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    Home > Active Ingredient News > Drugs Articles > Under the new situation, china's biomedical supply chain security analysis

    Under the new situation, china's biomedical supply chain security analysis

    • Last Update: 2020-12-25
    • Source: Internet
    • Author: User
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    Since the new U.S. president took office in 2017, China-U.S. relations have been strained, with the two sides starting a trade war until now when the U.S. talks about the "decoupling theory" between China and the U.S., and in order to achieve the goal of comprehensively curbing China, the U.S. has imposed extensive sanctions on Chinese high-tech companies, especially China's high-tech company Huawei, for supplying chips, giving Huawei products a huge challenge.
    , in China's biological industry, there is also a "Chinese core" problem? To answer these questions, we need to analyze in detail the main gap between China's biopharmaceutical industry and Europe, America and Japan.
    1. The main gap between China's biopharmaceutical industry and developed countries such as Europe and the United States Biopharmaceutical Industry is the sunrise industry, the development prospects are huge, however, China's biopharmaceutical science and technology and Europe and the United States and other countries have a clear gap, mainly manifested as follows: 1. The biological theoretical basis is weak, the lack of original theory and technical practice is the basis of theory, and theory can guide the practice.
    history of biology is a history of major technological discoveries and theoretical innovations.
    However, in the past few hundred years, biological theories and major discoveries almost all come from Europe and the United States and other Western countries, and our country in these theories and major discoveries, almost all are blank, the lack of original theories and the lack of major discoveries, so that our country can only learn Western theory and technology, imagine, if the most important theoretical foundation is not in their own hands, what discourse do we have in the world biological world? Where is the source of technological innovation in our country? The author combs through the world's biological field of theory and technology of major discoveries, Chinese of the world.
    1 Source of major theoretical and technological discoveries in the history of world biology: Firestone Creation can be seen from the above data that over the past four hundred years, the major discoveries and theories in the biological community have come from Western countries such as Europe and the United States.
    china only in 1965 the first synthetic crystalline bovine insulin, which caused the world's biological community to shake, so that the world's biological community to China's eye-opening, the Chinese people excited.
    overall, the theoretical original basis of biology in China is very weak and needs to be improved.
    2. Biological education is weak, the discipline is generally backward in Europe and the United States and other Western countries education is the basis of a country, but also the hope of the country.
    foreign universities have set up biology majors more than 400 years ago, and China's universities basically set up biology majors after the founding of the People's Republic of China in 1949.
    in the 70 years since the founding of the People's Republic of China, the biology majors of our universities have also flourished, but in the last 20 years, the distance between our universities and international universities has increased significantly, and few Chinese universities have made the list in the global biology rankings.
    the 2019 QS ranking of the world's leading universities in biology, only Tsinghua University (36) and Peking University (38) are on the list, and the ranking is relatively low.
    regret that other well-known Chinese universities are hard to find.
    table 2 2019 ranking data on biology at world-renowned universities: The leading biopharmaceutical industry in europe and the United States in the biopharmaceutical industry chain (supply chain) has become the third most valuable industry in addition to financial e-commerce and the Internet, and is a large and complex growth part of the global economy.
    if the biopharmaceutical industry were a country, its GDP would rank 15th in the world, ahead of Mexico, Indonesia, Sweden or Poland.
    more than half of the value of the biotech industry is in the U.S., while China ranks Second, currently at 8.2 percent, ahead of major European and Asian countries, but far from the U.S. at 58.3 percent.
    1 The share of biotechnology production in the world Source: Firestone Creation according to public data can be seen from the chart above, the United States accounts for 58.3 percent of the value of biotechnology, more than seven times that of China.
    U.S. companies still have an absolute advantage, as are the top 25 biotech companies in the world in 2019.
    Figure 2 The market capitalisation of the top 25 biotech companies in 2019 ($100 million) Source: Firestone Creations tops the list with $126.5 billion in market capitalisation, Noel and Nord are in second place with $103.5 billion, up one place from last year, and CSL is in third place with $80.3 billion, up two places from 2018.
    and Gilead Sciences dropped out of the top three, coming in fourth with a market capitalisation of $80 billion.
    , a biotech company particularly notable on the list, came in fourth place with $61.479 billion in 2018 and eighth with $54.1 billion in 2019, down 12.0 percent from the same period in 2018.
