Disclosure of the ranking of "first generic" R & D capability of Chinese Pharmaceutical Enterprises
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Last Update: 2015-10-21
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Source: Internet
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Author: User
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There is a kind of "generic drug", which is called class 3.1 new drug This kind of preparation or API has been listed abroad and has not entered China It is generally called "first generic" in the industry Because the Chinese market of "first generic drugs" is in blank, and the new drug monitoring period of 4 years, it is widely sought after by Chinese enterprises How popular is this kind of medicine? Let's take a look: 1 The same ingredient words in different years do not lose weight 2 The statistics include APIs 3 The statistics of 2015 data are as of October 12, 2015 As shown in the figure, the number of clinical application varieties of new drugs in category 3.1 has increased sharply since 2012 In contrast, the number of varieties applied for listing and approved for production has remained stable That is to say, even if the market prospect of class 3.1 new drugs is good, irrational declaration leads to a fierce competition situation of too many applications and too few approvals At the same time, policies such as centralized review, centralized review, reform of drug registration and classification, and establishment of CDE sub centers have come one after another Therefore, it's time to rank the R & D capability of the "first generic" of China Pharmaceutical to see who stands out in this competition In addition to the number of class 3.1 new drug varieties declared, the key indicators to reflect the R & D ability of enterprises depend more on which enterprises have reached the stage of listing application and been approved for listing In addition, the trend of rapid competition seems to be one of the embodiment of the R & D ability of pharmaceutical enterprises 1、 The number of declared clinical varieties ranks the second in cro Nanjing Huawei According to insight China Pharma data database, 539 new drugs (including APIs) of 3.1 categories were declared in 2008-2015 The pharmaceutical enterprises (consolidated subsidiaries) with the largest number of declared varieties are as follows: Note: 1 Statistics includes APIs; 2 2015 By the end of October 12, 2015 and 2008, Zhengda Tianqing has been focusing on making the first imitation, applying for 93 clinical applications of class 3.1 drugs, leaving other enterprises far behind Lihua biology, a subsidiary of Nanjing Huawei pharmaceutical, specializes in clinical cro, ranking second in the number of clinical applications for new drug varieties of 3.1 Nanjing Huawei's clinical approval transfer customer base includes Yangzi River, Qilu, Luoxin, Kelun and other companies on the list It is also a company that transfers clinical approval documents, while Tianjin hankang, Jinan banuo and Shandong innovation are slightly inferior Jiangsu Hengrui and hausen have more than 60 filings, ranking fourth and third respectively In addition, the strength of Qilu, Luoxin and Shiyao is stronger than those of aosaikang and Sichuan Kelun In terms of the number of applications, most of the enterprises have shifted their R & D direction to class 3.1 new drugs since 2012, while Yangtze River, Hefei Xinfeng and other enterprises have been closely watching the class 3.1 new drug market 2、 In the era when the application speed of 57 varieties of Zhengda Tianqing ranked in the top 3 of the same variety, category 3.1 new drugs was in flood, how much application was nothing, fast was the king After all, in the rules of the game for new drugs of category 3.1, if the application is too late, it will either be withdrawn from the trial after the original imported drugs are listed, or it will be returned because the first drugs are listed into the new drug monitoring period However, the arrival of the recent centralized review also makes the same variety enter the technical review at the same time In this special period, the advantage of application speed will be weakened According to insight database, the following is the ranking of enterprises with the fastest application varieties in the clinical application of class 3.1 new drugs in 2008-2015: Note: 1 The fastest application speed: under the same variety, the undertaking time is the top 3; 2 The statistics include API; 3 The statistics of 2015 data are as of October 12, 2015 Zhengda Tianqing, hausen, Huawei and Hengrui are in the top three Even if the number of varieties declared by these four enterprises is large, the speed is also ahead The R & D ability of these enterprises in category 3.1 new drugs, like the school bully, is not only smart, but also hard-working The top 15 companies in the competition for imitation include Tianjin hankang, Qilu pharmaceutical, Jinan