The consistency evaluation time of generic pharmaceutical enterprises entering the knockout competition is short and large

Source: from July 29, 2016, in August last year, the consistency evaluation of quality and efficacy of generic drugs (hereinafter referred to as "the consistency evaluation of generic drugs") once again entered the public view after four years, but at the beginning of the period, all circles did not take it seriously However, after various policy "patches" and a series of supporting policies were implemented in succession this year, the external attitude began to change The consistency evaluation of generic drugs, which has risen to the national strategy, is characterized by tight time, heavy task, great difficulty and wide coverage If the A-share investors who are keen on "drinking and taking medicine" do not pay enough attention to the consistency evaluation policy of generic drugs, the outcome may be very tragic Unprecedented efforts to promote policy, so that generic pharmaceutical companies are on pins and needles According to the schedule released by the State Food and drug administration, 289 generic drugs specified by the policy need to complete the consistency evaluation by the end of 2018, involving more than 1800 pharmaceutical companies, almost covering all generic pharmaceutical companies of a share The industry expects that in the next three years, the pharmaceutical industry will enter a painful period of "revenue pressure + cost rise" Focusing on the issues related to the consistency evaluation of generic drugs, recently, the reporter of securities times directly felt the latest developments of all parties through understanding and field visits to some pharmaceutical companies They also try to find the beneficiaries of this war without smoke of gunpowder through their thinking Intensive policies change the expectation of pharmaceutical companies that the sun will be scorching in Zhejiang Province in July, and with the approaching of G20, many enterprises in Zhejiang Province have started the "discussion model" But these are not available for the generic pharmaceutical enterprises here The consistency evaluation policies of generic drugs have been issued in succession, which make the generic drug companies feel like a needle in the coffin "IPO congestion in A-share market will be staged in the process of consistency evaluation of generic drugs Pharmaceutical companies are the companies to be listed in line for examination Clinical trial service institutions are like sponsors, and there is a time limit for consistency evaluation, so generic pharmaceutical companies will enter a fierce knockout competition " For the consistency evaluation of generic drugs, Chen Bo, Secretary of the board of East China Pharmaceutical (70.580,0.00, 0.00%) described it In August 2015, the State Council issued the opinions on the reform of the review and approval system of pharmaceutical and medical devices, which clearly pointed out that "accelerating the quality consistency evaluation of generic drugs", and strive to complete the quality consistency evaluation of national basic drug oral preparations and reference preparations by the end of 2018 In the following two months, the State Food and Drug Administration issued documents such as selection and determination of reference preparation, research technology of bioequivalence of human body and determination and comparison of dissolution curve At the beginning of this period, the consistency evaluation policy of generic drugs, I'm afraid, has not attracted much attention from pharmaceutical companies Back four years ago, in January 2012, the State Council proposed in the 12th Five Year Plan for national drug safety to comprehensively improve the quality of generic drugs and carry out the consistency evaluation of generic drugs by stages and batches However, due to various reasons, the progress was slow By the end of 2014, the consistency evaluation work had basically stagnated All of these, many pharmaceutical companies and people in the industry did not pay much attention to the implementation of this round of generic drug consistency evaluation at the beginning of the period However, the high-level attention to the consistency of generic drugs is increasing in the waiting and waiting of the pharmaceutical industry In March 2016, the State Council also issued the opinions on developing the conformity evaluation of generic drugs This marks that the consistency evaluation of generic drugs in China has risen to the national strategy The website of the State Food and drug administration even opened a column of "consistency evaluation of generic drugs", in which 16 relevant documents have been published since March this year According to this, it is not difficult to see the attention of the regulatory authorities to the consistency evaluation of generic drugs Why should we promote the consistency evaluation of generic drugs? The State Food and Drug Administration's public statement is that the quality of generic drugs has been improved, and they have been replaced with the original drugs in clinical practice It will change the current situation that the proportion of the original drugs in the drug sales of some large hospitals has reached 80%, which is conducive to reducing the total cost of drugs, eliminating backward production capacity, and improving the competitiveness of domestic generic drugs "Since this year, it feels like new documents have been released almost every week From the high standard and intensity of the policy, we can see the speed and determination of the regulators to promote the consistency evaluation " In the face of the policy that followed, the head of a listed pharmaceutical company expressed his feelings to the reporter The intensive policies have made many pharmaceutical companies wait and see and enter the stage of active action Taking Jingxin Pharmaceutical (12.490,0.00, 0.00%) as an example, the company has established a generic drug consistency evaluation research center and a full-time QA department, under the leadership of the deputy general manager of the company, giving priority to the evaluation of key varieties The company divides the whole work into reference preparation filing and purchasing, pharmaceutical research, stability test, be filing and research, filing and reporting of application data, etc the estimated time is 16-24 months According to the scientific decision-making schedule, a detailed development plan for key varieties has been formulated, and a linkage mechanism of R & D, production and marketing departments has been established to focus on promotion, so as to ensure the completion before the 2018 deadline In the middle of July, the first training course on the consistency evaluation of quality and efficacy of generic drugs was held in Hangzhou by the State Food and drug administration According to the plan of the State Food and drug administration, seven major pharmaceutical provinces, including Jiangsu, Shandong, Guangdong, Sichuan, Hebei and Heilongjiang, will also hold and complete the training on the consistency evaluation of quality and efficacy of generic