中国放射性药物的发展现状及趋势

Current Status and Future Perspective of Radiopharmaceuticals in China

  • 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。

     

    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, 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 for β-amyloid plaques; 2) tumor imaging agents including novel PSMA, FAP, HER2, PD-L1 targeted radiotracers, dual target radiotracers targeting αβ3-GRPR, αβ3-FAP, αβ3-CD13 etc., boramino acids based radiotracers, and antibody such as Claudin18.2 based radiotracers; 3) theranostic radiopharmaceuticals including Al18F-PSMA-Q/177LuLu-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.

     

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