banuo, Sichuan Kelun, aosaikang, Shiyao, Yangzi River, Shenzhen Hanyu, Tibet hisico, etc However, Hefei Xinfeng, Shandong innovation, Nanjing Haina and Xiansheng pharmaceutical, which are listed in the clinical application quantity, are not listed in the top 15 in terms of the overall application speed 3、 In the list of 14 3.1 drugs declared by Yangzi River in 7 years, which enterprises have the strength to go to the stage of listing application? According to insight database statistics, there are 251 class 3.1 new drugs (including APIs) declared for listing in 2008-2015, and the pharmaceutical enterprises with the largest number of declared varieties are as follows: Note: 1 Statistics include APIs; 2 Data statistics of 2015 are as of October 12, 2015 Zhengda Tianqing Pharmaceutical Group has 20 class 3.1 drugs in 7 years The results of application for listing of class a varieties ranked first Although Yangzi River group ranks 12th in clinical application, it ranks second in listing application On average, there is a class 3.1 drug application for listing every two years, including Nanjing hailing, Beijing Haiyan, Jiangsu Haici, etc Although there are more clinical application varieties of Jiangsu Haosen than Hengrui, at the stage of listing application, Hengrui, the leader of R & D, is still in the third place Among the other enterprises applying for listing on the list, there are many who made the first imitation in the past few years, and later focused on making generic drugs or turning to innovative drugs, such as Shandong Lukang, Shanghai pharmaceutical, etc 4、 Jiangsu Haosen and Jiangsu Hengrui ranked second and third respectively in the number of approved varieties to be listed It's the hero who comes last So, which enterprises are the winners of class 3.1 new drugs approved for listing at present? According to insight database, 171 new drugs of category 3.1 were approved for listing in 2008-2015 (by component words) The enterprises with the largest number of approved listed varieties are listed as follows: Note: 1 Statistics includes APIs; 2 Statistics of 2015 data: as of October 12, 2015, Zhengda Tianqing is still ranked first, with 15 new drugs of category 3.1 Among them, Jiangsu Zhengda Tianqing is stronger than Nanjing Zhengda Tianqing Yangtze River ranks second with 10 approval numbers of new drugs of category 3.1 Juxtaposed with the Yangtze River are Jiangsu Haosen and Lunan pharmaceutical The approved class 3.1 new drugs of Lunan Pharmaceutical Co., Ltd were all before 2013, and the number of clinical varieties applied for listing and application was also average, so it was possible to be overtaken Hisico, Tibet, came from behind, tied for third place with Jiangsu Hengrui There are as many as 15 companies tied for the fourth and fifth place Some enterprises have a number of first imitated varieties from 2008 to 2012, such as Qilu, Shandong Lukang, Fosun and Luoxin, and some enterprises are catching up with each other after 2012, such as Zhejiang Haizheng, UL, Shiyao group, Beijing Sihuan Kebao, etc In summary, Zhengda Tianqing, Yangzi River, Nanjing Huawei, Jiangsu Hengrui and hausen are in the forefront of the first generic drug research and development In general, Zhengda Tianqing is the leader of the first generic drug enterprise, and Yangzi River is in the second place However, Jiangsu Hengrui, the leader of new drug research and development, and Jiangsu hausen are closely behind in the first generic drug market, and may catch up at any time Among the clinical approval transfer enterprises, Nanjing Huawei is far ahead of other enterprises However, class 3.1 new drugs are the product of this era The sharp increase in the number of applications means that competition and opportunities are the same The backlog of acceptance quantity tells us that the registration and application of drugs are not rational The evaluation mode of class 3.1 + 6 also dilutes the strength of class 3.1 NEW drugs Therefore, in the drastic reform of drug review and approval, drug classification is bound to be changed According to the internal discussion draft of drug registration and classification, from then on, 3.1 and 6 categories are classified as "generic drugs", the difference is whether to imitate foreign drugs or domestic drugs For all enterprises that take new drugs of category 3.1 as their main research and development direction, this kind of drugs will no longer be handy Next, what they have to face is where to go when the application has been submitted for acceptance, and how to do a solid evaluation of the consistency of generic drugs Even if the light of 3.1 fades, there is no way out The real "first imitation" finally ushered in the spring of market monopoly period, which may be one year In the environment of policy turbulence and change, can these first imitated enterprises remain strong and steady, and leave more legends in the Jianghu?
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