The first batch of consistency evaluation varieties are the most comprehensive analysis! Market scale, competition pattern, future trend

The era of oligopoly is coming So, what are the current market patterns of the first 12 varieties that have passed the consistency evaluation? How do they stir up the market competition pattern and impact the original research drug? How much profit will it bring to related enterprises? These have become the industry's concern and expectation for these varieties On December 29, the first batch of runners who reached the end of the race finally came out fresh, with a total of 12 varieties and 17 specifications, four of which belong to the "289 catalog" variety Huahai pharmaceutical is undoubtedly the biggest winner, with 7 products and 9 product specifications listed, more than half In the early stage, Chengdu Beite's tenofovir, xinlitai's clopidogrel and other products predicted by major securities companies were among the first batch Guotai Junan Securities divides the ways to impact the market through the consistency evaluation of generic drugs into the following categories: the enterprises with large market scale, the dominant position of original research and numerous competitors, who are the first to pass the consistency evaluation, will stand out in the fierce competition, lead the competitors, and launch the impact on the original research drugs to achieve "pre emption"; For the varieties with large market scale, leading position of original research drugs and good competition pattern, the enterprises with small market share will seize the market share of original research through consistency evaluation, even threaten other domestic enterprises in the dominant position, with large space for market share promotion, and realize "counterattack of the weak"; The large-scale market, small share of original research, large number of domestic enterprises but lack of "dominant" leading generic drugs Because domestic enterprises are hard to distinguish between the top and bottom, the domestic enterprises that take the lead in passing the consistency evaluation will quickly seize the market share of other domestic enterprises and achieve "winner takes all"; Enterprises with more varieties and more small varieties should actively promote project approval to ensure that multiple core varieties pass the consistency evaluation, continue to contribute income and profits, and achieve quantity win The era of oligopoly is coming So, what are the current market patterns of the first 12 varieties? How did they stir up the market competition pattern and impact the original research drug? How much profit will it bring to related enterprises? These have become the industry's concern and expectation for these varieties 1 Zhengda Tianqing risuvastatin calcium tablet is the first-line statins in China, which has obvious lipid-lowering effect and is known as "super statins" Since 2007, the market share of lipid-lowering drugs in China has exploded After 2012, it ranks the second place in the sales volume of sample hospitals in key cities, second only to atorvastatin which was listed in China in the early 8 years As the core compounds do not enjoy patent rights in China, three domestic enterprises have obtained the approval documents for preparation production of rosuvastatin calcium as early as 2008, namely Lunan Beite Pharmaceutical Co., Ltd., Zhejiang Jingxin Pharmaceutical Co., Ltd and Nanjing Zhengda Tianqing Pharmaceutical Co., Ltd As of August 2017, 30 pharmaceutical companies have applied for nearly 60 generic drugs of rosuvastatin calcium It is not included in the 289 catalogue, but it is one of the varieties with fierce competition in consistency evaluation There are 7 domestic generic pharmaceutical enterprises filing 15 specifications of rosuvastatin calcium reference reagent, and 10 enterprises filing be test According to the data of minenet, in 2016, the sales volume of rosuvastatin calcium tablets in sample hospitals in key cities was about 650 million yuan, and the former research manufacturer AstraZeneca's "Keding" accounted for 73% of the market share, with lunanbeite accounting for 12%, Jingxin pharmaceutical accounting for 7%, Zhengda Tianqing 5.5% and other enterprises accounting for 2.5% Although the original research drug is still "one of the largest", the use of generic drugs has increased from 19% to 27% from 2012 to 2016 There is a huge import substitution space for domestic rosuvastatin, and the consistency evaluation of generic drugs is an important track for relevant enterprises to compete for the market From the perspective of time, "JINGNUO" of Jingxin pharmaceutical industry is the one with the fastest progress in consistency evaluation