    There are five Chinese biotech companies on this list: Hengrui Pharmaceuticals (market value 398.8 billion yuan, ranked 7th), Pharmaceutical Mingkang (market value of 133.5 billion yuan, ranked 14th), Haussen Pharmaceuticals (market value of HK$139.5 billion, ranked 16th), Yunnan White Pharmaceuticals (market value of 107.3 billion yuan, ranked 19th), and Guo Pharmaceutical Group (market value of HK$82.8 billion, ranked 24th).
    second, the United States, Europe and Japan biopharmaceutical industry in the global industrial chain leading the current, the global biopharmaceutical industry shows a significant trend of intensive development, the United States, Europe, Japan and a few developed countries and regions in the global biopharmaceutical industry chain and market dominance, India, China and Singapore and other countries and regions to increase support for biotechnology research, production equipment research and development, manufacturing, high-end medical equipment manufacturing and other aspects, to promote the continuous breakthrough of domestic biomedical technology.
    industry chain of biopharmaceuticals mainly consists of biopharmaceutical raw materials, pharmaceutical raw materials, pharmaceutical research and development and manufacturing, pharmaceutical circulation and application.
    industry upstream is mainly composed of biopharmaceutical raw materials, scientific research equipment manufacturing, midstream is mainly composed of pharmaceutical research and development, manufacturing, downstream is mainly pharmaceutical circulation, medical testing equipment, and finally applied to patients.
    3 Biopharmaceutical Industry Chain Illustration Data Source: State Information Center 1. Upstream, the market share of biopharmaceutical research and development equipment manufacturing is occupied by European, American and Japanese enterprises.
    biomedical research and development mainly involves fermentation, sterilization, centrifuges, mass spectromety, nuclear magnetism, electro-mirrors and other instruments.
    In terms of overall sales volume, U.S., European and Japanese companies ranked highest in the world in terms of sales revenue, and the latest data released in 2018 by the magazine C and EN show that there are eight U.S. companies, six European companies and six Japanese companies on the list of global analytical and life sciences instrument manufacturers TOP20.
    from a single instrument point of view, the United States and Japan, for example, are the main sources of new technologies, in the field of technological innovation in a dominant position, strong.
    As of 2018, the United States was ranked first with 1,511 patents, accounting for 35.45 percent of the total in the last two decades, Japan was second with 1,156 patents, accounting for 27.12 percent, China was third with 638 patents, accounting for 14.97 percent, and the United Kingdom was fourth and fifth with 170 patents, respectively.
    Table 3 2018 Global Analysis and Life Sciences Instrument Manufacturer TOP20 Data Source: National Information Center 2. From the middle of the tour, europe and the United States enterprises with high technical barriers, large market share (1) is the majority of European and American enterprises occupy the majority of the market share.
    statistics, the total number of global biotechnology companies has reached 4,362, of which 76% are concentrated in Europe and the United States, sales accounted for 93% of global biotechnology company sales, while sales in the Asia-Pacific region accounted for only about 3% of global sales.
    the United States is currently a leader in the biotechnology industry, developing more than 70% of the world's products and market sales.
    9 U.S. companies in the 2017 Global Biopharmaceuticals Rankings by Sales Revenue (Table 4);
    In the 2019 TOP50 list of global pharmaceutical companies published in the latest American Journal of Pharmaceutical Managers, the United States has 18 companies, of which 5 enterprises occupy the top 10, China has only 2, ranked 42 and 47, respectively, China's biopharmaceutical enterprises international competitiveness needs to be improved.
    Table 4 Global Biopharmaceutical Companies By Sales Revenue Ranking Data Source: National Information Center Figure 4 2018 Ranking Data Source: National Information Center Table 5 2019 Global Pharmaceutical Companies TOP10 (US$100 million) Source: Pharmaceutical Rubik's Cube (2) U.S., Japan and Europe companies own the vast majority of biotechnology patents.
    , Europe and Japan account for 59 per cent, 19 per cent and 17 per cent of global biotechnology patents, while developing countries, including China, account for only 5 per cent.
    there are currently more than 2,600 pharmaceutical preparations in the world are being developed, the first is malignant tumors, the second is a rare disease, of which more than 900 in the United States have entered the clinical stage.
    the same time, foreign enterprises continue to increase investment in technology research and development, to maintain the advantages of technology monopoly.
    the world's top 15 biopharmaceutical companies will spend more than $100 billion on new drug development for the first time in 2018, with Roche spending $11 billion.
