Injection consistency evaluation declaration "warming up" such enterprises and categories lead

Public information shows that in 2019, China's public medical institutions terminal injection market size exceeded 630 billion yuan, an increase of about 20 billion yuan over 2018, TOP20 products total sales of more than 100 billion yuan.
, generics make up a significant portion of this.
such huge health-care spending, it is certainly only a matter of time for regulators to fall to the scope of centralized procurement.
the performance of oral generic products in the national collection, injection companies certainly understand that the trend can not be reversed.
with the fourth batch of collection gradually approaching, injection consistency evaluation declaration and evaluation work is also in full swing.
Broad-spectrum antibiotic pile declaration Multiple anti-tumor categories have been evaluated We combed the latest situation of injection consistency evaluation, from the injection product declaration varieties of the adaptive classification, showing a wide range of coverage, type dispersion characteristics, and did not appear a particular concentration of an adaptive declaration situation.
From the injection consistency evaluation declaration acceptance ranking, injection with cephalosporine sodium, hydrochloride bromoso injection, injection of cephalosporine, injection of paroxeb sodium, injection of sodium pentoladium and other categories, the largest number of declared enterprises, the most intense.
, broad-spectrum antibiotic injection cephalosporine sodium reception number and the number of declared enterprises are the largest, followed by respiratory diseases, analgesic drugs and digestive tract categories of the number of declarations.
Chart 1 Injection Consistency Evaluation Report Accepts TOP10 Data Sources: CDE, Company Announcements, Public Information, Zhongkang Industrial Capital Research Center, as of early November 2020 from the declared variety terminal sales, the declared injection market size is large, such as ammonia hydrochloride In 2019, the end-sales of public medical institutions exceeded 6 billion yuan, as well as sodium cephalosporine for injection and sodium omeprazole for injection, all of which have a market size of more than 3 billion yuan.
and the number of the above-mentioned injection declaration enterprises is high, the consistency evaluation competition is fierce.
Chart 2 Key declared varieties terminal sales and adaptation classification data sources: NMPA, company announcements, brokerage research reports, public information, Zhongkang Industrial Capital Research Center, however, the number of declarations does not mean that the odds of over-evaluation must be high.
from the injection categories that have passed (or are treated as if they have been) consistently evaluated, there is not much intersection with the declared varieties.
According to the ranking of the number of manufacturers through (or as if) the number of hydrochloric acid moxisa star sodium chloride injection has 6 through, left ethyl laxitan injection with a thick solution has 5, injection with paricib sodium has 5.
Chart 3 Part of the injection data sources that have been evaluated by (or as if) consistency evaluation: CDE, company announcement, public information, China Health Industry Capital Research Center, updated to 2020.12.3 From the market size, the end-sales of over-evaluated injections in public medical institutions compared to the declared category higher, the adaptive category in addition to respiratory, digestive diseases, breast cancer, osteoblastoma and other anti-tumor injections also ranked in the category.
, there is greater market potential for injection with yew alcohol (albumin binding type), sodium pentorazole for injection, and ammonia hydrochloride injection.
Chart 4 Focuses on the end-of-sale data sources of varieties: NMPA, brokerage research reports, company announcements, public information, China Kang Industrial Capital Research Center consistent evaluation and declaration strategy: looking for competitors less track from the injection consistency evaluation declaration situation, application for production and supplementary applications for more enterprises for Yangzijiang Pharmaceuticals, Hengrui Pharmaceuticals, Qilu Pharmaceuticals, Sichuan Colum Pharmaceuticals and so on, both large generic pharmaceutical manufacturers, there are large generic pharmaceutical manufacturers, there are such as Colum Pharmaceuticals focus on injections. figure
5 Submission of injection consistency evaluation data sources: CDE, company announcements, public information, Zhongkang Industrial Capital Research Center, as of early December 2020 to early December, from the number of injection varieties evaluated by consistency, positive day Qing and Koren Pharmaceuticals have the most, each has 5, followed by Hengrui Pharmaceuticals, Howson Pharmaceuticals, Nanjing Zhengda Tianqing, Yangzijiang, each has 4;
Chart 6 Some enterprises through (or as if) consistency evaluation number (units: individual) data sources: CDE, company announcements, public information, Zhongkang Industrial Capital Research Center, as of the beginning of December 2020 from the evaluation of enterprises, mainly concentrated in large pharmaceutical companies, the overall strength of enterprises are strong.
