2016年美国FDA批准上市新药情况简析  

Brief analysis on new drugs approved by FDA in 2016

作　　者：尤佳 姜正羽 张连山 尤启冬[2] 

机构地区：[1]上海恒瑞医药有限公司,上海200245 [2]中国药科大学江苏省药物分子设计与成药性优化重点实验室,南京210009

出　　处：《中国新药杂志》2017年第11期1225-1230,共6页Chinese Journal of New Drugs

摘　　要：2016年美国FDA共批准了22种新药,其中新分子实体15种,新生物制品7种,新药批准数量较前两年有明显下降。但本年度的获批新药包含了8个首创新药,占比较大;同时,获批药物中包括首个小分子蛋白-蛋白相互作用抑制剂、首个PD-L1抗体和首个针对全部6个主要基因亚型的抗丙肝药物等多个重磅新药,共同凸显了获批药物较强的创新性。同时,2016年超过70%的新药(共16种)受益于FDA的非标准审评程序,大大加速了创新药物服务社会的进程。总体而言,2016年美国FDA批准的新药在数量上有所下降,但质量上仍然保持优势,更突出了创新在新药研发中的核心地位。The U. S. Food and Drug Administration （FDA） approved 22 new drugs in 2016, including 15 new molecular entities （NMEs） and 7 new biological applications （BLAs）, much less than those approved in the last two years. Among these approvals, 16 first-in-class drugs and several potential blockbusters, including the first small molecule protein-protein interaction inhibitor, the first PD-L1 antibody and the first drug to treat all six major forms of hepatitis C virus, together confirmed the innovation of these new drugs. Besides, more than 70% of new drugs benefited from the specialized designations, facilitating and expediting development and review of new drugs to address unmet medical need. Although the number of new drugs approved in 2016 showed a decline, the quality remains high standard, further stressing the core role of creativity in new drug R＆D filed.

关 键 词：新分子实体 新药批准 美国食品药品监督管理局 

分 类 号：R95[医药卫生—药学]