China-based BrightGene Bio-Medical Technology Co., Ltd (SHA: 688166) has announced receiving market approval from the National Medical Products Administration (NMPA) for its oseltamivir dry suspension. The drug is approved for treating influenza A and B in patients aged two weeks and older, and for the prophylaxis of influenza A and B in individuals aged one year and older.
Product Background and Market Potential
Oseltamivir, an essential drug recommended by the World Health Organization (WHO), was included in China’s National Essential Drug List (NEDL) in 2018. It is recognized as an anti-influenza virus drug in the “Influenza Diagnosis and Treatment Program” (2018 Revised Edition). Originated by Gilead Sciences and globally promoted by Roche, the drug was first approved in Switzerland and the US in 1999 and is now available in over 60 countries and regions worldwide.
Market Performance
From 1999 to 2017, oseltamivir generated at least USD 15 billion for Roche. In China, the drug achieved RMB 1.5 billion (USD 233.5 million) in public medical institutions in 2017, with YiChang HEC ChangJiang Pharmaceutical’s KeWei holding a 90.63% market share.-Fineline Info & Tech