Related through injection consistency evaluation of the number of enterprises such as Zhengda Tianqing, Hengrui Pharmaceuticals, Howson Pharmaceuticals, etc., are strong technical capacity, cost control, product echelon excellent enterprises, research and development, production strength are ranked in the first echelon.
is the other part of the large-scale generic pharmaceutical companies, such as Qilu Pharmaceuticals, Shijiazhuang four drugs and so on, the production scale is large, strong.
such head generics companies, not only in the field of injections have been rated a large number, in other categories of generic drugs also ranked highest.
following is a brief analysis of the injection declaration of large pharmaceutical companies, taking Hengrui as an example.
According to the research report of Xinda Securities, as of May 2020, Hengrui Pharmaceuticals has a total of about 20 stock injection varieties declared consistent evaluation, most of the sample hospital sales scale of >100 million yuan of injection varieties, have been declared>
Chart 7 Hengrui Pharmaceutical Injection Variety Declaration Consistency Evaluation Profile Data Source: GBISOURCE, Wind, Cyntharma Securities Research and Development Center, Zhongkang Industrial Capital Research Center, as of 2020-5-17, iodized salmanol injections, dositas injections Liquid, hydrochloric acid right metomide injections and other categories in the hospital end sales are high, in 2019 sample hospital sales of about 1.1 billion to 1.7 billion yuan, the market potential is large, from the type of mostly ivators, painkillers, tumor drugs.
is also the A-share market infusion leader Colum Pharmaceuticals.
the types of injections produced by Colum Pharmaceuticals mainly cover high-volume injections (infusions), small-volume injections (water needles), injection sterile powder needles (including split powder needles and freeze-dried powder needles) and so on.
Chart 8 Collum Pharmaceuticals by the new classification of the listed injection varieties competition pattern data source: Xinda Securities, Zhongkang Industrial Capital Research Center, as of 2020.5 from the Colum Pharmaceuticals declared listed varieties, can be divided into two types, one is the injection of various tumors and common diseases adaptive drugs, this type of injection market potential is greater But accordingly, the number of enterprises reporting consistent evaluation is also more, more intense competition, second, glucose, electrolytes, amino acids, fish oil medium long chain fat milk and other nutritional supplement types of injections, such sub-sectors of injections although their market potential is small, but also less over-evaluated enterprises, there are still some categories are still not listed, the same as the segment of the track "blue sea."
other types of companies have a higher rate of over-evaluation? There are several dimensions that can be used as a basis for consistent evaluation by injection manufacturers: First, the declaration of older varieties is expected to be adopted first in accordance with the priority of the review queue, but the possibility that some of the declared earlier varieties will need to be supplemented due to the update of technical requirements.
There is also a case that more varieties of declared enterprises may be the first to pass with the reviewer's familiarity with its key technical indicators, this situation is more reflected in large generic pharmaceutical companies, with the experience of other categories, large generic pharmaceutical companies in the injection consistency evaluation of the advantages of prominent.
is the comprehensive pharmaceutical enterprises, especially the quality control of good production enterprises, is expected to be in the injection consistency evaluation of a first.
development of injection consistency evaluation can not be separated from the driving role of the collection policy.
the first and second batch of injections were not included in the injections, seven injection varieties were included in the third batch this year.
in accordance with the national drug collection rules, any variety of generic drug consistency evaluation reached more than 3, can carry out volume procurement.
, the State Drug Administration issued a notice to carry out the evaluation of the quality and efficacy of chemical injection generics.
this is seen as a signal for injection collection.
, the process of evaluating injection consistency has accelerated.
the fourth batch of recently outflow notification list, including hydrochloric acid bromoso injections, ibuprofen injections and other 6 varieties.
with more and more injection products through consistent evaluation, the future collection will further expand the range of injection collection, its price will also be significantly reduced.
from the declaration and evaluation of the situation, broad-spectrum antibiotic injection competition is particularly fierce, and in addition to general adaptive categories, anti-tumor categories are gradually increasing.
head enterprises in the injection declaration strategy, the choice of the number of currently listed enterprises, a good competitive pattern of the category, enterprises will share the market head soup.
with rich technical experience and strong production strength of large generic pharmaceutical companies, it is easier to be in the first in the consistent evaluation.
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