Medical Isotope Development Plan: How To Break The "Bad Cycle" Of Nuclear Medicine Industry?

? ? ? ? Recently, the State Atomic Energy Agency, together with the Ministry of science and technology and other seven departments, officially released the medium and long term development plan for medical isotopes (2021-2035) (hereinafter referred to as the plan). This is the first programmatic document issued in China for the application of nuclear technology in the field of medical and health care, which is of great significance for improving the level of medical isotope related industries and ensuring the implementation of China's healthy strategy.

"After the promulgation of the" eight departments "plan, the lack of independent and original radioactive drugs in China will be greatly alleviated. In addition, relevant supporting policies may continue to be introduced to ease the problems of long supervision and mutual contradictions. At the same time, the approval and clinical use of radioactive drugs will also be accelerated. " Recently, Li Sijin, President of Shanxi Medical University, chairman of nuclear medicine of Chinese Medical Association and member of the CPPCC National Committee, who participated in the drafting of the plan, said in an exclusive interview with 21st century economic reporter.

? ? ?《 At present, cancer, neurodegenerative diseases, cardiovascular and cerebrovascular diseases have become the main factors that seriously threaten human health. Making use of the unique advantages of medical isotopes, diagnosis and treatment is an indispensable means to improve people's health level. By 2025, breakthroughs will be made in a number of key core technologies for the development of medical isotopes, and the construction of 1-2 special reactors for medical isotopes will be started in time to encourage social capital to enter and realize stable and independent supply of commonly used medical isotopes; By 2035, on the basis of fully ensuring the health needs of Chinese people, it will occupy a certain share in the global medical isotope supply system.

Li Sijin pointed out to the 21st century economic reporter that the promulgation of this programmatic document is actually to solve the problem of nuclear medicine development from the perspective of industrial chain and core foundation source. From the perspective of patients, this market is indeed huge. It is also understood that China's existing enterprises are in the layout, including China Tongfu, Dongcheng pharmaceutical and Yuanda pharmaceutical, which has entered the field in recent two years.

Nuclear medicine market space is large

It is understood that medical isotopes are the material basis for diagnosis and treatment of nuclear medicine. The use of medical isotopes in the diagnosis and treatment of major diseases such as cardiovascular and cerebrovascular diseases, malignant tumors and neurodegenerative diseases has irreplaceable advantages: in terms of diagnosis, it can make early diagnosis for lesions that have not yet undergone morphological and structural changes; In terms of treatment, it can achieve accurate removal of small lesions and achieve better therapeutic effect.

? ? ? Li Sijin said that in terms of diagnosis, many clinical treatment guidelines for tumors indicate that PET / CT, or positron imaging in nuclear medicine, is one of the most effective methods to diagnose tumors. For example, in lung cancer examination, because lung cancer is prone to bone metastasis, ect single photon imaging can see whether there is bone metastasis in the whole body. CT can accurately make the differential diagnosis, curative effect evaluation and clinical analysis of lung cancer; Before clinical diagnosis, PET / CT can be confirmed; After diagnosis, PET / CT imaging should be performed to determine whether the patient can undergo surgery. Studies have shown that about 30% - 50% of cancer patients, including lung cancer and other types of cancer, have changed the treatment plan after PET / CT examination.

? “ Another example is that patients with coronary heart disease need to do medical examination before cardiac stent surgery. The sensitivity, specificity and diagnostic accuracy of conventional ultrasound and ECG are far less than those of nuclear medicine. By doing a myocardial perfusion imaging in nuclear medicine, doctors can determine whether patients have myocardial ischemia and the location and scope of myocardial ischemia. Clinical data validation shows that only when the myocardial ischemia area is more than 10% of the heart, patients with cardiac stent surgery can reduce their mortality and improve their quality of life. However, if the ischemia is not serious or the scope of ischemia is very small, the death rate of patients will be increased by 2 times and the incidence of myocardial infarction will be increased by 4 times. In addition, patients who do not need stent implantation for cardiac stent surgery will not only be unable to obtain substantial clinical benefits, but also increase the invalid investment of tens of billions in national medical insurance Li Sijin believes that the future nuclear medicine examination method is expected to become the gold standard for the diagnosis of myocardial ischemia.

