Biopharmaceutical is a modern bioengineering based on genetic engineering, that is, using modern biotechnology to cut, connect and transform DNA to produce biopharmaceuticals that are difficult to obtain by traditional pharmaceutical technology. Modern biotechnology is a high-tech with genes as the source, genetic engineering and genome engineering as the leading technologies, and other high technologies. Bill Gates predicts that the next richest man may be an investor engaged in biotechnology.
The current situation of biopharmaceutical industry, the leading technology in the United States Since the first genetically engineered drug went on the market, biotechnology has become a new economic commanding height in developed countries because of its unique role in solving difficult human diseases. Since then, 53 kinds of genetically engineered drugs and vaccines have been listed in the United States. At present, there are 369 biotechnology products used in clinical trials of more than 200 diseases, including 175 drugs or vaccines for cancer and related diseases. Among them, 20 biotechnology products have been applied for marketing in the United States, and 107 is conducting or has completed clinical trials. Biotechnology products developed in the United States for diseases other than cancer include: infectious diseases (39), neuropathy (2), heart disease (26), respiratory diseases (22), AIDS//HIV infection and related diseases), autoimmune diseases (19), skin diseases (19) and transplantation (650). Other diseases that can be treated with biotechnology drugs include obesity, urinary incontinence, schizophrenia, osteoporosis, hyperparathyroidism, endometriosis, benign prostatic hyperplasia, chronic liver failure, mucositis, stagnant venous ulcer and partial hepatectomy. Fracture, periodontal disease, shock, acute liver failure, acute infectious polyneuritis (Ku- Barre syndrome), mucositis and trauma. Innovative biotechnological products currently under clinical research and development: ① Genentech's anti-vascular growth factor (VEGF) for colon cancer and non-small cell lung cancer (dish-level clinical trial); ②Dendreon's dendritic cell immune preparation, used in M-phase clinical trials of prostate cancer); ③ Dendritic cell immune preparation of ③GenvZme Company, used in dairy farm (1 clinical trial) and melanoma (two-cycle clinical trial); Onyx-015 @ onxx/$ TERM Lambert Company' s tumor inhibitor gene therapy for head and neck cancer (phase I clinical trial); ⑤ humanized monoclonal antibody against IgE, from ⑤ Genetech//Novartis//Tanox Blo Systems, used for asthma (clinical trial in dish stage has been completed); (3) PRO542； from ③Progenics Company for HIV; ① Pegasre, pegylated interferon from Roche Company, used in clinical trials of hepatitis C mM); ③ Recombinant human parathyroid hormone, produced by NPS Pharmaceutical Company, was used for osteoporosis (Phase Ⅱ clinical trial); ③ Somatopkin, an immune system enhancer, comes from ③CeltriX Pharmaceutical Company and is used for severe burns (completed 1 1 clinical trial); Onxn, a relaxin protein from @ @onnetics, comes from A6G6nix Company as antibody ABX—ILB, and its hardness (I/M clinical trial) is VIII 1 1. For psoriasis (liP clinical trial) PhRMA 1988. At the time of the first biotechnology survey, only a few products were in the clinical trial stage, but when the survey was conducted in February this year. "The sales of biotechnology products in the United States was $5.8 billion in 199 1 year, $0.8 billion in 1996, and reached $500 billion in 2000. At present, there are more than 1 140 companies engaged in biotechnology research in the United States alone, more than 800 in western Europe and more than 800 in Japan. Europe and Japan are also areas where biotechnology industries are developing rapidly. Among them, the sales of biotechnology products in Japan were only 264.8 billion yen in 199 1 year, 655.2 billion yen in 1996, and 0.0433 billion yen in1996. 2. China increased investment and entered the development stage. China's biopharmaceuticals began in 1970s, and entered the development stage after 1990s. Especially in recent years, great progress has been made, and a large number of biological products have obtained the production approval number (see the table below). Among them, five kinds of biological products were approved in the first half of 2000, namely: Serratia marcescens vaccine for treatment (trade name: Leishuning), recombinant human basic fibroblast growth factor for external use (trade name: Fudifu) (two kinds, different applicants, different specifications), freeze-dried recombinant human epidermal growth factor for external use and recombinant B subunit tumor cholera vaccine for oral use (enteric-coated capsules). At present, a number of biopharmaceutical bases with large investment have been built, mainly including chgb. Since its establishment, the Center has cooperated with domestic scientific research institutes, research institutes and universities to develop new cytokines of human fetal liver, locate and clone susceptible genes of type H diabetes in China, clone genes related to cardiovascular diseases, screen and develop gene drugs, large-scale sequencing of CDNA related to the development of central nervous system, research on susceptible genes of mental and nervous system diseases, and essential genes of hereditary breast Koga. At present, 348 new genes have been found in liver and human thigh and brain, and 13000 ESTs and 10 new genes have been patented. Huianke