【研究方向】

主要从事药品监管科学以及药物政策研究，卫生技术评估与创新药价值评估研究；真实世界证据支持药品和医疗器械审评决策研究。

从2020年10月入职清华大学以来，共主持国家药品监督管理局，比尔梅琳达盖茨基金会、海南省药品监督管理局、广东省药品监督管理局、行业协会、国内外顶尖企业等的纵向和横向科研项目50余项，发表SCI论文20篇，北大中文期刊论文第一作者或者通讯作者论文32篇。

代表性著作有专著《美国药品监管科学研究》《药品上市许可持有人制度导读》《WHO基本药物制度研究与应用》。编著《药用原辅料和包装材料关联审评改革》《药物临床试验动态管理改革与创新》《21世纪治愈法案》《FDA职责与权力》等。

【科学贡献】

在监管科学的理论、科学逻辑方面进行了深入的研究，形成了独特的研究和思维方法论体系，建立了制度、路径、程序、监管科学工具、标准和方法的基本研究框架，提出药品监管科学是基于比较的决策。在药品管理政策和立法方面具有很深的造诣，作为核心专家参与《药品管理法》《疫苗管理法》制修订工作，并作为药品上市许可持有人制度、专利链接制度、专利补偿制度、药品数据保护制度、罕见病药物研发注册与激励、儿童用药研发注册与激励、生物制品注册分类制度改革等的论证和咨询专家。

【代表性论文】

[1] Luo X, Du X, Huang L, Guo Q, Tan R, Zhou Y, Li Z, Xue X, Li T, Le K, Qian F, Chow SC, Yang Y. The price, efficacy, and safety of within-class targeted anticancer medicines between domestic and imported drugs in China: a comparative analysis. Lancet Reg Health West Pac. 2022 Dec 28;32:100670.

[2] Luo X, Du X, Huang L, Guo Q, Lv X, Wang C, Liu H, Zhou Y, Xue X, Li Z, Liu J, Chow SC, Yang Y. Evidence of pre-approval clinical trial supporting the granted conditional approval for novel cancer drugs in China between 2015 and 2022. EClinicalMedicine. 2023 Aug 24;63:102177.

[3] Luo X, Du X, Li Z, et al. Clinical Benefit, Price, and Uptake for Cancer Biosimilars vs Reference Drugs in China: A Systematic Review and Meta-Analysis. JAMA Netw Open. 2023;6(10):e2337348. Published 2023 Oct 2.

[4]Luo X, Guo Q, Du X, Huang L, Chow SC, Yang Y. Evaluation of clinical trial designs for novel anticancer drugs in China: A cohort study of drugs approved between 2015 and 2021. Drug Discov Today. 2023 Jun;28(6):103578.

[5]Xiangchuan He a,b,c , Yiwen Pu a,b , Zeyu Li a,b, Shitong Huan d* and Yue Yang a,bThe global regulatory landscape for combined vaccines: a comparative case study of registration strategies for diphtheria-teta-3 nus-pertussis-containing vaccines, Vaccine, 2025

[6]Xu Y, Li X, Guo Q, Yang Y*. et al. Assessment of Efficacy Evidence for Approvals of Novel Drugs in China Between 2018 and 2022. Clin Pharmacol Ther. 2025;117(3):749-758.

[7] Xu Y, Guo Q, Chen Z, Liu Y, Yang Y. Overview of new indications for novel drugs approved in China between 2018 and 2024. Drug Discov Today. Published online March 21, 2025.

[8] He X, Zhang T, Huan S, Yang Y. Novel Influenza Vaccines: From Research and Development (R&D) Challenges to Regulatory Responses. Vaccines (Basel). 2023;11(10):1573. Published 2023 Oct 9.

[9]Chen Q, Xu Y, Qu R, Luo X, Yang Y. Clinical trial evidence supporting FDA approval of novel orphan drugs between 2017 and 2023. Drug Discov Today. 2024;29(9):104102.

[10]Li Y, Jiang Y, Wang H, Zhang L, Yang Y. Safety-Related Drug Withdrawals in China Between 1999 and 2021: A Systematic Investigation and Analysis. Drug Saf. 2022 Jul;45(7):737-745.

[11] Luo, X., Xu, Y., Du, X., Lv, X., Chen, S., Yang, Y., Huang, L., & Zhang, X. (2024). Progress and challenges of confirmatory trials for cancer drugs granted conditional approval in China. The Lancet regional health. Western Pacific, 52, 101238.

[12] Luo, X., Huang, L., Du, X., Yang, Y., Lv, X., & Zhang, X. (2023). Current regulatory status in China of drugs withdrawn from the US FDA accelerated pathway: Implications for regulation globally. The Lancet Oncology, 25(6), 703–706.

[13]Luo X, Du X, Lv X, Yang Y, Zhang X, Huang L. Clinical Benefit, Price, and Regulatory Approval of Cancer Drugs Granted Breakthrough Therapy Designation in China, 2020-2024. JAMA Netw Open. 2024 Oct 1;7(10):e2439080.

[14]Du X, Luo X, Guo Q, Jiang X, Su Z, Zhou W, Wang Z, Li J, Yang Y, Zhang Y. Assessment of clinical benefit, cost and uptake of biosimilars versus reference biologics in immune-mediated inflammatory diseases in China. Front Public Health. 2024 Dec 4;12:1476213.

[15]Xingxian Luo, Jingwen Liu, Xin Du, Jingshu Yang, Xiaomeng Jiang, Zhuangqi Li, Yifan Wu and Yue Yang, A comparative analysis of vaccine lists, prices, and candidates, and the national immunization program between China and the United States, January 2024,Acta Materia Medica 3(1).

【联系方式】

联系邮箱：yanghappy@tsinghua.edu.cn