By analyzing the present situation, advantages and influencing factors of new drug research and development in China, the future prospect of new drug research and development in China is expounded.
Pharmaceutical R&D is a multi-professional, high-tech, high-difficulty, high-input, long-cycle, 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 lags behind developed countries for 20 years in research and development. We should be soberly aware that at present, 97% of the drugs in China's western medicine market are generic 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 mainly consists of four parts: scientific research institutes, universities, pharmaceutical technology development companies and R&D production enterprises. As of 2007, there are 3,775 R&D institutions in China. National and some local scientific research institutes undertake all kinds of national key scientific and technological projects, with different development directions and technical strength, and play a leading role in the field of pharmaceutical basic and applied research. 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 China's innovative drug research system. However, China's pharmaceutical industry has weak innovation ability and poor competitiveness in the international market. After decades of efforts and exploration, China has accumulated rich experience in the research and development of new drugs, established a large number of research institutions with comparable strength, and trained a large number of new drug researchers, laying a foundation for the research of new drugs in China. At present, China's new drug research and development is gradually in line with developed countries. Scientific research institutes pay 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. China's new drug research and development 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 has unique advantages in traditional Chinese medicine resources.
The new edition of the Dictionary of Traditional Chinese Medicine contains 12 807 species of Chinese herbal medicines, including1146 species of medicinal plants, 58 species of medicinal animals and 80 species of medicinal minerals. In recent years, the country has launched the GAP plan for Chinese herbal medicines, forming a number of high-quality Chinese herbal medicine production bases. The investment cost of building a Chinese patent medicine production enterprise is low, but the profit margin of the product is huge. If a stable and controllable quality monitoring system and effective marketing strategy are adopted, the profitability will be fully reflected.
2.2 advantages of industrial agglomeration
199 1 Since March, China has successively established 54 national high-tech industrial development zones, 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 Policy-oriented advantages
The Outline of the National Medium-and Long-term Scientific and Technological Development Plan (2006-2020) identifies "major drug creation" as one of the major scientific and technological projects of 16. According to the overall arrangement of the "major new drug discovery" project, China has invested 6.6 billion yuan to develop a series of innovative drugs for the treatment of malignant tumors, cardiovascular diseases and other major diseases.
2.4 Clinical trials have unique advantages.
The advantages of clinical trials in China include: diverse disease groups, easy selection, and easy to speed up the trial process; The cost is relatively low; The hardware facilities required for testing are basically perfect; Well-trained medical staff; Standard Clinical Trial Specification (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 research drug market.
3.2 Lack of funds
New drug research has the characteristics of high risk and long cycle, so it will cost a huge sum of 8-1billion dollars to develop a new chemical drug at present. However, for every 10 new drugs in the market, only three can make a profit, and only 1 0 is more profitable, and it often takes more than 10 years from drug screening to the final product listing. Therefore, the research and development of new drugs has a high demand for funds.
3.3 R&D industry risks increase
In recent decades, the cost of new drug research and development has been increasing. Relevant data show that, on the whole, NCE 1/3 that has completed Phase III I clinical trials cannot be listed.
3.4 poor awareness of intellectual property protection
According to statistics, more than 900 kinds of Chinese medicines have been patented by foreign enterprises.
3.5 global R&D competition intensified
The trend of world economic integration is increasingly obvious, and the asset reorganization and merger activities of the world pharmaceutical industry are very active.
4.
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 been basically stable at around 2% for several 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 growth of population and the aging of population, especially the gradual improvement of people's living standards, China's pharmaceutical market will expand rapidly, and the potential market of 800 million rural people will gradually be transformed 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 accession to the World Trade Organization (WTO)
As one of the basic principles of WTO, the principle of national treatment provides an opportunity for China pharmaceutical enterprises to carry out transnational R&D activities overseas. Enjoying national treatment is convenient for enterprises to make full use of foreign markets, financial resources and intellectual resources. The United States and other developed countries and regions help their pharmaceutical enterprises through preferential tax policies and financial support policies, which are determined by law. China enterprises can enjoy the same legal status in the United States if they enjoy national treatment. This not only brings new technology and R&D concept and direction to domestic enterprises, but also cultivates local technical talents through cooperation with local R&D institutions.
4.3 The legal environment continued to improve.
In recent years, China has gradually established and improved laws and regulations on drug management. The newly revised Measures for the Administration of Drug Registration came into effect on June 5438+0, 2007, the Supplementary Provisions on the Administration of Registration of Traditional Chinese Medicine on June 5438+0, 2008, and the Notice of Re-soliciting Opinions (Provisions on the Administration of Special Approval of Drug Registration (Draft for Comment)) on June/kloc-0, 2008. On April/0/6, 2004, the Administrative Measures for Certification of Quality Management Standards for Non-clinical Research of Drugs were issued, on March 4, 2004, the Administrative Measures for Reporting and Monitoring of Adverse Drug Reactions, and on February 6, 2007, the Administrative Measures for Drug Recall were issued and implemented. 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, and have important strategic significance for the historical transfer and leap-forward development of China's pharmaceutical industry from imitation to innovation.