溶瘤1型单纯疱疹病毒研究现状及其药学评价的一般考虑  

Current status and general considerations of chemistry, manufacturing, and control review of oncolytic herpes simplex virus 1

作　　者：崔靖(综述) 韦薇(审校) CUI Jing;WEI Wei(Center for Drug Evaluation,National Medical Products Administration(CDE,NMPA),Beijing 100022,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100022

出　　处：《微生物学免疫学进展》2021年第4期66-73,共8页Progress In Microbiology and Immunology

摘　　要：1型单纯疱疹病毒(herpes simplex virus 1, HSV-1)具有基因组大、允许插入多个外源基因、病毒复制周期短、可感染多种肿瘤细胞并易在肿瘤细胞中复制、对人体致病性弱且目前抗疱疹病毒药物(如阿昔洛韦)可有效控制病毒复制等优点,因而以HSV-1为基础开发的溶瘤1型单纯疱疹病毒(oncolytic herpes simplex virus 1, oHSV-1)产品在肿瘤治疗研究中受到广泛关注。虽然目前已经有多个产品获批开展临床试验,但在药学研究中仍存在诸多问题。现就oHSV-1的研究现状及目前该类产品在申报临床阶段药学研究中存在的主要问题展开论述和总结,以促进此类产品的临床开发与应用。Herpes simplex virus 1(HSV-1) has a large genome, allowing the insertion of multiple additional transgenes, and short replication cycle. Furthermore, HSV-1 infects and replicates in most tumor cell types and spreads throughout the tumor. It has weak pathogenicity to humans and the current anti-virus drugs(such as Acyclovir) can effectively control virus replication. Therefore, oncolytic HSV-1(oHSV-1) has received extensive attention in tumor treatments. Although many products have been approved for clinical trials, there are still many problems in chemistry, manufacturing and controls(CMC) research. The review summarizes the current status of oHSV-1 and analyzes main problems existing in CMC of investigational new drug(IND) application, hoping to accelerate the clinical development and application.

关 键 词：1型单纯疱疹病毒 溶瘤病毒 生物学特性 临床试验 药学评价 

分 类 号：R373[医药卫生—病原生物学]