Generic drugs have been approved one after another + medical insurance, stirring the hepatitis B market for novofibrate

With the acceleration of the listing process of tenofovir generic drugs, Chengdu Beite tenofovir dipivoxil tablets (2016.11.23), Fujian guangshengtang pharmaceutical's tenofovir dipivoxil capsules (2017.05.18), Qilu pharmaceutical's tenofovir dipivoxil tablets (2017.05.18) have been approved successively, and the market of tenofovir, a heavy-duty product, has attracted much attention Data shows that in recent years, the market size of hepatitis B drugs in China has increased from 6.881 billion yuan in 2011 to 16.276 billion yuan in 2015, with a compound annual growth rate of 22.4% It is estimated that the market scale of hepatitis B drugs in China will reach 20 billion yuan by 2020 According to statistics, about 100 million people in China are hepatitis B carriers, accounting for about 8% - 10% of the total population in China, of which more than 20 million are chronic hepatitis B patients, while less than 20% are patients who have received standard treatment in China The market scale and drug demand of hepatitis B in China are huge, and it will continue to maintain a high growth trend in the future Among them, nucleoside drugs have gradually become the mainstream drug for the treatment of hepatitis B Commonly used nucleoside drugs are: entecavir, telbivudine, adefovir dipivoxil, lamivudine, tenofovir Nucleoside analogues: the growth rate of entecavir and tenofovir is remarkable According to the data of domestic sample hospitals, in 2016, the total sales volume of entecavir, telbivudine, adefovir dipivoxil, lamivudine and tenofovir sample hospitals was 2.53 billion yuan Among them, entecavir's sales volume was 1.71 billion yuan, accounting for 63.4%; telbivudine's sales volume was 280 million yuan, accounting for 11.1%; adefovir's sales volume was 250 million yuan, accounting for 9.7%; Lamivudine's sales volume was 180 million yuan, accounting for 7.2%; tenofovir's sales volume was 110 million yuan, accounting for 1.5% From the sales data of nucleoside antiviral drugs in recent years, entecavir accounted for more than 60% of the market of nucleoside antiviral drugs in 2016, and has become the main product of nucleoside antiviral drugs in China Entecavir's sales have been growing rapidly since 2010 In addition to the rapid growth of tenofovir, sales of other products such as telbivudine, lamivudine and adefovir have declined In 2016, there were nearly 40 enterprises involved in the sale of nucleoside antiviral drugs in the sample hospital market, among which the top five enterprises accounted for 88.0% of the overall market with a total sales volume of 2.23 billion yuan The top five enterprises are: Squibb's product sales in Shanghai, China and the United States are 830 million yuan, accounting for 32.9%; chinda Tianqing pharmaceutical's product sales are 710 million yuan, accounting for 28.0%; GlaxoSmithKline's product sales are 310 million yuan, accounting for 12.5%; Novartis' product sales are 280 million yuan, accounting for 11.1%; guangshengtang's product sales are 87.63 million yuan, accounting for 3.5% Entecavir: it accounts for more than 60% of the global market of nucleoside antiviral drugs Entecavir is developed by Bristol Myers Squibb and approved by the FDA in March 2005 The product is called "Baraclude" In November 2005, entecavir of Shanghai Shiguibao company obtained the production approval, which was named "boluting" At present, there are 10 domestic enterprises participating in the competition, including tablets, capsules and dispersible tablets According to the statistics of global best-selling drugs, the global sales of entecavir in 2016 reached US $1192 million In 2015, entecavir entered the top 10 of domestic sample hospitals for the first time, with a sales volume of 1.47 billion yuan, ranking 7th; in 2016, its sales volume was 1.71 billion yuan, ranking 2nd in advance, ranking 5th, becoming the fastest-growing product in the top 10 of domestic sample hospitals, with a growth rate of 16.2% According to the sales trend of entecavir's domestic sample hospitals in 2006-2016, the sales volume in 2006 was 36.15 million yuan, and the sales volume in 2016 was 1.71 billion yuan, with a compound growth rate of 47.0% in 2006-2016, showing outstanding performance in the domestic market of nucleoside antiviral drugs The product quickly replaced adefovir as an early nucleoside drug after entering the Chinese market In 2009, the product entered the national medical insurance catalogue and became the first-line drug of choice for hepatitis B, ranking first in nucleoside antiviral drugs for many years Due to its good curative effect, the recommendation of authoritative clinical guidelines and the academic drive of various enterprises, the market sales have grown rapidly, which has become the leading and heavyweight product in the market of anti HBV drugs In 2016, domestic enterprises accelerated their progress The top five enterprises in entecavir's market sales were: Shanghai Squibb, Zhengda Tianqing pharmaceutical, Suzhou Dongrui pharmaceutical, Fujian guangshengtang pharmaceutical, and Jiangxi Qingfeng pharmaceutical, with sales of 830 million yuan, 640 million yuan, 50.86 million yuan, 70.28 million yuan and 57.27 million yuan, respectively Among them, China and the United States accounted for 48.8% of the "boluting" market of Shanghai Squibb, 37.7% of the "Runzhong" and "Tianding" market of Zhengda Tianqing pharmaceutical, 4.7% of the products of Suzhou Dongrui pharmaceutical, 4.1% of the products of