drugs in early August A series of training work in a number of pharmaceutical provinces is regarded as a signal that generic drug consistency evaluation work is about to spread in an all-round way by the industry However, from the policy push to the implementation, how many pharmaceutical enterprises can successfully break through the barriers, I'm afraid that not many enterprises have the foundation It is reported that although China is a big country of generic drugs, it is not a big country of generic drugs The phenomenon of low-level generic drugs is serious The number of approval documents for many drugs has reached dozens or even hundreds, and there is vicious competition among pharmaceutical enterprises At the same time, a large number of approved generic drugs have never been evaluated for consistency with the original drugs, and there are generally problems of poor quality and weak efficacy All these factors add uncertainty to the consistency evaluation of generic drugs It can be proved that in 2008, the State Food and Drug Administration once organized a spot check to select some domestic generic drugs and the original research drugs for in vitro dissolution test comparison It was found that the difference between domestic generic drugs and the original research drugs in vitro dissolution behavior was great, and none of them could reach the qualification standard "The structure of the drug determines the efficacy of its compounds For example, if we make dishes with the same formula, the taste of our dishes will be different from that of the chef At present, compared with domestic generic drugs, many of the original drugs are often several times or even dozens of times more expensive, but even so, patients tend to use imported drugs in the treatment of critical and difficult diseases All these indicate that there is still a gap in the process of domestic generic drugs " For the differences between domestic generic drugs and original research drugs, a listed pharmaceutical company's Board Secretary outlined this The gap between domestic generic drugs and original research drugs may indicate that the evaluation of generic drug consistency is not optimistic It is understood that the consistency evaluation principles of generic drugs mainly include: first, they have the same safety and effectiveness as the original drugs; second, they have the same pharmacy; in addition, they have the same biological toxicity According to a person in charge of the local disease control center, at the beginning, the consistency evaluation starts from the clinical evaluation, that is, when the quality and efficacy are the same, the drug companies check and correct themselves If there are false application materials, no new drug application will be allowed in the next three years, which has a greater impact on the drug companies At that time, many famous national pharmaceutical enterprises, such as Hengrui Pharmaceutical (43.800, 0.00, 0.00%), Shuanglu Pharmaceutical (32.150, 0.00, 0.00%), Tianshili (41.020, 0.00, 0.00%) and so on, withdrew their own heavy-duty varieties The above self inspection and self correction of pharmaceutical enterprises refers to the self inspection and verification of drug clinical trial data carried out by the State Food and Drug Administration in July 2015 Since then, China's pharmaceutical industry has set off an unprecedented wave of withdrawal of drugs under research, involving about 30 listed pharmaceutical companies For example, Hengrui pharmaceutical has withdrawn as many as 13 varieties According to the Research Report of Haitong Securities (15.460, 0.00, 0.00%), as of March 1, 1171 drug registration applications out of 1622 document numbers had been withdrawn, accounting for 72.2% of the total self-examination In addition, 24 drug registration applications are not approved by FDA, plus 6 applications published on April 29 are not approved 30 drugs account for 1.85% of the total self-examination The self-examination and verification of clinical trial data of new drugs initiated by the State Food and drug administration is regarded as the preliminary match of conformity evaluation of generic drugs by some people in the industry According to the head of the above CDC, famous pharmaceutical companies have withdrawn one after another, which shows that there are still many irregularities in the clinical process, which comes from the fact that the data processing of phase I and phase II is not standardized enough, or really can not do a good experimental effect, which is the withdrawal in case of necessity Four years ago, the State Food and drug administration started to promote the quality consistency evaluation of generic drugs, and 75 pilot varieties were selected in two batches for consistency evaluation However, only a few varieties have finally passed the evaluation There is a great controversy on the method of consistency evaluation, which makes this work in a real standstill by 2014 The signing of the vehicle in front of the pilot work makes the industry generally not optimistic about the generic enterprises Moreover, according to the policy requirements of the State Administration of drug administration, the conformity evaluation of generic drugs is a highly difficult project with a prescribed time limit First of all, time is tight The oral preparation of national essential drugs approved before October 1, 2007 is required to be completed by the end of 2018 Secondly, the task is heavy There are nearly 300 varieties with clear policy time limit mentioned above, involving 1883 enterprises and about 18000 approvals Moreover, the consistency evaluation of generic drugs also pointed out that, after the consistency evaluation of the first product, the consistency evaluation of the same product produced by other drugs should be completed in three years in principle If more than three manufacturers of the same product pass the consistency evaluation, the products that fail to pass the consistency evaluation will not be used in the procurement of drugs by the government The above-mentioned rules are commonly known as "three three principles" in the industry "According to the current policy and intermediary service capacity, at least two-thirds of the listed generic drugs will be eliminated, which is beyond doubt." Person in charge of the above listed pharmaceutical company At the same time, Guotai Junan (17.770, 0.00, 0.00%) research report pointed out that the basic research of domestic pharmaceutical enterprises is relatively weak, and the reference preparation and pharmaceutical evaluation generally need to start from scratch, and then considering the lack of clinical resources, the bottleneck of production capacity is obvious, it is expected that the whole consistency evaluation work will take 5-10 years to complete According to statistics of relevant organizations, the listed pharmaceutical enterprises with the largest number of approval documents for the first batch of consistency evaluation varieties include Shanghai Pharmaceutical (20.760,0.00, 0.00%), China Resources double crane (20.480, 0.00, 0.00%) and Baiyunshan (27.450, 0.00, 0.00%), with 505 approval numbers