Four years later, another domestic competitor came to US $7 billion

On May 21, according to the official website of the drug evaluation center of the State Drug Administration, Qilu pharmaceutical's application for the listing of inarcept biological similar drugs, with the acceptance number of cxss1900024, means that a strong Dieter is welcome in the "cake" of inarcept in China Etanercept is the first TNF antagonist approved for rheumatoid arthritis (RA) It was jointly developed by Amgen and Pfizer It was approved by the US FDA on November 2, 1998, the European EMA on February 3, 2000, and the Japanese PMDA on January 19, 2005 Etanercept was later listed in China and was approved on February 26, 2010, under the trade name of "enri" The imitation of Etanercept was carried out earlier in China Etanercept, a similar drug of Sansheng Guojian (a subsidiary of Sansheng pharmaceutical), was approved for listing in 2005, earlier than the domestic listing time of etanercept In addition, Shanghai SAIJIN's "qiangke" and Haizheng's "ambeno" were approved for listing in 2012 and 2015 respectively Table 1 enacept: rheumatoid arthritis (RA), one of the main traction agents of TNF - α inhibitors, is a chronic and inflammatory autoimmune disease, in which 70% of RA patients are moderate to severe Since TNF - α was revealed to be the most important proinflammatory cytokine in autoimmune arthritis in 1970s, it has been studied for more than 20 years In 1998, researchers successfully developed a biological agent for immunosuppressive therapy - TNF - α inhibitor, and applied it to the clinical treatment of rheumatoid arthritis, with good curative effect According to the forecast of nature, the market share of RA drugs in 2019 will reach US $30.5 billion, of which 71.1% will be TNF - α inhibitors At present, the main TNF - α inhibitors used in clinic are: adalimumab, etanercept, infliximab, cetuzumab and golimub According to the statistics of financial reports, adamumumab, etanercept and infliximab are the three best-selling TNF - α inhibitors, and the global market still performs well In 2018, in the global tpo10 list of drug sales, adalimumab reached the top with us $19.936 billion, while enacept ranked seventh with us $7.126 billion Although sales of infliximab declined, it also reached US $6.446 billion Domestic market: at present, 8 kinds of biomacromolecule drugs have been listed in the field of autoimmune diseases in China, 5 kinds of imported drugs and 3 kinds of domestic drugs, all of which are bio similar drugs Among them, Sansheng Guojian's "yisaipu (etanercept)" rate was first listed in 2005, becoming the first biologically similar drug accepted by the market The following table: after the above-mentioned original varieties enter China, the market penetration rate is poor due to a series of factors In the case of inarcept biological similar drug applied for listing by Qilu pharmaceutical this time, domestic product Sansheng Guojian's "yisaipu" has a first mover advantage and was included in the national medical insurance catalog in 2017, occupying an absolute advantage in the field of (rheumatoid + ankylosis + psoriasis) With the listing of "qiangke", "ambrano" and Qilu pharmaceutical's biological similar drugs, the market share of the original research drug variety "enri" will be gradually eroded It can not be ignored that although rheumatoid arthritis and ankylosing spondylitis are a huge market in China, the market share of these drugs is still very small due to the low awareness rate of patients and the low market penetration rate of biomacromolecule drugs At the same time, Qilu pharmaceutical and the latecomers face more fierce market competition Whether the products can survive or not needs to be severely tested What is the chance for the successor of TNF α mAb? Sina pharmaceutical has also discussed before (see the latest progress of TNF α antibody research and development and the market pattern of domestic bio macromolecule self immunity field for details) In this field, imported varieties and domestic varieties are mixed Therefore: a) For the varieties at the stage of market application, such as inarcept biological similar drugs of Qilu pharmaceutical, they are facing the strong challenges of "yisaipu", "enri", "qiangke" and "ambarox" Pricing is a very important publicity and entry point, and it is very important to strive for comprehensive medical insurance coverage and more in-depth patient medication, preference and insurance; b) For the early clinical products, we need to pay more attention to the safety of the products, the improvement of patients' compliance, and the development of more differentiated products.