One product soared by 150%! New antithrombotic varieties are growing rapidly

Medical research shows that the formation of vascular embolism is a changing process under the interaction of genetic factors and environmental factors Vascular embolism has complex characteristics of familial, recurrent and difference after healing, so active prevention, reasonable intervention and treatment are of positive significance Antithrombotic therapy is mainly based on the degree and location of vein, artery, distal circulatory system and blood vessels involved, weighing the advantages and disadvantages, using antiplatelet, thrombolysis, anticoagulation treatment In the current antithrombotic drugs, antiplatelet aggregation drugs play an important role After entering the 21st century, antithrombotic drugs at home and abroad have developed into a new era from R & D pipeline to market platform Top 10 accounts for nearly 90% of the market cardiovascular and cerebrovascular diseases, which are characterized by high incidence rate, high disability rate, high mortality rate, high recurrence rate and many complications According to the results of the third national death cause survey released by the Ministry of health of China, cerebrovascular diseases have accounted for 22.45% of the total deaths There are 2.5 million new cases of stroke every year in China, 1.3 million people die of stroke every year, and 7.5-8 million people survive Three quarters of them suffer from the sequelae of memory, facial and limb nerves Stroke has become the primary factor affecting the quality of life of the elderly Under the rigid demand, the antithrombotic drug market is full of infinite vitality
At the same time that the global new antithrombotic drugs have achieved a good harvest, the CDE green channel has also accelerated the pace of new drug listing: pradaxa (tibizone) of bringer Ingelheim company, xarelto (byrito) of Bayer company, brilinta (Belinda) of AstraZeneca company and a of Bristol Myers Squibb / Pfizer company have been approved successively Several new drugs, such as eliquis and elotal, have been registered in China, and they have quickly seized the market after they are put on the market, thus promoting the growth of domestic antithrombotic market According to the data of menet HDM system, the antithrombotic drug market of public hospitals in key cities in 2016 was 3.537 billion yuan, an increase of 12.51% over the previous year Among them, the top 10 varieties accounted for 88% of the total, namely, clopidogrel, low molecular weight heparin, rivaroxaban, enteric aspirin, beprost sodium, heparin, tegrilol, ateplase, cilostazol and agatraban The number of antithrombotic drug terminals in China's three major terminals and six major markets has reached 18.041 billion yuan, an increase of 13.85% over the previous year After the promulgation of the new national medical insurance catalogue, the government has promoted the continuous strategy of drug negotiation, price reduction and medical insurance Following the new drug rivaroxaban, in 2017, eight new antithrombotic drugs were added to the medical insurance catalog, including dabigatran ester, tegrilol, apixaban, sulodette, agatroban, etibatide, indobufen and fondagangui In the medical insurance catalog, there are 31 varieties of Western medicine in seven categories, including antiplatelet coacervation inhibitors, direct XA factor inhibitors, direct thrombin inhibitors, heparins, enzymes, vitamin K antagonists and other antithrombotic drugs So far, stroke is still a difficult medical disease Stroke refers to a disease in which blood cannot enter the brain due to sudden rupture or blockage of blood vessels in the brain, and hypoxia causes brain tissue damage Clinically, antiplatelet aggregation, anticoagulation, thrombolysis, neuroprotection and antihypertensive administration are the main means of treatment Driven by rigid demand, the development of antithrombotic market is promoted According to industry analysis data, the overall market of antithrombotic Chinese and Western medicine in 2017 will reach 30 billion yuan Clopidogrel is still the leader in the late 1990s The US FDA approved the listing of clopidogrel, a platelet aggregation inhibitor, which was developed and sold by Bristol Myers Squibb and Sanofi Aventis in the global market It is a landmark product in the field of antithrombotic and antiplatelet aggregation Clopidogrel was 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" On September 19 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" With the advent of aging society, the rapid development of cardiovascular and cerebrovascular interventional therapy in China, the simultaneous follow-up of anticoagulation, antiplatelet agglutination and hypolipidemic therapy after interventional therapy, has driven the market of clopidogrel to develop in depth At present, it is the first variety of antithrombotic market, and it is also an irreplaceable basic drug in the treatment of acute coronary syndrome According to the data of menet HDM system, in 2016, the sales volume of clopidogrel in public hospitals in key cities reached RMB 152.9 million, an increase of 5.17% over the previous year Sanofi Aventis accounted for 58.84%, Shenzhen xinlitai for 35.27% and Lepu pharmaceutical new Shuaike for 5.89% Data shows that the domestic Plavix terminal market has reached 8.683 billion yuan in 2016, and it is predicted that the overall market of clopidogrel preparations in 2017 will exceed 15 billion yuan Rivaroxaban is the first direct oral XA factor inhibitor listed by Bayer / Johnson in the world It was approved and registered by CFDA in March 2009, with the trade name of byritol The indication of the drug is to prevent and treat deep vein thrombosis It is mainly used to prevent the formation of deep vein thrombosis and pulmonary embolism in patients after hip joint and knee joint replacement It can also be used to prevent stroke and non central