Company: This company is a high-tech enterprise specializing in the research, development and production of genetic engineering drugs. International advanced biotechnology products such as affinity chromatography gel of monoclonal antibody against human interferon A, recombinant human interferon db and recombinant human growth hormone have been developed successively, which have filled many gaps in China, successfully realized industrialization and produced huge economic benefits. At present, the national first-class new drug "recombinant staphylokinase" being developed by the company has completed all the research and development of new drugs and will soon enter clinical trials. Shandong Dong 'e Ejiao Group: The research on biopharmaceuticals began in 1995, and in 1998, the recombinant human erythropoietin (EPO), a world-class high-precision technology product, was successfully completed, which was used to replace blood transfusion for renal anemia and various anemia. Experts and authorities agree that EPO developed by Dong 'e Ejiao Group is in a leading position in China in terms of internal quality and production technology, and its cell expression is also world-class. Subsequently, the company started with EPO, and successively invested heavily in developing three new genetic engineering drugs, such as interleukin -fi, which increased platelets, forming a high-tech product group in the enterprise. It is estimated that within three years, the company will develop into the largest genetic engineering pharmaceutical base in Shandong Province, and at least six genetic engineering pharmaceutical products will be listed. Yunnan University Biotechnology Co., Ltd.: The series of products produced by the company using monoclonal biotechnology-"safe period" contraceptive test paper, eugenic test paper and female infertility test paper have been officially put on the market in large quantities. Kunming Hi-tech Industrial Development Zone has invested and built a domestic first-class production line with a daily output of 80,000 test papers. Hangzhou biopharmaceuticals: At present, there are 15 pharmaceutical enterprises with modern biopharmaceuticals development capability in Hangzhou, which have successively developed and introduced more than 20 high-tech products, directly creating economic benefits of nearly 10 billion yuan. Some of these achievements are at the leading level in China. According to relevant sources, more than 10 new products will be put into production in Hangzhou this year, which is expected to bring an output value of nearly 10 billion yuan. Shenzhen Kexing Biological Products Co., Ltd.: The company invested 700 million yuan to build the largest bioengineering industrialization base in Asia-"Peking University Biological Valley" in Shenzhen. Peking University Bio-Valley is a Industry-University-Research base jointly built by Shenzhen Municipal Government, Peking University and Hong Kong University of Science and Technology. Its main projects include genetically engineered interferon and genetically engineered insulin. Lihu Technology Co., Ltd.: The company mainly invests in gene chips, and the company will invest 250 million yuan to set up Shanghai Boxing Gene Chip Co., Ltd. It is reported that Boxing Company will make full use of the existing gene chip technology and resources to produce, manage, develop and serve gene chip products such as gene expression port chips, commodity detection chips, disease diagnosis chips and chip laboratory systems. Zhejiang Qinghe Biochemical Co., Ltd.: Invested 65.438+0.36 billion yuan to build a "Qinghe Biochemical" bioengineering project-the development of Ritele Gan Bao capsules and bitter gourd series products. This project is a newly-built high-tech bioengineering, and its products can be used as bear bile substitutes for series development. Jilin Dongsheng Pharmaceutical Co., Ltd.: After the company is completed and put into production, it mainly produces biological products, immune products and biochemical products. It is estimated that the annual sales will reach 65.438+0.2 billion yuan and the profits and taxes will reach 50 million yuan. At the same time, the company will continue to produce domestic first-class new drugs such as "specific anti-rotavirus immunoglobulin enteric-coated microcapsules", which represent the international advanced level and fill the domestic gap. Qingdao will build an international innovative Bio-Valley and Life Science Research Institute: It is understood that Bio-Valley will follow the modern enterprise system, adopt a capital operation mode, vigorously promote the transformation of scientific and technological achievements, pay attention to mechanism innovation, improve the entrepreneurial environment, and eventually become an internationally renowned bio-science research and development and industrialization base. Tianjin will build a national stem cell genetic engineering industrialization base: the "base" has officially settled in Tianjin Huayuan Industrial Park, and it is expected that the largest stem cell bank, stem cell transplantation center and related scientific research infrastructure in China will be built within three years. Harbin Institute of Technology Gaoxing Technology Industry Development Co., Ltd. cooperates with Harvard to develop good drugs. There are two cooperative projects: one is a psoriasis gene drug therapy project with an investment of180,000 yuan, which is jointly developed by Harbin Institute of Technology, School of Life Sciences of Harvard University and Boston University. The second project is to invest 65.438+0.6 billion yuan to build the life science park of the University of Technology.
