Recently, China's NMPA official website announced that Xintai Pharmaceutical's oseltamivir phosphate capsule listing application has been reviewed and has now entered the administrative approval stage.

Oseltamivir phosphate was a new drug developed by Gilead, which was later transferred to Roche for joint development. It was listed in Switzerland in 1999 and in my country in 2001. The trade name is Tamiflu. It is the most commonly used and one of the most effective drugs against avian influenza, A H1N1 influenza virus and influenza B virus. It can greatly reduce influenza complications. The occurrence of disease can also reduce the use of other drugs, and Tamiflu can increase the survival rate of flu patients by about 37%.

The active metabolites of oseltamivir phosphate can inhibit the neuraminidase activity of influenza A and B viruses. This product inhibits the release of mature viruses from infected cells, thereby reducing influenza A or B viruses Of dissemination. When used for prevention, oseltamivir can reduce the risk of influenza infection for individuals and families.

In 2005, H5N1 avian influenza broke out globally, orders from countries around the world increased sharply, Roche's production capacity was insufficient, and pressure to release patent authorization. Shanghai Pharmaceutical subsidiary Shanghai Zhongxi Sanwei Pharmaceutical and Dongyang Sunshine Pharmaceutical Co., Ltd. successively obtained the drug in China. Patent license.

In 2005 and 2006, Roche licensed oseltamivir to Shanghai Zhongxi Sanwei Pharmaceutical Co., Ltd. and Dongyang Sunshine Pharmaceutical Co., Ltd. to produce them. The products were marketed under the trade names of "Orphi" and "Kewei" respectively. However, the oseltamivir produced by Zhongxi Sanwei Pharmaceutical is a government-purchased drug and is not circulated in the market. Therefore, Dongyang Sunshine dominates the domestic oseltamivir market.

Up to now, 10 companies have submitted applications for the listing of capsule dosage forms, including Xintai Pharmaceutical, CSPC Ouyi Pharmaceutical, Kelun Pharmaceutical, Guangdong Dongyang Sunshine Pharmaceutical, and Qilu Pharmaceutical. However, the oseltamivir dry suspension market has been blank and has not yet been approved.