On April 22nd, according to a public announcement from China National Nuclear Corporation (CNNC), today, CNNC's subsidiary China Isotope & Radiation Corporation (CIRC) announced: the first domestic production line capable of producing terabecquerel-grade lutetium-177 without a carrier per year, and the annual production capacity of kilobar-grade germanium-gallium [68Ge-68Ga] generators have been fully completed and put into operation.
This marks China's official capability to produce and supply terabecquerel-grade lutetium-177 and gallium-68, two medical isotopes, achieving true domestic large-scale commercial supply and effectively alleviating the problem of insufficient domestic supply and dependence on imports for these two isotopes.
It is reported that two products from China National Nuclear Corporation (CNNC), Lutetium-177 and Gallium-68, meet the standards set by the European Medicines Agency (EMA) in terms of production line design, manufacturing technology, quality indicators, equipment facilities, and management systems, placing them at the forefront globally.
Additionally, CNNC can now formally supply the emerging radionuclides Terbium-161 and Scandium-47 at Curie level.
Lutetium-177 possesses excellent radiophysical properties and coordination chemistry, allowing it to be labeled with monoclonal antibodies, peptides, and other small molecules for targeted radionuclide therapy in various diseases.
Its labeled drugs have shown significant clinical advantages in the treatment of prostate cancer and neuroendocrine tumors.
Gallium-68 is a highly attractive positron-emitting radionuclide used in the preparation of radiopharmaceuticals through coordination labeling.
Compared to traditional non-metallic nuclide-labeled peptides and other small molecules such as Fluorine-18 and Carbon-11, it offers advantages such as convenience, mild conditions, rapidity, and low cost.
In recent years, PET imaging of labeled somatostatin analogs has become the gold standard for clinical diagnosis of neuroendocrine tumors.
