2024年度中国新药盘点  

2024 annual review of new drug approvals in China

作　　者：李秋 戈乾玮 邵黎明[1,2] LI Qiu;GE Qian-wei;SHAO Li-ming(School of Pharmacy,Fudan University,Shanghai 201203,China;Shanghai Center for Drug Discovery&Development,Shanghai 201203,China)

机构地区：[1]复旦大学药学院,上海201203 [2]上海市药物研发协同创新中心,上海201203

出　　处：《中国新药与临床杂志》2025年第1期1-7,共7页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：本文盘点了2024年度国家药品监督管理局批准的新药上市申请,梳理了不同注册类别的新药、临床急需的短缺药、儿童用药、罕见疾病用药等信息,为生物医药从业者提供参考。截至2024年12月31日,NMPA共批准228个新药上市申请,其中1类新药48个,2类改良型新药67个,境外已上市原研药和改良型药品94个,治疗领域以肿瘤为主。儿童用药和罕见疾病用药获批总数保持增长。This article reviews the new drug applications(NDAs)approved by the National Medical Products Administration(NMPA)in 2024.It summarizes the information of new drugs in registration category,drugs with urgent clinical needs in shortage,pediatric drugs and rare disease drugs,providing valuable reference for researchers in fields related to pharmaceutical industry.As of December 31,2024,the NMPA had approved a total of 228 NDAs,including 48 Class 1 new drugs,67 Class 2 modified new drugs,and 94 original drugs and modified drugs that have been marketed overseas.Oncology drugs maintained a dominant position,while approvals for pediatric drugs and rare disease drugs continue to grow.

关 键 词：药物批准 1类新药 改良型新药 儿童用药 罕见病 

分 类 号：R95[医药卫生—药学]