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     Suzhou LAING BIOTEC (hereinafter referred to Lang Xing biological) is a foothold in China, for overseas high-tech enterprises. The company is located in the beautiful Suzhou Industrial Park, is committed to chemical raw materials intermediates, organic electronic materials, high-end biochemical reagents production, research and development, sales, and many domestic and foreign pharmaceutical manufacturers, new energy companies and research institutions to establish a stable Good working relations.
     The company has a number of doctorate or master's team of R & D team, supporting R & D center, pilot, production workshop; has a strong product research and development capabilities, according to customer needs to provide customized products and bulk production services; have a full set of analytical equipment, Including liquid chromatography, gas chromatography, ultraviolet chromatography and conventional analytical instruments, the quality of the product to do real-time detection control.
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  •       First, the industry overview 1, the industry profile Pharmaceutical intermediates industry refers to those in accordance with strict quality standards with chemical synthesis or biosynthesis method for the pharmaceutical production and processing of finished products for the manufacture of organic / inorganic intermediates or API drug companies. Here the pharmaceutical intermediates are divided into CMO, CRO two sub-sectors. CMO: Contract Manufacturing Organization refers to the contract manufacturing enterprises, that is, pharmaceutical companies will be part of the production outsourcing to the partners. Pharmaceutical CMO industry chain is generally starting from the special pharmaceutical raw materials. Industry companies need to purchase basic chemical raw materials and classified into specialized pharmaceutical raw materials, and then gradually form the raw materials to start raw materials, cGMP intermediates, APIs and preparations. At present, the major multinational pharmaceutical companies tend to establish a long-term strategic partnership with a small number of core suppliers, the company's survival within the industry through its partners basically at a glance. CRO: Contract (Clinical) Research Organization refers to the contract research institutions, pharmaceutical companies will be part of the research outsourcing to partners. At present, the industry mainly to custom production, custom research and development and pharmaceutical contract research and sales as the main mode of cooperation, no matter what way, regardless of whether the pharmaceutical intermediates for innovative products, the core competitiveness of enterprises is still to research and development technology as the first Elements, the side reflects the company's downstream customers or partners.2, the industry scale, the pace of development, major manufacturers and other professional medical research advisory agency IMS Health Incorporated data show that the global pharmaceutical market in 2012 reached 959 billion US dollars, is expected in 2017 the global pharmaceutical market will reach 1.2 trillion US dollars, according to projections 2012 - 2017 global pharmaceutical market average annual compound growth rate of 4.6%. The global pharmaceutical market is about 18 times the size of the global pesticide market. In 2010, the global pharmaceutical custom R & D and production industry market size of 24 billion US dollars, accounting for the same period the global pharmaceutical market size of 2.80%. 2011 - 2014, the global pharmaceutical custom R & D and production industry will maintain an average annual compound growth rate of 8.86%, higher than the growth rate of the global pharmaceutical market over the same period. In 2010, China's pharmaceutical R & D production scale was US $ 1.7 billion, which is expected to grow to US $ 3.1 billion by 2015, with an average compound annual growth rate of 12.77%. Combined with the relevant information of domestic listed companies, large manufacturers to custom production as the main business model, in the custom production mode, large customers and suppliers between the cooperative relationship is relatively stable, and the closer cooperation, the higher the degree of trust, The more cooperation will be provided. Replacement of suppliers need a long period of inspection period, therefore, as a strong sticky business, pharmaceutical intermediates industry enterprises at this stage the main direction for foreign well-known pharmaceutical companies. From the current perspective, the scale of domestic pharmaceutical intermediates industry is only tens of billions of dollars, the global scale is tens of billions of dollars. But taking into account the competitor of the company's products are mostly 2-3, the company once into the pharmaceutical giant's core supplier system, both in the scale of production or gross margin are maintained in a fairly stable state. Personally believe that the current external environment is not yet conditional to rely on environmental protection to reduce the supply side to the advantages of technology and cost to win the desert flower business, more likely to rely on technological advantages to form the advantages of scale, and then open up the upstream industry chain, forming a Breakdown of the pharmaceutical industry leading enterprises.Some domestic and foreign manufacturers:Among them, the bo teng shares although r&d and production in the global medical custom business market share only 0.34%, but in income accounted for 1%, has formed a certain influence. Another part of the listed companies benefit from the upstream costs down and customized production, in recent years, gradually expand the scale of production of pharmaceutical intermediates related products, pharmaceutical intermediates industry progresses day by day. Here a bit about the pesticide intermediates and pharmaceutical intermediates related (part of the company has, in the two pieces and higher proportion of pesticide intermediates). Pharmaceutical intermediates market capacity (about 180 billion yuan) is a pesticide intermediates (about 50 billion yuan) more than three times. Pesticide intermediates and pharmaceutical intermediates, both in common, and have obvious difference. Have in common is pesticide intermediates and pharmaceutical intermediates customers overlap degree is high, technical overlapping degree is higher also. Differences are pharmaceutical intermediates is a requirements more stringent business, for example, production process must comply with GMP standard. industry market structure analysis supply and demand in 2010-2020, the global pharmaceutical market will usher in a wave of Patent expirations * *, of which 2013-2020 patents expire a year an average of more than 200 varieties, international calls "Patent Cliff (Patent Cliff). Since 2000, the global generic-drugs market growth lasts for more than the growth of the whole medicine market, its growth speed is more than double Patent medicine. 