Injection consistency evaluation officially launched will benefit these 4 sectors

Since the implementation of the consistency evaluation of oral preparations of chemical drugs, the consistency evaluation of when injections start has been the focus of capital marketsfinally, a thousand calls began to come outRecently, the injection consistency evaluation document officially landed, the pharmaceutical industry will usher in a major changeOn May 14,, the State Drug Administration issued the Notice on the Quality and Efficacy consistency evaluation of chemical injection strains (hereinafter referred to as "Announcement"), which made it clear that generic drugs for chemical injections that have been listed and that varieties that have not been approved in accordance with the principle of consistency with the quality and efficacy of the original drugs in the study need to carry out a consistent evaluationThis means that the injection consistency evaluation officially launched, the industry concentration will usher in a significant increasenews, investors disagree, some think this is a good development "opportunity", but also think that the injection consistency evaluation will be more intense than oral solid preparations, the corresponding listed companies will face "risk."is it "opportunity" or "risk"? Which companies are worth investing in?market conditions
because the injection effect is fast, fast absorption, and the injection is not gastrointestinal tract, not affected by the digestive system, so it has become the mainstream dosage form of the pharmaceutical marketinjections include chemicals, biological products, traditional Chinese medicine three categoriesAmong them, chemical injections accounted for 72% of the share, including antibiotics, glucose, sodium chloride, etc, biological products injections accounted for 16%, including monosalivaric acid hexagon ized glycosinosatosin, calves blood deprotein extract, insulin, etc, and the share of Chinese medicine injections was 12%, mainly thrombosis, ginkgo biloba and so onmarket status quo: In 2018, china's public medical institutions end-chemical and traditional Chinese medicine injection sales reached 692 billion yuan, of which the proportion of chemical injections more than 85%There is no doubt that after the implementation of consistency evaluation, the chemical injection market will usher in a huge changeThe domestic injectable market in 2019 was 436.8 billion yuan, accounting for 60.51 percent of all dosage forms, twice the size of tablets and capsules, based on sample data from urban public hospitalsbecause the injection market is large, lots of approval, risk, and involves many large enterprises and multinational pharmaceutical enterprises, so, the start of injection consistency evaluation, the development of China's pharmaceutical industry will have a very large impactaffect geometry?there may be a lot of people who don't understand why an injection consistency evaluation should be initiated? in fact,, since the introduction of the "New Medical Reform" program in 2009, it has established a reform strategy with the "three-doctor linkage" as the core, respectively, in the reform of medical institutions, the reform of medical security system and the reform of drug production and circulation, popularly speaking, medical care, medical insurance, medicine, three medical linksthe purpose ofis to meet the general trend of meeting clinical needs and controlling overspending on health insuranceBy implementing the conformity evaluation of generic drugs on the supply side, injection consistency evaluation, etcto remove backward production capacity, some backward pharmaceutical enterprises are eliminated, so that structural adjustment and industrial upgradingwell-known, the problem of abuse of Chinese medicine injections and antibiotic injections is very serious, coupled with the complex competition pattern of the industry, domestic substitution space is limited, so the implementation of injection consistency evaluation is just in timeannouncement states that the core content of the technical requirements includes reference preparations, prescription processes, quality control of raw packages, quality research and control, stability studies, and the need for consistency evaluation of varieties, varieties that do not require a consistency evaluation include sodium chloride injections, glucose injections, sodium glucose chloride injections, water injections, some radioactive drugs, etcSo, what are the implications of initiating an injection consistency evaluation?