How many steps does a new drug need from research to marketing?

The process of independent research and development of new drugs refers to the process from the discovery of new compounds to the successful listing of new drugs, including the following four steps:-obtaining new chemical substances through computer drug molecular design or through various channels such as plants, animals, minerals, microorganisms and marine organisms, and then screening and evaluating these substances on specific pharmacological models in vitro or in vivo to find lead compounds with novel structural types and remarkable pharmacological characteristics. -Synthesize a series of substances with similar structures to the lead compounds, and study the structure-activity relationship, so as to optimize the therapeutic index of the compounds and select the best compounds as clinical candidate drugs. -Apply for clinical research of new drugs and conduct phase I, II and III clinical trials in strict accordance with GCP. If the new drug is proved to be safe, effective and stable, you can apply for registration. -Application for new drug registration. Compared with the independent research and development of new drugs, imitation innovation, a less difficult and risky research and development method, has attracted more and more attention from people in the industry. Imitation innovation is a gradual innovation activity. It takes the innovative ideas and behaviors of leading researchers who have been successful in the market as an example, takes their innovative products as a demonstration, follows their ideas, fully absorbs the successful experiences and failure lessons of leading researchers, and on this basis, improves and perfects leading innovations, and further develops and produces competitive products to participate in the competition. Compared with taking the lead in innovation, the advantages of imitation innovation are mainly reflected in the following three aspects: First, because there are ready-made successful examples, imitators can learn advanced methods and lessons from failures, thus reducing the technical difficulty. Secondly, Mannsfeld compares the costs of pioneering innovation and imitative innovation of 48 products in American chemical, pharmaceutical and electronic industries. The results show that the cost of imitation innovation is about 65% of the former, and the time consumption is about 70% of the former, so the research and development cost is low. Third, imitation innovation is basically equivalent to the first innovator in its product market share. Some scholars believe that imitators have certain advantages in market share and market guidance, which may be mainly due to the imperfect products of pioneers and the difficulty in market development, which has affected some of their interest markets. The fundamental reason why imitation innovation has so many advantages lies in the overflow of some benefits of the first batch of innovators, such as the enlightenment of new ideas to followers, the experience and lessons in innovation and the development of new markets. Imitation innovators can own this part of profit spillover for free and promote their own innovation activities. For the research and development of new drugs, imitation innovation is to modify and transform the chemical structure on the basis of others' patented drugs, taking the known drug structure as the lead compound, and obtain their own patented drugs through systematic pre-clinical and clinical research, which is different from generic drugs that completely copy others' chemical structure. At the same time, this method does not need to go through the process of finding lead compounds, has a pharmacological evaluation system for reference, has strong purpose, less investment, short cycle and high success rate, and has been widely used at present. According to statistics, from 1975 to 1994, there were 106 1 new chemical entities listed in the world, of which 802 * * were imitative and innovative, accounting for 76% of the total. It can be seen that imitation innovation is a popular way of new drug research and development in the world, and its late-comer advantage is obvious. B, the difficulty of research and development is reduced. New drug research and development is a complex and systematic innovation activity, involving chemistry, biology, pharmacy, physiology, medicine and economics. As an innovative activity, it has certain accumulation, that is to say: first, in most cases, the possibility of enterprises, organizations and countries to achieve innovation is determined by their technological level; Second, with the continuous innovation activities, employees can constantly gain new experience to carry out updated innovation activities. Therefore, the progress of new drug research and development generally follows the development model of lagging imitation-following imitation-imitation innovation-pioneering innovation. At present, a key bottleneck in the process of new drug research and development is the determination of candidate compounds. The conventional method is to evaluate the pharmacokinetics and safety item by item after the compounds are identified by pharmacodynamic screening. All kinds of uncertain parameters lead to repeated optimization of the structure, and finally an optimal clinical candidate drug is obtained. Due to the lack of experience in innovative drug R&D, the level of structure-activity relationship research and drug screening in China is quite low. From this point of view, as far as the current situation is concerned, it is still quite difficult for China to directly research and develop innovative drugs. A considerable part of the technology accumulation of imitation innovation is through "learning while learning", that is, by observing, selecting, learning from and imitating the invention process of existing patented drugs, learning from observing the successes and mistakes of pioneers, absorbing a lot of external knowledge in imitation, cultivating and improving their own skills, thus promoting the improvement of their own innovation ability, so it is especially suitable for countries or enterprises with relatively backward technology. Therefore, for China pharmaceutical enterprises with weak R&D strength, imitation and innovation is a shortcut to break through the bottleneck and independently develop R&D. Through imitation and innovation, the difficulty of new drug research and development can be significantly reduced. On the other hand, China, as the largest developing country in the world, has considerable strength in basic disciplines such as chemistry and biology, and before the implementation of patent protection and administrative protection for new drugs, the scientific and technological workers engaged in the research and development of new drugs in China have accumulated a lot of imitation experience, and the synthesis process also has a considerable foundation. Now we can't copy new drugs unconditionally as in the past, and objective conditions require our scientific research institutions to transform the past imitation ability into innovation ability. In this transformation process, imitation innovation is undoubtedly a good starting point, because it can effectively integrate China's superior resources in research and development, and can effectively develop new drugs with independent intellectual property rights on the basis of imitating the ideas of new drug research and development in developed countries and absorbing their failed experiences. C. reducing investment risk from the perspective of economic benefits, new drug research and development is a work with large investment, long cycle and high risk. At present, in the United States, the average cost of a new drug from research to marketing exceeds 300 million dollars, and the research cycle is about 10 years, or even longer. And the probability that a new compound will eventually become a new drug is only one in ten thousand. There is an important concept in economics: opportunity cost. This concept means that if a factor of production is used for a specific purpose, it will give up the income that may be obtained in other alternative uses. Considering the problem from the perspective of opportunity cost, people are required to concentrate every factor of production on the use that may achieve the best economic benefits, so as to make the best use of everything and make the best use of people. Compared with the research and development of innovative drugs, in the process of imitation and innovation, a lot of manpower and capital investment can be saved because of the ready-made lead compounds. On the other hand, we can refer to the existing experimental schemes and data of similar new drugs to reduce unnecessary investment and avoid detours in imitation and innovation. Therefore, imitation and innovation can reduce investment, shorten cycle and reduce risk. In the case of serious shortage of funds for research and development of new drugs in China, imitation innovation is more in line with the principle of opportunity cost. In addition, as an innovative activity, the research and development of new drugs is based on the expectation and fundamental purpose of its wide application. As far as the whole R&D process is concerned, the introduction of new ideas and theories is of course very important, but how to further put its achievements into commercial applications, spread them to the society, transform them into real productive forces, truly realize the R&D goals and obtain huge profits is also very important. Compared with pioneering innovation research and development, imitative innovation can concentrate more manpower, material resources and financial resources on more applied processes. Therefore, it is especially suitable for China with insufficient capital investment and relatively backward technology. In the pharmaceutical industry, examples of great success in imitation and innovation are ranitidine and famotidine. In order to find drugs to inhibit gastric acid secretion and treat digestive tract ulcers, SmithKline conducted in-depth research on histamine H and 2 receptors. After a long process, the first H2 receptor blocker cimetidine was finally listed in 1976. Subsequently, GlaxoSmithKline and Merck made further research on it and soon developed ranitidine and famotidine respectively. In the subsequent marketing, the annual sales of ranitidine greatly surpassed that of cimetidine and became one of the best-selling drugs in the world. The implementation of this strategy will promote the development of new drugs in China into the fast lane.