New trend: selection of non 289 varieties for consistency evaluation, enabling more than 1 billion large varieties of traditional Chinese Medicine

At the stage of time race, the time limit of related varieties is less than 300 days On April 13, the official website of the State Drug Administration released the catalogue of generic drugs approved for conformity assessment of quality and efficacy (the third batch), and 7 varieties of Amoxicillin Capsules, azithromycin tablets, enalapril maleate tablets, etc ran faster than the running line Up to now, a total of three batches of 8 "289 catalogue" varieties (10 specifications) have passed the consistency evaluation, accounting for only 2.77% It is reported that many enterprises are "working overtime" for the final sprint 　　 After all, the State encourages the policy of "combination" one after another In addition to the opinions on reforming and improving the supply guarantee and use policy of generic drugs issued by the State Council on April 3, it has been made clear that the alternative use of generic drugs should be promoted; the generic drugs with the same quality and effect as the original research drugs should be included in the catalogue of alternative drugs with the original research drugs; the generic drugs passed should be the same as the original research drugs In addition to standard payment, policy "resonance" is also forming in all regions: Zhejiang and other local governments have successively issued policies to give various subsidies to varieties passing the consistency evaluation On April 9, Jiangsu public resources trading center made another ripple with a notice: the core content of the notice on submitting innovative drugs and materials related to generic drugs through consistency evaluation issued by Jiangsu public resources trading center is that the supply prices of innovative drugs and generic drugs independently declared by relevant pharmaceutical companies through consistency evaluation are directly linked to the Internet, and the price is promised to be the lowest in China Many enterprise representatives told reporters that it is not exaggeration to describe the consistency evaluation of relevant varieties by "racing against the clock", most of which are in the be stage The prototype of the pattern is "time is tight, push forward with all strength." Almost all business representatives have the same view From the policy point of view, high-quality generic drugs are about to receive structural dividends According to the regulations, there are more than three manufacturers that have passed the consistency evaluation of the same kind of drugs In terms of centralized purchase of drugs, the varieties that have not passed the consistency evaluation are no longer selected The enthusiasm of the enterprises is fully mobilized, which means that the low-quality products will be gradually kicked out of the market, and the market space vacated by them will enable the high-quality generic drugs to take advantage of their price advantages and launch the market with the original research drug enterprises Competition for market share A change worthy of attention is that the generic pharmaceutical market is undergoing systematic structural upgrading From clinical, production, medical information, pharmacovigilance, medical insurance payment and other aspects, China is comprehensively improving the life cycle management of drug quality, and the new pattern of generic drugs is emerging in the new era How to seize this structural opportunity? At present, 8 varieties (10 specifications) of 289 catalog have passed the consistency evaluation, and only 26% of the first 10 batches of reference preparations are 289 varieties Dr Cheng Zengjiang, an expert in drug clinical research, believes that there should be two preparations to seize the opportunity "One is that enterprises with foundation and strength should speed up the promotion of limited varieties and obtain admission tickets in priority; the other is that they should pay attention to new trends If their own varieties have no specific advantages, many enterprises choose non 289 varieties to carry out consistency evaluation." He explained that because 289 varieties have the risk of closing the door, most of them are low-cost drugs, with large evaluation costs and many manufacturers, while competing for large varieties, they can also incline to small varieties and "three changes" varieties In addition, at present, some enterprises are doing injection consistency evaluation, and relevant enterprises should be prepared It is worth noting that the National Overseas reference preparation procurement service platform was launched in Beijing recently It will be more convenient for domestic enterprises to query reference preparations, order requirements, purchase and transport abroad, customs clearance at import port, domestic storage and distribution, etc., which will greatly reduce the cost of enterprises' participation in the evaluation and compete more fully "Lose the guard"? An expert from the national health and Health Commission pointed out that the market share of generic drugs in the United States is 90%, while the market share of generic drugs in China is only 70% Through this data, we can see that there is a huge market space, which is also the driving force for many enterprises to rush to carry out consistency evaluation Which varieties will win the chance first? Chen Baiping, general manager of Boston Consulting Agency China, said frankly, "the quality problem of patient medication is solved in the field of generic drugs According to the current situation, if some powerful listed companies succeed in breaking through the barriers, their growth is very predictable The biggest test of this opportunity is the R & D strength, capital reserve and synergy of be resources Strength and the clinical value space of the product itself " It is not hard to speculate that there will be more popular varieties with market potential in the future According to Cheng Zengjiang's analysis, when choosing products for consistency evaluation, enterprises mainly consider two issues: market potential and difficulty He listed