Abstract:
This study examines the current state of medical radioisotope production in China. It aims to evaluate production technologies, industrial applications, and clinical impacts of diagnostic and therapeutic radioisotopes. The work identifies barriers to progress, including limited infrastructure and a reliance on imported materials. It proposes solutions to enhance self-sufficiency and scalability. The ultimate goal is to strengthen nuclear medicine for diagnosing and treating diseases like cancer, heart conditions, and neurological disorders. A systematic literature review was performed, covering peer-reviewed articles, industry reports, and government documents from 2015 to 2025. Radioisotopes were categorized into diagnostic isotopes for single-photon emission computed tomography(SPECT), such as
99Tc
m,
123I, and
201Tl; diagnostic isotopes for positron emission tomography(PET), including
68Ga,
64Cu, and
89Zr; and therapeutic isotopes, such as
131I,
177Lu,
90Y,
225Ac, and
211At. For each isotope, key parameters such as half-life, decay type, and production method were reviewed. The historical progress in isotope development was summarized, and efforts in the preparation of specific radioisotopes were evaluated. Additionally, the availability of target materials and the role of production infrastructure, including cyclotrons, research reactors, and generator systems, were analyzed to assess scalability. China has achieved significant progress in medical radioisotope production.
99Tc
m and
68Ga production increases due to advanced generator technologies,
64Cu, and
89Zr has achieved scale production. These isotopes support widespread use in cancer imaging and molecular diagnostics. Several β-emitting therapeutic isotopes, including
125I,
89Sr, and
90Y, have achieved partial domestic production, marking progress toward reducing reliance on imported radioisotopes. The output of carrier-free
177Lu has also advanced, enabling its application in targeted radionuclide therapies for neuroendocrine tumors. Alpha-emitting isotopes, such as
225Ac and
211At, demonstrate strong therapeutic potential in oncology. However, their development remains constrained by limited production capacity and supply chain challenges. Over 90% of target materials(e.g.,
160Gd,
176Yb) are imported. High-energy accelerators and reactors remain insufficient. Despite these challenges, national policies have played a critical role in promoting research and investment, including the 《Medium- and Long-Term Development Plan for Medical Radioisotopes(2021–2035)》 and the 《Three-Year Action Plan for High-Quality Development of Nuclear Technology Applications(2024–2026)》. China’s medical radioisotope sector is experiencing rapid growth, driven by policy support and increasing clinical needs. However, reliance on imported materials and insufficient infrastructure hinder progress. Solutions include expanding high-energy cyclotron and reactor capacity, localizing the production of target materials, and integrating automation for quality control. Artificial intelligence enhances process optimization and data analysis. Investment in research, workforce training, and international collaboration is critical. These steps ensure a sustainable and self-reliant radioisotope supply, thereby improving access to nuclear medicine and advancing healthcare outcomes in China.