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Medicine Network January 19th, just concluded 2020, the sudden outbreak of new crowns, followed by pharmaceutical policies, to domestic pharmaceutical companies bring opportunities and challenges.
As a well-known domestic private pharmaceutical enterprises, Yangzijiang in the past year harvest full: 13 heavy-weight new products were approved, messing up the 35 billion market, 26 varieties through or as if through consistency evaluation (cumulative number of over-evaluated varieties 46);
13 new heavy-weight products were approved, 46 over-rated varieties of over-rated varieties of barbed-screen rice intranet data show that in terms of status start time, in 2020 the State Drug Administration approved a total of 714 domestic generic drug approvals (imitation) 3/4/6 category, excluding API), involving 250 varieties (by drug name), China Biopharmaceuticals, Qilu Pharmaceuticals, Colum Pharmaceuticals, Dongsian Pharmaceuticals, Yangzijiang Pharmaceuticals approved the number of generic varieties ranked in the top five.
In 2020, Yangzijiang has 13 generic drugs approved for market, all with a new registration classification of production, approved after production as if through the consistent evaluation, of which Entekave oral solution for the dosage form of the first imitation of the first evaluation, left oxyfluorosa star eye drops for the first evaluation.
Table 1: Varieties approved for listing in 2020 Source: MED2.0 China Drug Review Database Minet Data show that 13 generic drugs approved by Yangzijiang (in general name) were approved in 201 In the past nine years, the end-market size of China's urban public hospitals, county-level public hospitals, urban community centers and township hospitals (China's public medical institutions) exceeded 35 billion yuan;
Entekawe oral fluid for the first imitation of the dosage form, the current domestic listing of Entekawe mainly for oral normal release dosage form (tablets, dispersion tablets and capsules), has been included in the 4 plus 7 collection, in China's public medical institutions terminal sales peak of more than 8.5 billion yuan;
In terms of consistency evaluation, a total of 517 acceptance numbers in 2020 by means of supplementary applications through the consistent evaluation, involving 205 varieties (by drug name), Yangzijiang Pharmaceuticals, Shanghai Pharmaceutical Group, Shi Pharmaceutical Group, China Biopharmaceuticals, Fosun Pharmaceuticals ranked in TOP5, of which Yangzijiang with 13 over-rated varieties and Shanghai Pharmaceutical Group ranked first.
Table 2: 2020 Yangzijiang Review Variety Source: MED2.0 China Drug Review Database in Consistency Evaluation, Yangzijiang specializes in clinical large varieties, 2020 Review Eight of the 13 varieties will have a market size of more than 1 billion yuan in 2019 at the end of China's public medical institutions, with sales of sodium vitolazole for injection, sodium cephalosporine for injection, and sodium bisodium for injection with pyrethroids exceeding 4 billion yuan.
6 of the 13 varieties were the first to be evaluated, with methylcobalamin injections, sodium fluconazole chloride injections, cephalosporine for injections, and Ipasta tablets as exclusive reviews.
since the official launch of the chemical injection consistency evaluation, Yangzijiang injection consistency evaluation is in the outbreak period, in November-December 2020, 7 injections have passed the consistency evaluation.
As of January 13, 46 varieties in Yangzijiang have passed or assidable through consistency evaluation, of which 30 varieties have been evaluated by supplementary application, 15 varieties have been reported with new classifications, approved for production are treated as reviews, and non-amine tablets cover two ways of evaluation; Eighteen of the varieties were the first to be evaluated, of which methylcobalamin injections, sodium fluoroconazole sodium chloride injections, injections of cephalosporine sodium, entikave oral solution, ipasta tablets, traquine hydrochloric acid capsules,acid tamoxifen tablets for exclusive evaluation.
generic drug declaration NO.1, 6 varieties to grab the first imitation 2020 CDE to accept a total of 968 domestic generic drug applications (imitation 3/4/6 categories, excluding raw materials), involving 382 varieties (by drug name), Yangzijiang with 37 varieties of leading, stone medicine, Chinese biopharmaceuticals, Qilu, Colum among top 5.
form 3: 2020 Yangzijiang declared listed generic drug source: MED2.0 China Drug Review Database Minet data show that in 2020 Yangzijiang declared the listing of 37 generic drugs are declared according to the new registration classification, approved for production will be treated as if through consistency evaluation.
from the treatment category, 11 of the 37 varieties are nervous system drugs, digestive and metabolic drugs and systemic anti-infective drugs are 5.
Azishatan tablets, hydrochloric acid right metomide sodium chloride injection, sodium sulfate potassium magnesium oral solution 3 varieties in the domestic market temporarily blank, Fumarate vonora biopic tablets, hydrochloric acid lulasitone tablets, sithassin tablets 3 varieties have not yet been approved for the first time, of which sodium sulfate potassium magnesium oral solution by Yangzijiang exclusive to the new classification.
17 varieties declaration consistency evaluation, 7 varieties to seize the first 2020 CDE to accept the conformity evaluation of supplementary applications received a total of 915, involving 348 varieties (in terms of drug name), Shanghai Pharmaceutical Group with 20 declared varieties leading, Yangzijiang with 17 declared varieties immediately followed.
Table 4: 2020 Yangzijiang obtained the contractor's consistency evaluation supplementary application Source: Minet MED2.0 China Drug Review Database Injection is one of Yangzijiang's main dosage forms, 17 consistency Of the evaluation applications, 12 were injections, most of which were large clinical varieties, such as injection of thymosin, injection of thymus, injection of gisithamin hydrochloric acid, Ida Lafon injection, injection of sodium Esomeladium, etc.
7 varieties of no enterprises through or as if through the consistency evaluation, of which Fumaric acid Lupata tablets, lisse sodium tablets by Yangzijiang exclusive declaration, is expected to win the first review.
2019, China's public medical institutions terminal Fuma acid Lupata fixed film sales of more than 200 million yuan, up 37.39 percent year-on-year, Yangzijiang market share of more than 80 percent.
source: MiNet database note: data statistics as of January 13, if there are omissions, welcome to point out!