amlodipine besylate tablets, rosuvastatin calcium tablets, irbesartan tablets, cefuroxime ester tablets and other products, "these drugs are all large varieties, the enterprises that get the tickets first mean to share policy opportunities first, and even seize the market share of competitors According to the market share of the original research products, amlodipine besylate tablets, rosuvastatin calcium tablets, irbesartan tablets and escitalopram oxalate tablets all belong to the varieties with high market share of the original research products, with great potential for import substitution, and later can achieve growth by seizing the share of the imported products Cefuroxime axetil tablets belong to the varieties with low market share of the original research products, the proportion of the original research products is low, the concentration of the existing brand products is relatively scattered, and the enterprises that have priority to pass the consistency evaluation can achieve the growth of their own varieties by competing for the share of other enterprises " First mover market opportunities of course, the reporter also noted a data, at present, nearly 80% of "289 varieties" no be clinical trial registration, no be application application and no product passed the consistency evaluation Compared with the published catalogue, many of these products are "three changes" and featured varieties, such as rifampin tablets, compound reserpine tablets, Compound Glycyrrhiza tablets, etc., some of which have small clinical dosage or risk of safety, or the varieties account for a small share of enterprise sales "If there is not enough market space and effective clinical resources and reference preparations, giving up is also the result of natural purification of industrial upgrading It's probably the common strategy of the business community to focus on the core products " Some experts say so In the interview, some experts mentioned Huahai pharmaceutical, which has benefited the most at present Yu Mingde, honorary president of China Pharmaceutical Enterprise Management Association, said: "in terms of consistency evaluation, overseas products of Huahai pharmaceutical industry currently enter the domestic market mainly through two application methods: supplementary application for domestic listed products and direct application for four categories of new drugs overseas Both methods only need to declare the test data of foreign listing instead of be test in China Compared with domestic similar product enterprises, the cost and time of declaration are greatly reduced This development idea is also worthy of attention " Obviously, some enterprises are "losing their guard", while others are looking for other ways Zero sum game to forge big varieties for this quality upgrading game, frankly speaking, this is zero sum game According to the deconstruction analysis of last year's top 100 list of Nanfang Institute, 5500 pharmaceutical industry manufacturing enterprises in China, less than 2% of large-scale enterprises, have created nearly a quarter of industrial sales revenue and profits The number of pharmaceutical enterprises accounts for 82%, the sales scale is less than 500 million yuan, and the sales revenue accounts for only a quarter of the proportion of the pharmaceutical industry In 2016, the sales of the top 100 pharmaceutical enterprises in China accounted for 47.2% of the total pharmaceutical industry It can be said that pharmaceutical enterprises will step into the era of "stronger ones" If the vision is further extended, Chinese patent medicine is also actively participating in this quality upgrading competition Many enterprises have accelerated the research of post market re evaluation of large varieties Although more than 500 large varieties of Chinese patent medicine have been cultivated, it should be noted that about 30% of the exclusive varieties have not entered the mainstream hospital market In a deeper level, the statistical data of minenet shows that 11 varieties with annual sales scale of more than 3 billion yuan are all injection There are 321 oral preparations, which are the mainstream of traditional Chinese medicine The reporter noted that at present, more than 1 billion varieties of traditional Chinese medicine are still enabling, some of the single products have exceeded 3 billion, while most of the 100 million to 300 million yuan varieties, the single product sales are only 170 million yuan It is not difficult to judge by analyzing this data Under the influence of policies such as medical insurance payment and drug proportion control, there will be obvious differentiation in the market of Chinese patent medicine, and the market will gradually concentrate on the large varieties to be re evaluated after they are put on the market At the same time, the production of new large varieties requires more investment At the same time, the current situation also brings new thinking to the industry How to make large varieties bigger? Zhao Chao, President of step group, pointed out that "a product with a scale of 300-500 million yuan can be realized with excellent marketing mode and effective organization management But in order to reach a scale of more than 1 billion yuan, or even larger, there must be a large number of repeat customers, quality assurance is the core, and such products must be technology intensive Under the guidance of the theory of "brain and heart", step pharmaceutical developed a series of patent medicines with special characteristics, forming a patent product group in the serious diseases with high incidence rate, large dosage and long treatment cycle At the same time, continue to re evaluate the superior products For example, the evidence-based medicine research of Wenxin Granules has made great contribution to improving its production process, improving product quality and prolonging product life cycle " In short, at present, the pharmaceutical industry is opening a quality competition competition competition of "Pan generic pharmaceutical concept" Who can come to the end of the competition is still fighting for comprehensive strength, and it is the key to practice internal skills.