摘要
Abstract
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,1231,89Zr,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 for β-amyloid plaques;2)tumor imaging agents including novel PSMA,FAP,HER2,PD-L1 targeted radiotracers,dual target radiotracers targeting αvβ3-GRPR,αvβ3-FAP,αvβ3-CD13 etc.,boramino acids based radiotracers,and antibody such as Claudinl8.2 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.Meanwhile,the current status of radiopharmaceuticals under clinical trial,registration and marketing authorization application in China was also briefly introduced.Multiple radiopharmaceuticals targeting SSTR2,PSMA,FAP are currently undergoing clinical trial studies.Finally,the future perspective and suggestions for the research and development of radiopharmaceuticals in China are discussed.关键词
医用同位素/放射性药物/发展现状/趋势Key words
medical radioisotope/radiopharmaceuticals/current status/future perspective分类
能源科技
