Research and development mode and status of Chinese new drugs

1 Analysis of all levels of China's pharmaceutical R & D forces at present, China's new pharmaceutical R & D forces include: national research institutes, private R & D institutions, "turtle" team, cro company, pharmaceutical enterprise research institute, foreign enterprise R & D center in China The research institutes include the former medical administration system, the medical institute system, the medical engineering institute system, the military medical system, and the Ministry of health system For example, Sichuan Antibiotic Industry Research Institute, Tianjin Pharmaceutical Research Institute, Shanghai Pharmaceutical Industry Research Institute, Shanghai Traditional Chinese Medicine Innovation Research Center, Beijing Institute of biological products of the Ministry of health, Chengdu Institute of biological products of the Ministry of health, Lanzhou Institute of biological products of the Ministry of health, Chengdu Institute of biology of the Chinese Academy of Sciences, Guangzhou, Chinese Academy of Sciences Institute of chemistry, South China Botanical Garden, Chinese Academy of Sciences (former South China Botanical Institute), Kunming Institute of Botany, Chinese Academy of Sciences, Shanghai Academy of life sciences, Chinese Academy of Sciences, Shanghai Biochemistry and cell biology research Institute, Shanghai Institute of medicine, Chinese Academy of Sciences, Institute of Botany, Chinese Academy of Sciences, Academy of Military Medical Sciences, Institute of medicine, Chinese Academy of Medical Sciences, Institute of pharmaceutical botany, Chinese Academy of Medical Sciences The provincial institutes of medical college are still owned by the state The state-owned pharmaceutical universities include: School of pharmacy of Peking University, School of pharmacy of Fudan University, School of pharmacy of East China University of science and technology, School of pharmacy of Shandong University, Shenyang Pharmaceutical University, Department of pharmacy of West China Medical Center of Sichuan University, School of pharmaceutical science and technology of Tianjin University, Xiamen University Department of pharmacy, School of pharmacy, Zhejiang University, China Pharmaceutical University, Institute of Central South University, School of pharmacy, Sun Yat sen University, Department of pharmacy, Second Military Medical University, School of pharmacy, Yantai University, and several universities of traditional Chinese medicine Engineering Center: with the development and Reform Commission, the Ministry of education and the Ministry of science and technology: genetic engineering and resource drug Engineering Research Center, key technology engineering research center of traditional Chinese medicine pharmacy and new drug development, new drug Engineering Research Center, national project of traditional Chinese medicine compound drug development Research Center, National Engineering Research Center for genomic drugs, National Pharmaceutical Engineering Technology Research Center for traditional Chinese medicine, national marine pharmaceutical engineering technology research center, National Natural Drug Engineering Technology Research Center, national new drug development engineering technology research center, national patent medicine engineering technology research center, national modernization Engineering Technology Research Center for traditional Chinese medicine , agricultural and pharmaceutical genetic engineering research center, National Engineering Research Center for solid preparation manufacturing technology of traditional Chinese medicine, national drug and metabolite analysis research center National new drug screening laboratory: Shanghai Institute of medicine, Chinese Academy of Sciences, drug screening center of Institute of medicine, Chinese Academy of Medical Sciences, China Union Medical University, new drug screening center of China Pharmaceutical University, new Chinese new drug screening laboratory, School of medicine, Fudan University, antiviral drug screening center, new drug screening center of Di'ao group Platform research of new drug screening technology: key technology and platform research of pharmacodynamics, key technology and platform research of preclinical pharmacokinetics, key technology and platform research of preclinical safety evaluation, key technology and platform research of clinical trials All national institutes and universities have the best talents, equipment and technology platform Before the ninth five year plan, it was considered as the main body of new drug research and development in China However, huge national investment has been transformed into academic papers and paper achievements, not into the expected new drug projects Under the impact of the market mechanism, these institutions appear to be rigid and lack of vitality They are like lions in the cage of talents, poor utilization of equipment, and the technical platform bears heavy tasks They are not used to project management and have limited understanding of the market The biggest problem is that the way of large-scale cooperation of national institutes is gradually being broken down by the way of research group In fact, large-scale institutes have become many paper production organizations and small R & D companies The courtyard is no longer large What about the tiger in the cage? Wait for the keeper to throw a piece of meat Many researchers are waiting for the country's cheese So that some people describe the "national team" of new drug research and development as "sheep herding" Think of the varieties that Chinese pharmaceutical companies produced before 1998 China is seriously short of medicine In 1999, with the vigorous development of private R & D institutions, the varieties of drug market in China were booming rapidly, and the gap between domestic drug use and developed countries was rapidly closing In this regard, private R & D institutions have made great contributions, but bad development is also pregnant at the same time At present, how many private R & D institutions are there? I'm afraid it's difficult to count 3000? The 5000 one? It is estimated that the number should be equal to that of domestic pharmaceutical enterprises Private R & D institutions basically start from the imitation and change of dosage forms, "do everything" and do everything in a short and smooth way Provide one-stop service for enterprises Imagine who can quickly get through the industrial chain of drug R & D, production, sales and approval? It could be them At present, these institutions exist in the gap between policy, technology and market Although they are indispensable, they are regarded as the great beasts after the unhealthy development For innovative drug development, private R & D institutions have also shown their pursuit of ideals, including the team led by Liu Ke, a target drug R & D company in Yantai However, generally speaking, funds, talents and technology do not support the general private R & D units to engage in the development of original new drugs Cro company has been copied very loudly and developed rapidly in recent years Cro engaged in preclinical research: engaged in chemistry, preclinical pharmacology and toxicology experiments related to new drug research and development For example, Wuxi's wuxipharmatech, Beijing's bridge pharmaceuticals, Shanghai medicilon, Shanghai hdbiosciences, Shanghai chemexplorer, etc Cro companies engaged in clinical trials, such as Excel Pharma studies, kendlewits medical consulting, complete sunshine, etc Some people think that cro is new drug research and development, or can lead new drug research and development in China In fact, Chen Li, director of scientific research and chief scientific officer of Roche R & D (China) Co., Ltd., said that outsourcing can not solve the real problem of new drug research and development in China Although the company has made profits through outsourcing, the development of China's pharmaceutical industry must learn to "make blood" Although some pharmaceutical research forces are forced to turn to cro business under the pressure of survival, "no matter how long cro grows, it's mostly for people's support (because it's too specialized to integrate upstream and downstream resources, it will always be controlled if it can't get through the industrial chain)" In recent years, some successful R & D talents working in overseas multinational companies have returned to China to start their own businesses They have brought the R & D mode of multinational companies to China and attracted the involvement of private capital As a result, there have emerged some R & D institutions of turtle teams, such as Shenzhen microchip, Zhejiang Beida, Yantai medejin, Shanghai Zesheng, etc These companies are strong in technology, committed to international market competition, easy to get the support of policies and funds After several years of efforts, they have achieved little results These forces may become the backbone of original new drugs 1.5 there are about 500 domestic pharmaceutical enterprises in the R & D center of pharmaceutical enterprises with unclear positioning, and less than 5% of the research institutes with more than 120 people There is a big puzzle in this poor research institute, that is, the location is unclear: whether to become a profit center or a service center? To become a profit center, one has to go out independently to establish a second level legal person, and one has to go out and take projects, which is no longer the original intention of setting up an enterprise research institute; to become a service center, one can not support many people, many people will also be lazy and unable to support, so it is difficult to assess the performance of these talents, and become a "captive animal" again It can be seen that those enterprises with their own research institutes still rely on selling projects In fact, the current position of the Research Institute of pharmaceutical enterprises should be to do project connection and registration for approval Since Novo Nordisk took the lead in setting up a development center in Beijing, AstraZeneca, Lilai, Roche, Pfizer and other multinational pharmaceutical enterprises have successively established R & D institutions in Shanghai, GSK has established an over-the-counter drug R & D center in Tianjin, and oganon has established a R & D center in Nanjing Many people applaud this, saying: "to promote the further improvement of the independent innovation ability of local enterprises in China; local enterprises can understand the global drug R & D trend in the first time, accumulate drug R & D and Management experience can also improve the intellectual property protection level of local R & D enterprises, bring more and better pharmaceutical products to the Chinese pharmaceutical consumer market, and cultivate more excellent talents " But there are still voices about "the wolf is coming, though it is getting smaller and smaller." In May 2007, the national development and Reform Commission issued the development of the biological industry in 2006 and policy recommendations for 2007, which mentioned that: the development of foreign investment in the pharmaceutical industry shows the characteristics of extending from the upstream and downstream industries of simple processing and sub packaging boxes In order to reduce the research and development cost of biological medicine, multinational pharmaceutical enterprises in developed countries are strengthening the protection of intellectual property rights, while they are developing one after another China has set up R & D centers, and the pace of transferring R & D links to China has been significantly accelerated; foreign investment has obtained the research results that will soon mature in China through legal capital operation means such as cooperation, acquisition and merger While domestic pharmaceutical companies are still trying to invest in new drugs, the pace of multinational pharmaceutical companies in this regard can be described as "running" In any case, the trend of internationalization cannot be stopped, and national medicine cannot be lost.