The consistency evaluation of chemical injections officially launched the 630 billion market ushered in a big reshuffle!

Before may 21, the State Drug Administration issued a public announcement to officially launch the consistency evaluation of chemical injectionsMinet data show that in 2019 China's public medical institutions end-of-drug injection market size exceeded 630 billion, TOP20 products total sales of more than 100 billionConsistency evaluation and collection of double-punch attack, chemical injection market is about to usher in a big shuffleat present, only 31 injections have enterprise evaluation, 155 injections have enterprises to submit supplementary applications, of which 142 injections have not been evaluated by enterprises (125 varieties declared enterprises number of 3); The number of injection declaration enterprises reached 6 or more, of which 15 in 2019 China's public medical institutions terminal sales of more than 1 billion yuan;On May 14, the State Drug Administration issued a public announcement to officially launch the evaluation of the consistency of chemical injectionsThe announcement clearly states that, in addition to sodium chloride injections, glucose injections, sodium glucose chloride injections, injection water, some radioactive drugs (e.gradon (99mTc)) and other varieties do not need to carry out a consistency evaluation, the listed generic drug injection drugs, not in accordance with the original drug quality and efficacy consistent principle of approval of varieties need to carry out a consistency evaluationFigure 1: 2015-2019 China's public medical institutions end-of-drug injection sales (units: 100 million yuan)meters of internal network data show that the total number of domestic injections in the current nearly 33,000, of which the proportion of domestic batch more than 95%In recent years, the growth rate of drug injections in China's urban public, county-level public hospitals, urban community centers and township hospitals (China's public health institutions) has slowed year by year, and the proportion of China's public medical institutions' terminal market has also declined from 63.80 percent in 2015 to 58.15 percent in 2019although the growth rate of chemical injections has slowed and the market share has declined, its market size has increased year by year, reaching 635.493 billion yuan in 2019, an increase of about 20 billion yuan over 2018Compared to oral solid preparations, injection terminals are more in amount, involve more enterprises, and the impact of consistency evaluation on the industry is greaterin addition,, the injection consistency evaluation is highly concerned about the reasons for the, before the relevant documents landed, the injection evaluation enterprises are few, and its safety issues are controversial, so in the 4 plus 7 sets of harvesting, expansion of the collection and the second batch of collection, are mainly oral preparations, injections as a supplementFrom the results of the first three rounds of national collection injections, the newly registered classification of corner overtaking "barefoot enterprises" have earned dividends, quickly seize the market, and the original dominant enterprises because the product scored no bid, market share is gradually "nibbled" now the injection consistency evaluation guidance has landed, and the speed of the review greatly improved (completed within 120 days after acceptance), from the national level, once the consistency evaluation of this key factor, then the inclusion of injectionin in the collection is a water-to-channel thing, when the injection will officially enter the "national harvest and provincial harvest" division surrounded by a new stage need to note that oral preparations can be sold in retail or online channels, and the basic injection terminals are in the hospital, once due to non-evaluation and suspension of the network or no chance to participate in the collection, that means the basic loss of the market, which also determines that the injection consistency evaluation declaration will be fiercer than oral preparations, and once included in the collection, the price reduction will be greater than oral preparations Table 1: 2019 China's public medical institutions end-of-drug injection TOP20 products note: no biological products, with the existing enterprises have been evaluated meters of intranet data show that in 2019 China's public medical institutions end-of-drug injection TOP20 products are more than 3 billion varieties, total sales of more than 100 billion yuan Sales of 11 injections increased year-on-year in 2018, with double-digit growth rates for Dzosin injections, miero-penan injections, sodium subatan (2:1) for injectioncephalosporine, and iodxaol injections large infusion leading enterprise, Colum Pharmaceuticals, dominated the sodium chloride injection and glucose injection, and the two varieties did not need to carry out a consistent evaluation, while Yangzijiang Pharmaceuticals had the largest market share in the three varieties of Dizozin injection, sodium pentoraquinine, and iodide sea alcohol injection 20 injections only injectionwith with pemequer disodium, dositarace injection has been evaluated by enterprises, in addition to injection with cephalosporine sodium shubatan sodium (2:1), the remaining varieties have enterprises to submit a consistency evaluation supplementary application or according to the new classification reported production Table 2: Injections evaluated by enterprises: With the for the national collection of varieties
although in recent years, the number of injection consistency evaluation declaration increased year by year, but as of May 20, only 31 injections have enterprises through or as see through the consistency evaluation, in addition to Hainan Puli Pharmaceutical injection with azithromycin, the remaining rated varieties are newly registered classification declaration varieties from the enterprise evaluation situation, Hengrui with 4 injections over the leader, Sichuan Huiyu Pharmaceutical, China Biopharmaceutical 3 injections over-rated, Shijiazhuang four drugs, Suzhou Dazhao Pharmaceutical, Qilu Pharmaceutical 2 injections over-rated; Injection with a strong solution, injection with yew alcohol (albumin binding type) over the number of a full number of 3, hydrochloric acid moxisaxasa sodium chloride injection, injection with azastine, ibuprofen injection over the number of enterprises up to 2, the remaining 26 injections are exclusive evaluation injection with pemephorice sodium, hydrochloric acid right metformin injection, fluobilobineste injection was included in the 4 plus 7 sets of harvest, injection with yew alcohol (albumin binding type) was included in the second batch of national collection, now the third batch of national collection exhaled, left ethyllactan injection with a strong solution, hydrochloric acid moxixachloride injection, injection with azastin, ibufen injection is expected to be included in 4 injections As of May 20, CDE has accepted 724 supplementary applications for injection consistency evaluation, involving 155 varieties, 13 of which have been evaluated by enterprises, according to the data There are no enterprises have been evaluated 142 injectable varieties, 125 varieties submitted consistency evaluation supplementary applications of enterprises, accounting for about 88% of the total declared injection varieties, there are still more opportunities later on Figure 2: Consistency evaluation supplementary application suing varieties up to 10 or more enterprises
11 pharmaceutical enterprises (in group) injection consistency evaluation supplementary application sinuses to declare the number of varieties up to 10 or more, Colum Pharmaceuticals with 31 varieties lead, Yangzijiang Pharmaceuticals with 26 varieties closely followed by Qilu Pharmaceuticals with 24 varieties ranked third, ranked fifth in hengrui medicine has 4 injection evaluation Table 3: Consistency evaluation supplementary application sodium injection more than 6 injections: the declared enterprises to the Group 17 injections to submit a consistency evaluation supplementary application enterprises reached 6 or more, of which 15 in 2019 China's public medical institutions terminal sales of more than 1 billion yuan, injection with omelarzine sodium, injection cephalazole, injection sodium with clotazine, injection of clyme sales of more than 400 million ammonia bromide injection, injection with omeprazole sodium, injection with cephalosporine sodium, injection with Parixib sodium, injection with cephalosporine 5 injections fierce competition, the number of declared enterprises are more than 10, in addition to ammonia brominated hydrochloric acid injection, the remaining 4 injections have not been evaluated by enterprises Table 4: Injections (units: 100 million yuan) have been announced for the active evaluation of the enterprise layout of the participating agents Note: Sales refers to 2019 China's public medical institutions terminal sales, less than 30 million yuan - representing the self-injection "figure" for the first time Since the 21st batch of reference preparations, the State Drug Administration has announced that 345 injections of the reference preparations (in names), of which 144 injections have not yet been submitted by enterprises to submit a supplementary application for consistency evaluation or reported for production according to the newly registered classification Sixty-eight of the 144 injections were sold at the end of China's public medical institutions in 2019 (10 were over 1 billion varieties).