生物制品的研发现状和发展趋势  

Current State and Future Trends in the Research and Development of Biologics

作　　者：李敏[1] 郭志鑫 付志浩[2] 张辉 LI Min;GUO Zhi-xin;FU Zhi-hao;ZHANG Hui(Center for Drug Evaluation,NMPA;National Institutes for Food and Drug Control)

机构地区：[1]国家药品监督管理局药品审评中心 [2]中国食品药品检定研究院

出　　处：《中国食品药品监管》2023年第12期18-33,共16页China Food & Drug Administration Magazine

摘　　要：随着现代生物技术的快速发展及其在制药领域的应用,生物制品在药物研发中的地位日益突显。目前,为满足更多的临床需求,除传统的生物制品外,应用新技术的生物制品也在开发和探索阶段。本文综述了生物制品的发展现状,并以抗体类药物、疫苗类产品、血液制品及细胞和基因治疗产品为例,结合我国监管科学的发展,概述了相关类别生物制品的国内外研发现状及发展趋势,并对开发相关产品的优势和挑战进行了剖析。With the rapid development of modern biotechnology and its increasing application in the pharmaceutical field,the significance of biologics in drug research and development has become more pronounced.At present,in order to meet expanding clinical demands,there is ongoing development and exploration of biologics using new technologies,in addition to traditional biologics.This paper provides an overview of the development status of biologics,focusing on categories such as antibody drugs,vaccine products,blood products,cell and gene therapy products.It combines the progress in regulatory science in China,summarizing the research and development status and trends of related biologics at home and abroad was summarized.The paper also analyzes the advantages and challenges of developing these products.

关 键 词：生物制品 研发现状 发展趋势 抗体类药物 疫苗 

分 类 号：R95[医药卫生—药学]