On April 28, Hengrui Medicine issued an announcement stating that it had recently received the "Drug Supplement Application Approval Notice" for iodixanol injection approved and issued by the State Food and Drug Administration.
The company's iodixanol injection passed the quality of generic drugs.
And evaluation of consistency of efficacy.
Iodixanol injection is an X-ray contrast agent, suitable for adult cardiovascular angiography, cerebrovascular angiography, peripheral arteriography, abdominal angiography, urography and CT enhanced examination; children's cardiovascular angiography, urography and CT enhanced examination.
Iodixanol injection was originally developed by Norwegian Nycomed Pharmaceutical Co.
, and was approved by the U.
Food and Drug Administration in 1996 to be marketed in the United States.
In 2001, iodixanol injection (trade name: Weishi Parker) was approved to be imported and marketed by the State Food and Drug Administration.
In addition to the company, many domestic companies such as Yangzijiang Pharmaceutical, Nanjing Chia Tai Tianqing, Beijing Beilu Pharmaceutical and other companies have been approved for production.
Among them, Yangzijiang Pharmaceutical, Chia Tai Tianqing Pharmaceutical, and Shanghai Stellite have passed (or regarded as Pass) Consistency evaluation of generic drugs.
After inquiries, the global sales of iodixanol injections in 2019 were approximately US$688 million, and the 2020 sales data have not yet been found.
Up to now, iodixanol injection (specification: 100ml: 32g(I)) has invested 10.
67 million yuan in research and development on the consistency evaluation project of generic drugs.