Page 13 - 《中国药房》2025年5期

我国优先审评审批上市儿童用药的特征分析
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杨浩宇 ，田 侃 ，游 雪 ，淡宏伟 ，王 乾 ，喻小勇 （1. 南京中医药大学卫生经济管理学院，南京
1＊
210023；2. 南京中医药大学养老服务与管理研究院，南京 210029；3. 南京市第一医院重症医学科，南京
210006；4.东南大学附属中大医院麻醉手术与疼痛管理科，南京 210009；5.石河子大学第一附属医院发展规
划科，新疆 石河子 832008；6.南京中医药大学养老服务与管理学院，南京 210023）
中图分类号 R95；R985 文献标志码 A 文章编号 1001-0408（2025）05-0519-05
DOI 10.6039/j.issn.1001-0408.2025.05.02

摘 要 目的 分析我国优先审评审批上市儿童用药的特征，为促进企业研发生产和完善儿童用药供应保障机制提供参考。
方法 基于《优先审评审批的儿童用药批准信息清单》、药融云生物医药数据库、《国家医保药品目录》等公开数据源，对优先审评审
批上市儿童用药的主要特征进行梳理分析。结果 截至2024年6月30日，共有68个优先审评审批上市的儿童用药，涉及12个治
疗领域，其中口服剂型的占比达64.71%。从申请到纳入优先审评的中位数时间为35.50 d，平均时间为41.69 d；从纳入优先审评至
批准上市的中位数时间为1.24年，平均时间为1.42年。68个优先审评审批上市儿童用药中包括12个国产新药、21个国产仿制药、
35个进口药品，共涉及29个儿童专用药和21个罕见病用药。其中，有31个药品被纳入医保目录，占比为45.59%。结论 国产与进
口儿童用药之间显示出差异化竞争趋势，儿童用药的治疗领域不断丰富且剂型更贴近儿童需求，但仍存在新药研发进展缓慢、审
评审批程序内部稳定性不足、医保纳入比例有待提高等问题。
关键词 优先审评审批；儿童用药；儿童专用药；罕见病用药

Characteristics analysis of pediatric medicines with priority review and approval for marketing in China
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YANG Haoyu ，TIAN Kan ，YOU Xue ，DAN Hongwei ，WANG Qian ，YU Xiaoyong （1. School of Health
2， 6
1
2
3
4
Economics and Management， Nanjing University of Chinese Medicine， Nanjing 210023， China；2. Institute of
Elderly Care Services and Management， Nanjing University of Chinese Medicine， Nanjing 210029， China；
3. Dept. of ICU， Nanjing First Hospital， Nanjing 210006， China；4. Dept. of Anesthesiology and Pain
Management， Zhongda Hospital， Southeast University， Nanjing 210009， China；5. Dept. of Development and
Planning， the First Affiliated Hospital of Shihezi University， Xinjiang Shihezi 832008， China；6. School of
Elderly Care Services and Management， Nanjing University of Chinese Medicine， Nanjing 210023， China）

ABSTRACT OBJECTIVE To analyze the characteristics of pediatric medicines with priority review and approval for marketing
in China， providing a reference for promoting enterprise R&D and production， as well as improving the supply guarantee
mechanism for pediatric medicines. METHODS Based on publicly available data sources such as List of Approved Information for
Pediatric Medications Subject to Priority Review and Approval， Pharnexcloud biomedical database， and National Medical
Insurance Drug Directory， this study conducted a comprehensive analysis of the main characteristics of pediatric medicines with
priority review and approval for marketing. RESULTS As of June 30， 2024， a total of 68 pediatric medicines had been approved
through the priority review and approval process， covering 12 therapeutic areas， with oral dosage forms accounting for 64.71%.
The median time from application to inclusion in priority review was 35.50 days， with an average of 41.69 days. The median time
from inclusion in priority review to market approval was 1.24 years， with an average of 1.42 years. This included 12 domestic new
medicines， 21 domestic generic medicines， 35 imported medicines， as well as 29 pediatric-specific medicines and 21 orphan
medicines. Additionally， 31 of these medicines had been
Δ 基金项目 江苏省社会科学基金后期资助项目（No.20HQ019）； included in the medical insurance catalog， representing a
江苏省研究生科研创新计划项目（No.KYCX24_2114）；南京中医药大 proportion of 45.59%. CONCLUSIONS Currently， a trend of
学养老服务与管理学院（养老产业学院）专项研究立项项目（No.
differentiated competition is emerging between domestic and
2024YLFWYGL002） imported pediatric medicines. The therapeutic areas for
＊第一作者 硕士研究生。研究方向：医药政策与法规。E-mail：
pediatric medicines are continuously expanding， and the
yanghaoyu9857@163.com
# 通信作者 副教授，硕士生导师，博士。研究方向：医药政策与法 dosage forms are becoming more tailored to children’s needs.
规。电话：025-85811760。E-mail：yxy8823@aliyun.com However， there are still issues such as slow progress in new

中国药房 2025年第36卷第5期 China Pharmacy 2025 Vol. 36 No. 5 · 519 ·