"Good Medicine" Mid-Year Summary! Fosun, stone medicine busy declaration, Qilu, Huahai busy harvest;

Guide: Consistency evaluation mid-year big point of view!is particularly different in 2020, half-timeIn the first half of the year, while we struggled with the epidemic, while ruling out all difficulties to resume production, consistent evaluation methodical lying and continuous progress, to maintain the pace of accelerating generic drug substitution of original researchoverviewconsistency evaluation harvest period came, 217 and 100 approval s evaluationaccording to drug intelligence data, as of July 3, 2020, CDE acceptance of consistency evaluation acceptance number of 2155 (514 varieties of 570 enterprises, according to supplementary applications, the same), has passed the acceptance number of 600Of these, 432 consistency evaluation numbers were received in the first half of 2020 (January 1, 2020 to June 30, 2020), down 18.64% from 531 in the first half of 2019;the first half of 2020 and the first half of 2019 consistency evaluation details comparison table
the first half of 2020 consistency evaluation acceptance number reduction is undoubtedly the main reason is affected by the epidemic, the following figure can clearly see the January consistency evaluation as the peak of this year, due to the outbreak, February to March, a significant decline;declaration acceptanceinjection consistency evaluation into the main theme, injection with omeprazole sodium 8 enterprises rush editingfrom the variety declaration acceptance number,the first half of the most than the number of contractors received is the injection with cephalosporine sodium and hydrochloric acid ammonia brosoinjection, the first half of the 12 acceptance number; Number of TOP10from the number of varieties declared enterprises, the first half of the injection with omeprazole sodium as the most sought after by enterprises, 8 have been declared accepted, followed by hydrochloric acid ammonia bromine injections have 7 enterprises declared, and TOP10 has 7 injections as follows:the first half of 2020 varieties declared enterprises TOP10according to public data, the national injection market, the total injection market, the total injection market, the total And in 2019, the chinese chemical injection market size exceeded 630 billion, like other chemical drugs, due to historical factors, the safety and effectiveness of domestic generic injections and the original development agent there is difference, and in the current scale procurement gradually normal situation, the consistency evaluation of the collection of tickets, and in several batches of varieties have been collected In addition, on May 14 this year, the State Drug Administration issued the "State Drug Administration on the implementation of chemical injection generics quality and efficacy consistency evaluation work" document (No62 of 2020) document, chemical injection agent generic sydment consistency evaluation beganFosun, stone medicine declaration busy; people Fu preemptively into the bureau heavy injectionfrom the number of enterprise declaration acceptance number, Fosun Pharmaceutical subsidiary Suzhou Two Leaf Pharmaceutical Co., Ltdwas the most than the number of acceptance number, there are 9, followed by Shi medicine Ouyi and Yichang Renfu, respectively, there are 8 and 7, more details are as follows:2020 In the first half of the enterprise declaration number TOP10from the enterprise declaration varieties, stone medicine Ouyi and Yichang Renfu Pharmaceutical in the first half of each 6 varieties were accepted, as follows:the first half of 2020 enterprise sdeclared number of top10in addition, Yichang Renfu Pharmaceutical son of 6 varieties or contractors, there are 5 injectionsYichang Manfu Pharmaceutical first half consistency evaluation declaration details table
it is worth mentioning is that up to now stone medicine European-Italian cumulative 42 acceptance number (27 varieties) consistency evaluation declaration was accepted, People Fu Medicine has 37 acceptance number (25 varieties), according to the first half of the declaration rate, there is to catch up with Yangzijiang Pharmaceutical Group Co., Ltdand Sichuan Collum Pharmaceutical Co., Ltd., and the current number of declaredvarieties in the top five230 plus 126 acceptance numbers passed or passed as if, 4 varieties of over 10according to the drug registration and acceptance database statistics, the first half of 2020 accumulated 230 acceptance numbers (106 varieties) through consistency evaluation, 126 acceptance numbers (74 varieties) as passed, including sulfonate chlorpyrifos, acetaminophen, biphenyl acid, diphazine, Amoxilin capsules only in the first half of 2020 each have more than 10 enterprises through consistency evaluation, the following figure is the first half of 2020 varieties through the ranking top10:up to the present accumulation of 28 enterprises through consistency evaluation, hydrochloric acid metformin 26 enterprises, Amoxicillin capsules have 18 enterprises, stable ranking of the top three enterprisesstone medicine, Huahai harvest, Qilu pharmaceutical big winner position solidfrom the perspective of enterprises, the first half of stone medicine European-Italian in addition to the above mentioned declaration acceptance varieties more than the following, the number of over-rated varieties again bright eyes, there are 11 acceptance number 8 varieties have been evaluated Number1, which was a big harvest in the first half of the year, followed by Huahai Pharmaceuticals with 13 acceptance numbers (7 varieties), Qilu Pharmaceuticals with 10 acceptance numbers (7 varieties), Hengrui Pharmaceuticals and Zhengda Tianqing also had 4 varieties stone drug Ouyi, Qilu Pharmaceutical, Zhejiang Huahai Pharmaceutical salutation in the first half of the harvest, firmly solidified their respective enterprises in the consistency evaluation to become a big winner of the position Up to now, Qilu Pharmaceuticals has 25 products through / as if through consistency evaluation, the high bureau of the top of the list of enterprises, followed by stone drug Europa has 23, Huahai has 19 And Qilu Pharmaceutical saurate has declared consistency evaluation of 32 varieties, now has 23 over reviews, more than 70% of the varieties have been evaluated, leading the consistency evaluation 21 varieties approved, benzene sulfonate ammonia chlorine flat film evaluation enterprises or broken 30 the first half, there are 34 acceptance number 21 varieties approved, showing a "issued" status Among them, phenyl sulfonate ammonia chlorpyrifos flat tablets have 2 enterprises, or will become the first over-rated enterprises more than 30 varieties, in addition, Zhengda Qing in June 2019 the first imitation of the domestic listing of diazepam di sodium injection, as well as the global sales amount of 846 million U.S dollars, domestic sales of 739 million yuan (data unenlarged) hydrochloric acid Palonos injection scoring the same approval, breaking the original research barriers to expand sales the first half of 2020 consistency evaluation approval completion of the details table
in the collection of normalization of the present, in the consistency evaluation has long been its tickets today, want to survive under the general trend of medical reform, and seize the opportunity to occupy a large share of the public hospital market, generic drug enterprises have to speed up the development of product consistency evaluation work To this end, the drug intelligence network specially built a generic consistency evaluation progress database, and generic consistency evaluation analysis system, intelligent analysis, convenient and fast, time-saving and effort-saving, let you know each other quickly click on the "link" to a consistent evaluation of the data journey! data sources: drug intelligence data, enterprise announcements and other network public data, information sources: drug intelligence network, enterprise announcements and other network public information