结合案例介绍ICH溶瘤病毒非临床研究一般考虑  

Introduction to the ICH considerations on nonclinical studies of oncolytic virus products in conjugation with the practice of talimogene laherparepvec

作　　者：张旻 宫新江 邵雪 闫莉萍[1] 于冰 叶旋 王庆利[1] 王海学[1] ZHANG Min;GONG Xin-jiang;SHAO Xue;YAN Li-ping;YU Bing;YE Xuan;WANG Qing-li;WANG Hai-xue(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)

机构地区：[1]国家药品监督管理局药品审评中心

出　　处：《中国新药杂志》2019年第16期1982-1986,共5页Chinese Journal of New Drugs

基　　金：国家“重大新药创制”科技重大专项资助项目(2014ZX09102041)

摘　　要：作为一种新兴的肿瘤免疫治疗方法,溶瘤病毒在肿瘤免疫治疗领域表现出较好的应用前景。溶瘤病毒除了能产生选择性溶瘤作用外,还可诱导产生局部和/或系统性的抗肿瘤免疫应答。ICH于2009年9月发布了关于《溶瘤病毒》的指导文件,就溶瘤病毒开发相关的表征、非临床和临床研究等方面的内容给出了建议。我国尚无关于溶瘤病毒产品开发相关的指南,本文结合FDA和EMA批准的溶瘤病毒药物talimogene laherparepvec(T-VEC)已公开的非临床研究资料,对该文件中涉及的非临床研究相关的内容进行了简要介绍,以期对我国溶瘤病毒产品的研发和审评工作提供参考。Oncolytic virus represents a new class of therapeutic agents which can promote anti-tumor responses through selective tumor-lysis and induction of local and /or systemic anti-tumor immune responses and therefore shows a promising prospect in oncology immunotherapy. ICH issued consideration document on oncolytic virus in September 2009,and gave suggestions on product characterization,non-clinical and clinical studies related to oncolytic virus products development. As there is no similar document in China currently,we introduce the key points of non-clinical studies covered in this document based on the public practices of talimogene laherparepvec ( T-VEC) already approved by FDA and EMA,hoping to provide some references for the development and review of oncolytic virus products in China.

关 键 词：T-VEC ICH 溶瘤病毒 非临床研究 

分 类 号：R979.1[医药卫生—药品]