It will take a long time for a new drug to go on the market from the initial discovery of the lead compound. The cost of developing a new drug in the world has exceeded US $1 billion, and the R & D cycle has exceeded 10 years. However, if a new drug with broad market prospect is successfully developed, it will bring huge profits to the research and development enterprises. The annual sales revenue of "blockbuster" new drugs of multinational pharmaceutical enterprises is more than 1 billion US dollars.
In general, China's pharmaceutical R & D strength includes: national research institutes, cro companies, pharmaceutical enterprise research institutes, foreign enterprise R & D centers in China.
In 2018, the R & D expenditure of biomedical A-share listed companies was 43.014 billion yuan, a year-on-year increase of 41.87%, accounting for 2.94% of the main business income; among them, the R & D expenditure of meinian health, Luyan medicine and Tianmu pharmaceutical industry increased by more than 300% over the previous year; the R & D expenditure of Yihua health, Guofa shares and Guoxin health decreased by more than 70% over the previous year. It is estimated that the R & D expenditure of A-share listed companies of China's biomedical industry will exceed 50 billion yuan in 2019.
Since 2017, the policy supervision of China's pharmaceutical industry has become more and more strict, and the requirements for drug registration applications have become more and more perfect. Whether it is generic drugs, new drugs or supplementary applications, they must strictly comply with the relevant requirements of registration laws and regulations, and provide a complete, authentic and traceable set of pharmaceutical research, non clinical research and clinical research materials. Due to the impact of policies, the number of drug registration applications is similar Compared with the previous years, although it has been reduced, the quality of drugs has been significantly improved, which promotes the development of domestic pharmaceutical industry from extensive to refined, and gradually integrates with international standards. As of December 6, 2018, the number of new chemical drug registration application acceptance numbers undertaken by CDE in China has exceeded 5200. Based on the average acceptance number from January to November 2018, it is estimated that the number of chemical drug acceptance numbers undertaken by CDE in 2018 will exceed 5600.
Through data query, as of August 7, 2019, China's CDE has undertaken 4348 new chemical drug registration application acceptance numbers.
Compared with developed countries, China's innovative drug research and development is still at a significant disadvantage in many indicators. There is a certain gap with developed countries in R & D input capacity and output. Even compared with India, which has similar level, there is a certain gap in new drug R & D investment.
Since the reform and opening up, especially the implementation of the innovation driven development strategy in China, the party and the state have attached great importance to new drug research and development, not only through major national science and technology special projects for new drug creation, but also through sharp reform in key links such as clinical evaluation, listing approval and promotion of new drugs, which has greatly stimulated the enthusiasm of researchers in innovation and entrepreneurship, research and development of new drugs. The Chinese government attaches great importance to the research and development of domestic new drugs, promulgates a series of policies to encourage the research and development of new drugs, and launched and implemented the major science and technology projects of "major new drug creation" in 2008.
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