Pharmaceutical Network October 15th, October 9th, NMPA's official website released the latest approved product information, Sichuan Haisco Pharmaceutical's Pei pulistadine tablets were approved for sale and became the first enterprise to be evaluated, the product is the third generation Angiotensin conversion enzyme inhibitor; on October 10, Chengdu Bett Pharmaceuticals declared a class 4 imitation of Shakuba quercosatan sodium tablets, the world's first angiotensin-receiving brain morphinease inhibitor.
recent years, drugs acting on the renin-angiosin system have gradually become an important subsecret in the cardiovascular drug market, with the total market size rising to more than 30 billion yuan in 2019.
30 billion market achievements TOP1 sub-category, compound preparations rapid growth of Mienet data show that in 2019 in China's urban public hospitals, county-level public hospitals, urban community centers and township hospitals (China's public medical institutions) terminal and China's urban retail pharmacies terminal cardiovascular system drug market, the total market size of drugs acting on the nephrine-angiosin system rose to more than 30 billion yuan, and successfully surpassed the lipid regulator into the top 1 sub-class.
from the perspective of the growth rate of the terminal situation, the sub-category in China's public medical institutions terminal growth rate of 7.09% in 2019, in China's urban retail pharmacy terminal growth rate of 5.10%, both have significant growth.
table 1: Drug growth rates for drugs acting on the nephrine-angiotrophic system Source: Drugs acting on the nephrine-angiotrophic system in the mininet database can be subdivided into angiosin II antagonists (unilateral, complex) and angiotrophic conversion enzyme inhibitors (one-way, compound) unilateral, compound), while Hesco's newly approved pyridoxine tablets are an angiotensin conversion enzyme inhibitors (unilateral), and Chengdu Beet Pharmaceuticals' newly declared saccharin sodium tablets are angiotensin II antagonists (complex).
From the sales growth of various categories in recent years, angiosin II antagonists (compound), angiosin conversion enzyme inhibitors (complex) in China's public medical institutions terminal or in China's urban retail pharmacy terminal each year more than 10% growth, the market potential can not be underestimated.
10 major compound preparation sales broke 100 million, collection impact multinational pharmaceutical enterprises leading situation Table 2: 2019 total sales of more than 100 million yuan angionea ii antagonist (complex) varieties Source: Minnet database Besatan hydrochlorochloride, pyrithione, chlorosatan potassium hydrochlorochlorine, and python are the largest varieties with total sales of more than 1 billion in 2019 and are currently leading the market by multinational pharmaceutical companies.
Erbeshatan hydrochlorochlorophenicol was included in the first batch of national harvesting, 4 plus 7 pilot Huahai exclusive winning bid, the alliance expanded by Nanjing Zhengda Tianqing, Huahai, Sanofi share market.
sets led to the domestic generic drug replacement original research, Sanofi in China's public medical institutions terminal market leadership gradually declined, however, in the retail market, because multinational brands have a good long-term reputation and patient drug compliance is difficult to change immediately, the original research brand market leadership position has not been shaken.
Figure 1: The current evaluation of the situation of the products related to the chlorine level of the pyrethroma: Mi net one-click search 2020 so far, there have been Hengrui, Beijing Baiao Pharmaceuticals, Garden Pharmaceuticals of the prostamin chloride tablets (I.) category 4 Imitation listing application was approved and treated as a review, the product into the market will break The situation of Novarma's exclusive market, while the "3 imitation of the original research" pattern has been formed, if adopted by the next batch of national collection into the catalog, will accelerate the domestic generic food market.
Figure 2: Currently reviewed products related to pyridohydrochlorophene Source: MED2.0 China Drug Review Database Beijing Baio Pharmaceuticals' Python hydrochloride tablet 4 imitation listing application in 20202 Monthly approval and as a review, in September this year, China Resources Seko's consistent evaluation of supplementary applications were also approved, the current product has also formed a "2 imitation of the original research" situation, under the normalization of collection, into the next batch of collection catalog is not impossible.
