Whose home is the first imitation of flowers in China? 21 pharmaceutical companies compete for two global heavyweight products

In recent days, Hyundai pharmaceutical has issued two successive announcements, saying that the company and its wholly-owned subsidiary Shanghai Hyundai pharmaceutical Haimen Co., Ltd have received the notice of approval opinions and approval documents for clinical trials of drugs approved and issued by CFDA, involving two APIs, apixaban and sigletin phosphate, as well as their two tablets According to the data, apixaban tablets and cigliptin phosphate tablets belong to the world's heavyweight products, with sales of more than $3 billion in 2016 At present, both products have entered the new version of the medical insurance catalogue, so who can win the first imitation? Attract domestic enterprises to apply for imitation Table 1: details of the four approved clinical products of modern pharmaceutical (source: announcement of listed companies) table 2: enterprises of domestic approved clinical application of apixaban tablets and sigletin phosphate tablets (data source: midnet Med drug evaluation database, as of October 25, 2017) according to midnet data, at present, there are 19 domestic enterprises that have been approved to apply for apixaban, and 6 enterprises that have been approved to apply for xigliptin phosphate, including Shanghai modern pharmaceutical, Jiangsu Haosen pharmaceutical, Sichuan Kelun pharmaceutical and Zhengda Tianqing pharmaceutical Excluding the overlapping enterprises, 21 of the two products have been approved for clinical application What's the reason for such a big competition? The global sales of the new oral anticoagulant apixaban has exceeded 3.3 billion US dollars Apixaban is a powerful, reversible and highly selective XA factor inhibitor It is a new oral anticoagulant It can play an antithrombotic role at a dose level that does not affect the hemostatic function It can be used to prevent and treat thrombus To prevent venous thromboembolism in adult patients undergoing selective hip or knee replacement Figure 1: global sales of apixaban from 2012 to 2016 (in millions of US dollars) (data source: performance database of MNCs in minai.com) Apixaban was jointly developed by Bristol Myers Squibb and Pfizer It was first approved for listing in the EU in 2011, with specifications of 2.5mg and 5mg According to data from minenet, global sales of apixaban have been rising rapidly in the past five years, breaking through the $1 billion threshold in 2015 and rising to $3.343 billion in 2016 Figure 2: Sales of apixaban in China's public medical institutions from 2013 to 2016 (unit: 10000 yuan) (data source: China's public medical institutions' terminal competition pattern of minenet) table 3: Winning of apixaban in some provinces and regions of China in 2017 (data source: China drug bidding database of minenet, as of October 13, 2017, the unit price of the smallest preparation remains two decimal places.) CFDA approved the listing of apixaban in China in 2013, with the specification of 2.5mg Data shows that during 2014-2016, the total sales of apixaban in China's urban public hospitals, county-level public hospitals, urban community centers and township health centers (referred to as China's public medical institutions) terminals remained at about 9-10 million yuan At present, apixaban has entered the new version of the medical insurance catalog, is one of the new class B products, the use of which is limited to patients undergoing lower extremity joint replacement surgery Sigletin phosphate, an oral antidiabetic drug, has been sold for more than 3.9 billion US dollars worldwide as an oral antidiabetic drug of dipeptidyl peptidase-4 (DPP-4) inhibitors It can be used alone or in combination with metformin in clinical treatment of type 2 diabetes Sitagliptin phosphate can control blood glucose in type 2 diabetic patients by increasing the level of active incretin Figure 3: global sales of cigliptin phosphate (in millions of US dollars) in 2009-2016 (data source: performance database of MNE) Cigliptin phosphate was first developed by Merck, and was approved for listing in the United States as early as October 2006 According to the data of minenet, the global sales of cigliptin phosphate reached the peak in 2012, which had exceeded 4 billion US dollars in that year, and then the sales fell slightly in the following years, but remained above 3.8 billion US dollars Figure 4: Sales of sigletin phosphate in China's public medical institutions from 2013 to 2016 (unit: 10000 yuan) (data source: minenet China's public medical institutions terminal competition pattern) table 4: bidding winning of sigletin phosphate tablets in some provinces and regions of China in 2017 (data source: China drug bidding database of minenet, as of October 13, 2017, the unit price of the smallest preparation remains two decimal places) CFDA approved xigliptin phosphate tablets to enter China in 2009 In recent years, the total terminal sales of cigliptin phosphate tablets in China's public medical institutions have grown rapidly, with an annual growth rate of more than 30%, according to the data of minenet In 2016, cigliptin phosphate tablets ranked 16th in the top 20 pattern of chemical oral hypoglycemic drugs in public medical institutions in China At present, cigliptin phosphate tablets have entered the new version of the medical insurance catalog, which is one of the new class B products, and the scope of use is limited to second-line drugs   none="shifuMouseDown('shifu_t_002')" style="margin: 1em auto; padding: 0.5em 0px; max-width: 100%; color: rgb(62, 62, 62); font-family: "Hiragino Sans GB", "Microsoft YaHei", Arial, sans-serif; font-size: 16px; line-height: 25.6px; widows: 1; border: none; text-align: center; width: 670px; box-sizing: border-box !im portant; Word wrap: break word! Im portant; "> conclusion from the global sales situation in 2016, apixaban tablets and cigliptin phosphate tablets have both exceeded US $3 billion, and have made outstanding achievements in anticoagulation and glucose reduction Apixaban has not entered the Chinese market for a long time, but with its rapid growth in the global market, it has also attracted the attention of many domestic enterprises; Although xigliptin phosphate tablets have entered the Chinese market earlier and its market share has been firmly held by Merck, the advantages of domestic products will be shown after entering the new medical insurance catalog, so there are also domestic enterprises focusing on it In addition, since the implementation of be filing management, pharmaceutical companies have seized this great opportunity According to media reports, Jiangsu Haosen and Zhengda Tianqing have completed the be test of apixaban tablets and submitted the application for listing, while Sichuan Kelun, Jiangsu Jiayi, Jiangsu Wanbang and Jiangxi Qingfeng are registered; Sichuan Kelun also completed the be test of xigliptin phosphate tablets and submitted the generic drug listing application Currently, Tonghua Dongbao, Zhengda Tianqing and Zhejiang medicine are registered There will be winners in every battle What is the final outcome of these two first imitative seizing wars? Let's wait and see.