"13th Five-Year Plan" on the occasion of China's class 1 chemical new drug progress and trend? (Lower)

Through the "13th Five-Year Plan" official, China's class 1 chemical new drug progress and trends? We understand that, after the "13th Five-Year Plan" period of efforts, China's class 1 chemical research and development has a solid foundationOn this basis, the "14th Five-Year Plan" chemical new drug development will usher in greater development opportunities, and will present the following industrial trendsTrend 1: 1 chemical new drug research and development closeto the four chronic diseases
with industrialization, urbanization, aging progress and ecological environment, lifestyle changes, chronic non-communicable diseases have become the main cause of death and disease burden of China's residents, at present, China's cardiovascular disease, cancer, chronic respiratory diseases, diabetes and other chronic noncommunicable diseases accounted for 88% of the total number of deaths, resulting in diseases accounted for more than 70% of the total burden of disease, is a major affecting health of China's residentsAt the same time, hepatitis, tuberculosis, AIDS and other major infectious diseases prevention and control situation is still serious, local diseases, parasitic diseases and other serious threats to the health of the population of endemic areasthe United Nations Agenda for Sustainable Development 2030 has made reducing premature mortality from these four major chronic diseases an important development goalThe "Healthy China 2030" program outline also incorporates this goal into the main indicators of healthy China's constructionTherefore, from the point of view of clinical demand, the future research and development of China's class 1 chemical innovation drug will mainly focus on malignant tumors, cardiovascular diseases, diabetes and respiratory diseases and other chronic diseases, in the context of the global spread of the new coronavirus, anti-infection, antiviral drugs will still maintain a certain proportion of research and developmentFigure 5 "Healthy China 2030" major chronic disease prevention and control actiontrend II: Class 1 chemical new drug innovation more adapted to the inherent requirements of precision medicine
the top 30 "heavy bomb" grade drugs in the global sales rankings, usually effective in 40% to 60%For the vast majority of drugs, there is about 1/3 can not achieve satisfactory efficacy, about 1/6 of the occurrence of different degrees of adverse reactions, the total safety and efficiency of only about 50%At present, adverse drug reactions have become the fifth leading cause of death in humanstherefore, according to the individual carrying genetic information to develop for the needs of patients, for individual "tailored" personalized prevention, diagnosis, treatment programs of the medical model, which is a revolution brought about by the development of genetic pharmacology and pharmacogenomicsFigure 6 The National Research Council (NRC) publishes the Biomedical Research Knowledge Network and the new disease classification system
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Biomarker refers to molecular markers that determine drug efficacy, assess disease treatment responses, and prognosisCan be used to predict diseases (individual disease sensitivity prediction), early diagnosis of disease, determine drug efficacy, and evaluate patient prognosisFigure 7 Tumor biomarkers are used in cancer treatment
In recent years, some leading multinational pharmaceutical companies, including Genentech, Novartis, Pfizer, etc., have adopted biomarker-driven new drug development models, given the drawbacks of traditional modelsThis model in the clinical trial, combined with the role of the compound target, to find the most suitable compound to play the efficacy of the target population biomarkers, so as to accurately design clinical trial into the group conditions, optimize the test design, accelerate the progress of the test, greatly improve the efficiency and success rate of new drug developmentTrend 3: Chemical new drug development more rely on open innovation and international vision
open innovation has become the mainstream trend of pharmaceutical research and developmentPharmaceutical companies obtain complementary resources (funds, new drug research and development technologies, new drug research and development platforms, production locations, etc.) from the outside, shorten research and development time, reduce research and development and production costs, and accelerate the entry of innovative drugs into the marketMore and more open innovation models such as joint research and development, licensing, mergers and acquisitions, joint ventures (JVs), corporate venture capital (CVCs), academic centers, incubators, etcare being used by innovative pharmaceutical developers, and cutting-edge models such as crowdsourcing, built-in buying (built-to-buy) and virtual pharmaceutical companies (VPcs) are being actively exploredIn general, large pharmaceutical companies primarily use external innovation tools to solve drug development problems, while small biotechnology companies mainly use external innovation tools to solve drug development and commercializationFigure 8 Some mergers and acquisitions and joint ventures by different types of companies, using external innovation resources
domestic pharmaceutical companies, have involved foreign participants, such as the acquisition of Celgene's China operations, the joint venture between Beta Pharmaceuticals and Amgen, and the joint venture between Hutchison Pharmaceuticals and Nestle Health SciencesExternal innovation interaction has become a mainstream trendChinese biotech companies are also eager to break into the global market while focusing on the domestic marketChina's innovative pharmaceutical enterprises on the one hand to accelerate domestic research and development and listing, on the other hand, but also strive to expand overseas markets, there are a number of enterprises have carried out overseas multi-center clinical trials, "China-U.Sdouble newspaper" has become an important strategy for domestic enterprises to carry out new drug research and development from the "China-U.S Double News" business headquarters geographical distribution, Shanghai, Jiangsu enterprises (a total of 30) accounted for 60% of all enterprises Hengrui Pharma has 7 products in both China and the United States to carry out clinical trials, is the company with the largest number of Sino-US double-report varieties, followed by Fosun Pharma, there are 6 varieties of Sino-American double newspaper, Axa Pharma performance is very eye-catching, is a leader in non-listed companies, 5 products at the same time received clinical approval between China and the United States Figure 9 "China-U.S Double News" enterprise regional distribution Note: data as of May 20, 2019 Trend 4: China's class 1 chemical new drugs to First in class
China's biopharmaceutical industry from the tracking imitation stage (1950s-1990s), imitation innovation stage (1990s-2020s) to the original innovation stage (2020s -future) transformation Figure 10 China's biopharmaceutical industry development stage
Although the "13th Five-Year Plan" period, China emerged Rosasta, Zebutini and other high-innovation products, but overall, China's class 1 chemical new drugs for foreign existing new drugs follow-up (follow on), mostly me-too or me-better and other rapid imitation of innovative varieties, although these new drugs have new chemical structure and independent intellectual property rights, but its research and development ideas have been found in foreign countries on the role of targets and mechanisms new disciplines such as life group, system biology, structural biology, mathematical and information science (such as high-performance computing and big data analytics) methods and technologies, deeply integrated into drug research and development, resulting in new strategies, new methods and technologies for drug research and development With the continuous improvement of the domestic innovation ecology, the future of China's independent discovery of new targets of the role of drugs, new mechanisms and the development of the first in class new drugs will emerge in bulk, China's innovative drug research and developed countries significantly narrowed the gap between the birth of a number of enterprises with international influence Figure 11 Original innovation path based on new target discovery
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