Reverse attack and virtual value of pharmaceutical industry

[market analysis of China Pharmaceutical network] on May 12, the 2017 China pharmaceutical industry future summit hosted by yiou.com, an industry innovation service platform, was held in Beijing At the scene of the summit, the participating pharmaceutical industry leaders shared with each other and talked about the new future of the pharmaceutical industry In the wave of policy change and deepening reform, where is China's innovative pharmaceutical industry going, and what challenges and opportunities are it facing? (source: Baidu picture) recently, the frequent news of the political figures in the pharmaceutical industry will have an important impact on China's pharmaceutical industry On May 11, the US FDA confirmed that the new director took office and expected to make important changes in the simplification of FDA approval process; On the same day, China's CFDA General Administration issued three public notices for comments, including relevant policies on encouraging innovation of medical devices to accelerate the review and approval of new medical devices on the market, relevant policies on encouraging innovation of medical devices to reform clinical trial management, and relevant policies on encouraging innovation of medical devices to implement full life cycle management of medical devices It puts forward a series of reasonable and standardized requirements for promoting the innovation and reform of pharmaceutical machinery, deepening the examination and approval system, and improving the industrial competitiveness The nightmare is just beginning to wake up The global pharmaceutical industry has reversed its trend China has supported the domestic health medicine market with imitated products for more than 60 years Innovative drugs have been rare for half a century Until more than ten years ago, China's biomedical industry began to be included in the scope of national strategy China's health industry is growing rapidly at a rate about twice that of GDP Through large-scale introduction of returnees and internal and external cooperation, China has started a new stage of new drug research and development towards the world What is the difference between innovative drugs and generic drugs? According to Guo Ming, co-founder and general manager of Yasheng pharmaceutical, innovative drugs mainly refer to compounds, macromolecules or small molecules that have not been used in clinical treatment before, have independent intellectual property rights or belong to proprietary brand drugs, and generally have effective protection (with new chemical structure, new drug delivery routes, new dosage forms, new application diseases, etc Characteristics) or various administrative protection (such as orphan drug market monopoly, approval time compensation, etc.) Generic drugs are non-original Drug molecules have been used in 1 clinical treatment before, but the monopoly period expires Other enterprises can use all the research and development data to copy the main drug ingredients The hatch Waxman Act (drug price competition and period Compensation Act) proposed by the United States in 1984 has made a good balance between protecting innovative drug enterprises to obtain R & D returns and promoting the listing of generic drugs, bringing great value to the society, and alleviating the contradiction between the short time of original research drug companies' rights and the listing of generic drugs as soon as possible Guo Ming said that the United States is the main market to support the research and development of global innovative drugs Innovative drug enterprises cannot be monopolized once and for all, and cannot achieve the optimization of social resources Therefore, generic drugs are needed to participate in the competition, reduce drug prices, and benefit patients all over the world for a long time "Just because the bill balances enterprise innovation and social benefits, the United States has become a global innovative drug country Now more than three quarters of innovative drugs come from the United States, which is called new molecular drugs Other countries are catching up China is basically zero now." Deloitte reported in December 2016 that the average cost of developing a new drug has increased to $1.54 billion, and it will take 14 years to launch a new drug Another survey (from Innovation Center for research in Biomedical Innovation) assessed the cost of R & D funds and approved drugs invested in the past 15 years by 100 pharmaceutical companies around the world, and calculated the average investment of each drug The top companies spent nearly 6 billion dollars on each drug on average New drug research and development has gone through several stages, from laboratory to animal, to clinical, in clinical conceptual verification, but also on the market, there is a marketing period, after the expiration of which is the period of generic drugs The past decade has been a nightmare period for the global pharmaceutical industry The efficiency of new drug research and development has been reduced and the productivity has been reduced The input-output ratio has been reduced by half every nine years in the past six decades Under the condition of a sharp decline in output, it has encountered a cliff In the past few years, nearly 200 billion US dollars of drugs have expired, and at the same time, it has faced a major global financial crisis However, the extremes of things are bound to change Guo Ming said that in recent years, the situation has changed rapidly The process of FDA's new drug approval accelerated, reaching the second peak in history in 2015, 45 new drugs were approved (53 new drugs were approved in 1996, a large number) In 2016, due to the speed of FDA's approval after reporting, there was no acceptance, so there was a small low peak, but not the reason for drug research and development Since 2017, 20 new drugs have been approved In recent years, the global drug market sales have been growing steadily In 2015, the global sales volume of the top 50 drugs increased rapidly The cumulative sales volume of the top 50 drugs reached US $41 billion It is estimated that in the future, all products and drugs will exceed US $1 trillion, about 20% of generic drugs and about 20% of innovative drugs will be sold There was a view that the death of new drugs with heavy bombs, but after 2013, data show that the drug sales market is very good, many drugs can reach the sales Standard of several billion every year "I expect the rebound will continue, especially in recent years, the development of some breakthrough new drugs will continue to accelerate." For example, the PPI inhibitor approved by FDA in 2016, the anticancer drug venclexta, can promote the process of cancer cell self apoptosis, as well as the Parkinson's mental disorder treatment drug nuplazid, which is also a drug approved by FDA to treat Parkinson's related hallucinations and delusions, are all examples of successful marketing of revolutionary new drugs In recent years, new technologies