At present, the question-and-answer investment model of biopharmaceuticals in China is not conducive to the development of biopharmaceuticals industry. The great economic benefits of international pharmaceutical industry come from innovation. The modern biomedical industry in developed countries has its own powerful research institutions, and the annual investment usually accounts for %-20% of the total sales, while the annual R&D investment of biopharmaceuticals in the United States accounts for 60%-70% of the total investment. Every large pharmaceutical company has its own "fist product", and the annual sales of a single product can reach one billion to several billion yuan. The company owns the intellectual property rights of these products, and the state gives them patent protection. Production and occupation can monopolize the market in 10 years or longer, a product can win huge profits, and then huge funds are invested in the research and development of innovative new drugs with intellectual property rights, forming a virtuous circle again and again. From the perspective of the development model of biopharmaceuticals in the United States, the key to the healthy development of biopharmaceuticals industry is the organic combination of technological development and innovation by small expert biotechnological companies with strong technical strength, industrialization of biotechnology by large pharmaceutical companies through strategic alliances, and financial support provided by venture capital for biotechnological development. Judging from the current biopharmaceutical industry model in China, production is mainly realized by purchasing technology, with insufficient venture capital mechanism, too little capital and weak technological innovation. Therefore, it is difficult for the biotechnology industry to form a climate. China's pharmaceutical enterprises are small and scattered, and most of them do not have the ability of technology development and innovation. The products produced are basically imitation products, and the phenomenon of repeated development investment is also very serious. Vicious competition will inevitably lead to inefficiency. China's drug imports are increasing year by year, and the product sales of foreign-funded enterprises are also increasing year by year. A foreign research report pointed out: "If the government does not intervene, China's pharmaceutical market will be completely manipulated by international pharmaceutical companies within five years." 2. Low-level repeated research and repeated construction are serious, and the market competition is fierce. The broad prospects and rich profits of biotechnology products have attracted many domestic enterprises to develop them, but most of them are copied from abroad, with few varieties and many manufacturers, and repeated investment in construction at the same level. For example, 18 companies develop rhuG—CSF. According to statistics, only 1996- 1998 has 10 recombinant human interleukin-2 (L -2 (L-2) and 10 recombinant human erythropoietin (EPO). This will inevitably lead to waste of resources, price suppression and market chaos. Moreover, due to the lack of product market investigation and analysis, some enterprises accumulate a large number of products, which leads to the low utilization rate of complete assembly line equipment with high investment price, and some of them have an annual utilization rate of less than one month. The price war in turn caused the quality of products to decline, and counterfeit and shoddy products flooded the market. Consumers have low trust in domestic biotechnology products and prefer to use expensive imported products. In addition, the disconnection between scientific research and industry is still serious. At home, the research purpose of scientific research institutions is to follow up the development of international advanced science and technology, and the research direction is too focused on the upstream technology development of several popular varieties, but few projects can be industrialized. In foreign countries, after the scientific research results are completed, they fall into the R&D center of the enterprise for further incubation, forming a technical process, and then mass production, which is seriously out of line in China. The lack of entrepreneurs with scientific minds and enterprises with technological development capabilities to turn research results into production has greatly hindered the development of industrialization. 3. Low market development ability. Due to the backward production technology and management methods, the domestic market will face the impact of imported drugs. The specific manifestations are as follows: First, the efforts to open up foreign markets are not enough, and many enterprises are not well positioned in the market; Second, the investment in developing the market is insufficient; Third, although the good clinical effect of biological drugs has been affirmed by medical staff and patients, their prices are relatively high and their consumption capacity is insufficient. Therefore, China needs to further increase investment in biopharmaceutical industry and deepen the mechanism reform of industrialization of scientific research achievements. In this process, the capital market and venture capital companies should play an active role.