However, although nuclear medicine is widely used, some data show that there is a big gap between China and developed countries in Europe and the United States in terms of the types of medical nuclides and the number of drugs approved for marketing. In 2017, the global sales of nuclear drugs reached 4.5 billion US dollars, of which the United States accounted for 38%, Europe accounted for 24%, and China only accounted for less than 8%, At present, the penetration rate of nuclear drugs in China is far lower than that in mature European and American markets.

"The annual number of nuclear medical examinations in the United States is about 20 million, while the number of nuclear medical examinations in our country is less than 3.5 million." Li Sijin pointed out.

Zhou Chao, CEO of Yuanda pharmaceutical, pointed out to the 21st century economic reporter that the field of radioactive drugs is a treatment field with high growth and high barriers. The early growth of nuclear drug market is mainly driven by diagnostic drugs. As international pharmaceutical giants such as Bayer and Novartis enter the nuclear drug field, therapeutic nuclear drugs will become a new driving force in the global nuclear drug market. It is estimated that by 2030, the proportion of therapeutic nuclear drugs will reach 60%, and the market size will reach 24 billion US dollars. Compared with developed countries, China's nuclear medicine has a huge room for improvement in the number of equipment and inspection, as well as the number of nuclear drugs on the market.

There are many factors restricting the use of R & D

? However, there are still many deficiencies in the development and use of nuclear medicine in China.

Li Sijin pointed out that at present, many domestic radioactive drugs rely on imports, including some of the most commonly used radioactive drugs, such as technetium-99, which is used for nuclear medicine imaging and single photon imaging. Once foreign countries stop exporting, there will be thousands of patients can not get timely diagnosis and treatment.

"Another nuclear drug is iodine-131 for hyperthyroidism and postoperative treatment of thyroid cancer. Iodine-131 is the most commonly used drug in nuclear medicine. More than 80000 thyroid cancer patients and 150000 hyperthyroidism patients need iodine-131 treatment every year. However, our domestic iodine-131 can only meet the needs of 20% of patients, and 80% of them need to rely on import. " Li Sijin further gave an example.

In addition, according to Li Sijin, as of the end of 2019, only 1148 hospitals in China have opened nuclear medicine discipline, of which more than 960 of 2760 tertiary hospitals have opened nuclear medicine discipline, and only more than 100 of nearly 10000 secondary hospitals have opened nuclear medicine discipline. This means that 65% of the tertiary hospitals and 99% of the secondary hospitals in China have no nuclear medicine discipline, which further reveals that many patients in our country can not get timely diagnosis and treatment of nuclear medicine.

In terms of drug research and development, China's R & D of radioactive drugs also started late and made slow progress, lacking of independent and original radiopharmaceuticals, especially some therapeutic radiopharmaceuticals.

The shortage of radionuclide raw materials is the pain of the development of radiopharmaceuticals in China. However, the basis of radiopharmaceuticals is medical isotopes. In China, medical isotopes, especially those for therapeutic use, are still lacking, which seriously limits the research and clinical transformation of radiopharmaceuticals α The supply of particulate radionuclides is almost entirely blank.

Li Sijin pointed out to the 21st century economic reporter that the bottleneck of the development of China's radiopharmaceuticals is not only the supply of high-quality medical nuclides, but also from the lack of clarity of relevant supporting policies for the radioactive drug industry. The scientific supervision and related matching management policies of the radiopharmaceutical industry need to be issued as soon as possible“ In fact, enterprises in our country are capable of R & D, but they have no enthusiasm. " Li added.