2013 global generic-drugs market is expected to reach $180 billion, according to the estimated 2005-2013, the global generic-drugs market scale is expected to reach a CAGR of 14.7%. The relevant authorities to predict the future five years the global generics market size will be increasing at the rate of 10% to 14%, far higher than 4% to 6% of the entire pharmaceutical industry expected growth. It follows that the generics market development will significantly promote the development of pharmaceutical intermediates industry. European and American customers due to the environmental protection, cost, the original drug patents expire more willing to put some factors such as production technology transfer to China, with the domestic local rapid rise of the production capacity and research and development capacity and the intermediate of the features of many varieties, small batch, pharmaceutical intermediates company has the ability to receive, and in related synthesis process for postpartum, scale advantage. 2, main products of domestic manufacturers and in investment projects (subject to pharmaceutical intermediates as the research object, by the following data are harvesting company related data) in pharmaceutical intermediates. Jas this chemistry: main products include antitumor drug intermediates, antiepileptic drug intermediates and antiviral intermediates. The antiepileptic drug intermediates ABAH has in October 2014 formally put into production, production capacity of 1000 tons, according to the China international capital corporation to provide data, thickening of the project profit is expected to more than 30 million yuan. Otherwise pesticide intermediates (project thickness increases the profit of 100 million yuan of above).
  • The world's richest man, Bill Gates predicted: more than the next world's richest man, he must come from field.
    A basic situation analysis, biological medicine industry
    (a) biological technology and its application in the pharmaceutical industry
    With genetic engineering, cell engineering, enzyme engineering, fermentation engineering of modern biological technology developing rapidly in recent 20 years, and is increasingly influencing and changing people's production and way of life. Biotechnology (Biotechnology) refers to "living organisms (or organism substance) to improve products, improve plants and animals, or for special purposes and the training of microbial technology". Biological engineering is generally referred to as the biological technology, refers to the use of biochemistry, molecular biology, microbiology, genetics, and the principle of the combination of biochemical engineering to transform or re-create design cell's genetic material, develop new varieties, use of the existing biological systems in industrial scale, manufacturing of industrial products by biochemical process. In short, is to living organisms, life system or process industrialization process. Including genetic engineering, cell engineering, enzyme engineering, fermentation engineering, electrical engineering, biological bioreactor, sterilization technology and emerging protein engineering, etc., among them, the genetic engineering is the core of modern biological engineering. Genetic engineering (genetic engineering, gene recombination technology) is to different biological gene in vitro shear combination, and carrier (plasmid, bacteriophages, viruses) DNA, connection, and then turn to microorganisms or cells, cloning, and expressed in the microbes transferred to genes in cell/produce the protein needed to.
    According to different technical methods, the biological engineering can also be specific can be divided into: dosing method (DrugDelivery), gene therapy (GeneTherapy), Genetics, Genetics, genetic engineering (FunctionalGenetics), restructuring chemical (CombinatorialChemistry), detection technology (Diagnostics), Reagents (Reagents), Monoclonal/polyclonal (Monoclonal/PoliclonalAntibody), Light activated carcinoma (Light - activated, cancer - therpy), carcinoma (CancerVaccine), fermentation (Fermention), etc.
    At present, more than 60% of the human biological and technological achievements focus on application in the pharmaceutical industry, to develop new drugs or characteristic to improvement of traditional medicine, which caused the reform of pharmaceutical industry, biotechnology, pharmaceutical development rapidly.
    Biopharmaceutical is the application of biological engineering technology to the drug in the field of manufacturing process, is one of the most main genetic engineering methods. It is using cloning technology and tissue culture technology, cutting, inserted on DNA, connection and restructuring, to obtain biological pharmaceutical products. Biotech drugs is the microorganisms, parasites, animal toxins, biological tissue as the starting materials, adopting biological process or the preparation and purification technology to biological technology and analysis technology made of intermediate and final quality control biological activation agents, including vaccine, vaccine, toxins, vaccine, blood serum, blood products, immune preparation, cell factor, the antigen, monoclonal antibody and genetic engineering products (recombinant DNA products), in vitro diagnostic reagent, etc. At present, biological pharmaceutical product mainly includes three categories: genetic engineering drugs, biological vaccines and biological diagnostic reagents. In the diagnosis, prevention, control and eliminate infectious diseases, protect human health life extension plays an increasingly important role.