The influence of China's entry into WTO on biopharmaceuticals: biopharmaceuticals are knowledge and capital-intensive industries; Therefore, the negative impact of China's entry into WTO is also great. 1, the impact of foreign new products. After China's entry into WTO, the import tariff rate in 10 will be reduced from 20% to 6.5%, and the price of imported products will drop, so the price advantage of domestic products will no longer exist. In addition, China's capital investment in biopharmaceutical research is seriously insufficient, and it is very competitive in the research of new products. Therefore, China's accession to the WTO will continue to be impacted by new foreign products. 2. The imitation of foreign patented products will be restricted. At present, almost all bioengineering drugs in China are imitations, and the export of some products is restricted. Therefore, China's accession to the WTO will not increase the export of these products, and the practice of copying foreign patented products will be restricted, and intellectual property disputes may also occur. 3. Direct entry by foreign companies. After China's entry into the WTO, it will surely participate in international competition. Foreign enterprises with abundant funds and strong technological innovation ability will flood into China, which will have a great impact on China enterprises. Many biopharmaceutical companies in the world have directly or indirectly entered the China market. In 196, the import value of biomedicine was1900 million US dollars, accounting for 60% of the domestic market, and in197, it was 345 million US dollars, accounting for 40% of the domestic market. Although the proportion has declined, with the increase of domestic or joint ventures, they rely on the advantages of capital and technology. In addition, many international pharmaceutical companies not only registered their approved products quickly in China, but also established production lines in China, completed clinical trials in China and established research centers in China. At present, the most powerful 16 enterprises in China have established their own research institutions in Beijing. If we don't speed up the research and development of innovative products with independent intellectual property rights and great market potential, strengthen the ability of technology incubation and realize industrial production quickly, Chinese biopharmaceutical enterprises will face great difficulties in participating in international competition. 4. Advantages of foreign companies in market development. It takes a long time and a lot of money to develop a new genetically engineered drug. Due to the strong financial strength of European and American companies, they can invest huge sums of money in market development and do a lot of product promotion, and they can continue to survive in the long-term unprofitable situation, which is incomparable to domestic enterprises. There are also some companies whose export share is already very large. It is estimated that China's accession to the WTO will not have much positive or negative impact on them.