Li Sijin further pointed out some restrictive factors in the research and development of radiopharmaceuticals in China. First of all, there are few nuclear medicine departments in our country's hospitals, and correspondingly fewer patients use radioactive drugs clinically. However, it takes a long time for enterprises to develop drugs, but the corresponding market is insufficient after research and development. Therefore, enterprises lack the enthusiasm of research and development.

Secondly, the national registration and approval time for radioactive drugs is very long. In recent ten years, almost no new radioactive drugs have been approved. After the enterprises invest capital in R & D, they have to go through a long approval process, and their enthusiasm for R & D will also be reduced. At present, some top three hospitals, especially teaching hospitals, are also developing some new drugs, but they are doing some small-scale clinical experiments and using them internally, because each hospital has no ability to invest a lot of money in commercial transformation.

In fact, this is a vicious circle. There are few nuclear medicine departments in China, and the corresponding production of radioactive drugs is less; Less drug production, less dosage; If the dosage is small, the relevant enterprises will not have the enthusiasm to invest, but as mentioned above, the real market demand for radioactive drugs is actually very huge.

The bottleneck is being broken

Li Sijin believed that with the release of the plan and the improvement of relevant supporting policies, the bottlenecks and problems encountered in nuclear medicine in China will be gradually broken through and solved.

According to the plan, breakthroughs in a number of key core technologies restricting the development of medical isotopes should be achieved in 2025, the existing production facilities and supporting support conditions should be gradually improved, the construction of 1-2 medical isotope production reactors should be started, and the production of medical isotopes such as molybdenum-99, iodine-125, iodine-131, strontium-89 and phosphorus-32 will be gradually restored, To establish the production capacity of medical isotopes such as ge-68 / Ga-68 generator, and promote the situation that medical isotope supply is controlled by people.

It is understood that there are three main production methods of medical radionuclides: reactor, medical cyclotron and generator. At present, with the aging and decommissioning of domestic reactors, and under the state's plan of focusing on scientific research tasks and supplemented by medical isotope production, radionuclide production has almost stopped after 2008, and the main medical isotope raw materials basically rely on imports. In terms of medical accelerators, there are more than 130 domestic accelerators and target systems for mass production of various nuclides, which seriously restricts the R & D and manufacturing of radiopharmaceuticals in China.

According to the plan, the key tasks for the development of medical isotopes include improving the research and development technology capacity of accelerator, the production capacity of existing reactors, and the construction of new medical isotope production reactors.

Li Sijin said that after the promulgation of the eight departments' plan, the state has made it clear to build 1-2 civilian reactors, which will greatly ease the lack of indigenous and original radioactive drugs in China. In addition, some related supporting policies may continue to be introduced to alleviate the problems of multi supervision and mutual contradiction. Meanwhile, the approval and clinical use of radioactive drugs will also be accelerated. This actually solves some source problems from the industrial chain.

Li Sijin further said that hospitals would benefit from the completion of the reactor. At the same time, the State supports the establishment of nuclear medicine discipline, and the full coverage of tertiary hospitals will be realized by 2025. With the increase of nuclear medicine disciplines, the sales of drugs produced will also increase. This is a virtuous circle, which can not only meet the needs of domestic nuclear medicine, but also be exported to the "belt and road" countries.

At the same time, the plan proposes to coordinate social resources, encourage social capital to enter the field of medical isotopes, and form a government guided and market-oriented medical isotope promotion and application system.

Zhou Chao pointed out to the 21st century economic reporter that encouraging the entry of social capital will also accelerate the development of the industry“ In China, the core positioning of capital market is to serve the real economy. The idea of introducing capital water to promote the rapid development of medical isotope industry is also reflected in the plan. In this regard, various departments will optimize industrial policies to drain social capital. The release of the plan is not only an opportunity for isotope subdivision, but also an important boost for the development of the whole nuclear medicine industry. With the support of national strategy, the nuclear medicine industry based on medical isotopes will usher in rapid development. "

Li Sijin believed that the release of the plan is an important boost to the development of the whole nuclear medicine industry, and the nuclear medicine industry based on medical isotopes will usher in rapid development.

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