The market pattern of hepatitis B drugs may change

Source: pharmadl 2016-12-01 hepatitis B is one of the three major persistent diseases in the world Globally, there are 350-400 million hepatitis B patients China is a big country of hepatitis B, with about 100 million hepatitis B carriers and 20 million chronic hepatitis B patients Hepatitis B virus is highly infectious, and can be transmitted through blood and saliva In recent years, the incidence rate of hepatitis B has been decreasing with the increase of vaccination rate, but it is still severe On November 10, 2016, FDA approved the new Gilead drug vemlidy (tenofovir alafinade, TAF) to be used in adult chronic hepatitis B virus infection patients with compensatory liver disease TAF belongs to nucleoside reverse transcriptase inhibitor (NRTI), which is a precursor drug of tenofovir fumarate dipivoxil (TDF) At present, hepatitis B treatment drugs on the market in the world mainly include: anti hepatitis B virus drugs, preventive vaccines and immune stimulants Anti hepatitis virus drugs are the mainstream, and anti hepatitis virus drugs include: nucleoside and interferon In 2015, the top 5 drug sales volume of hospitals in key cities in China were all antiviral drugs, including 4 nucleoside antiviral drugs: entecavir, adefovir dipivoxil, telbivudine and lamivudine In 2015, entecavir led the hepatitis B drug market with sales of 1.469 billion Looking at its sales in the past five years, we found that although the growth rate slowed down, it still maintained an optimistic growth trend In the past five years, the market share of original research firm BMS entecavir has decreased year by year, from 83.44% in 2011 to 57.38% in 2015, while the competitiveness of domestic varieties has gradually increased, and by 2015, it will occupy nearly half of the market, especially the leading enterprise of liver disease, Zhengda Tianqing, with a market share of 31% Source: drug comprehensive database PDB source: drug comprehensive database PDB has to mention tenofovir, developed by Gilead company, approved by FDA in 2001 to treat HIV, approved by FDA in 2012 to add new indications to treat chronic hepatitis B, approved by CFDA in 2013 to import tenofovir dipivoxil Gilead fumarate tablets, 2015 In 1998, tenofovir dipivoxil fumarate tablets of GlaxoSmithKline (Tianjin) Co., Ltd were approved to be made in China In 2015, entecavir and tenofovir were listed as the first-line treatment drugs for chronic hepatitis B in the World Health Organization guidelines for hepatitis B prevention and treatment Due to the late time of listing and other factors, the market share is less than the above varieties With the drug price negotiation and the inclusion of the medical insurance catalog, the market is relatively considerable In recent five years, the number of CFDA acceptance cases of tenofovir has increased almost every year, especially in 2014, the number reached 39, only slightly decreased in 2015 Source: China new drug R & D monitoring database CPM geelide new drug vemlidy (TAF) is an upgraded version of the already listed drug Viread (TDF) Both have the same mechanism of action and antiviral spectrum, but the former has higher antiviral effect, only needs tdf1 / 10 dose, lower nephrotoxicity, better safety, and the market of hepatitis B may be reshuffled after its listing.