(1) injection consistency evaluation is more intenseBecause the "ticket" for quantity purchases can only be obtained through consistency evaluation, and unlike oral solid preparations, injection sales are mainly hospital-basedThis means that if a company loses a bid in the collection, it will directly lose the entire end marketTherefore, pharmaceutical companies will accelerate the promotion of consistency evaluation, no doubt the competition will be very fierce from the point of view of the declared enterprises, Colum Pharmaceuticals, Qilu Pharmaceuticals, China Biopharmaceuticals for the injection consistency evaluation of the declaration of the top three enterprises Source: Insight Database (2) More over-rated varieties The announcement pointed out that the injection consistency evaluation is similar to solid oral preparations, the Health Insurance Bureau will give priority to the evaluation of the enterprise's varieties into the collection In order to win the bid, to maintain market share, the future enterprises will submit applications for more varieties According to the Insight database, as of May 15, 2020, only 31 injectable varieties had passed the consistency evaluation, with the exception of Pripharma's injection azithromycin, all of which were evaluated in accordance with the same-pass (new Class 4) generic spree consistency Note: The database shows 33 varieties, which are counted according to the drug name, and here the compound amino acid injectionIII, IX, VII, 3 specifications are counted as 1 species from the declared varieties, Dosita sai, right metomeding, Gisitabin and other terminal sales of more than 2 billion varieties of the most intense competition source: Insight database (3) uncertainty about the performance of pharmaceutical companies over the next few years Although it is said that the launch of injection consistency evaluation is conducive to rapidly improve the concentration of the industry, but then still have to face the problem of bidding to reduce prices For example, in the first two years, oral preparations after passing the consistency evaluation into the collection in batches, the final price fell by an average of 50%, the impact is very large (4) injections to accelerate internationalization As a result of the european and American standards approved for listing, export to domestic sales of the preparation varieties, can be seen directly through consistency evaluation, to achieve corner overtaking, such as the typical Huahai pharmaceutical industry What are the good? However, the evaluation of injection consistency also had a positive impact on the stock market from the announcement content can be seen, the following sectors: (1) clinical CRO enterprises Because CDE requires special injections (e.g liposomes, venous milk, microspheres, etc.) to require BE trials or clinical trials in the consistency evaluation process, and the standards need to be internationally aligned, it is stimulating for the pharmaceutical outsourcing industry in addition, enterprises to do injection consistency evaluation also need to pay a certain cost, ordinary varieties due to raw materials, batch size, impurities vary at least 5 million to 30 million If there are multiple varieties, but also special injections, then through cooperation with THE CRO enterprises can save a lot of people's power, material resources, financial resources (2) accessories and package supted enterprises It is well known that injections are more demanding and risk yrisk soldering than oral solid formulations For example, because of the problem of production pollution, so that injections do not meet the requirements of sterile and other conditions, it will lead to non-conformity evaluation in addition, in addition to the characteristics of the product itself and the production process, the package and accessories will seriously affect the quality of the injection Therefore, those suppliers with excellent quality and better performance will undoubtedly be favored by injectable drug companies (3) policy-immune enterprises For example, the announcement states that companies that do not need a consistency evaluation include nuclear drugs (4) industry chain benefits In the future, the variety of injections gradually increased, the upstream medicinal glass, especially the Xilin bottle (mold anti-bottle) and other production enterprises have a very large performance to promote in addition, the layout of the injection industry, naturally inseparable from the raw materials Whether it is generic tape procurement, or increased competition for injections, the future cost advantage of API enterprises, will have a greater benefit conclusion
so, in the future, the injection consistency evaluation has been launched, the industry has the greatest impact on the collection when will it be carried out? According to the content of the announcement, the review time limit for the consistency evaluation supplementary approval is 4 months, i.e the first batch of products that pass the consistency evaluation will be around October Subsequent injectioncollections will not be selected until at least October Therefore, the final implementation of the words, as soon as early next year however, capital markets' expectations were reflected before the official document was released For example, the pharmaceutical glass packaging leader Shandong Pharmaceutical Glass, because it is the only domestic boronician silicon molding bottle company, with monopoly properties, so the stock price has increased more than 3 times since January 2019; summary, consistency evaluation and the promotion of the national collection policy, for small and medium-sized pharmaceutical enterprises, is a "knockout game", if you can not afford to reduce prices significantly, then it will be cruelly eliminated And those in the research and development capabilities, cost control and product echelons have a huge advantage of the leading enterprises, in the long run, will benefit from it, and ultimately win original title: Change is on the horizon! Only 31 injection varieties have been rated, which will benefit these 4 major sectors