    Biotechnology, pharmaceutical industry is introduced so that biological pharmaceutical become one of the most active and fastest progress in industry. At present, the humanity has developed into the stage of clinical application of biological medicine, according to its USES different can be divided into three categories, namely, genetic engineering drugs, biological vaccines and diagnostic reagents.
    (2) biological medicine industry characteristics
    Low to high technology. This is mainly manifested in its high knowledge level of talents and high new technology. Biological pharmaceutical is a knowledge-intensive, high technical content, height of multidisciplinary comprehensive mutual penetration of emerging industries. In genetic engineering drugs, for example, the technology (i.e., the construction of engineering bacteria) involves the synthesis, purification, gene sequencing. Gene cloning, import; The cultivation of engineering bacteria and screening; Downstream technique involves the target protein purification and amplification, product testing and quality assurance. Biomedical applications to expand the research field of difficult diseases, make originally threat to effective control of major diseases of human life and health. In the 21st century, the development of biological drugs will enter ENABLINGTECHNOLOGIES stage of maturity, made an enormous change medical practice, thus greatly improving people's health.
    Low high investment. Biological pharmaceutical is a pretty big industry, mainly used in the research and development of new products and medicine plant construction and equipment configuration of the instrument. At present abroad the average cost of a new biological medicine research and development in 1 - about $300 million, and with the increase with the increase of the difficulty of new drug development (some even as high as $600 million) at present. Some large biopharmaceutical company research and development cost of sales ratio exceeded 40%. Obviously, abundant capital is biological pharmaceutical development necessary guarantee of success.
    Low long cycle. Biotech drugs from began to develop into the end product to go through a lot of links: laboratory research stage, pilot production stage, stage of clinical trials (I, II, III), mass production stage, market commercialization stage, and supervise each link strict complex drug administration examination and approval procedures, and product training and difficult market development; So with a long cycle to develop a new drug, typically 8 to 10 years, or even more than 10 years of time.
    Low risk. The development of biomedical products with a greater risk of uncertainty. Investment from biological screening of new drugs, pharmacology, toxicology, etc before the clinical experiment, formulation and stability, bioavailability tests until used in human clinical trials and registration listing and after-sales supervision and a series of steps, is expensive system engineering. Any link failure will be reversed, and certain drugs has the "duality", may be in the process of using the adverse reactions and need reappraisal. A biological engineering products, in general, the success rate of only 5-10%. Need to 8-10 years time, $1, 300 million. In addition, the risk of market competition intensifying, "focuses on new drug certificate and grab market share" is the key to development technology into products, is also the goal of different developers, fierce competition, if preferred by others get medicine certificate or seize market, will be disqualified.
    Low high yield. Biological engineering pharmaceutical profit return on high. A new biological drugs commonly listed after 2-3 years to recover all the investment, in particular, with the new product, the patented product enterprise, once successful development will form a technological monopoly advantage, returns can be as high as more than 10 times. Amgen companies in the United States in 1989 launched erythropoietin (EPO) and was launched in 1991, granulocyte colony stimulating factor (g-csf) in sales in 1997 were over and close to $2 billion. Biological medicine, as it were, once the successful development on the market, will receive a windfall.
    Second, the development of biological medicine abroad
    (a) development situation
    The United States is the birthplace of modern biological technology, and application of modern biological technology the first country in the development of the new drug. Most genetic engineering drugs have pioneered in the United States. Since 1971, the first biopharmaceutical company Cetus start date of trial production of biological medicine company, founded in the United States has more than 1300 biotechnology companies (two-thirds of the world's biotech companies), biological technology market capitalization of more than $40 billion, annual research budget of more than $5 billion; Formal biotechnology drugs launched more than 40, has successfully created a 35 important therapeutic drugs, and widely used to treat cancer, multiple sclerosis, anemia, dysplasia, heart failure, diabetes, hepatitis, hemophilia, cystic fibrosis, and some rare genetic disorder. In addition, there are more than 300 varieties entered the stage of clinical trials or for approval; Biological pharmaceutical market in 1995 sales of about $4.8 billion, more than $1997 in 6 billion, the annual growth rate of more than 20%.
    Europe is also in the development of biological medicine progress faster, Britain, France, Germany, Russia and other countries in development and production of biological medicine, also in some areas of biotechnology and even catch up with and surpass the United States. Such as Germany Hearst corporation changed its focus to life sciences, the Russian academy of sciences institute of molecular biology, Moscow, Russia and the Moscow institute of obstetrics and gynecology, medical genetic biology department research center, and other research institutions in recent years in the research and application of gene therapy has made major progress.
    Japan also has certain contribution in the field of life science, there are 65% of biotech companies engaged in biomedical research, Japan's kirin biological medicine practice also listed in the world, the Singapore government recently announced to draw a piece of science and technology park and expensive construction used to attract the world's several big in the biological medicine company, South Korea, China Taiwan in this aspect also ambitious. Biological medicine industry rapid development in recent years the main reason is:
    Low international pharmaceutical group and the related university, scientific research institutions established close mode of research and development, is advantageous to the new biotechnology and biological medicine research and development and to enter clinical trials, is conducive to science and technology into productivity quickly.
