Opinions of the People's Government of Sichuan Province on Promoting the High-Quality Development of the Nuclear Medicine Industry
2024-07-23 00:00

People’s Governments of All Cities (Prefectures), Departments of the Provincial Government, Directly Affiliated Agencies, and Relevant Units:

To fully leverage the unique resource advantages of Sichuan as a major nuclear industry province, vigorously develop an independent and controllable nuclear medical industry, accelerate the addressing of shortcomings in China’s medical isotopes, radiopharmaceuticals, high-end nuclear medical equipment, and the translational application of nuclear medicine, and make every effort to build a world-class hub for the nuclear medical industry, the following opinions are hereby put forward.

I. General Requirements

Guided by Xi Jinping Thought on Socialism with Chinese Characteristics for a New Era, we will fully implement the spirit of the 20th National Congress of the Communist Party of China and carry out the arrangements made at all plenary sessions of the 12th Provincial Party Committee. We will position the nuclear medical industry as a key sector for developing new-quality productive forces,We will adhere to the fundamental principles of innovation-driven development, scientific planning, cluster formation, and safe development. We will focus on building an autonomous, controllable, comprehensive, and advanced nuclear medical industry system, and create a domestically leading, world-class nuclear medical industry cluster. This will contribute to the high-level self-reliance and self-strengthening of the national nuclear medical industry and provide strong support for safeguarding the health and lives of the people.

By 2027, we aim to achieve domestic self-sufficiency in the supply of more than 10 major medical isotopes, with at least five radiopharmaceuticals and high-end nuclear medical devices either completed or entering clinical trials. We will establish a standardized system for medical isotopes, radiopharmaceuticals, and nuclear medical equipment, as well as a comprehensive system for clinical translation, research, and diagnosis and treatment in nuclear medicine, thereby building a domestically leading nuclear medical industry cluster.By 2030, we will establish the world’s largest medical isotope production base, the nation’s largest hub for radiopharmaceuticals and nuclear medical equipment production, and the country’s premier nuclear medicine center, thereby creating a world-class hub for the development of the nuclear medicine industry.

II. Overall Layout

Focusing on key regions such as Leshan, Chengdu, Mianyang, and Luzhou, we will advance scientific and technological innovation and the industrialization of scientific achievements in an integrated manner. We will concentrate efforts on building a full industrial chain that spans medical isotope production, radiopharmaceutical R&D, nuclear medical equipment manufacturing, and clinical application promotion, forming a “One Chain, Four Hubs” development pattern.Fully leveraging Leshan’s reactor resources, we will focus on building a production hub for medical isotopes and radionuclide APIs; fully leveraging Chengdu’s platform and talent pool, we will focus on building a R&D and production hub for radiopharmaceuticals; fully leveraging Mianyang’s first-mover advantage in new radiotherapy technologies, we will focus on building a manufacturing hub for high-end nuclear medical equipment; and fully leveraging Luzhou’s pioneering advantage in integrated nuclear medicine diagnosis and treatment, we will focus on building a hub for clinical translation and application.

III. Key Tasks

(1) Ensure a stable supply of key medical isotopes. Promote the completion and commissioning of dedicated production reactors for solution-based medical isotopes; accelerate the renovation of the Minjiang Experimental Reactor; enhance supporting production capabilities such as isotope separation and purification at the reactor facility; and achieve stable production and supply of medical isotopes such as molybdenum-99 and lutetium-177.Accelerate the completion of the medium-to-high-energy accelerator-based isotope production project to ensure a stable supply of medical isotopes such as Actinium-225, Copper-64, and Germanium-68 (Gallium-68).Support research and development of key technologies for medical isotope generators to ensure a stable supply of medical isotopes such as strontium-90/yttrium-90, dysprosium-166/holmium-166, and tungsten-188/rhenium-188. Strive to establish a National Medical Isotope Demonstration Center.

(2) Intensify research, development, and production of radiopharmaceuticals. Relying on high-level innovation platforms such as national key laboratories and engineering research centers, strengthen research and development of original targets; support joint development with enterprises of dual-target and multi-target radiopharmaceuticals; overcome technical challenges in the combined use of radiopharmaceuticals with immunotherapy and chemotherapy; and explore the research and testing of cutting-edge medical isotopes in radiopharmaceuticals.Intensify research and development of radiolabeled drugs, support the development of innovative radiolabeled drugs with precise targeting capabilities—including antibodies, peptides, and small molecules—and promote the production and application of highly specific diagnostic tracers, radiotherapeutic agents, and integrated radiodiagnostic and therapeutic drugs. For major radiodiagnostic and therapeutic drug varieties that are already marketed and clinically established abroad, intensify technological R&D and clinical trials to develop a range of domestically produced alternatives.Actively attract leading enterprises in the industry to establish radiopharmaceutical R&D centers and production bases in Sichuan.