The time for filing be test is 3 months earlier than Zhengda Tianqing, and it passed the on-site inspection of Zhejiang Provincial Drug Administration in June 2017, which has been regarded as the first in the industry However, due to the use of some of its own personnel in the be test, it was suspended by the drug Audit Center, and it needs to be determined by CFDA In the end, Zhengda Tianqing, the No 1 market share ranked No 4, finally ranked No 1 From the previous competition pattern, the advantages of Beijing new pharmaceutical industry are that rosuvastatin API business is mature and cost is lower, and it can be appropriately low bid price in exchange for the market, while Zhengda Tianqing mainly purchases APIs from Beijing new pharmaceutical industry, which has disadvantages Lunambert benefited from the success in price maintenance of rosuvastatin, with the fastest market share increase It also launched the be trial in August 2017 As of July 2017, there are 5 winning provinces of rosuvastatin in Zhengda Tianqing, which is lower than that of Jingxin pharmaceutical For the first time, the consistency evaluation will greatly improve the popularity of its varieties, enjoy preferential policies, and increase market share, which is a great opportunity for it to achieve counter attack However, the two competitors, Jingxin pharmaceutical and lunanbeite, will soon catch up with each other Zhengda Tianqing needs to seize the opportunity to plan ahead 2 Cefuroxime axetil tablets, which is one of the best-selling anti infective drugs in the world in the 1990s, are favored by the clinic for its strong antibacterial effect and safety There are many dosage forms of cefuroxime, mainly including injection, tablet, capsule, etc in the list of unilateral cephalosporin antibiotics purchased by public hospitals in key cities in 2014, cefuroxime is the leading variety, with the drug amount of 547 million yuan, an increase of 8.39% over the previous year Now, the products of cefuroxime preparations produced in China are not only supplied to the domestic market, but also exported to the overseas market In 2013, Sinopharm group realized the export of 58.89 million yuan, mainly for the export of cefuroxime powder to the UK market In September 2013, the company passed the EU certification for solid preparations, and it is expected that the export of cefuroxime preparations will continue to increase in the future A total of 13 domestic enterprises have listed cefuroxime ester tablets, and a number of foreign-funded enterprises have also participated in product competition By the end of November 2015, there were 13 approval numbers of cefuroxime imported drugs in China's pharmaceutical market, and the sales price of foreign-funded enterprises' products is generally higher than that of domestic products In 2008, the original brand and imported powder injection of cefuroxime ester accounted for 30% of the market share of domestic city sample hospitals, and domestic products accounted for 70% There is still alternative space in the original research, but there is still a lack of market leader in China Zhijun (Shenzhen) Pharmaceutical Co., Ltd of Sinopharm group has occupied a certain market share Through one-off evaluation, it will help it dominate the domestic market and formally impact on the original R & D Chengdu Beite tenofovir dipivoxil tablet is a classic oral nucleoside antiviral drug Tenofovir developed by Gilead has become the first-line long-term drug for the treatment of hepatitis B patients in the world with many advantages, with the highest annual sales of 2.22 billion US dollars, higher than 1.77 billion US dollars of entecavir It is the best-selling variety of such drugs In April 2016, the Beijing Higher People's court ruled that Geely tenofovir's patent was invalid, which opened the way for domestic pharmaceutical enterprises to rush to apply for listing of tenofovir China is a big country of hepatitis B, with 22 million hepatitis B patients According to the penetration rate of 10%, the annual treatment cost of hepatitis B patients is about 11 billion The considerable market space naturally attracts the relevant enterprises to rise up and play games In November 2016, Chengdu Beite's application for tenofovir for HIV infection was approved, becoming the first domestic manufacturer of tenofovir In May 2017, guangshengtang included the first approved qualification for hepatitis B indications of tenofovir in China, while Chengdu Beite's approval for hepatitis B indications was only one minute later than guangshengtang On December 5, 2017, Zhengda Tianqing took the lead in completing the bioequivalence study of tenofovir in accordance with the standards of "quality and efficacy evaluation of generic