Tenofovir dipivoxil fumarate (raw material + tablet), a Class 3 hepatitis B drug of Anke biology, will obtain clinical approval

Tenofovir fumarate dipivoxil tablet is the original research drug of Gilead company in the United States Its trade name is "viride" It is a new type of nucleoside oral antiviral drug, which is used to treat HIV-1 and hepatitis B infection Werder was listed in the United States and the European Union in 2001 and 2002 respectively In 2008, it was listed in China with anti HIV-1 infection indications In 2012, its API also entered China Compared with the anti HIV or anti hepatitis B drugs currently on the market in China, viride has the advantages of high effectiveness, high safety, difficult to form drug resistance and high compliance, and has become a first-line anti HIV drug According to the 2010 annual report of Gilead, the global sales volume of tenofovir and its compound preparations in 2010 has exceeded 6 billion US dollars Heavyweight medicine is naturally sought after by many companies In addition to the declaration of ankehengyi, a wholly-owned subsidiary of Anke biology, there are nearly 10 enterprises applying for the product However, except for the production of API by Anhui Baker Pharmaceutical Co., Ltd., there are no domestic enterprises producing tablets Although Anke Hengyi has 14 production lines of 6 dosage forms and more than 50 varieties of chemical drugs, the product aging has always been the biggest bottleneck restricting its development Anke biology has previously said that chemical synthetic drugs are easy to produce large varieties (i.e large output, large consumption and large sales), and variety innovation is an urgent task for the development of Anke Hengyi This product will add a heavy variety to the company after being launched This time, ankehengyi's product is only approved for clinical use, at least 3-5 years from its launch Moreover, in the case that the products of Anhui Baker and Zhengda Tianqing are about to go on the market, it may be difficult for Anke Hengyi to increase the market share of the products According to CFDA, tenofovir fumarate dipivoxil tablets declared for production by Anhui Baker biopharmaceutical Co., Ltd have been in the state of "approval".