Biopharmaceutical technology can be said to be "rare things are precious". All people engaged in this job are very rich, earning at least 10 thousand yuan a month. Biopharmaceutical technology is difficult to imitate and industrialize, and the technical achievements are relatively few, accounting for less than 5% of the technical transaction volume. However, due to the high-tech content of its industrial achievements, it can bring huge social and economic benefits. Good biopharmaceutical technology projects have always been a rare "treasure" in the technology market, but due to the lack of independent intellectual property rights and other factors, the transaction is not active.
-Less variety? Less transactions? expensive
According to statistics, from September 2000 to September 2004, there were 0/08 biological products with approval number in China, but the main varieties involved were recombinant human interferon, recombinant human erythropoietin, recombinant human granulocyte colony stimulating factor, recombinant human interleukin and recombinant human growth hormone. The application for clinical research of new drugs 175 involves only the following varieties: split influenza virus vaccine, recombinant reteplase for injection (TPA) and recombinant human interferon β1b. There are 230 approvals for applying for new drug certificates and production approvals, but the main varieties included are human nerve growth factor, recombinant human basic fibroblast growth factor, recombinant human interleukin-1 1, recombinant human interleukin-2 and recombinant human tumor necrosis factor -NC. It can be seen that at present, the application of biopharmaceutical technology in China seems to be "active", but in fact there are few completely innovative technologies. Due to the lack of independent intellectual property rights and technical conditions, China's biotechnology market transactions are not active. However, due to the high technical requirements of new biotechnological drugs and high research and development funds, the technology transfer price of a single biotechnological drug is relatively high. According to Rui, director of China Medical Science and Technology Achievements Transformation Center, the technology transfer price of a clinical approval number of a new biological drug in China is about 6.5438+0.2 million-20 million yuan, and the transfer price of a new drug certificate is about 25 million-50 million yuan. However, the patent license price of a biological product from Europe and America in China is generally between 5 million and 6 million dollars.
-Industrialization and the widening global gap.
In China, biotechnology is unilaterally understood as the concepts of gene therapy, gene drugs or peptides, protein drugs and so on. However, the development of life science and biotechnology has brought about changes in the management and scientific model of pharmaceutical field, which has not been paid attention to in China. Rui Guo Zhong summarized three main modes of research and development of new biotechnological drugs and technology industrialization:
Mode 1: Government-led. In this model, the government is the main force to integrate or reorganize resources such as technology, capital and talents, and help to set up biopharmaceutical companies, so as to develop some promising projects and realize industrialization. Origin technology is generally the technological achievements of universities or research institutes under the government. These achievements are owned by enterprises in the form of technology transfer or technology shareholding, and the government can also directly combine some biotechnology research centers with modern enterprise management systems as needed to form a special organizational structure in which enterprises and research institutes coexist.
Mode 2: independent growth. This model means that enterprises in the industry start from venture enterprises, rely on their own core technologies and develop through closed companies and public companies. In Shanghai's biopharmaceutical industry, "returnees" and entrepreneurs from scientific research institutes are typical models of independent growth. The technical source of this model is generally the technical achievements obtained by entrepreneurs through years of research, and most of them have independent intellectual property rights. Mode 3: transformation type. This model means that some traditional pharmaceutical enterprises or non-pharmaceutical enterprises enter the biopharmaceutical industry through investment or technology introduction in order to find new growth space. Its corresponding technical sources are diversified and can be obtained through technical imitation, technology introduction, merger and acquisition of biotechnology companies and other channels.
Due to the lack of independent intellectual property rights in China's pharmaceutical biotechnology achievements, only a few biopharmaceutical companies in China have relatively mature technology and industrial development, such as Beijing Tiantan Bio, Shenzhen Kangtai Bio, Shenzhen Kexing, Changchun Jinsai, etc., with small industrial scale; However, due to the influence of technical conditions, it is difficult for some traditional pharmaceutical enterprises to quickly enter the biopharmaceutical field.
-R&D and three modes of industrialization of science and technology
By the beginning of 2004, there were more than 2,200 biotechnological drugs under development in the world, of which 65,438+0,700 had entered clinical trials and about 65,438+0,40 had been put on the market. It is estimated that more than 200 drugs will be put on the market in five years. Of the above 2,200 drugs, 80% are related to immunology and 50% are related to tumors. In contrast, so far, only 20 biotechnological drugs have been put into the market in China, 10 more than a few new biotechnological drugs are in the clinical trial stage, and more than 40 genetic engineering drugs are in the research and development stage. Compared with developed countries, the technological gap between biotechnology laboratories in China is not big, but the gap with the world in industrialization is gradually increasing: when there are more than 20 best-selling biopharmaceuticals in the world, China can produce 10; At present, there are more than 40 kinds of/kloc-0 in the world, and China can only produce more than 20 kinds.
Rui Guo Zhong believes that the main reasons for such a big gap are as follows: First, the technical level of China's biopharmaceutical industry chain is not balanced enough, and some technologies and equipment needed for industrialization are not up to standard; Second, the decision-makers in the industry are not strong enough in industrialization consciousness, and the management is not rich enough in experience in biotechnology industrialization; Third, due to the lack of high-investment and high-risk return mechanism, traditional pharmaceutical companies unfamiliar with biotechnology have insufficient confidence in entering the pharmaceutical field; Fourth, at present, China's patent ownership in the field of biopharmaceuticals is low, and imitation production is still the mainstay, lacking competitiveness; Fifth, the development of downstream engineering technology of biopharmaceutical technology in China lags behind the development of biotechnology and cannot meet the needs of industrialized production of biotechnology products. It can be seen that the domestic biopharmaceutical industrialization has not really formed a climate in China.