nervous system embolism in patients with non valvular atrial fibrillation and reduce the risk of recurrence and stroke of coronary syndrome In 2016, the global market recorded US $4.986 billion in sales, an increase of 14.20% over the previous year According to the data of menet HDM system, in 2016, the sales volume of public hospitals in key cities in China was 219 million yuan, an increase of 42.93% over the previous year It ranks third in antithrombotic market and becomes the biggest threat of low molecular weight heparin products Especially in the 2017 national medical insurance catalogue, on the basis of the indications originally limited for lower extremity joint replacement surgery, rivaroxaban added "limited warfarin for the treatment of non valvular atrial fibrillation patients with poor control or high risk of bleeding", so that rivaroxaban has a new development space However, in 2017, eight new products of antithrombotic drugs (dabigatran ester, tegrilol, apixaban, sulodette, agatroban, etibatide, indobufen and fondagangui) were added to the medical insurance catalogue, which also intensified the market competition of the same variety Therefore, Bayer's rivaroxaban has planned active price reduction actions in many provinces and cities due to various factors such as competition and market expansion The average reduction rate of three specifications, 10mg, 15mg and 20mg, is 64.22% After the price reduction, the daily drug cost is 36.77% lower than dabigatran and 65.09% lower than apixaban The competition shows a white hot trend Tegrilol is a new, selective, small molecule anticoagulant developed by AstraZeneca It was approved by FDA in July 2011 and marketed under the trade name of brinita Tegrilol has the advantages of rapid onset, direct effect of non precursor drugs, independent of individual gene differences, and reversible binding mechanism with platelets After discontinuation of tegrilol, platelet function can be restored rapidly The Plato study also showed that tegrarol was more effective than clopidogrel It has been recommended by 10 international treatment guidelines for patients with acute coronary syndrome In November 2012, CFDA approved to register for greero under the trade name of Belinda As of the beginning of 2016, 31 domestic enterprises have submitted applications for registration of tegrilol, 16 of which have been approved for clinical use According to the data of menet HDM system, in 2016, the sales amount of tegrilo, a public hospital in key cities in China, was 83.93 million yuan, an increase of 59.02% over the previous year, which is one of the fast-growing varieties At present, the domestic market of the exclusive AstraZeneca product tegrilo has reached 424 million yuan In 2017, tegrillo entered the medical insurance catalog through negotiation, and the negotiation price was reduced by 22.78% compared with the lowest bidding price of the hospital Tegrillo (90mg) dropped from the original 10.94 yuan / tablet to 8.45 yuan / tablet, which will continue to drive market volume Dabigatran is a new anticoagulant developed by Berlin Ingelheim company It was approved by FDA in October 2010 It is known as the first anticoagulant new oral drug in the 50 years after warfarin It is a milestone in the field of anticoagulant treatment and prevention of potentially fatal thrombus FDA approved the fourth indication of dabigatran ester, prevention of postoperative deep vein thrombosis and pulmonary embolism, thus promoting market growth In February 2013, CFDA approved the registration of dabigatran ester under the trade name of tibizone According to the data of menet HDM system, in 2016, the sales volume of public hospitals in key cities in China was 42.67 million yuan, an increase of 149.53% over the previous year With the wide clinical application in our country, we have compiled and published "dabigatran ester for the clinical application of stroke prevention in patients with non valvular atrial fibrillation", which has taken an important step in standardizing anticoagulant oral drugs Ischemic stroke is the most serious complication of atrial fibrillation, and stroke prevention has become an important part of comprehensive management of atrial fibrillation In recent years, the global competition for new antithrombotic drugs is fierce, and the global harvest of new antithrombotic drugs is good In 2015, the US FDA approved two new antithrombotic drugs, edoxaban (savaysa), the first three in common, and candillo (kengreal) from Madison pharmaceutical company At the same time, FDA of the United States also approved the fourth indication of dabigatran ester mesylate of bringer Ingelheim company - prevention of postoperative deep vein thrombosis and pulmonary embolism, thus adding new vitality to the global antithrombotic market In June 2017, FDA approved betrixaban capsule, a XA factor inhibitor from Portola biology company, which is marketed as bevyxxa, to prevent stroke in people with irregular heart rhythm It is mainly aimed at patients with atrial irregular fibrillation, which may be fatal This is the fourth direct XA factor inhibitor anticoagulant after rivaroxaban, apixaban and edaxaban It is used to prevent the risk of venous thromboembolism complications in adults with acute medical diseases It is also the only alternative to warfarin It provides a new choice for the treatment of antithrombotic and anticoagulant AF Conclusion In the domestic antithrombotic market, thrombolytic drugs have limited wide clinical application due to their own limitations; the market share of antiplatelet drugs is the largest, accounting for 60% of the antithrombotic drug market; the market growth of anticoagulant drugs is fast, the traditional heparin drugs still occupy a large part of the market share (about 70%), and the new type of direct thrombin inhibitors and coagulation factor Xa Inhibitors also gradually enter the market and will become the future development direction.