(3) Achieve breakthroughs in the domestic production of high-end nuclear medical equipment. Accelerate the R&D and production of high-energy accelerators, and promote domestic substitution for high-end nuclear medical imaging equipment such as single-photon emission computed tomography (SPECT/CT) and positron emission tomography (PET/CT) systems.Accelerate medical mechanism research, technical breakthroughs, equipment R&D, and clinical validation for Flash Radiotherapy (FLASH) equipment to achieve mass production and market launch as soon as possible; advance technical breakthroughs in boron neutron capture therapy (BNCT) equipment, multi-chamber proton therapy equipment, and heavy-ion therapy systems to accelerate industrialization. Actively attract leading industry enterprises to establish integrated diagnostic, therapeutic, and clinical equipment facilities in Sichuan.

(IV) Establish and Improve the Nuclear Medicine Clinical Application System. Promote the development of nuclear medicine departments in tertiary public general hospitals within the province; starting in 2025, include nuclear medicine department development plans as a key evaluation criterion in the accreditation and re-accreditation of new tertiary public general hospitals.Deeply implement the “One County, One Department” nuclear medicine promotion plan to establish distinctive nuclear medicine departments. Complete and put into operation the West China International Cancer (Heavy Ion and Proton) Treatment Center, and encourage medical institutions such as West China Hospital of Sichuan University, Sichuan Provincial Cancer Hospital, Nuclear Industry 416 Hospital, Mianyang Central Hospital, and Chengdu Fifth People’s Hospital to upgrade and renovate their in-house nuclear medicine departments and optimize the allocation of clinical resources for radionuclide therapy.Advance the construction of the Oncology Nuclear Medicine Center at the Affiliated Hospital of Southwest Medical University to expand the scope of nuclear medicine applications, meet multi-level and diverse nuclear medicine service needs, and actively establish a nuclear medicine wellness destination with international influence. Support Chengdu, Mianyang, and other regions in accelerating the development of nuclear medicine diagnostics and treatment while ensuring safety, and encourage qualified Grade A tertiary hospitals to seek qualifications for the clinical evaluation of radiopharmaceuticals.

(5) Create distinctive industrial clusters.Emphasizing the principle of “one park, one focus,” we will accelerate infrastructure development in key parks and enhance supporting service capabilities. We will support the Leshan Nuclear Technology Application Industrial Park in prioritizing the development of medical isotopes; the Chengdu Tianfu International Bio-City and Chengdu Medical City in prioritizing the development of radiopharmaceuticals; the Mianyang Nuclear Medicine and Healthcare Industrial Park in prioritizing the development of high-end nuclear medicine equipment; and the Luzhou Nuclear Medicine Diagnostic and Treatment Service Industrial Park in prioritizing the development of distinctive medical and wellness services, thereby promoting the clustered development of the nuclear medicine industry.

(6) Promote industrial integration and upgrading. Fully leverage new-generation information technologies such as artificial intelligence and big data to empower the research and development, clinical trials, registration, production, diagnosis, and treatment of radiopharmaceuticals and nuclear medical equipment. Support the establishment of precision nuclear medicine molecular imaging centers to enable visual, quantitative, and precise clinical drug assessment, effectively facilitating preclinical efficacy screening of innovative drugs and accelerating the clinical trial process. Encourage qualified medical institutions to advance full-cycle smart nuclear medical services.

(7) Enhance public service capabilities for the industry. Support Leshan in building a metrology, inspection, and testing platform for medical radioisotopes, as well as a platform for the research, development, and production of isotope reference materials and labeled compounds. Support Chengdu in establishing a service platform for the preclinical safety and efficacy evaluation of radiopharmaceuticals and a radiopharmaceutical inspection and testing platform, and actively seek to establish a review and evaluation center for pharmaceuticals and medical devices, including nuclear medicine drugs and devices.Support Mianyang in establishing a testing, inspection, and certification platform for nuclear medicine equipment. Support Luzhou in strengthening clinical skills training in nuclear medicine. Support the China Academy of Engineering Physics and the China Nuclear Power Design Institute in establishing a radioactive nuclear waste treatment service platform, and support West China Hospital of Sichuan University in establishing the Sichuan Provincial Engineering Technology Research Center for Radionuclide Drug R&D and Clinical Translation. Relying on various public service platforms, strengthen the training of professional and technical personnel to enhance the capacity for generating technological innovations and providing talent support that serves the province and extends nationwide.

(8) Strengthen the development of intellectual property and standardization systems. Establish a “green channel” for the expedited review of patent applications for medical isotopes, radiopharmaceuticals, and nuclear medical equipment; enhance the overseas deployment of intellectual property; and strengthen the protection of intellectual property rights for key core technologies.Conduct systematic research on quality standards and specifications for major medical isotopes, and accelerate the formulation of medical quality standards for isotopes; expedite the development of standards for high-end nuclear medical equipment such as X-ray Flash Therapy (X-FLASH); promote the formulation of preclinical evaluation standards for radiopharmaceuticals, and improve clinical application specifications and guidelines for radiopharmaceuticals. Support key enterprises and research institutes in leading or participating in the formulation of relevant industry and national standards to enhance the industry’s influence.