    New technology "toolbox" (toolbox) flow like a gene in learning (genomics, bioinformatics (bioinformatics), gene image (transcriptimaging), information transmission (signaltransduction), restructuring, such as chemical (combinatorialchemistly) brought product discovery and development of the great leap forward;
    Low international venture capital as the biological pharmaceutical industry offers huge financing;
    Low biotechnology industry the impact on the pharmaceutical, promising, biotechnology company is confirmed;
    When the FDA itself makes the reform of new drug approval time reduced, especially in new drug approval to speed up the time for the treatment of cancer, HIV/AIDS.
    (2) the market present situation and prospect
    Relevant statistical data show that global biotech drugs market in 96 was $12.7 billion, about $14.6 billion in 1997 (+ 15%). If current growth rates, total market sales could exceed $20 billion in 2000, and there will be 100 kinds of modern biotechnology drugs. Although biotechnology drugs currently the world's $150 billion drugs in the market accounted for only 8%, but because of its fundamental flaws can make up for the chemicals (low cost, high success rate, safe and reliable, etc), with a strong vitality and growth.
    According to the 1995 and 1996, a survey of the pharmaceutical research and manufacturers association of America, biotechnology drug development approved by the FDA and the European Union and audit into clinical trials of drugs in 1994 to 143, 1995 to 234, 1996 to 250. In main product categories, the international market sales the best genetic engineering drugs to promote red blood cell auxin (EPO), g-csf, interleukin, interferon (alpha, beta, gamma), insulin, T - PA, etc., and cytokines, receptors drugs, blood coagulation Ⅷ factors, such as vaccines for hepatitis b vaccine is given priority to, and used to detect the diagnostic PCR technology of reagents, probe experiment items such as cloning.
    Biotech drugs on the market in Europe, in 1995, the biggest market share was human insulin, at 38%, but it has reached the growth peak, from the point of the growth, interferon growth rate will be increased from 2.3% in 95 to 9.5% in 2002, the species from the past, g - a - interferon interferon increased to four varieties, restructuring DNAb - interferon in Europe for multiple sclerosis will improve interferon total market share. Colony stimulating factor also maintain the growth rate, but the market is mainly governed by granulocyte macrophage colony stimulating factor, and the product because of its side effects have a sales promotion problems, its turnover is expected to be decreased from 4.5% in 1995 to 13% in 2002. EPO will rise to 22.5% from 0.6% in 1995, growth hormone, approval and apply new indications may speed up the development of the market, in 95 16.3% of European biotech drugs market, but the government's price cut may reduce growth to 14% in 2002. According to the new market research report estimated the frost &sullivan, European EPO, colony stimulating factor, interferon, insulin and growth hormone in areas such as biotechnology derived the size of the market will increase by $1995 in 2.34 billion to $2002 in 4.15 billion, this is mainly due to the new product listings and indications of increasing.
    (3) the latest development tendency of the biological medicine abroad In Europe and America market, in view of the existing of recombinant drug molecule modification has listed some of the second generation of genetic drugs, such as restructuring new sodium element, intracellular polypeptide, etc.; In addition, the recombinant cytokines fusion protein, important role of monoclonal antibodies, cytokines, antisense nucleic acid, gene therapy and new methods of preparation of antigen, new technology, the application of transgenic animal model has made substantial progress. Biological medicine abroad the latest development trend of outstanding performance in the following aspects:
    Low cloning technology. 1997 cloned dolly the sheep appeared in the human cloning epoch-making revolution. Even more remarkable is related to the cloning technology, a new progress. In April 1999, researchers in the United States will derive from adult bone marrow mesenchymal stem cells in in vitro culture between the differentiation into cartilage, fat, and bone cells. Adopt the technology development on the basis of the stem cell regenerative medicine will have a huge market, in the treatment of cartilage injury, the poor healing of fracture, heart disease, cancer and degeneration diseases associated with aging.
    Low angiogenesis. Used for the treatment of cancer angiogenesis inhibiting factor caused the media attention. In May 1998, the New York times introduced two kinds of preclinical development stage of vascular growth factor a angiostatin tube wei Yang (system) and endostatin (endothelial statin), investors rushed to buy EntreMed shares in the company, the company's market value add $487 million to $487 million in one day. The third fight blood-vessel growth protein called vasculostatin inhibin (blood vessels), released in May 1998, when only in vitro test data. Released in March 1998 for the first time using growth hormone to stimulate the heart blood vessel growth around clinical experimental results, the law can be used for the prevention and treatment of coronary artery disease caused by blocked arteries. Such angiogenesis therapy is the opposite of the role of cancer therapy, it through stimulation of the artery wall endothelial cell growth, the formation of new blood vessels, to treat coronary artery disease and ischemia.