drugs", and obtained the CFDA drug registration approval for the treatment of chronic hepatitis B The fight for the first imitation of novovi is a twists and turns, and the players have made strange moves Limited by price, medical insurance reimbursement and other factors, in 2016, the domestic sales of tenofovir was only 54 million In the last round of national drug price negotiations, the price of Gilead's original research drug dropped by half, coupled with the successive listing of generic drugs, tenofovir's overall market will usher in explosive growth Chengdu Beite and Zhengda Tianqing, which have passed the consistency evaluation, will also launch an impact on the original research of Gilead 4 Huahai pharmaceutical 7 varieties passed the consistency evaluation Looking at the first batch of varieties passed the consistency evaluation, Huahai pharmaceutical industry dominated more than half of them, which was extremely dazzling This benefits from the internationalization strategy of preparations confirmed by Huahai pharmaceutical ten years ago The 7 varieties of paroxetine, risperidone, irbesartan hydrochlorothiazide, fosinopril, irbesartan, losartan potassium and lisinopril that passed the consistency evaluation were all approved in China and the United States and produced in the same production line Huahai pharmaceutical confirmed to e pharmaceutical manager that all 7 varieties applied to CDE in accordance with the path of "conforming to the European and American Certified varieties are automatically deemed to pass the consistency evaluation", and obtained the acceptance of CDE After several meetings and supplementary information, the seven varieties were all in the first echelon to pass the consistency evaluation In addition, another product is in the process of supplementing information, and will soon get the "pass consistency evaluation" logo After more than ten years of accumulation, Huahai pharmaceutical industry has stepped into the list of mainstream US generic pharmaceutical enterprises About 35 products have been approved in the United States, and the market share of multiple varieties in the United States ranks first Its export products focus on high difficulty, high added value and large varieties, and high-quality generic drugs are the banner of Huahai, and this consistency evaluation is to establish the benchmark position of high-quality generic drugs in China Most of the seven varieties passed this time belong to antihypertensive products, with a small market share and a large market space occupied by the original research With the advantages of internationalization and consistency evaluation of preparations, Huahai pharmaceutical industry has a huge market alternative space Risperidone tablet is a large variety in the field of psychotherapy In 1993, Johnson & Johnson launched in the U.S market, and the peak sales reached 3.4 billion yuan in 2007 On the basis of ordinary tablets, Johnson & Johnson continues to develop injection, orally disintegrating tablets, long-acting microspheres, etc to extend the product cycle In China, there are many risperidone imitation enterprises with fierce competition At present, the original manufacturer Johnson & Johnson still occupies the largest market share According to the data of Ameda national sample public hospitals, Huahai pharmaceutical occupies 8.47% of the market share, which is lower than four domestic enterprises, namely Qilu pharmaceutical, Jiangsu Enhua, Jilin West Point pharmaceutical and Changzhou four pharmaceutical, ranking fifth According to the data of minenet, the average growth rate of domestic compound antihypertensive market in five years is 29.28%, which has reached 6 billion yuan in 2016, and it is predicted that it will exceed 10 billion yuan in recent years Among them, the market share of top 5 varieties accounted for 88% of the total, and irbesartan hydrochlorothiazide tablets ranked second, second only to valsartan amlodipine In 2016, the sales volume of irbesartan hydrochlorothiazide tablet PDB sample hospital was 219 million yuan, and Sanofi, the original research enterprise, accounted for 64% The market share of Huahai pharmaceutical industry is 5%, which is lower than that of Zhengda Pharmaceutical Group and Inner Mongolia Yuanhe pharmaceutical industry Huahai Pharmaceutical Co., Ltd and Hezheng Pfizer's irbesartan tablets passed the consistency evaluation at the same time Both of them completed the listing in the United States and turned to domestic application for consistency evaluation Among them, three regulations of Haizheng Pfizer were listed in the United States in June 2016, and one regulation of Huahai pharmaceutical was approved to be listed in the United States as early as September 2012