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我国放射性药物创新体系发展战略研究
Development Strategy for Innovation System of Radiopharmaceuticals in China
核医学在多种疾病的诊疗及预后判断方面发挥着不可替代的作用；放射性药物（放药）是核医学发展的基石，相应体系化发展有助于加快放药创新与应用，保障人民身体健康。本文深入调研了数十年来放药研究方向的文献，实地走访了国内10 余家核医疗相关高校、研究院所、医院及企业，以邀请专家开展咨询交流与行业研讨等方式，相对全面地掌握了放药研制和应用领域的发展态势与格局。在分析国外放药发展现状、技术水平及趋势的基础上，总结了我国放药发展的基本情况并辨识了面临的迫切问题；从技术研发体系、技术监管体系两方面阐述了重点建设内容，提出了放药靶点研究及靶向结构开发，新型放射性标记，放药自动化、智能化、规模化可控制备，放药辐射剂量检测及评价、放药联合诊疗等关键技术突破点。研究建议，以临床为导向鼓励多学科交叉融合的创新发展，加快放药技术创新体系建设，加强放药研发专业化人才队伍建设，以此促进核医学水平的整体提升。
Nuclear medicine plays an irreplaceable role in the diagnosis, therapy, and prognosis of various diseases. Radiopharmaceuticals are the cornerstone of nuclear medicine; their systematic development could accelerate the innovation and clinical application of radiopharmaceuticals to ensure people's health. In this study, we conducted in-depth research on the literature on the research direction of radiopharmaceuticals, visited over 10 domestic universities, institutes, hospitals, and enterprises related to nuclear medicine, and invited experts to conduct consultation, exchange, and industry discussion, to grasp the development trend and pattern of the research and application of radiopharmaceuticals in a relatively comprehensive way. Based on the analysis of the current status, technical level, and trend of radiopharmaceuticals in China and abroad, the development status of radiopharmaceuticals in China is summarized and the urgent problems faced are identified. This study introduces the contents that need to be focused on from two aspects: the technology research and development (R&D) system and the technology supervision system, and proposes key technological breakthroughs including the study on radiopharmaceutical targets and development of targeted structures; new radio-labelling; automatic, intelligent, and large-scale controllable preparation of radiopharmaceuticals; detection and evaluation of radiation dose of radiopharmaceuticals; and combined diagnosis and therapy of radiopharmaceuticals. The study suggests to (1) encourage the innovative development of interdisciplinary integration with a clinical orientation; (2) accelerate the construction of a technological innovation system for radiopharmaceuticals; and (3) strengthen the construction of a professional team for the R&D of radioactive drugs, so as to promote the overall improvement of nuclear medicine.
核医学 / 放射性药物 / 放药审评 / 靶向药物 / 核素诊疗
nuclear medicine / radiopharmaceuticals / radiopharmaceutical evaluation / targeted medicine / radionuclide diagnosis and therapy
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