have also made breakthroughs, such as medical / big data research, cancer immunotherapy, antiviral therapy, gene editing, anti-aging fields, etc Guo Ming believes that the new president of the United States will bring uncertainty to science and pharmaceutical laws and regulations, but the new director of FDA can buffer the uncertainty For China, Bi Jingquan, the director of CFDA in 2015, has brought a lot of policy progress to the pharmaceutical industry, pushing forward reform measures vigorously, which is generally felt by the industry According to the data of mienei.com, in 2016, the sales volume of China's drug terminal market reached nearly 1.5 trillion yuan, an increase of 8.3% year on year The policy environment continues to improve, and CFDA accelerates the approval of new drugs The international market think tank has summarized several points for China's pharmaceutical industry sales market In terms of driving force, there are the following positive factors, including the expansion of medical insurance coverage, the listing of new products, the continuous improvement and reform of medical infrastructure and services, the rapid growth of chronic diseases incidence rate, the reimbursement of high value drugs in provincial and municipal levels, private investment in medical care industry, etc On the contrary, the foreseeable challenges include stricter general control of medical insurance, severe bidding situation, quality consistency evaluation, rational drug use regulations, lower drug proportion, and national price negotiation According to the current situation of new drug research and development, Guo Ming proposed the bottleneck of current regulatory measures in China: the lack of clear regulatory path of differential registration to distinguish the clinical research application ind and listing application NDA The difference between ind and NDA is obvious Facing different public risk factors, the success rate of different stages is also different The supervision is based on the risk supervision of the whole public The clinical phase I risk is completely controllable, and should not be the same as the listing In addition, the clinical application time is too long, hoping to save the inspection time for domestic pharmaceutical enterprises to participate in the international innovation competition as soon as possible; Different regulatory agencies and different levels of CFDA institutions need to pay attention to consistency in implementing policies; major policy changes need to pay attention to top-level design and coordinate all stakeholders, such as opening up the clinical trials of international pharmaceutical industry in China and removing similar barriers to domestic enterprises In addition to the improvement of the approval process of clinical research application ind, domestic pharmaceutical enterprises also need self-examination and self-examination In the newly released "relevant policies on encouraging innovation and implementation of life cycle management of pharmaceutical and medical devices", CFDA explicitly proposed to seriously investigate and punish the falsification of clinical trial data Guo Ming said that when he was interviewed a few years ago, he thought that the lack of integrity system and contract spirit is a big obstacle in making innovative drugs in China This obstacle is higher than other legal and technical barriers, because other obstacles can be overcome slowly, but integrity is something outside the industry In recent two years, CFDA has done a lot of things, and this level is gradually getting better On July 22, 2016, the national drug clinical trial data self-examination and verification work was carried out, with more than 1000 items self-examination, and 80% - 90% of them were voluntarily removed "From this point of view, the integrity and contractual spirit of the senior management can see great changes." Guo Ming explained that "the general environment has been improved, and other technological environments that need to be improved and the accumulation of new R & D forces are easier to improve Otherwise, a new drug will be approved in China, but the world will not recognize your clinical data and new drugs, and will not believe you." Xiong Lei, chairman of the board of directors of 3Dmed, also put forward some views on the difficulties encountered in the research and development of new drugs He believes that the problem can be divided into several levels: financial issues, policy supervision, new technology and talent In terms of capital support, based on the improvement of the current environment, it has not become a major obstacle The current new drug investment environment is different from the past, and the industry laments the high cost of new drug investment, which is a good thing If the new drug investment is low, it is meaningless, and the industry has no power and lacks sufficient funds for research and development Because new drug R & D is a high-tech, high knowledge industry, with high barriers and capital as one of the key factors; secondly, policies have changed a lot in the past two years, and the policies released intensively will greatly speed up the approval of new drugs; The third is knowledge technology, which depends on talents The above two problems need to be solved Giving full play to the value of capital and policy, a large number of overseas scholars will return to China and accelerate the flow of talents The fourth is the problem of talents themselves Technology is driven by talents Even if technology can not achieve global originality, talents can quickly follow up Xiong Lei explained: "the scientists we participated in the original work are all abroad, a very small number of them happen to be Chinese, and they also belong to the original work, but the place where the original work took place is not in China We can do original applications " As far as the gap is concerned, it will take 20-30 years for Chinese medicine itself to truly enter the original ranks like the United States and European and American countries At present, many cases in China are original at a certain point, or original products, but can not do original technology Virtual value attracts more and more capital to bet If China's policy environment is getting better and better, how does the capital market change its attitude towards new drug research and development? Guo Ming, general manager of AXA pharmaceuticals, said that in the past, Chinese investors did not understand new drug research and development After more than ten years of new drug research and development, more and more money has been spent What can we do if billions of dollars can't be invested successfully? So five years ago, financing was very difficult But now, investors and government departments have changed their ideas The virtual value in the value chain and the real tangible value in the drug R & D pipeline are transferring conceptually "For example, although there is no patent medicine, as long as we go further, we are creating value This value may be virtual value