    "AIDS vaccine. AIDS vaccine research to arouse people's attention. In June 1998 by VaxGen announced in the United States and Thailand for a new AIDS vaccine clinical Aidsvaxgpl20 Ⅲ period. This is a new kind of bivalent vaccine, the company believes it will be more effective than monovalent vaccine before. In June 1999, the national institutes of health established a new vaccine research center, to develop an AIDS vaccine, as one of the central task.
    Low pharmacogenomics. Pharmacogenomics using genomics and bioinformatics research about detailed knowledge of the patient and disease, for a specific people design and development of the most effective drugs, diagnostic methods, and to identify the specific populations make the treatment of diseases more efficient and safer. Take this strategy, pharmaceutical companies can target different subtypes of a disease, produce the same kind of drugs in a series of allosteric body, the doctor can be selected according to different patients corresponding allosteric body of the drug. This technique according to tailor drugs to patients, the efficacy and indication is clear, can reduce the patients clinical trials and cost, shortening the period of clinical examination and approval; Drug post-marketing, with clear, specific efficacy and less side effects, it is easier to persuade doctors to use this kind of expensive new drugs. Of course, the application of the drug genome technology also has a downside. Most drugs targeted to strengthen, reduces indications, market size is smaller; In addition, as with genetics caused by combination of privacy issues also need to be resolved.
    When the human genome project. The human genome sequencing presented a new round of competition. PerkinElmer and j.c. raigVenter formed a new genomics, human genome sequencing plan in three years to complete. The national human genome research institute was announced in September 1998, to celebrate the 50th anniversary of the DNA double helix found, "will be held before the end of 2003 persons whole genome DNA sequence determination. Almost at the same time, belongs to the IncyteGenetics Incyte pharmaceutical company announced that it would all persons involved in 1 year genome and to establish all the genome sequence of gene single nucleotide polymorphisms data repository.
    Low (GENE - BASEDTREATMENT) GENE therapy. Gene therapy is the exogenous gene by carriers into the body and in the body, organs, tissues, cells, etc.), so as to achieve purpose to treat diseases. Clinical for the first time since 1990, adenosine deaminase (ADA) genes into patients' white blood cells, the treatment of genetic disorders, severe combined immunodeficiency disease, gene therapy by 98 already amounted to more than 400 cases of patients, the clinical research in foreign countries mainly focused on the genetic disorders (such as the degree of joint SCID, ADA deficit disorder, immune deficiency disease, etc.), cardiovascular disease, cancer, AIDS, hemophilia and cystic fibrosis (CF), but clinical results show that the current gene therapy to ADA only curative effect is distinct, as for diabetes, hemophilia and cystic fibrosis (CF) replacement therapy have certain curative effect. Gene therapy caused a revolution of clinical medicine, as there is no ideal treatment of genetic disorders, most of the important viral diseases such as hepatitis, AIDS, etc.), malignant tumors, such as opened up broad prospects, with the advent of "genome" after, gene therapy may be before the 2020 s as one of routine treatment on clinical medicine.
    Low tt content and the technology of animal and plant varieties. After 20 years of development, biotechnology has from the narrow sense of recombinant DNA technology extended to more wide range of areas, human have already master the use of biological molecules, cells and the technology for production of drugs and animal and plant varieties of genetics.
    Third, the biological medicine industry in our country present situation and development prospects
    (a) industry status quo
    Biotech drugs research and development in China started late, it was not until the early 70 s began to recombinant DNA technology is applied to the medicine, but in the country industrial policy, especially the national "863" high technology program), under the support of this area developed rapidly and gradually shorten the gap with advanced countries, product from scratch, some we have basically done abroad, there are 15 kinds of genetic engineering drugs and some kinds of vaccine approved, otherwise a dozen genetic engineering drugs are in clinical validation, about dozens of also in the development. Domestic development production and marketing of genetic engineering drugs, broke the biological products abroad long-term monopoly in China the situation of clinical drug use. At present, the market share of domestically-produced interferon alpha has been more than the imported products. Pioneered in China and has set up a new type of recombinant human gamma interferon has the ability to transfer technology and contracted projects abroad, is developing a new generation of interferon.
    As domestic biological drugs listed in succession, the domestic pharmaceutical enterprises not only in infrastructure, particularly in the upstream, pilot and foreign gap, emerged a large number of strong technical strength of enterprises. Implement GMP management of pharmaceutical production enterprises in China, recently there has been a formal production approval document of the enterprise, is in accordance with the requirements of international standards for GMP certification, there are four through the scene of the GMP certification, through the GMP certification enterprises in the aspect of software and hardware and a higher level, is not only beneficial to product sales, but also to develop international market products. Around the country more than 80 genetic engineering product development research unit. From upstream, pilot, is trial production process of a large number of practice, accumulated rich experience, the backbone of the cultivating and training a large number of engaged in biotechnology, for our country in the 21st century biotechnology development, participate in international competition has laid a good foundation.
