放射性核素偶联药物的研究进展及技术评价层面的思考
Research progress in radionuclide drug conjugates and considerations on its technology evaluation
王佳静 1张静烨 1董文彬 1陈一飞 1陈桂良 1颛孙燕1
作者信息
- 1. 上海药品审评核查中心 上海 201210
- 折叠
摘要
随着核医疗、核技术和分子生物学的发展,放射性配体疗法逐渐成为精准医疗的一个重要发展方向.国内通常将放射性配体疗法药物称为放射性核素偶联药物.这类药物通过将靶向配体分子与不同的放射性核素偶联,将放射性核素递送至特定肿瘤部位,产生诊断或治疗功能.本文分析放射性核素偶联药物的研究进展及技术评价层面面临的问题,并提出相关思考和研究思路,为我国药品监管部门制定相应的政策和措施提供参考.
Abstract
With the development of nuclear medicine,nuclear technology and molecular biology,radioligand therapy has become an important development direction of precision medicine.In China,radioligand therapy drugs are usually called radionuclide drug conjugates(RDC).These drugs deliver radionuclides to specific tumor sites by coupling targeted ligand molecules to realize different functions of diagnosis or treatment.This article analyzes the research progress of RDC and the issues faced at the level of technical evaluation,and puts forward relevant reflections and research paths,aiming to provide reference for China's drug regulatory authorities to formulate corresponding policies and measures.
关键词
放射性配体疗法/放射性核素偶联药物/研发Key words
radioligand therapy/radionuclide drug conjugates/R&D引用本文复制引用
出版年
2024
NETL
NSTL
万方数据