Application for listing of generic drugs of rivaro Shaaban and lenalidomide of Changzhou pharmaceutical factory was accepted on the same day

Wen Jie DOPINE On January 20, two types of generic drugs, rivaroxaban tablets and lenalidomide capsules, were accepted by CDE At present, both generic drugs in China have been approved The following is a detailed introduction of the enterprise structure and market competition in these two fields Rivaroxaban is a selective clotting factor Xa inhibitor It can inhibit the production of thrombin and play an antithrombotic role by competitively inhibiting free and binding XA factors, interrupting the endogenous and exogenous pathway of clotting cascade reaction, and inhibiting the production of thrombin The original research drug was jointly developed by Bayer and Johnson's subsidiary Xi'an Janssen It was approved by EMA in September 2008, FDA in November 2011, and nmpa in March 2009 for the prevention of venous thrombosis after elective total hip or total knee arthroplasty in adults The trade name is bairuituo Later, it was approved by nmpa in May 2015 for the treatment and prevention of deep vein thrombosis and the prevention of pulmonary embolism and atrial fibrillation Prevention of stroke Up to now, there are four kinds of Saban drugs approved to be listed in the world (see the table below for details), among which, except for betroxaban, the other three are approved to be listed in China Among them, rivaroxaban, as the first marketed oral antithrombotic drug of Saban, has seen a year-on-year increase in sales since its launch (see the table below for details), and has been ranked first in the list of Saban drugs for many years In this field, rivaroxaban and apixaban occupy most of the market share, but in recent years, apixaban's annual sales have exceeded that of rivaroxaban In China, the market of rivaroxaban has been monopolized by Bayer, the original research enterprise, with a rapid growth in sales According to minenet, in 2019, the sales of rivaroxaban in the terminals of China's public medical institutions and China's urban retail drugstores will be nearly 1.9 billion At present, the State Intellectual Property Office has issued a notice that a patent for the preparation of Bayer rivaroxaban tablets is invalid, and the compound patent for the product will expire this year According to insight database, more than 40 enterprises have laid out the field of rivaroxaban, among which Zhengda Tianqing has taken the first imitation of rivaroxaban, and 5 enterprises are conducting be test In addition, when it comes to Saban anticoagulants, we have to mention the first new drug, zhifeisaban, independently developed by Tianjin Pharmaceutical Research Institute It is the first Saban anticoagulant drug independently developed and entering the clinical research stage in China Lenalidomide is a new generation of immunomodulator, which has the characteristics of immunomodulation, anti angiogenesis and anti-tumor It is widely used in the treatment of multiple myeloma, lymphoma, myelodysplastic syndrome, acute myeloid leukemia and other diseases It is currently a common drug for the treatment of multiple myeloma and myelodysplastic syndrome at home and abroad The original research enterprise of lenalidomide is Xinji, which was approved in the United States in December 2005, approved in China in 2013, and entered the national medical insurance catalogue in 2017 Compared with the global sales of lenalidomide, the domestic market of lenalidomide is relatively bleak At first, due to its high price, less patients were benefited Later, although the price was reduced by 60% to enter the national health insurance in 2017, the sales situation was still not optimistic due to the limitation of reimbursement However, with the approval of generic drugs, the sales volume of lenalidomide began to increase significantly According to the data of mienei.com, the sales volume of lenalidomide capsule in public hospitals in key provinces and cities in 2018 was 143 million yuan, an increase of 592.75% over the previous year In view of the huge market potential of lenalidomide, domestic enterprises have begun to lay out this field So far, three generic drugs of lenalidomide have been approved in China, including Lisheng of Shuanglu pharmaceutical, Anxian of Zhengda Tianqing and qipuyi of Qilu pharmaceutical Qilu pharmaceutical and Zhengda Tianqing have passed the consistency evaluation successively In addition, according to insight database, Jiangsu Haosen, Yangzijiang pharmaceutical, Baiji Shenzhou and Changzhou pharmaceutical have also applied for listing, and it is expected that in the future, domestic patients will use the drug at a more people-friendly price reference material: