2023年度中国新药盘点  

2023 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》2024年第1期4-11,共8页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：为了解我国新药创新现状,本文盘点了2023年度国家药品监督管理局(NMPA)批准的新药上市申请信息,通过对药品类型、治疗领域、靶点分布和优先审评审批等内容的梳理,为生物医药创新相关领域的研究者提供参考。截至2023年12月31日,NMPA共批准190个新药上市申请,化学药品、治疗用生物制品和中药分别为117、64和9个。1类新药37个,改良型新药117个。抗肿瘤药物仍占主导(34.2%)。儿童用药和罕见疾病用药批准数量大幅提升。To comprehend the current status of new drug development in China,this article examines the new drug applications(NDAs)approved by the National Medical Products Administration(NMPA)in 2023.The analysis is conducted based on drug category,therapeutic area,target,and priority review and approval,providing a valuable reference for researchers in fields related to pharmaceutical innovation.As of December 31,2023,the NMPA had approved a total of 190 NDAs,comprising 117 chemical drugs,64 biological products,and 9 traditional Chinese medicines.Among these,37 were categorized as new drugs in Class 1,and 117 were improved new drugs.Notably,anti-tumor drugs maintained a dominant position,accounting for 34.2%of the total approvals.Furthermore,there was a significant increase in approvals for pediatric drugs and drugs targeting rare diseases.

关 键 词：药物批准 1类新药 改良型新药 生物制品 治疗应用 靶点 

分 类 号：R95[医药卫生—药学]