Clopidogrel to meet the fierce enemy: the new antithrombotic "heavy bomb" has grown by more than 60% in China, and the first generic drug will be approved soon!

CDE recently released the public list of the 24th batch of drug registration applications to be included in the priority review process, among which tegrilol and tablets of xinlitai are listed as the first domestic generic drugs As a new generation of antiplatelet drugs, tegrilol is widely concerned Clopidogrel (Plavix), the "blockbuster", ranked first in the global platelet aggregation inhibitor sales in 2016 with a sales performance of US $1.709 billion The sales of subsequent blockbuster tegrilol in the first half of 2017 was US $496 million, an increase of 26.0% over the same period It is estimated that the global sales in 2017 will exceed US $1 billion, becoming the family's new blockbuster product Clopidogrel, a new antithrombotic "blockbuster", was approved by Bristol Myers Squibb in 1997 Its trade name is "Plavix" It is a milestone in the field of antithrombotic and antiplatelet aggregation The drug market was jointly developed by Bristol Myers Squibb and Sanofi Prior to the expiration of the patent in 2012, Plavix ranked behind Lipitor for many years, becoming the second largest selling drug in the world After the expiration of the patent, Plavix triggered a global imitation boom According to the statistics of global best-selling drug data, the global market scale of antithrombotic drugs remained at more than 10 billion US dollars in 2005-2006; the market scale remained between 14 billion and 18 billion US dollars in 2007-2011 During this period, clopidogrel played a leading role in the market, and the sales volume of the product was close to 10 billion US dollars in 2011 After the expiration of heavy-duty product patents in 2012, the global antithrombotic drug market has been declining year by year, and clopidogrel is also declining Tegrilol is a new and selective small molecule anticoagulant developed by AstraZeneca The drug was approved by FDA in July 2011, and the trade name is "brilinta" Compared with clopidogrel, tegrarol has faster effect and stronger inhibition on platelet aggregation, which can significantly reduce the incidence of cardiovascular death, myocardial infarction or stroke The product has been approved for marketing in 85 countries around the world and is a new generation of clopidogrel Among the guidelines in many countries, tegrilol has also become a recommended drug Figure 1 global sales situation of clopidogrel and tegrilol (unit: US $million) According to the statistics of global best-selling drug data, tegrilol's sales volume in 2013-2016 were US $283 million, US $476 million, US $619 million and US $839 million, respectively, with a rapid growth since its listing Due to the huge antiplatelet market, according to the prediction of professionals, the global sales of tegrilol will exceed US $1 billion in 2017, and tegrilol will catch up with and surpass clopidogrel in 2019 Clopidogrel has been developed and listed earlier in China In 2000, clopidogrel of Shenzhen xinlitai Pharmaceutical Co., Ltd was first approved to be registered for production, with the trade name of "Taijia" In September of the same year, clopidogrel of Sanofi Aventis and Bristol Myers Squibb was granted administrative protection in China In 2001, clopidogrel of Sanofi Aventis was approved to be listed in China under the trade name of "Plavix" According to the data of domestic sample hospitals, clopidogrel is one of the best-selling drugs at present, with sales volume of 126 million yuan in 2005, over 1 billion yuan in 2011 and 1.86 billion yuan in 2016 There are three domestic manufacturers of the drug In 2016, the specific performance of the sample hospital market is as follows: Sanofi Aventis "Plavix" sales volume is 1.11 billion yuan, accounting for 59.7%; xinlitai "Taijia" sales volume is 550 million yuan, accounting for 29.7%; Lepu pharmaceutical "Shuaike" sales volume is 200 million yuan, accounting for 10.5% Clopidogrel has been the top antithrombotic drug market for many years, accounting for half of the market Tegrilol was approved to be imported by AstraZeneca in China in November 2012, with the trade name of "Belinda" The dosage form is tablet and the specification is 90mg / tablet The product is a new antiplatelet drug, which has the similar effect with clopidogrel It is mainly used in the prevention and treatment of cardiovascular and cerebrovascular thrombosis Figure 2 sales situation of clopidogrel and tegrilol in domestic sample hospitals (unit: 10000 yuan) data of domestic sample hospitals show that sales volume of tegrilol in 2013 was 4.08 million yuan, 28.02 million yuan in 2014, 61.4 million yuan in 2015, a year-on-year increase of 119%; 99 million yuan in 2016, a year-on-year increase of 61.2% After being put on the market in China, the sales volume of tegrarol has grown rapidly, and it is the product with extremely prominent growth rate in antithrombotic drugs at present At present, the growth rate of clopidogrel, a direct competitor of tegralol, has slowed down However, although the growth rate of tegralol's domestic market is fast, it will take a long time to surpass clopidogrel In July this year, tegrillo entered the medical insurance catalog through negotiation, and the negotiated price was 22.8% lower than the lowest price of hospital bidding After being included in the medical insurance, tegrillo's sales are expected to continue to accelerate At present, nearly 40 domestic enterprises have applied for tegrilol preparation, including Hengrui, Zhengda Tianqing, Qilu, Shiyao, Kelun, Haizheng, Lizhu, Xiansheng and many other strong R & D enterprises It can be seen from the application that, with the expiration of the compound patent of the product, the market is optimistic about the prospect of tegrilol, which has become a hot application variety of generic drugs The tegrilol of sinolates is included in the priority review If the first generic drug can be obtained, sinolates will become the most powerful competitor of imported tegrilol Tegrarol is the next generation of clopidogrel, which has some advantages in clinical mechanism It is worth noting that xinlitai is the first enterprise in China to have two varieties of tegrilol and clopidogrel Over the years, clopidogrel has become a key product of the company, and the market recognition of tegrilol is also very high, which is expected to become the next "clopidogrel" If it can become the first imitated enterprise of tegrilol, xinlitai is expected to take this opportunity to complete the upgrading of drugs, further strengthen its competitive advantage, and continue to consolidate its strong position in the field of antiplatelet in China.