    At present, the domestic market of domestic biotech drugs mainly genetic second liver vaccine, interferon, interleukin - 2, g-csf (whitening cells), recombinant streptokinase and restructuring the epidermal growth factor, 15 kinds of genetic engineering drugs. T - PA (soluble fiber original activator), interleukin - 3, recombinant human insulin, urokinase and so on dozens of polypeptide drugs for clinical Ⅰ, Ⅱ period test, monoclonal antibody by experiment in clinical, hemophilia B gene therapy has been preliminary clinical therapeutic effects of genetic disease gene diagnosis technology reached the international advanced level. Recombinant chymosin 40 kinds of genetic engineering drugs such as the ongoing development research. According to the relevant departments of the prediction of future biotech drugs in China an average annual growth rate of no less than 25%, to 2000 total output value of 54-7.2 billion yuan, the profit can be up to 16, 2.6 billion yuan. Can be seen from the above data, the biological medicine industry in our country's market potential, market expansion speed faster, promising prospects.
    Biological medicine industry in China developed rapidly, but there are serious problems, the prominent problems in research and development strength is weak, backward technology level; Project redundant construction is serious; Enterprise scale is small, poor equipment and so on several aspects. Due to a serious shortage of biomedical research funding in our country, the industry investment in 98 to more than 40, one hundred million yuan, equivalent to the biological medicine companies in the United States to develop a new drug investment), laboratory equipment, directly restricted the ability of scientific research institutions to develop new drugs. Manufacturers want to secure at the same time, do not take the research and development investment, don't pay attention to the training of the ability of independent development of new drugs. At present domestic most of the genetic engineering drugs is generic and abroad to develop a new drug to 5 to 8 years, the average cost of $300 million, and only several million yuan to the generic a new drug, five years; Plus the added value of biotech drugs is quite high, such as PCR diagnostic reagent cost only 10 yuan, but the market is to sell more than one hundred yuan, so many enterprises (including pharmaceutical companies) have on biomedical projects, caused the phenomenon of the same product production and a number of repeat. Such as interferon production enterprises more than 20. EPO has more than 10, the interleukin 10 or so, blind repeat production will likely lead to a vicious competition. Although there have been more than 200 biotech pharmaceutical company in China, but the real obtained the genetic engineering drugs production document number less than 30. Only two companies with annual sales of more than 1998 100 million yuan, only more than 10 sales across thousands of manufacturers, the rest of the company's sales in millions of yuan to ten million yuan, all kinds of interferon combined sales of 500 million yuan or so, though. The national production of genetic engineering drugs company total sales is less than the us or Japan a medium company annual output value. Enterprise scale is too small, can't form scale economy to participate in international competition.
    (2) the "wto" the potential impact of biopharmaceutical industry in China
    Opening to the outside world gradually thorough along with our country market, pharmaceutical companies in the developed countries abroad through to our country direct export drugs or wholly-owned factories, joint venture holding a variety of ways, such as "into" pharmaceutical market in our country. Imported drugs in the sharp rise in Chinese medical market share. At 11% in 1993, in 1998, accounts for more than 40%, and with the reduction of tariffs on imported drug varieties and quantity also will increase further, "the medicine" the influx of will severely impact the young Chinese biopharmaceutical industry. In addition, with China's accession to the WTO is approaching, the intellectual property rights protection will become a heavy yoke which restrict the development of the biological medicine company in China. The potential impact of wto on Chinese bio-pharmaceutical industry mainly displays in:
    1, the impact of biological medicine imports. From the perspective of import tariffs, the preparation and drug import tariffs for 20%; "Wto", after 10 years will be reduced to 6.5%. At present our country's biological pharmaceutical enterprise scale economic benefit can't compete with foreign companies, once the wto, the domestic biological pharmaceutical enterprises will lose competitiveness by the tariff policy under protection. Faced with such serious challenges, biological pharmaceutical industry in our country can't pessimistic passively waiting for the "Wolf", but should grasp the opportunity. Objectively speaking, research on biotechnology, China did not start late, the international breakthrough, a number of biological technology in the laboratory stage in our country with international level close to and even some technology leading international level, but biotechnology industrialization level is very low. Biological pharmaceutical industry should take advantage of China's scientific research, the path of combining "production", the project to raise funds through various channels, increase the risk of science and technology investment, strengthen the technical reform and innovation ability, attaches great importance to the development with independent intellectual property rights of high-tech bio-pharmaceutical new products.
    2, direct access to the impact of the foreign-capital enterprise. Many biological pharmaceutical companies in the world are directly or indirectly into the market in our country, they will not only own approved drugs rapidly to registered in China, at the same time the production line to build production in China, some clinical trials of new drugs development will be moved to China to complete, this will pose a threat to domestic related enterprises. Biological engineering pharmaceutical imports in 1996 was $190 million, accounting for 60% of the domestic market, in 1997 was $145 million, accounting for 40% of the domestic market, although the amount and proportion fell, but wholly owned or joint venture in China increased significantly, they rely on funding and technology advantages, to our country is developing the biological industry has a huge impact. After joining the WTO, this phenomenon will be intensified.
