Break import dependence!Sichuan has achieved large-scale production of key medical isotopes

2022-06-22 0 By

On February 2, the Institute of Nuclear Physics and Chemistry of The Chinese Academy of Engineering Physics (hereinafter referred to as “the second Institute of The Chinese Academy of Science”) announced that through continuous key research,Recently, the institute has made substantial progress in the large-scale production of GMP luteium-177 API, the establishment of product quality standards, the research and development of new drugs and clinical transformation, and has reached a new level.Luteium-177 products without carrier said luteium-177, we may not be familiar, it belongs to radioactive medical isotope.Medical isotopes are the material basis for the diagnosis and treatment of nuclear medicine. They have irreplaceable advantages in the diagnosis and treatment of major diseases such as cardiovascular and cerebrovascular diseases, malignant tumors and neurodegeneration.Luteium-177 is one of the most important and common nuclides, and with its excellent nuclide properties, luteium-177 has become the most promising nuclide for targeted radiation therapy.Combined with a variety of targeted molecular marker drugs, it has achieved remarkable curative effect in the clinical targeted radiation therapy of neuroendocrine tumor, prostate cancer and other malignant tumor diseases.More than 90% of the medical isotopes used in China have been imported, which leads to a shortage of medical isotopes and often cut off supplies.Luteium-177 solution is no exception, and it is difficult, slow and expensive to use in clinical research.2 class lutetium – 177 drug GMP production line To achieve the stability of the commonly used medical isotopes of autonomous supply, since 2018, the second ZhongWuYuan by relying on mianyang research reactor, nuclear energy development in the country with science and technology of sichuan province under the support of major projects, start no carrier lutetium – 177 independent large-scale production key technology research and application of industrialization.At the end of 2019, they took the lead in developing a carrier free luteium-177 product with independent intellectual property rights in China, achieving the first carrier free luteium-177 Curie grade domestic mass production, and successfully applied it in clinical pre-research and new drug development.2 class lutetium – 177 drug products Through continuous research, project team broke through the relevant key core technology, developed a high efficiency, less waste, stable and reliable, satisfies the requirement of injection drug raw materials without carrier lutetium – 177 large-scale production technology, built the engineering production line, realized the whole process of independent innovation, single production capacity of up to 25 ci/time,Annual production capacity has exceeded 1000 curies.The project team independently established the quality inspection and verification method for luteium-177 products without carrier, and formed and published the first technical standard for medical nuclide raw materials in China, providing effective specifications for luteium-177 products.At present, independent GMP luteium-177 products have been officially on the market.ZhongWuYuan ii and also the first hospital affiliated to nanjing medical university, southwest medical university affiliated hospital, west China hospital of sichuan university and so on more than 20 medical research and develop the new drugs and new drug research and development institutions and clinical research, to solve the nuclide dependence on imported raw materials, drug use, drug use in clinical research the key problems of slow, medication expensive.The first class 2 luteium-177 new drug developed by the institute in cooperation with pharmaceutical companies in China has successfully completed clinical application and been accepted by the Drug Evaluation Center of the State Medical Products Administration. A number of class 1 new drug r&d projects are in progress.The relevant person in charge of the second Institute of Chinese Academy of Sciences said that the large-scale production and clinical application of fully independent GMP-grade luteium-177 raw material solution greatly enhanced the confidence of radiopharma and nuclear medicine industry in the independent radionuclide, and accelerated the clinical use and r&d registration of luteium-177 drugs approved internationally in China.It significantly promoted the development and transformation of luteium-177 targeted innovative drugs in China.The above person in charge said that in the future, the second Institute of Chinese Academy of Science will further promote the domestic carrier free luteium-177 and iodine-131, realize the domestic production of molybdenum-99 as soon as possible, simultaneously carry out the research and development of a series of new targeted label drug release, complete the project demonstration, and accelerate the construction of China’s medical isotope and drug independent guarantee system.The copyright of this article belongs to the original author, if there is a source error or infringement of your legitimate rights and interests, you can contact us through email, we will deal with it in time.Email address: jpbl@jp.jiupainews.com