China-based Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced receiving Abbreviated New Drug Application (ANDA) status from the US FDA for its generic version of Bayer’s Gadovist (gadobutrol injection), marking the first generic approval of this kind in the United States. This approval positions Hengrui to expand its presence in the US market for contrast agents used in MRI scans.
Gadovist Profile
Gadovist is a contrast agent used to enhance the clarity of MRI scans, significantly improving the display of lesion details and diagnostic accuracy in detecting primary and metastatic tumors of the central nervous system, multiple sclerosis, and other conditions. Its high concentration and high relaxation rate make it a valuable tool in medical imaging.
Regulatory and Market Context
Hengrui’s generic gadobutrol was approved for marketing in China in March of this year, becoming the first generic product of its kind to pass the generic quality consistency evaluation (QGCE) in the country. Globally, Gadovist generated USD 495 million in sales in 2021. The FDA’s ANDA approval for Hengrui’s generic version underscores the company’s commitment to providing accessible and high-quality medical imaging solutions.-Fineline Info & Tech