    3, the impact of the new drug development abroad. Biological pharmaceutical is a new industry which needs high investment, the United States in 1997 to biological engineering risk investment has more than $50 billion, and additional investment in more than $5 billion a year. In biomedical research in China on a serious shortage of funding, extremely lack of competitiveness on the research of new products, new drug development process is slow. In foreign countries, the development of a genetic engineering drugs will need to cost $one hundred million or more, and more than ten years in our country of biopharmaceutical total investment is less than 10 billion yuan. After China's accession to the wto, China's biopharmaceutical companies will continue to impact of new products abroad, also is a kind of new drug development, once the foreign competitors beat declare drug patents, will make the early development of domestic investment.
    4, foreign companies the advantage of market development. A genetic engineering drugs market development takes a long time and a lot of money. Due to the European and American companies strong financial strength, which can be large sums of money on market development, a lot of products publicity, and can be in for a long time without profits continue to survive, it is unmatched by Chinese firms.
    5, the intellectual property rights disputes. Due to China's national strength is limited, the new drug research and development funding shortage, now in addition to the firm sinovac biotech companies interferon, most of the genetic engineering drugs are domestic product imitation and come, it will great crisis lurks. On the one hand can't export, sale in domestic market. Generic production, on the other hand, the practice of foreign patent products will be limited, some products may even encounter the problem of property disputes. As foreign high-tech products in the domestic patent application, more and more European and American countries to apply for a patent in China, such as EPO, gm-csf, TPA, EGF, etc. China will one day join gatt, sooner or later admitted to the national patent, at present a large number of generic genetic engineering drugs can cause a lot of litigation. Large foreign pharmaceutical companies are eyeing, aimed at the nation's largest enterprises laid hands on him, if lost, is the greatest loss is a production enterprise. Such as a pharmaceutical investment about 100 million yuan, the development of human growth hormone secretion type, products haven't listed by the United States as a blacklist of prosecution.
    (3) the direction of biological medicine industry development in our country
    Given biological medicine in our country the current situation and national conditions, the development of our country must closely track biological medicine developed abroad the latest developments, closely around the establishment of new industries and traditional industries of biotechnology modifications to the development of biotech drugs in China, in particular to strengthen the advantage and resource advantage of science and technology projects in our country, strengthen the ability of technological innovation, innovation and product innovation, gradually formed the advantage technology and advantage in the field of biomedical products. Specifically, the future development of China's biological medicine should be around the following aspects mainly:
    "Chinese herbal medicine and its effective fermentation production of biological active ingredients. Chinese herbal medicine after fermentation, enzymatic, its effective ingredients can be fully separation, extraction, make it more bioactive, and contains a lot of active enzyme, can be absorbed by human body tissue cell rapidly, after taking to illnesses, fitness, two-way adjust the immune function, better play a role of the natural medicine efficacy of Chinese herbal medicine. Therefore, the application of modern biological technology of large-scale industrialized extraction of Chinese herbal medicine effective biological active ingredients, development with Chinese characteristics net t scene wide pharmaceutical biotechnology industry.
    Low antibiotic technology. All kinds of drugs in current antibiotic dosage the biggest, should study using gene engineering and cell engineering technology and the method of combining the traditional production technology, breeding good strains, study and use for mass production as soon as possible - table toxin acylation enzyme fixed technology process semisynthetic table. To speed up the application of modern production technology in the production of high-efficiency, broad-spectrum antibiotics.
    Low to develop vaccines and diagnostic reagents. This aspect has certain base in our country, development is focused on hepatitis b gene vaccine and monoclonal antibody diagnostic reagents.
    Low activity of protein and polypeptide drugs development. This aspect of the development is focused on interferon, hormone and T - PA, etc.
    Development of targeted drugs, focusing on the development of tumor drug. At present there is a so-called tumor drug treatment "against both" problem. At the same time of killing cancer cells, also kill normal cells. Guide treatment is aimed at the question to ask. So-called guide treatment is to make use of antibodies to find targets such as missile navigator, introduce the medicine accurate lesions, and not hurt other tissues and cells. What sea medicine development of antineoplastic drugs "paclitaxel injection" belong to this kind of drugs. It has been launched in July 1998 formally.
    Low development of amino acid industry and development of steroid hormones. Application of microorganism and enzyme immobilization technology development process of amino acid industry and development of steroid hormones, and to modify the traditional production process now.
    The research and development of low humanized monoclonal antibodies. Antibodies against all kinds of pathogens, can be as a guide, but the current of monoclonal antibodies, for rat source antibody, after injection of the human body will produce antibodies (resistance) antibodies or stimulate immune response. Current research abroad has phage antibody technology, chimeric antibody technology, genetic engineering antibody technology to solve problems on study of humanized anti-platelet antibody.
