ChengDu ShengNuo Biotech Co., Ltd (SHA: 688117), a China-based polypeptide specialist, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its generic version of Shire’s Firazyr (icatibant). This marks a significant milestone as the company becomes the first manufacturer to file for Drug Master File (DMF) status for the generic in the United States.
Icatibant’s Background and Clinical Use
Originally developed by Shire Pharmaceutical, icatibant is a selective bradykinin B2 receptor antagonist indicated for the treatment of acute hereditary angioedema attacks in adults. The drug was first approved for marketing in the US in 2011 and made its way to China in April 2021. Shire was later acquired by Takeda in January 2019.
Market Competition and Previous Approvals
On a related note, Hansoh Pharma’s generic version of icatibant was the first to be approved in the China market, ahead of the originator, in November 2020. This competition underscores the growing interest and development in generic drugs that offer cost-effective alternatives to patented medications.-Fineline Info & Tech
