中国放射性药物的发展现状及趋势  

Current Status and Future Perspective of Radiopharmaceuticals in China

作　　者：杜进 黄旭虎 宋志浩 马承伟 李洪玉 DU Jin;HUANG Xuhu;SONG Zhihao;MA Chengwei;LI Hongyu(China Isotope&Radiation Corporation,Beijing 100089,China;CAEA Center of Excellence on Nuclear Technology Applications for Engineering and Industrialization of Radiopharmaceuticals,Beijing 102413,China;CNNC Engineering Research Center of Radiopharmaceuticals,Beijing 102413,China;HTA Co.,Ltd.,Beijing 102413,China)

机构地区：[1]中国同辐股份有限公司,北京100089 [2]国家原子能机构核技术(放射性药物工程转化)研发中心,北京102413 [3]中核集团放射性药物工程技术研究中心,北京102413 [4]原子高科股份有限公司,北京102413

出　　处：《原子能科学技术》2024年第S02期231-240,共10页Atomic Energy Science and Technology

摘　　要：放射性药物是核医学发展的重要内容和精准医学的基石,为疾病的早期诊断、及时治疗提供了新的手段和途径。2021年6月,国家原子能机构、科技部、国家药品监督管理局等八部委发布《医用同位素中长期发展规划(2021-2035年)》(简称规划),对中国放射性药物的产业发展起到积极的推动作用,具有重要意义。本文主要综述规划发布以来我国医用同位素制备的研究进展以及在我国开展临床试验研究的新型放射性药物的最新进展,总结了我国放射性药物的申请和审批现状,并对放射性药物未来的发展方向提出了建议。The radiopharmaceutical is an essential component of nuclear medicine and serves as one of the cornerstones for molecular imaging and precision medicine,which provides new means and approaches for early diagnosis and treatment of diseases.The Mid-and Long-term Development Plan(2021-2035)for Medical Isotopes(Plan for short)was jointly issued by eight state departments including the China Atomic Energy Authority,the Ministry of Science and Technology and the National Medical Products Administration in June 2021,which plays a positive role in promoting the development of the radiopharmaceutical industry in China.In this paper,the latest development in the new technologies and the construction of mass production capacity of medical radioisotopes and the latest progress in the clinical translation of radiopharmaceuticals especially for those that have already been conducted clinical trial studies since the release of the Plan were summarized.The new progress has been made in the development of new technologies and the construction of mass production capacity by using reactors and accelerators to produce medical radioisotopes such as 99Mo,177Lu,64Cu,103Pd,123I,89Zr,225Ac,etc.In recent years,with the support of national policies,the explosive progress has been made in the research and development,clinical translation of diagnostic and therapeutic radiopharmaceuticals.The radiopharmaceuticals developed and under clinical translation in China are mainly concentrated in the following categories:1)central nervous system radiotracers forβ-amyloid plaques;2)tumor imaging agents including novel PSMA,FAP,HER2,PD-L1 targeted radiotracers,dual target radiotracers targetingαⅤβ3-GRPR,αⅤβ3-FAP,αⅤβ3-CD13 etc.,boramino acids based radiotracers,and antibody such as Claudin18.2 based radiotracers;3)theranostic radiopharmaceuticals including Al18F-PSMA-Q/[177Lu]Lu-PSMA-Q for prostate cancer and 68Ga/177Lu-DOTA-IBA for tumor bone metastasis;4)211At and 225Ac-labelled radiopharmaceuticals for tumor targeted alpha therapy.Meanw

关 键 词：医用同位素 放射性药物 发展现状 趋势 

分 类 号：TL99[核科学技术—核技术及应用] R816[医药卫生—放射医学]