Fujian guangshengtang, 3.4% of the products of Jiangxi Qingfeng, and 1.3% of the other five enterprises In terms of sales volume in 2016, Shanghai Squibb of China and the United States accounted for the largest share, but decreased by 1.2% compared with the same period; Zhengda Tianqing Pharmaceutical Co., Ltd accounted for nearly 40% of the share, an increase of 48.8% compared with the same period It can be seen that Zhengda Tianqing pharmaceutical is speeding up its development in entecavir market Since 2010, domestic entecavir manufacturing enterprises have broken the pattern of exclusive market of Bristol Myers Squibb Since then, generic drugs of several domestic enterprises have been approved successively With more and more manufacturers, especially in recent years, the domestic market growth situation is rapid, the competition is extremely fierce At present, there are more than 80 domestic enterprises applying for entecavir preparation, which is extremely popular Tenofovir: rapid growth under multiple advantages global sales volume is 1.186 billion US dollars Tenofovir, developed by Gilead company of the United States, is a new type of nucleotide reverse transcriptase inhibitor It was approved by the FDA of the United States in 2001 for the treatment of AIDS In 2008, tenofovir was approved by the European Union and the FDA for the treatment of hepatitis B, with the trade name of "Viread" Tenofovir is a star variety of Gilead, which is currently a specific drug for the treatment of AIDS and hepatitis B Tenofovir has some advantages over the main competing drugs, such as adefovir dipivoxil, telbivudine and entecavir According to the statistics of global best-selling drugs, the global sales of tenofovir in 2016 has reached US $1186 million In 2016, an increase of 354.1% over the same period, tenofovir was approved to enter China by Gilead company in June 2008, with the trade name of "Werder", dosage form of tablets and specification of 300mg In November 2009, Gilead and GlaxoSmithKline worked together, and GlaxoSmithKline was responsible for the promotion of tenofovir anti hepatitis B drugs in the Chinese market In April 2015, CFDA approved the listing of Werder of GlaxoSmithKline (Tianjin) in China According to the statistics of domestic sample hospitals, the sales volume of tenofovir in 2012 was 2.42 million yuan, the sales volume in 2015 was 25.09 million yuan, and the sales volume in 2016 was 114 million yuan, an increase of 354.1% compared with the same period, with a rapid growth in 2016 The rapid growth of the product is mainly due to the results of the national drug price negotiation in May 2016 The monthly average drug cost of tenofovir decreased from 1500 yuan to 490 yuan, a 67% drop, becoming the lowest price in the world for the treatment of chronic hepatitis B indications, which objectively promoted the market volume of tenofovir in 2016 In addition, tenofovir has entered the 2017 version of the medical insurance catalog, plus the listing of three domestic generic drugs, the overall market of tenofovir will usher in explosive growth, which will also lead to changes in the anti hepatitis B drug market Generic drugs were successively approved by Chengdu Beite Pharmaceutical Co., Ltd on November 23, 2016 It obtained the production approval of tenofovir raw materials and tablets The company took the lead in obtaining the approval of AIDS indications, and then increased the hepatitis B indications through supplementary application According to statistics, in May 2017, tenofovir was approved to be manufactured by two other enterprises, namely: tenofovir fumarate dipivoxil capsule in guangshengtang, Fujian Province, with the indication of hepatitis B infection; tenofovir fumarate dipivoxil API and its tablet in Qilu pharmaceutical The door of domestic tenofovir generic drugs has been opened After being included in the national medical insurance catalog, the price has also dropped significantly, and the overall market will surely grow greatly in the future Tenofovir is the latest generation of anti hepatitis B drugs in the world It has been recommended as the first-line drug for the treatment of chronic hepatitis B by the guidelines for the prevention and treatment of chronic hepatitis B all over the world It can be called a heavyweight variety in terms of efficacy and market performance At present, there are few kinds of anti hepatitis B drugs in China Clinical experts agree that tenofovir is the only anti hepatitis B drug that does not produce drug resistance Therefore, many domestic enterprises also aim at this market At present, there are more than 40 enterprises applying, and more generic drugs will be approved by the end of 2017 Domestic tenofovir imitation enterprises are still in fierce competition Conclusion at present, entecavir is the most competitive product of tenofovir Both of them have similar mechanism of action and are the first-line antiviral drugs recommended by the major hepatitis B treatment guidelines After entecavir went on the market, it quickly occupied the market leading position with good curative effect However, tenofovir entered the domestic market later, and there is still a large gap between the sales volume of tenofovir and that of entecavir In 2017, tenofovir was included in the national medical insurance catalog and its price was lowered, with obvious policy advantages After the products of a number of generic pharmaceutical companies are launched, they will definitely carve up the market of entecavir, and it remains to be seen whether they will shake the top position of entecavir in the future.