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1 billion anti-thrombotic large varieties of Yangtze River, Zhengda Tianqing review!9 injection sprints, Hengrui, Beite...Who will run out first
The editor said: A few days ago，Yangzijiang Pharmaceutical Group Guangzhou Hairui Pharmaceutical in accordance with the new category 4 declaration of ticagrelor tablets approved by the State Food and Drug Administration，Deemed to pass the consistency evaluation;China Biopharmaceutical issued a statement said，The antithrombotic ticagrelor tablets developed by the subsidiary Zhengda Tianqing Pharmaceutical Group，Has been issued by the State drug Administration drug registration approval。The product is also declared in accordance with the new 4 categories of chemical drugs and is deemed to have passed the consistency evaluation。Midnet data show that in 2018, the market sales of terminal antithrombotic drugs in China's public medical institutions exceeded 30 billion yuan。Up to now, there are 5 varieties have been reviewed, Tigrillo tablets have been reviewed by the most companies, and no injection has been reviewed。In addition, there are 11 supplementary applications for variety consistency evaluation under review, of which 9 are injections, involving 10 enterprises such as Hengrui Pharmaceutical, Xinlitai, Hainan Bate Pharmaceutical, Nanjing Jianyou Biochemical Pharmaceutical, and 18 acceptance numbers。
Wonderful content
日前，Yangzijiang Pharmaceutical Group Guangzhou Hairui Pharmaceutical in accordance with the new category 4 declaration of ticagrelor tablets approved by the State Food and Drug Administration，Deemed to pass the consistency evaluation;China Biopharmaceutical issued a statement said，The antithrombotic ticagrelor tablets developed by the subsidiary Zhengda Tianqing Pharmaceutical Group，Has been issued by the State drug Administration drug registration approval。The product is also declared in accordance with the new 4 categories of chemical drugs and is deemed to have passed the consistency evaluation。Midnet data show that in 2018, the market sales of terminal antithrombotic drugs in China's public medical institutions exceeded 30 billion yuan。Up to now, there are 5 varieties have been reviewed, Tigrillo tablets have been reviewed by the most companies, and no injection has been reviewed。In addition, there are 11 supplementary applications for variety consistency evaluation under review, of which 9 are injections, involving 10 enterprises such as Hengrui Pharmaceutical, Xinlitai, Hainan Bate Pharmaceutical, Nanjing Jianyou Biochemical Pharmaceutical, and 18 acceptance numbers。
1 billion varieties of the Yangtze River, Zhengda sunny review, Astrazeneca market can hold？
Data show that Ticagrelor is a new antithrombotic drug, which blocks platelet activation by reversely binding to platelet P2Y12 ADP(adenosine diphosphate) receptor, and is mainly used in clinical prevention and treatment of ACS and cardiovascular and cerebrovascular thrombotic events。Ticagrelor does not need to be activated by liver metabolism, and has the characteristics of rapid and powerful, which has been recommended by many domestic and foreign treatment guidelines, and has great market potential。
Sales of terminal Ticagrelor tablets in public medical institutions in China (unit: ten thousand yuan)
Midnet data show that in 2018, the sales volume of terminal ticagrelor tablets 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) exceeded 1 billion yuan, an increase of 68 percent year-on-year.95%。Astrazeneca holds the absolute market share, while Xinlitai is the first imitation company。At present, there are 8 manufacturers of this product, including Astrazeneca, Xinlitai, Shiyao Euitech Pharmaceutical, Nanjing Zhengda Tianqing Pharmaceutical, Zhengda Tianqing Pharmaceutical Group, Yangzijiang Pharmaceutical Group Guangzhou Hairui Pharmaceutical。
Brand pattern of terminal Ticagrelor tablets in Chinese public medical institutions in 2018
In terms of consistency evaluation, seven pharmaceutical companies such as Xinlitai, Shiyao Euyi Pharmaceutical, Nanjing Zhengda Tianqing Pharmaceutical have reviewed the 90mg Tigrillo tablet, and after Xinlitai's first imitation was approved in China, 60mg was reviewed in the form of supplementary application, and it is currently the only domestic pharmaceutical company that has reviewed the product。It is worth noting that most of the enterprises are imitation 4 or 6 new classification review approved as through the consistency evaluation。
China Biopharmaceutical said that Ticagrelor as a blockbuster anti-clotting drug, there are many domestic imitators。The Group is expected to capture the market share of Tiglor tablets developed by two subsidiaries of the Group, Nanjing Zhengda Tianqing Pharmaceutical and Zhengda Tianqing Pharmaceutical Group, which have been approved for listing during the year。
30 billion antithrombotic market 5 varieties reviewed, TOP10 who is the most sought-after
TOP10 terminal antithrombotic drug products of Chinese public medical institutions in 2018 (unit: 100 million yuan)
In 2018, the sales volume of terminal antithrombotic drugs in China's public medical institutions exceeded 30 billion yuan, an increase of 19 percent year-on-year.46%。Among the TOP10 products, 7 products such as Clopidogrel bisulfate tablets, low molecular weight heparin calcium injection and enoxparin sodium injection have sales of more than 1 billion yuan。Among them, clopidogrel bisulfate tablet sales more than 10 billion scale, Sanofi market share accounted for nearly 60%。At present, the number of approvals for this product is 17, including Sanofi, Actavis, Dr. Reddy Laboratory of India, Lepu Pharmaceutical, Xinlitai, Shiyao Euitech Pharmaceutical and other 7 companies。In terms of consistency evaluation, only Clopidogrel bisulphate tablets, rivaroxaban tablets and ticagrelor tablets were reviewed in the TOP10, and the number of overrated enterprises was 3 or more。
Evaluation of antithrombotic drugs
As of December 25, 5 antithrombotic drugs have passed (including deemed to pass) consistency evaluation, of which warfarin sodium tablets and rivaroxaban tablets were reviewed by only 1 company, while Tiglor tablets were reviewed by the most companies。It is worth noting that most of the overrated products are approved under the new classification。
11 varieties under review, 9 injections, Hengrui, Bate, Xinlitai...Who will run out first
Status of additional applications for conformance evaluation of antithrombotic drugs under review
According to the data of the Mi network, there are 11 varieties of supplementary applications for the conformity evaluation of antithrombotic drugs under review, involving 21 acceptance numbers。It is worth noting that 9 of the varieties examined are injections, involving 10 enterprises such as Hengrui Pharmaceutical, Xinlitai, Hainan Bate Pharmaceutical, Nanjing Jianyou Biochemical Pharmaceutical, and 18 acceptance numbers, of which Enoxparin sodium injection declaration enterprises are the most。Who will be the first to review？We'll wait and see.。
Source: Listed company announcement, Mi Intranet database
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