Recently, Jiangsu Hengrui Medicine Co.Ltd(600276) received the drug registration certificate approved and issued by the State Drug Administration and approved the company’s “gadolinium butoxide” injection to be listed. In addition to the original products, only Jiangsu Hengrui Medicine Co.Ltd(600276) of “gadolinium butoxide” injection in China has been approved for production, which is deemed to have passed the evaluation of the consistency of quality and efficacy of generic drugs.
Nuclear magnetic resonance imaging technology is an essential examination method for the diagnosis of some diseases. In the early stage, its application scope is limited due to the problems of blurred imaging, unclear resolution, and even missed diagnosis and misdiagnosis. The use of magnetic resonance imaging contrast agent can effectively solve the above problems and improve the sensitivity and specificity of magnetic resonance imaging (MRI) diagnosis.
According to reports, “gadolinium butoxide” injection is a paramagnetic contrast agent for magnetic resonance imaging (MRI), which was first listed in Switzerland in March 1999. Gadolinium butoxide injection can significantly improve the display of lesion details in MRI detection of primary and metastatic tumors and multiple sclerosis of the central nervous system. It can find more lesions and improve the diagnostic level compared with conventional contrast agents. In addition, based on this advantage, when the contrast agent with the same gadolinium content is used, the injection dose is halved to make the development clearer, provide more ideal contrast between blood vessels and surrounding tissues, and improve the display ability of blood vessels, especially small blood vessels.
“Gadolinium butoxide” injection is suitable for adults and children of all ages (including full-term newborns), and is only for intravenous administration. Contrast-enhanced magnetic resonance imaging (CE-MRI) and contrast-enhanced magnetic resonance angiography (CE-MRA) were used to diagnose lesions in various parts of the body (including brain and spinal cord).
Jiangsu Hengrui Medicine Co.Ltd(600276) “gadolinium butoxide” injection was applied for listing according to category 4 chemical drugs in May 2020. In addition to the original products, only Jiangsu Hengrui Medicine Co.Ltd(600276) of gadolinium butoxide injection in China has been approved for production, which is deemed to have passed the evaluation of the consistency of quality and efficacy of generic drugs. According to the data, in 2020, the global sales of “gadolinium butoxide” injection was about US $307 million.