At present, Shakuba Qulu Shatan is also exclusive to Novartis, the original research products in China in 2016 was included in the priority review, in 2017 was approved to enter the domestic market, and then entered Shandong Province, Jiangsu Province, Jilin Province, Anhui Province, Tibet Autonomous Region health insurance directory (Class B), in 2019 through health care negotiations into the new version of the National Health Insurance Directory (Class B).
total sales of this product exceeded 400 million yuan in 2019, with terminal growth of more than 500% in China's public medical institutions and more than 300% growth in retail pharmacies in Chinese cities. Table
: Total sales of more than 100 million yuan in 2019 angiotensin conversion enzyme inhibitor (complex) variety source: Milnet database angiotensin conversion enzyme inhibitor (complex) varieties with total sales of more than 100 million yuan are ininaprilfate, pyripridapaamine and ammonia chlorpyridine Benaspri.
Inaprilf acid is the exclusive variety of Shenzhen Osa Pharmaceuticals, with total sales of more than 500 million yuan in 2019, and the product is growing by more than 10% in china's public medical institutions and retail pharmacies terminals in China's cities.
ammonia chlorine pinnapri is currently approved by domestic pharmaceutical companies have Yangzijiang and Chengdu Deo Pharmaceutical Group, the two enterprises' product dosage is not the same, in China's public medical institutions terminal Yangzijiang dominance, in China's urban retail pharmacy terminal is led by Chengdu Deo Pharmaceutical Group, but because of the large volume of hospital terminal sales, Yangzijiang is still in a leading position overall.
Huahai, Hengrui with new products into the game, stone medicine, zhengda sunny ... Mammoth 8 compound preparations first imitation table 4: 2020 to date approved for the role of the nephrine-angiosin system drug source: Minet 2.0MED China Drug Review Database Minet data show that 2020 to date approved for the role of nephrine-angiostritic system drugs have 11 (by product name) Enterprise statistics), of which Omeshatan hydrochlorochloride tablets, Ebersatan hydrochlorochlorine tablets, prostatin ammonia chloride tablets (I.), pyrotan hydrochloride tablets belong to angiotensin II antagonists (compound), involving Huahai, Fangsheng, Baiao Pharmaceuticals, Hengrui Pharmaceuticals and many other domestic star pharmaceutical companies.
Table 5: 2018 to date in the review and is expected to impact the role of the first imitation in the nephrine-angiosin system drug source: Minet 2.0MED China Drug Review Database 2018 to date, the role in the review of the renin-vascular tension system drug imitation listing applications involving 68 acceptance numbers involving 22 products, of which 12 products are expected to usher in the first imitation.
Among them, the compound preparations include ammonia chlorpyridine chloratetan potassium tablets (I.), ammonia chloraten tablets (II.), Ebersatan ammonia chloride tablets (I.), Ebeshatan chlorine tablets (II.), shakuba quercetin sodium tablets, peplidapa tablets, pyridine tablets, pyridine tablets, pyridine tablets Shatan ammonia chloride tablets, prostatin chloride tablets (II), the current domestic market is temporarily free of ammonia chlorpyrine chloraten potassium, Ebersatan ammonia chloride-related imported products and domestic generic drugs, while the Pythapridapaamine tablets are currently only Svea, Shakuba quercetin sodium tablets only Novartic received approval.
Conclusion In recent years, clinical data show that single-piece compound preparation can improve patient compliance more effectively than free combined therapy, and because the compound preparation reduces the number and number of patients taking drugs, blood pressure compliance rate in treatment also has obvious advantages, the study of single-chip compound preparation has gradually become the main direction of pharmaceutical production research.
At present, in addition to domestic pharmaceutical companies are riveting enough energy, Sanders, Alain Bick Pharmaceuticals and other foreign pharmaceutical companies are also declaring the import of generic drugs listed, the role of the nephrine-angiosygen system compound preparation drug market will become more and more popular.
sources: Minet China's public medical institutions terminal competition pattern, China's urban retail pharmacy competition pattern, MED2.0 China drug review database, one-click search and so on.