Market trend analysis of 8 serious drug declaration varieties

Source: medical economic news April 15, 2015 CDE will issue annual drug review report every year On the one hand, it shows the annual domestic drug declaration and the work of the review institutions; on the other hand, it also plays a guiding and warning role, hoping that the pharmaceutical enterprises can make more scientific product line planning and reduce unreasonable declaration through reporting On March 13, the latest 2014 annual drug review report arrived as promised What can we get from it? In 2014, the number of chemical application increased rapidly, while the number of traditional Chinese medicine decreased significantly, suggesting that some chemical varieties may have the problem of repeated application, which also reflects the difficulty of application of traditional Chinese medicine In 2014, the overall disapproval rate of traditional Chinese medicine application reached 60%, far higher than that of chemical and biological drugs In terms of new drug approval, the review report focuses on 12 new drug products that have made major breakthroughs, including apatinib, sidazaniline and polio inactivated vaccine However, the breakthrough of new drugs does not cover up the fact that China's drug declaration is still dominated by generic drugs The number of excellent imitated varieties is limited, which leads to serious declaration of some varieties In 2014, there were more than 1000 chemical generic drugs to be reviewed, of which 31 drugs were declared more than 50, and more than 100 were declared for esomeprazole, atorvastatin calcium, clopidogrel, entecavir, fasudil, cefdini, ambroxol and moxifloxacin The application for scrambling for imitations is also serious Among the varieties to be reviewed, the number of application for azilsartan, rofluoristone, ibuprofen (injection) and lulasidone exceeds 50 Considering that most varieties have 2-3 content specifications, there are more than 20 manufacturers applying for these varieties Under the system of "one product and two specifications", many domestic generic drugs will compete for the admission qualification of only two specifications of the hospital In addition, at present, the original research drugs can generally occupy one of the specifications, which makes the entrance of generic drugs will have to "squeeze thousands of troops into a single bridge" Even if the problem of entering the hospital is solved, the market fight of many manufacturers will also lead to the sharp reduction of prices among enterprises in the stage of competition, such as bidding, in order to obtain market access qualifications A series of problems caused by the group declaration will break out in succession in various problems after the product goes on the market Enterprises should further evaluate whether they should continue to apply for the serious varieties announced by CDE The enterprise needs to assess: is its declaration process in the front line of duplicate varieties? Is it a superior variety in the treatment field involved? Is there a mature team supporting the market promotion of this variety? For the pharmaceutical companies that are expected to be the first ones or the first ones to be listed, as well as have advantages in this market field, it is no doubt that they will be invincible to speed up the development and prepare for the listing earlier For those enterprises that do not have advantages, it is better to stop development as soon as possible, "stop loss" is also a kind of revenue More than 100 esomeprazole applications for 8 Chemical generic drugs are under review: 257 sample hospital sales: 864 million yuan area: digestive system drug esomeprazole developed by AstraZeneca, first approved for market in 2000, the trade name is "Nexium" Esomeprazole is the left-handed isomer of omeprazole Compared with omeprazole, esomeprazole has stronger acid inhibition and faster effect, and it is also suitable for patients with CYP2C19 enzyme metabolism abnormality As a new generation of PPI drugs, esomeprazole was approved to enter the Chinese market in 2004 Esomeprazole grows rapidly in China because of its exclusive monopoly of the original research drug market and its high cost of treatment In 2014, the sales volume of esomeprazole sample hospitals reached 864 million yuan, with a compound growth rate of 29% in the past five years [trend analysis] the sample hospitals alone have a market scale of nearly 1 billion yuan, which is undoubtedly quite attractive With the expiration of the patent, many domestic pharmaceutical companies are trying to share this huge market But here comes the problem: it seems that every company can get a huge piece of cheese in this market At present, the number of esomeprazole under review by CDE is up to 257, that is to say, nearly 100 enterprises are applying for it Among the numerous imitations, only esomeprazole of Chongqing Laimei stands out and was approved in 2013 The medicine is based on the non salt model of esomeprazole rather than the magnesium or sodium used in other generic drugs Due to the short time to market, the market share of lesomeprazole is still very small In 2014, the sample hospital market was about 1 million yuan As the first generic drug, it still has an excellent market opportunity, but its pricing is close to that of Nexium, lacking price advantage In addition to Laimei, a number of generic drugs of enterprises are expected to be approved in the near future, all of which are esomeprazole injection, including Zhengda Tianqing, Jiangsu aosaikang, Yichang Changjiang, Jiangsu Haosen, etc It should be pointed out that the market size of esomeprazole has a certain relationship with the high price, and the price of a large number of generic drugs will inevitably go down after being listed In addition, compared with other PPIs, esomeprazole has no significant advantages, so generic drugs need to face not only the original research drug, but also the competition of other PPI generic drugs Atorvastatin is under review: sales volume of 168 sample hospitals: 1.374 billion yuan area: cardiovascular drug atorvastatin is a kind of statins developed by Pfizer, which was approved to be listed in the United States in 1997, with the trade name of "Lipitor" Atorvastatin is the sixth FDA approved statins Its lipid-lowering effect is better than that of earlier drugs, and its safety is still satisfactory "Lipitor" entered China in 1999 In the same year, the generic drug of Beijing Jialin was approved, with the trade name of "alle" Lipitor has applied for new drug protection while entering China, so for a long time, the domestic market of atorvastatin calcium was shared by Lipitor and aloe In 2005, "Youjia" of Henan Tianfang, the second generic drug, was approved for listing Since then, Guangdong encyclopedia and atorvastatin calcium preparation of Zhejiang xindonggang have also been approved With the development of the original drugs and several generic drugs, atorvastatin has always maintained a rapid development In 2014, the sales volume of atorvastatin sample hospital reached 1.374 billion yuan, with a compound growth rate of 28% in the past five years [trend analysis] atorvastatin is not only used for hyperlipidemia, but also as an auxiliary medicine in hypertension, diabetes and stroke The huge existing market scale makes many domestic pharmaceutical enterprises greedy and hope to share the market This led to a serious build-up of atorvastatin filings At present, the number of atorvastatin under review by CDE is up to 168 In addition, the enterprises that have passed the review, that is to say, nearly 100 enterprises have declared or are declaring the same As the original research drug, "Lipitor" still leads the market, accounting for 81% of the market share, the first generic drug "aloe" accounts for 16%, and the share of other generic drugs is limited In terms of pricing, aloe's pricing is slightly higher, about 70% of Lipitor's, and the prices of the other three companies are about 60% of Lipitor's As other generic drugs go on the market, the price will go down further, and low price competition is inevitable Clopidogrel is under review: 167 sample hospital sales: 1.599 billion yuan area: antiplatelet drug clopidogrel is a antiplatelet drug jointly developed by Sanofi and BMS, which was first approved for market in 1998, and the trade name is "Plavix" Many cardiovascular and cerebrovascular diseases advocate antiplatelet therapy, while traditional aspirin has the risk of peptic ulcer, so clopidogrel, which has good curative effect and does not hurt the stomach, is full of opportunities "Plavix" was approved to enter China in 2001, while xinlitai took advantage of the loophole of patent policy at that time to copy and list "Taijia" in 2000 Before the approval of Lepu's new Shuaike in 2012, the market of clopidogrel was monopolized by "Plavix" and "Taijia" In 2014, the sales volume of clopidogrel sample hospitals reached 1.599 billion yuan, with a compound growth rate of 17% in the past five years [trend analysis] the market scale of sample hospitals reached 1.6 billion yuan, making clopidogrel become the imitation target of domestic enterprises At present, the number of clopidogrel under review by CDE has reached 167, and more than 50 pharmaceutical companies are copying or applying for it The first imitated "Taijia" occupies 34.4% of the market share, and the sample hospital market alone exceeds 500 million yuan; the newly listed "xinshuaike" successfully shares 4% of the market share through the low price strategy After "xinshuaike", more than 10 generic drugs of clopidogrel have completed the application and are ready to be listed, including Hengrui, Zhengda Tianqing, Shiyao and other large-scale enterprises It can be predicted that the competition for clopidogrel will become quite fierce in the next two years as these varieties enter the market Entecavir is under review: sales volume of 125 sample hospitals: 1.207 billion yuan area: antiviral drug entecavir is a new generation of nucleoside Antihepatitis B drugs developed by BMS, which was first approved for market in 1995, and the trade name is "boluting" As China is the most important market for hepatitis B treatment drugs, BMS attaches great importance to the Chinese market, and its products will soon enter China Compared with early nucleoside drugs such as lamivudine and adefovir dipivoxil, entecavir has a significantly lower drug resistance rate and improved efficacy Compared with interferon, entecavir has a higher safety and compliance Therefore, it soon became a first-line hepatitis B treatment drug, with a rapid growth in sales In 2014, the sales volume of entecavir sample hospital reached 1.207 billion yuan, with a compound growth rate of 42% in the past five years [trend analysis] China is a big country of hepatitis B, and the market of hepatitis B drugs is huge New generation nucleoside anti hepatitis drugs such as entecavir and tenofovir have huge market capacity Liver disease giant Zhengda Tianqing's entecavir first imitated drug "Runzhong" was approved as early as 2010 Henceforth, entecavir of Lukang, guangshengtang, Anhui Baker, hisico, Jiangxi Qingfeng and other enterprises was approved in succession At present, there are dozens of enterprises in the declaration status of entecavir, and CDE is reviewing 125 entecavir In 2014, "boluting" and "Runzhong" respectively accounted for 65% and 26% of the market share, and the rest of the varieties shared 9% of the market share With the subsequent varieties coming into the market, the higher price of entecavir will be impacted, but the lower price will also give more hepatitis B patients the opportunity to use entecavir, so as to expand the patient population Ambroxol is under review: the sales volume of 101 sample hospitals is 943 million yuan Ambroxol is developed by bringer Ingelheim and used for respiratory diseases such as bronchitis It is a first-line cough and expectorant drug with the trade name of "ambroxol" "Mucosolvan" has been in China for a long time, and there are many imitations At present, there are nearly 70 ambroxol preparation manufacturers in China In 2014, the sales volume of ambroxol sample hospital reached 943 million yuan, with a compound growth rate of 10% in the past five years [trend analysis] although there are many listed companies and the market growth slows down, there are 101 ambroxol generic applications under review by CDE In contrast, in 2014, the original research drug of sample hospital“