    3. On the downstream side, developed countries such as the United States use a large number of biopharmaceutical products in treatment, accounting for more than 50 per cent of global consumption in terms of market size in a single country.
    from a single technology application, in the case of clinical trials of gene therapy, as of November 2017, there were 2,597 major countries in the world, including 1,643 in the United States and 84 in China.
    , China's biopharmaceutical supply chain exists in the safety problem 1. Biopharmaceutical patent technology base is weak, the proportion of original research drugs, innovative drugs is low.
    , 97% of China's biopharmaceuticals are generic drugs, most pharmaceutical companies to generic drugs as the main products.
    However, the world's largest pharmaceutical companies tend to build a set of patent applications and defense strategies around an original drug, for a drug to file a number of patent applications, respectively, to protect the original drug itself, crystalline, composition, derivatives and preparation methods, so that even if the original drug patents have expired, generic drugs will encounter patent problems, resulting in many Chinese pharmaceutical companies to produce generic drugs to avoid or take longer to study the risk of generic drugs on the market.
    biotechnology patent problem is a big pain point in China's biopharmaceuticals, it is difficult to break the patent blockade abroad for a short time, not only difficult to meet the needs of national health, but also in the international industrial chain in a passive situation.
    At present, China has approved the listing of 13 categories of 25 kinds of 182 different specifications of genetic engineering drugs and genetic engineering vaccine products, only 6 categories of 9 kinds of 21 different specifications of products are original, the rest are imitation.
    the author has participated in some biopharmaceutical exhibition this year, found that there are a large number of generic drug research and development CRO outsourcing companies, its business demand is very strong, behind a large number of generic drug demand in China.
    , generic drugs are characterized by short cycles and fast economic benefits, but behind the benefits are the loss of core technology, lost innovation.
    . Biomedical research and development materials, equipment and equipment, reagent supplies are seriously subject to human.
    (1) the cell model used for research depends on imports.
    There is a biopharmaceutical industry "primitive chip" called the cell model, China currently mainly depends on imports from Europe and the United States, but Chinese and Western cell model there is a certain difference, import model-based research results are mostly for Westerners rather than Chinese diseases, which led to China invested a lot of resources in biomedical basic research and drug research is actually "for others to marry."
    is worth noting that the long-term "card neck" cell model has been in the window of upgrading and substitution, which gives our country to get rid of the source of biomedicine dependence, oversized has brought opportunities.
    for fermentation and cell culture of primary cells, are from the United States' largest cell manufacturer ATCC company, China has no company can replace ATCC cell products, once the other side cut off supply, many of China's biopharmaceutical companies relying on cell culture will face the danger of no "seeds", some similar to the biological industry "Chinese core" problem.
    (2) high-end research instruments are subject to human control.
    biomedical laboratory in China, most of the instruments and raw materials involved in micro-qualitative quantification come from imports.
    the 2018 Global Analysis and Life Sciences Instrument Manufacturer TOP20 list published in the journal C and EN, no Chinese-based company has yet been selected.
    In the manufacture of high-end instruments, such as gene sequencer, quotation synthesis instrument, mass spectrometer, electroscope, MRI instrument, etc., China's enterprises seriously lag behind Europe, the United States and Japan and other countries, in the field of gene sequencing the most core equipment - gene sequencer, for example, the global market share of nearly 90% in the hands of two U.S. biological companies, respectively, Ill. umina company (70% market share) and Thermofisher's Ion Torrent company (20% market share), although China's Huada gene has also developed a domestic sequencer, but there is still a big gap in performance, technology level, can not be achieved in the short term domestic replacement, once there is a risk of supply cut-off, will further hinder the development of China's biomedical technology.
    (3) biopharmaceutical enterprises to produce reagent supplies for research and development, etc. are seriously subject to human control, mostly from Europe and the United States imported products.
    According to statistics, imported products account for about 80-90% of the total demand, especially enzymes, proteins, antibodies, IVD diagnostic reagents, fluorescent dyes, gene sequencing reagents, reagent supplies mainly monopolize the hands of several major European and American companies, including Thermofisher, Merck (Sigma-Aldrish), Roche, GE, Corning, Qiagen and other major brands, there is no domestic company can completely replace any of the above companies.
    domestic reagent supplies in the technical level, quality stability and so on there is a big gap, in the short term is difficult to replace.
    Fourth, how should we deal with the security problems of China's biological supply chain Today is facing a century-old change, China-U.S. confrontation, China-U.S. decoupling and so on have brought to China's biopharmaceutical industry
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