US-based Amneal Pharmaceuticals Inc. (NYSE: AMRX) has announced that it has received approval from the Chinese market for its sevelamer carbonate, marking the company’s inaugural product approval in China. The drug is indicated for the treatment of hyperphosphatemia in patients with chronic kidney disease who are undergoing dialysis. Sevelamer represents the first non-aluminum, non-calcium-based phosphate binder developed for managing hyperphosphatemia in end-stage renal disease (ESRD).
History and Development of Sevelamer
The sevelamer molecule was originally developed by GelTex Pharmaceuticals and gained its first global approval in 1998. GelTex was later acquired by Genzyme in 2000, which then became part of Sanofi in 2011. Sanofi secured the first China approval for sevelamer in 2013. Amneal’s approval makes it the fifth generic version to enter the market, competing with the likes of Simcere Pharmaceutical and Dr. Reddy’s.
Strategic Partnership and Market Expansion
The approval is a milestone for Amneal, as it signifies the company’s first successful product approval in China. Fosun Pharmaceutical has been Amneal’s local co-development partner since 2019, and Fosun International is also Amneal’s largest shareholder, holding at least a 13% stake in the company. With this approval, Amneal joins a market where it has six additional products awaiting regulatory decisions. Established in the US in 2002 with a focus on generics, Amneal now has a global presence in over 30 countries, and developing its presence in the China market is a strategic priority.-Fineline Info & Tech
