2014至2018年我国自主研发并获准上市的1类新药概述  

An overview of category 1 new drugs self-developed and approved in China from 2014 to 2018

作　　者：杨臻峥[1] 孙友松 魏利军 吴小涛 乔思邈 郑晓南[1] YANG Zhen-zheng;SUN You-song;WEI Li-jun;WU Xiao-tao;QIAO Si-miao;ZHENG Xiao-nan(Editorial Office of Progress in Pharmaceutical Sciences ,China Pharmaceutical University y Nanjing 210009 ,China;Shanghai Pharmadigger Technology Co. ,Ltd. ,Shanghai 201210 ,China;Harbin Pharmaceutical Group Co.,Ltd.,Harbin 150070 ,China;Nanjing Gritpharma Co. ,Ltd. ,Nanjing 211112 ,China;Department of Pharmacology of Chinese Materia Medica,School of Traditional Chinese Pharmacy,China Pharmaceutical University,Nanjing 210009 ,China)

机构地区：[1]中国药科大学《药学进展》编辑部,南京210009 [2]上海递鸽医药科技有限公司,上海201210 [3]哈药集团股份有限公司,哈尔滨150070 [4]南京济群医药科技股份有限公司,南京211112 [5]中国药科大学中药学院中药药理与中医药学系,南京210009

出　　处：《中国新药杂志》2019年第13期1537-1546,共10页Chinese Journal of New Drugs

摘　　要：新药研发是国际科技与经济竞争的战略制高点。国家对新药研发寄予厚望,近年来从政策导向、技术支撑、人才资源和资金投入等多个维度,为医药产业构建了可持续发展的创新环境。经过多年的厚积薄发,我国的创新药研发稳健前行、渐入佳境,申请临床试验和上市的1类新药数量亦逐年攀升。对2014-2018年我国自主研发并获得国家药品监督管理局(NMPA)及原国家食品药品监督管理总局(CFDA)批准的9个1类化学创新药和5个1类生物创新药进行回顾,简介其作用机制、适应证和临床研究结果,并总结了已提交上市申请的27个国产1类新药的信息,包括剂型、作用靶点、适应证、申报企业、审评方式等,以便读者管中窥豹,了解我国医药产业的发展现状。New drugs R&D is the strategic high ground in global technology and economic competition. Our nation places high hopes on new drugs R&D, and has created a sustainable development innovation environment for pharmaceutical industry from multiple dimensions such as policy orientation, technological support, talent resources and funding investment in recent years. With years of accumulation , Chinese original new drugs R&D has maintained steady growth , and the number of category 1 new drugs applying for clinical trial and marketing has increased year by year. This article has reviewed 9 category 1 new chemical drugs and 5 category 1 new biological drugs developed by domestic pharmaceutical enterprises and approved by National Medical Products Administration (NMPA), including its predecessor, former China Food and Drug Administration ( CFDA) from 2014 to 2018. Their action mechanisms, indications and clinical research results were introduced briefly. Moreover, the information of 27 category 1 new drugs which have been submitted application were summarized , including drug form , targets, indications, companies, evaluation mode, and etc., so as to provide references for readers, and help them to understand the development status of Chinese pharmaceutical industry.

关 键 词：1类新药 自主研发 化学药 生物药 临床试验 新药申请 抗肿瘤 抗感染 

分 类 号：R95[医药卫生—药学]