Consistency evaluation "burn money" competition increase of R & D investment of lison pharmaceutical

[China Pharmaceutical network enterprise news] in the next two or three years, ordinary consumers may be able to distinguish the similarity between two generic drugs and the original drugs through drug labels and instructions, so as to make easy choices It will be a nightmare for many pharmaceutical companies if the original research drug fails to compete with foreign giants and generic drugs are "stuck" by domestic peers In order to avoid these nightmares, many generic pharmaceutical companies have made efforts, even under the pressure of increasing costs Lisheng pharmaceutical is such a company In the first half of 2017, the company's management expenses increased by 45.38% compared with the same period of last year, and the R & D investment increased by 282.87% compared with the same period of last year, all of which are due to the promotion of consistency evaluation by enterprises Lisheng pharmaceutical is mainly engaged in the production and sales of chemical tablets, hard capsules, drop pills, freeze-dried powder injection, water injection, API and other products In the first half of 2017, Lisheng pharmaceutical achieved an operating revenue of 525 million yuan, an increase of 14.85% over the same period of last year; the net profit attributable to the parent company was 78.3835 million yuan, an increase of 13.14% over the same period of last year The list of reference reagents for the conformity assessment of generic drugs has been successively published in 8 batches The time limit for a batch of generic drugs to be completed by the end of 2018 is only more than one year Lisheng pharmaceutical also lists it as one of the key works In the first half of 2017, Lisheng pharmaceutical said that it would comprehensively accelerate the promotion of drug consistency evaluation, of which 21 products had signed the consistency evaluation contract, and all these products had carried out pharmaceutical research; its subsidiary Tianjin Central Pharmaceutical Co., Ltd completed the contract signing of 5 products and the price comparison investigation of 4 products In the first half of 2017, the R & D investment of Lisheng pharmaceutical was 54.3255 million yuan, an increase of 282.87% over the previous year; the management cost was 93.43 million yuan, an increase of 45.38% over the previous year, all due to the company's consistency evaluation Even though the consistency evaluation of more than 20 varieties at the same time is not common in the industry, Lisheng pharmaceutical still said that "many varieties cannot find reference preparations, so the consistency evaluation is difficult to carry out" The reporter tried to inquire about the promotion of specific varieties, but as of the time of publication, there was no response The reporter noted that at present, the progress of consistency evaluation of various pharmaceutical enterprises is different, some are in the early stage of research, some are applying, most are in the stage of being test or preparing to be test For example, Yabao pharmaceutical's 2017 half year report shows that after evaluation and selection, the company has established 10 products to carry out consistency evaluation, including 2 be tests; Harbin Pharmaceutical's 2017 half year report disclosed that the company has started the consistency evaluation of 20 varieties (24 specifications), and it is expected that 15 varieties will enter the preparation stage of be tests in the second half of the year Pharmaceutical companies "snatch" the first mover advantage to complete a batch of drug consistency evaluation work by the end of 2018 At present, there is only more than one year left If it cannot be completed on time, the drug approval number will be cancelled Because of this, many pharmaceutical companies in the first half of this year, the pressure increased rapidly, but a small number of enterprises are still waiting
In accordance with the opinions of the general office of the State Council on the evaluation of the consistency of quality and efficacy of generic drugs (hereinafter referred to as the opinions) issued in March 2016, the conformity evaluation of chemical generic oral solid preparations approved for marketing before October 1, 2007 in the national essential drugs catalogue (2012 Edition) shall be completed by the end of 2018, in which the clinical effectiveness test and storage shall be carried out In case of special circumstances, the consistency evaluation shall be completed before the end of 2021; if it is not completed within the time limit, it shall not be re registered At the same time, the above opinions also encourage enterprises to carry out consistency evaluation For example, drug manufacturers can mark in the drug instructions and labels; drug varieties that pass the consistency evaluation should be properly supported in the payment of medical insurance, and medical institutions should give priority to purchase and clinical use In addition, if there are more than three manufacturers that have passed the consistency evaluation for the same kind of drugs, the products that have failed the consistency evaluation will no longer be selected for centralized purchase of drugs Because of this, pharmaceutical companies generally believe that this process is an opportunity to reshuffle Some pharmaceutical companies speed up their progress and hope to take the lead in the next drug bidding For example, rosuvastatin is not included in the list of drugs to be evaluated by the end of 2018, but the evaluation of this variety in Beijing new pharmaceutical industry is still advancing rapidly Because the consistency evaluation will get certain results, and pharmaceutical companies can mark the results of their own products in the drug specification, that is, the similarity with the original research drug, the industry generally believes that there will be "differential treatment" for the acceptance of these drugs in the market in the future A listed pharmaceutical company secretary told reporters that those generic drugs that completed the consistency evaluation earlier and had a high degree of similarity with the original research drugs will have obvious advantages in the market In essence, consistency evaluation guides the operation of the whole industry from the aspect of professional technology Enterprises with the above characteristics of drugs will have advantages in medical insurance and drug bidding Once the market is concentrated in the hands of these pioneers, the latter will spend more energy and cost if they want to take it back Original title: consistency evaluation "burning money" competition: R & D investment of Lisheng pharmaceutical in the first half of the year increased by 2.8 times year on year