Brave biomedical industry has the characteristics of high technology, high investment, long cycle and high risk. Although China's biomedical industry has developed rapidly, the problems are serious, which are manifested in weak R&D strength and backward technical level. The phenomenon of repeated construction of projects is serious; Small-scale enterprises, backward equipment and so on. Although there are more than 200 biotechnological pharmaceutical companies in China, less than 30 companies have actually obtained the production numbers of genetically engineered drugs. The total sales of companies producing genetically engineered drugs in China is less than the annual output value of a medium-sized company in the United States or Japan. The scale of enterprises is too small to form economies of scale to participate in international competition. Therefore, investment in talent and technology market should be increased in the future. L, training scientific research and development decision-making and management personnel: In the knowledge economy, people will truly become the most active factor, and the combination of people and technology will surpass the production factors such as capital, equipment and land, and become the most important competitive weapon in the new century. Bio-pharmacy is a knowledge-intensive industry, which requires higher talents and their quality. We should not only pay attention to cultivating the scientific research level of new drug developers, but also improve the decision-making level of new drug research and development. Management level. It is necessary to raise the decision-making and management level of new drug development to the same level as the technical level. 2. Meet the international standards and shorten the research and development time: China's biopharmaceutical technology development is still in the research and development stage, with a gap of about 5 years compared with advanced countries, while the gap between manufacturing and production is about 10 year. However, the gap does not mean that there is no opportunity. When talking about this topic, Lou Dan, chairman and president of Shenyang Sansheng Pharmaceutical Co., Ltd. said that Sansheng saw the huge gap between the domestic R&D capability and the international modern biotechnology level very early, so they turned their attention to international cooperation and set up an R&D center in the United States, which benefited Sansheng Company a lot. When the company independently developed interferon and interleukin -2 in China, it took 9 years and 1 1 year respectively, while the American Sansheng R&D Center successfully developed recombinant erythropoietin, which took only 4 and a half years. Thrombopoietin, a national first-class new drug being developed by Sansheng, goes hand in hand with the research and development process in the United States. 3. Introduce venture capital and participate in market competition: Venture capital has played an extremely important role in the development of biotechnology industry in all countries of the world. Mr. Zhang Xiaojun, Vice President of Beijing Science and Technology Venture Capital Co., Ltd., when analyzing the prospect of China's biomedical industry, thinks that China's R&D strength is very weak compared with developed countries, which is creating good opportunities for venture capital intermediaries. At the same time, he pointed out that the competition among enterprises in the future is the competition of technology, speed, responsiveness and large-scale operation. New products developed by enterprises must enter the market quickly and make profits before they can be transformed into productive forces. The development of high-tech technology determines that a product will be quickly eliminated if it cannot enter the industrial operation in time. Therefore, marketing ability may also become an obstacle to the industrialization of biomedical industry. Internationally renowned biotechnology companies have been groping in the market for decades, and a product can achieve billions of dollars. The traditional management mode of domestic pharmaceutical companies making their own medicines and selling them themselves will face failure. It is an inevitable trend to "outsource" the non-growth links of their own enterprises and realize strategic alliances with venture capital companies. 4. R&D direction: The R&D direction of China's biopharmaceutical industry should be combined with the advantages of traditional medicine, and the development focus should be on the peptides, protein and nucleic acids of major diseases such as nervous system, tumor, cardiovascular system, AIDS and immunodeficiency. Research and development of hepatitis B gene vaccine and monoclonal antibody, research and development of blood substitutes, and application of biotechnology in medical field, such as gene therapy, bio-human gene chip, stem cells, etc. As a country with a population of 65.438+0.2 billion, the population of China is increasing by 65.438+0.7 million every year. In 2000, the population over 60 years old reached about 654.38+0 billion, which provided a huge market demand for the development of biopharmaceuticals in China. Therefore, biopharmaceuticals have broad market prospects in China: first, with the reform of drug management system, the OTC market and rural market have good prospects; Secondly, compared with the production of chemicals and APIs, biopharmaceuticals have unique technical barriers; Thirdly, once the developed new drug is recognized by the market, it will bring huge economic benefits to the producers in its life cycle. At present, China has formulated a clear biopharmaceutical industry development plan and industrial technology policy, and the government supports biotechnology research and development from top to bottom. The attention and capital investment of major domestic enterprises (including private enterprises) on biotechnology; China's financial sector actively participates in the development of biotechnology industry, especially many powerful companies. At present, China's biotechnology industry has gathered a group of highly educated and high-quality scientists and entrepreneurs, all of whom were trained by themselves and returned from abroad. These four factors have played a very important role in the rapid development of biotechnology industry in China. Because the investment return period of biomedical industry is five to eight years, and China has only entered the field of bioengineering for a short time, and the return period has not yet arrived. It is predicted that the first few years of 2 1 century will be the harvest season of biopharmaceutical industry in China.