Hualan biology is the first to obtain the approval for clinical trial of h7n9 influenza vaccine

The national pharmaceutical regulatory authorities are speeding up the approval of class 1 innovative drugs Only yesterday, the two heavyweight biological vaccine drugs obtained clinical approval, closer to the market Yesterday, the latest information from the website of the State Food and drug administration showed that the status of h7n9 influenza vaccine of Hualan biology was changed to "the certification has been completed and the approval has been issued" At the same time, the approved vaccine was also the "Freund sonnei's diarrhea bivalent combined vaccine" declared by Beijing green bamboo Biological Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Zhifei biology Hualan biology is the first company in China to obtain clinical approval of h7n9 vaccine The two vaccines approved this time are split vaccine and influenza whole virus inactivated vaccine There are four approvals, all of which are class 1 new biological drugs encouraged by the state to innovate Since 2013, the h7n9 virus has been in constant shadow, while winter is the season of high incidence of this kind of influenza According to the latest report from the health and Family Planning Commission of Guangdong Province on January 24, Meizhou and Chaozhou respectively reported one h7n9 case So far, since November last year, the number of h7n9 cases reported in Guangdong Province has increased to 20, among which 7 cases were reported in Shenzhen According to the information survey of Shanghai Stock Exchange, there are more than ten influenza vaccine manufacturers in China, including Hualan biology, Kexing biology, Tianyuan biology, Haiwang biology, Tiantan biology, etc., which have successively said that they are developing h7n9 influenza vaccine Hualan biology is the first company to apply for approval As early as last January, the company announced that the h7n9 influenza vaccine developed by the holding subsidiary Hualan biological vaccine Co., Ltd has successfully passed the on-site verification of drug registration and development by Henan food and drug administration, and has been accepted by Henan food and drug administration The bivalent combination vaccine of Freund's and sonnei's dysentery, which was approved by Zhifei green bamboo yesterday, is also a class 1 new drug It is not only a major national major new drug project, but also a global original According to the Chinese Centers for Disease Control and prevention, dysentery is the main clinical infection in China, accounting for more than 90% of the total number of cases, with a large market demand This means that once the vaccine is approved, Zhifei biology will gradually establish its position as the leading enterprise of bacterial vaccine, according to brokers It is worth noting that these two vaccine products are of great significance to the company, but they will not affect the company's performance in the short term In an interview, the company said that "no approval has been received".