The first imitation of rivaroxaban tablets is about to be approved. Two major anticoagulants are in hand. Zhengda Tianqing will occupy an important position in the market!

Rivaroxaban (trade nameXarelto)

On August 8, 2019, on the official website of the State Food and Drug Administration, the new 4-class chemical drug listing application (CYHS1700574) of Zhengda Tianqing Rivaroxaban Tablets was displayed as "issued" and willIs the first domestic to get the variety of generic drug listing qualification manufacturers.

Rivaroxaban is a new type of oral anticoagulant, mainly by inhibiting the activity of coagulation factor Xa, reducing thrombin (coagulation factor Ⅱa) to play an anticoagulant effect, does not affect the activity of the generated thrombin. At present, rivaroxaban has been widely used in the prevention and treatment of venous thromboembolic disease and stroke prevention of non-valvular atrial fibrillation. Compared with warfarin, rivaroxaban has the advantages of rapid onset, predictable efficacy, low incidence of intracranial hemorrhage, no need for regular coagulation monitoring and regular dose adjustment.

Rivaroxaban TabletsDeveloped jointly by Bayer and Johnson,The earliest inIn September 2008, it was approved by the European Medicines Agency for listing; in July 2011, it was approved by the FDA for listing in the United States. 2009 3Approved for listing in China and included in the 2009 National Health Insurance Catalog.The original research has monopolized the domestic market for 10 years..Rivaroxaban 2017GlobalSales reached $6.54 billion,$6.2 billion in 2018;Bayer reported that Rivaroxaban's 2019H1 sales revenue in markets outside the United States was 1.944 billion million euros, up 14% year-on-year.

From a patent perspective,On July 18 this year, the State Administration of Knowledge declared Bayer Rivaroxaban's formulation patent (200480035106.X) valid until November 13, 2024 invalid. Compound patent (CN1262551C) for rivaroxaban will expire in December 2020,Add new variables to the domestic anticoagulant market. At present, there are 43 domestic enterprises layout imitation, of which 23 have4 categories by new registrationlisted. Competition is particularly fierce, but Zhengda Tianqing is undoubtedly the first to hit the line among the 23 reported generic drugs.

Apixaban(Trade name Eliquis)

In May 2019, Zhengda Tianqing developedAnother star.Anticoagulant drug apixaban tablets obtained the drug registration approval issued by the China Food and Drug Administration. And beforeHaosen Pharmaceuticals' Apixaban tablets were approved to be included in the listed drug catalog in January with a newly registered classification, seizing the first imitation.

ApixabanYesAn oral selective activation factor Xa inhibitor developed by Bristle-Myers Squibb (BMS) in conjunction with Pfizer. In May 2011, it was approved for listing in the European Union; in December 2012, it was approved by FDA for listing in the United States.It entered China in 2013 and entered the new medical insurance catalogue in 2017 for adult patients undergoing elective hip or knee replacement to prevent venous thromboembolic events.

Based on its outstanding product advantages, apixaban is becoming more and more prominent in the new generation of oral anticoagulants. In the past five years, its global sales have risen rapidly, exceeding US $1 billion in 2015, rising to US $3.343 billion in 2016, and reaching US $7.4 billion in 2017;2018For9.8 billion dollars.Although dueLate entry into the health insurance catalogue and less promotion of the original research in the country,ApixabanSales Performance in ChinaOnly a very small share of the anticoagulant market,itsThe strong growth in the world has attracted the attention of many domestic pharmaceutical companies.

In terms of patents, while the NMPA approved Apixaban for Howson and Chia Tai, it did notNotIt involves challenging the original research patent.The domestic compound patent of the original research drug will expire on September 17, 2022 (CN1578660A).Subject to this constraint, if there is no turning point in the success of the patent challenge, before this time node, there will be no domestic apixaban generic drug market sales.At present, there are as many as 27 apixaban tablets in research and development in China, of which Hausen and Zhengda Tianqing have been the first to be approved.andWaiting for the market to open.

Summary

Rivaroxaban and apixaban are the most prescribed non-vitamin K antagonist oral anticoagulants (NOACs) worldwide. As early as 2017, rivaroxaban and apixaban were already the top 20 anticoagulant drugs in the Top50, the world's best-selling drugs. Rivaroxaban and apixaban were superior in the RECORD trial and the ADVANCE trial, respectively, compared with enoxaparin, the current standard of care for the prevention of venous thromboembolism after orthopedic surgery.

Studies have shown that 20-30% of the first venous thrombotic events are related to cancer. If the future correlation between cancer and thrombosis market is large, then the domestic demand for the above two drugs will increase significantly, which shows that the market potential is huge. The domestic anticoagulant market has grown rapidly in recent years, with a 5-year compound growth rate of 16.19. In 2018, the sales of anticoagulants in the sample hospitals were 29.2 billion yuan, accounting for 41.35 of the sales of antithrombotic drugs.

Before the expiration of foreign Shaban patents, the scale of application of Shaban drugs in China will still be very limited..However, after 2020, with the listing of domestic generic drugs, this situation will be completely changed, and the foreign monopoly pattern will be broken. It is estimated that by 2026, the market supply scale of Shaban drugs in China will reach 28.47 billion yuan, and the demand scale will reach 27.48 billion yuan.Competition in the field of domestic anticoagulant drugs will be further intensified, and the sawing between original research and imitation, imitation and imitation will gradually form a new pattern.

The first imitation of rivaroxaban is about to be approved for listing,Plus beforeApixaban Tabletshas been approved,Zhengda TianqingEntering the harvest period, willBecoming the first enterprise in China to own "rivaroxaban apixaban" double-pound anticoagulant,There are many advantages in market share competition,FurtherAnticoagulation in the domestic market occupies an important position!