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    Home > Active Ingredient News > Drugs Articles > Chemical injection consistency evaluation started, drug companies corner overtaking opportunities?

    Chemical injection consistency evaluation started, drug companies corner overtaking opportunities?

    • Last Update: 2020-05-18
    • Source: Internet
    • Author: User
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    pharmacy network market analysisRecently, the Food and Drug Administration issued a notice on the site to carry out chemical injection generic drug quality and efficacy evaluation of consistencyState Food and Drug Administration issued "regarding the development of chemical injection drug quality and efficacy of generic consistency of evaluation work (2020, No62)." This means that, after two years, about the consistency of evaluation of drug injections now officially landedconformance assessment injection officially launched, welcome or industry changesIn fact, injections conformance assessment has been the focus of the industry, also has relevant documents stepping upAs early as December 2017, the center released a drug trial "has been listed chemical generic drugs (injection) to evaluate the agreement technical requirements (draft)", to select the reference formulation, formulation and process technology requirements, quality control and research technical requirements and other comments, but I do not know why the draft has not been formally issuedThe first time in two years, the document formally floor, which means the industry has reached a consensus, consistent follow-up work will be carried out graduallyIn fact, in recent years, with the consistency of evaluation policy gradually clear, the Senate continue to publish regulations than the preparation and registration of new drugs to encourage innovation declaration listing, injections of the drug market is gradually being more and more impactBut in comparison, its sales are still growing year by year, 4085 has been 2013 billion to 2018's 615.2 billion yuanThis fully shows that, in the case of emerging challenges, the industry is full of many new market opportunitiesThe industry believes that the current evaluation of the consistency of the competitive landscape has become a key factor in the amount of purchases with the backdrop of the decision generics kinds of pattern, consistency evaluation of drug injections species may also become competitive generic drugs the main battlefield, and even lead to industry changesSo for the relevant pharmaceutical companies, the need of promoting consistency evaluation of their products as soon as possibleAfter all, this is the only way of drugs, only with the amount involved in the subsequent purchase by conformance assessment to be eligible, if missed with volume purchases, we lost more than half of the domestic marketinjection of the drug market, there are three "overtaking" opportunityInsight database, according to statistics, as of 17 April 2020, it has 255 varieties by / deemed by generics consistency evaluation, only 33 species which is an injectionOverall, the fact of drug injections over assessment of the situation is not optimisticBut it also means that many companies still have a chance to enter and NuggetsIf the company can consider market conditions suitable species distribution, it will be a good opportunity for overtaking around the curve, you can establish their own dominance, while the development of the domestic pharmaceutical industry is also of great significanceCurrently, industry experts based on the current situation of market competition and progress injection conformance assessment trends, analysis out there is still a greater chance of the following three characteristics of injection, it is worth the relevant pharmaceutical companies to increase investmentFirst, 2019 annual sales of over $ 500 million injection single-family species, such as dezocine injection, sodium chloride injection, injection paclitaxel liposomes, peptide-butylbenzene and the likeThese varieties can be seen from the sales market prospectsAs dezocine injection, Yangtze River Pharmaceutical Group is a single-family varietyStatistics show that in the US market in 1990, 2009, Yangtze River Pharmaceutical Group production dezocine first injection simulation marketAccording to statistics, in recent years, dezocine injection in the rapid growth of domestic sales, the growth rate has remained at double digits, urban public hospitals and county-level public hospitals are the main distribution channels of the product, 2018 sales have exceeded 5.0 billionSecondly, China 2019 catalog reference formulation sales over 300 million, and the number of manufacturers conformance assessment ≤3 home speciesThe injection butorphanol tartrate, voriconazole injection, injection raltitrexed, acetic acid injection scores glass forestsAmong them, butorphanol tartrate injection in 2019 sales exceeded 1.4 billion yuan, the major manufacturers of domestic sales but only Hengrui Medicine one can imagine such a drug development prospects will be very substantialThere is other countries have listed Chinese unlisted, and 2019 annual sales of more than $ 200 million speciesThe injection carfilzomib, Ruijiadesong injectionObviously these products, have excellent sales performance in other countries, overweight development and sales of these medicines, it will be relatively simpler and development opportunities will be more.
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