(9) Strengthen the development of professional talent teams. Support qualified universities and research institutions in optimizing their academic programs; promote the establishment of specialized schools of nuclear medicine at institutions such as Southwest Medical University; and support universities including Sichuan University, Southwest Medical University, and North Sichuan Medical College in intensifying efforts to cultivate master’s and doctoral students in nuclear medicine and nuclear pharmacy, while providing preferential treatment in enrollment quotas.Promote the integration of industry and education, as well as the convergence of vocational and general education, to establish a talent cultivation system for nuclear medicine encompassing medicine, pharmacy, nursing, and technical fields. Relying on initiatives such as the “Tianfu Qingcheng Plan” and the “Tianfu Emei Plan,” vigorously cultivate and attract high-level talents and teams urgently needed by the industry, and improve incentive mechanisms for practitioners.

(10) Accelerate the expansion of domestic and international markets. Encourage medical institutions within the province to legally procure and use the first-of-their-kind sets of nuclear medical equipment and innovative drugs “Made in Sichuan.” Relying on medical institutions such as West China Hospital of Sichuan University, Sichuan Provincial People’s Hospital, Sichuan Provincial Cancer Hospital, the affiliated hospitals of Southwest Medical University, and Mianyang Central Hospital, we will carry out multi-channel cooperation. We will encourage key nuclear medical enterprises to strengthen exchanges with countries and regions along the “Belt and Road” route, helping “Made in Sichuan” nuclear medical products expand into domestic and international markets.Host the World Nuclear Medicine Industry Conference to establish an internationally influential platform for nuclear medicine exchange and cooperation.

IV. Support Measures

(1) Strengthen policy support. The Provincial Party Committee’s Office for Military-Civil Fusion and the Department of Economy and Information Technology shall take the lead in providing policy guidance for key sectors such as medical isotopes, radiopharmaceuticals, and nuclear medical equipment, and increase efforts to foster and support these industries. The Provincial Medical Insurance Bureau shall include eligible radioactive diagnostic and therapeutic costs within the scope of medical insurance fund coverage in accordance with regulations. The Provincial Development and Reform Commission shall prioritize the inclusion of nuclear medical projects that align with industrial layout in national and provincial lists of major projects.The Department of Natural Resources shall ensure land allocation for key nuclear medicine projects that meet the criteria. Insurance companies are encouraged to launch specialized insurance products for nuclear medicine. Key regions are encouraged to introduce targeted support policies.

(2) Increase financial support. The Provincial Development and Reform Commission, the Department of Finance, and the People’s Bank of China Sichuan Branch shall support eligible localities in applying for and issuing local government special bonds, ultra-long-term special treasury bonds, and medium- to long-term loans for the manufacturing sector. The Provincial Office for Military-Civil Fusion, the Department of Economy and Information Technology, the Department of Science and Technology, and the Provincial Health Commission shall provide support to eligible projects from relevant special funds within their respective sectors, while actively seeking support from central government special funds. Enterprises are encouraged to actively seek government-guided funds and state-owned capital funds.

(3) Enhance Safety Protection and Assurance Capabilities. Balancing high-quality development with high-level security, competent authorities across all sectors and localities developing the nuclear medicine industry must adhere to the “zero-tolerance” safety standard. They must strictly implement relevant laws and regulations, including the Nuclear Safety Law of the People’s Republic of China and the Administrative Measures for Radioactive Drugs, and ensure that national regulations and standards regarding the safety protection of radioactive isotopes are integrated into every stage and aspect of the nuclear medicine industry’s research and development, production, storage, transportation, operation, inspection, use, and disposal.Process supervision and quality control must be strengthened. Regulatory models for radiation safety licensing, radioactive isotope approvals, and the circulation of radiopharmaceuticals should be optimized to continuously improve safety risk management across the entire nuclear medicine industry chain. Radiation safety detection and monitoring in nuclear medicine must be enhanced, data sharing for radiation safety supervision promoted, and emergency response plans formulated and improved to continuously elevate monitoring, early warning, and emergency response capabilities.

(4) Foster a favorable development environment. Fully leverage the guiding role of the media to intensify publicity efforts regarding major scientific and technological innovations, exemplary enterprises, and talent pools within the nuclear medicine industry. Strengthen the dissemination of scientific knowledge regarding radiopharmaceuticals and high-end nuclear medicine equipment, and organize community outreach activities to promote nuclear medicine science, thereby creating a favorable social atmosphere that fosters the innovative development of the nuclear medicine industry.

People’s Government of Sichuan Province

July 23, 2024

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