    The research and development of low blood substitutes. Blood products is made use of pooled human plasma and to avoid due to human blood pollution by all kinds of pathogens, such as HIV and hepatitis b virus (HBV), through a blood transfusion and make the patients infected with AIDS or hepatitis b cases occurred frequently, so the use of genetic engineering to develop blood substitutes. Shanghai hai dhi biological engineering co., LTD. Has developed to study the serum albumin gene engineering, 3 system success benefit patients.
    When the human genome research. Human disease is two reasons, one is outside the invasion of the pathogen, 2 it is physiological function disorder. Whether can resist pathogens, the human body has a stable good physiological states are related to gene regulation, the study of human genes, will discover new pathogenic or resistance genes, genetic passwords can be built in artificial, certain gene product can be developed as a drug. About 100000 genes, the human body is composed of 3 billion nucleotides, the United States for 15 years since 1991, the complete human genome sequencing project at a cost of $3 billion. So far have been cloned human genes is less than 4000, accounts for only 3-4% of the human genome. The study of the human genome will lead to a lot of new drug development. Can be expected, in the 21st century from the human genome looking for developing all kinds of new drugs will be a very exciting feat.
    Four, the rise of biological medicine industry to our enlightenment
    Biological pharmaceutical as biological engineering research, development and application of the most active and fastest progress in the field, is recognized as one of the most promising industries in the 21st century. Listed companies as a group, the most dynamic companies in the country has been an enabler of industrialization of scientific and technological achievements and active participant, in this emerging bio-pharmaceutical industry is no exception. At present, our country involved in the field of biological medicine more than forty of listed companies, but the real biological engineering pharmaceutical as the main business rarely, only the temple of heaven biology, golden flower co, fosun industrial, haiwang biology, such as a few, most of the rest of the company is still in the original traditional business as its main business, biological medicine constitute only a small proportion of its business, some are still just involved in the industry. Many of these companies is through mergers and reorganization towards in the field of biological pharmacy.
    The rise of biological medicine on a global scale, the domestic listed companies active in this emerging industry has given us a lot of enlightenment.
    First, we should develop high technology level, workshop equipment is advanced, and have the patent right of biological pharmaceutical companies to focus on investment. Biopharmaceutical company a few years ago with software companies in the us stock market led coquettish, make countless millions of millionaires. Recently, with the great progress of human gene technology, continuously of new gene drugs, biological pharmaceutical companies in the us stock market and scenery, attracted a large number of investors, is expected to be together with network company became the new one thousand is the most popular stocks. Biological pharmaceutical company in China is not only listed later, quantity is little, and never for a long time in the stock market "appearance", the fundamental reason is that investors are concerned about our country once "wto", the domestic pharmaceutical companies will be subject to import pharmaceuticals and similar foreign companies about "intellectual property" infringement prosecution. Investors worry that it is the weakness of the biopharmaceutical companies in China. But if is to abandon the "bright future" in the field of investment is not the right thing to do, we can find, mining companies that have the patent right, proprietary intellectual property rights, especially the biological technology to extract of Chinese herbal medicine effective active ingredient of the listed company to carry on the key investment.
    Second, investment banking should be the key to cultivate the biological medicine companies and mining, and recommend the listing. In October last year, the central in the "on strengthening technological innovation, the development of high-tech, realize the industrialization of decision" explicitly puts forward, to "give priority to support conditional high-tech enterprises to enter the domestic and international capital markets,". Securities regulators have repeatedly stressed that the securities market should be further support of new and high technology enterprises, for qualified, will not be restricted by lines, number, granting priority listing. At the same time, the "high-tech listed companies because of the development of high-tech projects in urgent need of money, give priority to in pilot issuance scope; high-tech listed company to declare a rights issue, the yields and a rights issue two intervals of time and amount of rights constraints can be considered appropriate to relax. Part of hi-tech listed companies to raise funds, on the premise of full disclosure, allowing for intermediate test and risk investment." Can be seen from the above "decision", including biological medicine high-tech companies listed on the issue, a rights issue and issuance prior to the company in general. In order to improve the business efficiency, the company investment bank staff looking for and train project should have the consciousness, focused attention to biological medicine such as high-tech enterprises.
    Third, actively help the good quality, high technical level of biological pharmaceutical companies implement "backdoor listings". At present, more than 40 biopharmaceutical class most of the listed company is through the assets reorganization to biomedical fields, after the "entry" is likely to draw lessons from this way, what's more, high and new technology enterprise through asset replacement, equity transfer, merger and acquisition "backdoor listings", indirect entering the securities market is encouraged by the state industrial policy. Can "decision" points out that the "high-tech enterprise through restructuring methods such as holding listed companies, the implementation of asset replacement and change its main business". Moreover, with the continuous development of China's securities market, asset restructuring will become one of the important business of brokerage, investment bank. Our company do business of asset restructuring can key planning bio-pharmaceutical and other high-tech enterprises, in order to improve the survival rate of the project.
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