月接受了信迪利单抗的新药研究申请。本文总结了信迪利单抗开发过程中的重要里程碑，这些里程碑促成了信迪利单抗在中国首次获批用于治疗复发或难治性经典型霍奇金淋巴瘤患者，这些患者在接受≥2 线系统化疗后复发或难治。