Abstract: By analyzing the present situation, advantages and influencing factors of new drug research and development in China, this paper expounds the future prospect of new drug research and development in China. Key words: prospect, advantages, influencing factors and opportunities of new drug research and development
Pharmaceutical research and development is a multidisciplinary, high-tech, difficult, high-input, long-term, high-risk and high-return industry. In terms of production capacity, China's pharmaceutical production capacity ranks among the top in the world, but China has fallen behind developed countries for 2 years in research and development. We should be soberly aware that at present, 97% of the drugs in China's western medicine market are imitation drugs. Among the main drugs that dominate the international market, there are almost no patented products from China. Therefore, it is necessary to study the development prospect of new drug research and development in China.
1. Current situation of new drug research and development in China
China's new drug research and development system is mainly composed of research institutes, universities, pharmaceutical technology development companies and R&D departments of production enterprises. By 27, there were 3 775 R&D institutions in China. National and some local scientific research institutes undertake all kinds of national key scientific and technological projects, and their development direction and technical strength are different, playing a leading role in the field of basic and applied research of drugs. The key laboratories of subordinate colleges and some comprehensive universities have also undertaken many national scientific research projects with their own characteristics, which are the main training bases for high-end pharmaceutical talents and an important part of the innovative drug research system in China. However, China's pharmaceutical industry has weak innovation ability and poor competitiveness in the international market. After decades of efforts and exploration, China's new drug research and development work has accumulated rich experience, established a large number of research institutions with comparable strength, and trained a large number of new drug researchers, laying a foundation for China's new drug research. At present, the research and development of new drugs in China is gradually in line with the developed countries. Scientific research institutes are paying more and more attention to basic research. Enterprises are gradually becoming the main body of new drug research and development, and the number of patent applications for new drug inventions is increasing every year. The research and development of new drugs in China has entered a new stage. But as far as the overall level is concerned, the research on innovative drugs in China is still in its infancy, and there is still a considerable gap compared with advanced countries.
2. Advantages of new drug research and development in China
2.1 The advantages of traditional Chinese medicine resources are unique
The new Dictionary of Traditional Chinese Medicine contains 12,87 kinds of traditional Chinese medicines, including 11,146 kinds of medicinal plants, 1,581 kinds of medicinal animals and 8 kinds of medicinal minerals. In recent years, the country has launched the GAP plan of Chinese herbal medicine, and a number of high-quality Chinese herbal medicine production bases have been formed. The investment cost of building Chinese patent medicine manufacturing enterprises is low, but the profit margin of products is huge. If a stable and controllable quality monitoring system and effective marketing strategies are adopted, the profitability will be fully reflected.
2.2 advantages of industrial agglomeration
China has established 54 national high-tech industrial development zones since March 1991, and on this basis, a number of new drug research and development parks including national biomedical industrial bases are being or have been established.
2.3 advantages of policy orientation
The Outline of the National Medium-and Long-term Science and Technology Development Plan (26-22) identifies "the creation of major new drugs" as one of 16 major science and technology projects. According to the overall arrangement of the "major new drug creation" project, China has invested 6.6 billion yuan to develop a series of innovative drugs for treating 1 major diseases such as malignant tumors and cardiovascular diseases.
2.4 unique advantages of clinical trials
The advantages of developing clinical trials in China include: diverse disease groups, easy selection, and easy to accelerate the trial process; Relatively low cost; Basically perfect hardware facilities required by the test; Well-trained medical staff; Standard Clinical Trial Practice (GCP) has been implemented on a large scale in China.
3. Factors affecting the research and development of new drugs in China
3.1 Lack of independent intellectual property rights
According to statistics, less than 3% of the drugs currently produced in China have independent intellectual property rights, and more than 97% of domestic drugs are generic drugs. Foreign pharmaceutical companies and joint venture pharmaceutical companies basically occupy the original drug research market.
3.2 Shortage of R&D funds
New drug research has the characteristics of high risk and long cycle, so developing a new chemical drug will cost 8-1 million dollars at present. However, only three out of every 1 new drugs on the market are profitable, and only one of them is profitable, and it often takes more than 1 years from drug screening to final product listing. Therefore, the research and development of new drugs has a high demand for funds.
3.3 Risk of R&D industry increases
The R&D expenses of new drugs have been increasing in recent decades. Relevant data show that 1/3 of NCE, which has completed Phase III I clinical trials as a whole, cannot be listed.
3.4 Poor awareness of intellectual property protection
According to statistics, more than 9 kinds of Chinese medicines have been patented by foreign enterprises.
3.5 Global R&D competition intensifies
The trend of world economic integration is becoming more and more obvious, and the asset reorganization and merger activities of the world pharmaceutical industry are very active.
4.
The development prospect of new drug research and development in China
4.1 The market demand is huge
The proportion of per capita medical consumption in China's per capita national income has basically stabilized at around 2% in recent years. Compared with other people, the drug use level of the elderly is 4: 1, and China is gradually entering the ranks of aging. With the natural population growth and population aging, especially the gradual improvement of people's living standards, China's pharmaceutical market will expand rapidly, and the potential market of 8 million rural people will gradually turn into a real market, which undoubtedly provides a broad space for the development of China's pharmaceutical industry.
4.2 Opportunities brought by China's entry into the World Trade Organization (WTO)
The principle of national treatment, one of the basic principles of WTO, is an opportunity for Chinese pharmaceutical enterprises to carry out transnational R&D activities abroad. Enjoy national treatment, which is convenient for enterprises to make full use of foreign markets, financial resources and intellectual resources. Developed countries and regions such as the United States help their pharmaceutical enterprises through preferential tax policies and financial support policies, which are determined in the form of law. If they enjoy national treatment, Chinese enterprises can also enjoy the same legal status in the United States. This not only brings new technology and R&D ideas and directions to domestic enterprises, but also cultivates local technical talents through cooperation with local R&D institutions.
4.3 The legal environment has been continuously improved
In recent years, China has gradually established and improved the laws and regulations on drug management. The newly revised Measures for the Administration of Drug Registration came into effect on October 1, 27, and the Supplementary Provisions for the Administration of Chinese Medicine Registration was issued on January 8, 28. On October 6, 28, the Notice of Re-soliciting Opinions on the Administrative Provisions on Special Approval of Drug Registration (Draft for Comment) was issued, and on April 16, 24, the Administrative Measures for the Certification of Quality Management Standards for Drug Non-clinical Research was issued. The promulgation and implementation of the above-mentioned laws and regulations have made drug research and production and drug registration management more standardized and scientific, which is of great strategic significance for the historical transfer and leap-forward development of China's pharmaceutical industry from imitation to innovation.