摘要
2022年生物医药全行业热力指数逐渐下行,但基因治疗、细胞治疗等细分赛道依然活跃,源头技术突破、多学科交叉整合创新加快了新药研发进程。2022年全球获批新药的种类丰富,一些重磅新药和新技术疗法为复杂疾病带来了新的治疗希望。美国FDA药品评估和研究中心(CDER)在2022年共批准了37款新药,其中25款为全球首次批准;欧洲EMA全年共批准了51款新药,其中8款为全球首次批准;日本PMDA全年共批准了48款新药,其中12款为全球首次批准;我国国家药品监督管理局(NMPA)全年共批准了40款新药,其中11款为全球首次批准。本文总结了2022年美国、欧洲、日本和中国获批上市的新药,并对2023年新药研发和生物医药发展态势进行展望。
In 2022,the heat index of the whole biomedical industry gradually declined,but the hot track such as gene therapy and cell therapy remains active.Source technology breakthroughs and multidisciplinary crossintegration innovation have accelerated the process of new drug development.There are a rich variety of new drugs approved in 2022,and some blockbuster new drugs and new technology therapies have brought new therapeutic hope for complex diseases.The Center for Drug Evaluation and Research(CDER)of the US FDA approved 37 innovative drugs in 2022,25 of which were first approved worldwide.The European EMA approved 51 innovative medicines throughout the year,8 of which were first approved worldwide.Japan's Pharmaceutical and Medical Device Agency(PMDA)approved 48 new drugs throughout the year,12 of which were first approved in the world.The National Medical Products Administration(NMPA)of China approved 40 new drugs throughout the year,11 of which were first approved worldwide.This paper summarized the new drugs approved for market in the US,EU,Japan and China in 2022,and provided an outlook on new drug development and biopharmaceutical development trends in 2023.
作者
韩杭丽
孙友松
陈倩
杨臻峥
郑晓南
HAN Hang-li;SUN You-song;CHEN Qian;YANG Zhen-zheng;ZHENG Xiao-nan(School of Science,China Pharmaceutical University,Nanjing 210009,China;Shanghai Pharmadigger Technology Co.,Ltd.,Shanghai 201210,China;D Medicines Inc.,Shanghai 200126,China;Editorial Office of Progress in Pharmaceutical Sciences,China Pharmaceutical University,Nanjing 210009,China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2023年第18期1801-1808,共8页
Chinese Journal of New Drugs
关键词
创新药
全球首批
细胞与基因治疗
孤儿药
original new drug
first approval
cell and gene therapy
orphan drug
