China Drug Promotion Association Anti-tumor Committee Released | Review of Clinical Research on New Anti-tumor Drugs in China 2020

since 2015, under the guidance of the national "innovation driven" and "healthy China" strategy, the reform of drug review and approval system has been continuously deepened, and the R & D environment of pharmaceutical innovation in China has been greatly improved. China's pharmaceutical innovation is moving from imitation to independent innovation, and the quality and quantity of innovative drugs have been greatly improved. In October 2017, the General Office of the Central Committee of the Communist Party of China and the General Office of the State Council issued the Opinions on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Drugs and Medical Devices, which further established the reform ideas of drug scientific supervision, and systematically proposed drug regulatory reform. The specific policies of the People's Republic of China and the legalization of reform policies through the newly revised "Drug Administration Law" have opened a new era of drug regulatory reform in China, it is an important milestone to bring spring to the innovation and development of China's pharmaceutical industry, which greatly encourages the innovation and development of China's pharmaceutical industry.

, with the introduction of the 18A policy of the Hong Kong Stock Exchange and the opening of the Science and Technology Innovation Board of the Shanghai Stock Exchange, biomedical enterprises are allowed to raise funds through IPO without making profits, which not only provides a broader financing platform for innovative pharmaceutical enterprises, but also provides a faster channel for the withdrawal of capital, which greatly stimulates the enthusiasm of capital to participate in innovative investment. Since 2018, a total of 33 biopharmaceutical companies on the Hong Kong Stock Exchange have been successfully listed through Section 18A, raising a total of HK $87 billion; since the inception of the Shanghai Stock Exchange's CRE Board, a total of 29 biopharmaceutical companies have been listed, raising a total of HK $41.969 billion. Policy guidance and capital empowerment have pushed China's pharmaceutical innovation to a climax and stepped into the fast lane of development.

is developing at a high speed, we have also noticed that according to the official statistics of the Drug Evaluation Center (CDE) of the State Food and Drug Administration, CDE will accept 9768 applications for registration in 2020, of which 60% are anti-tumor drug applications, and 777 anti-tumor drug clinical trial applications approved in 2020 cover 150 targets, there were 133, 68, 46, 34, and 33 clinical trials for PD-1/PD-L1, VEGF, EGFR, FGFR, and HER-2 targets, respectively. With the increasing number of clinical trials with the same target and indication, the speed of clinical trials has gradually slowed down, and the lack of subjects has become one of the factors hindering the development of new drug innovation.

from the market side, a report shows that the first listed product can obtain 45% of the market, the second to fourth listed products can obtain 27.9, 14% and 11.3 of the market respectively, while the remaining products can only obtain the remaining 1.7 of the market share.

In order to facilitate relevant investment institutions, pharmaceutical enterprises and researchers to master the clinical trials of anti-tumor drugs, the Anti-tumor Drug Clinical Research Committee of the China Drug Promotion Association (hereinafter referred to as the Anti-tumor Committee of the China Drug Promotion Association) has comprehensively sorted out the current hot targets and their drugs from the aspects of target mechanism and domestic research and development status, and given a pertinent academic brief evaluation, hoping to promote rational investment and research and development by investors and research institutions, avoid the phenomenon of "high-level duplication" caused by excessive investment, thus releasing excessive social resources, especially clinical trial resources, optimizing the allocation of new drug research and development resources, and facilitating the development process of innovative drugs more smoothly.

I would like to express my heartfelt thanks to the careful guidance of the leaders of the China Drug Promotion Association and the strong support of the experts of the anti-tumor special committee. This report is an attempt to promote the rational and orderly development of drug research and development. The purpose is to improve the level of cancer drug research and development in my country to fill the clinical gap, achieve effective substitution, and better meet the needs of patients. Due to the different sources of data collected, there may be inconsistencies in statistical caliber. This report is only used as a reference material for academic research. If there are any errors or omissions, criticism and correction from all walks of life are welcome. (Click "Read the original" at the bottom left to download the detailed report)

-- This article is selected from the website of China Pharmaceutical Innovation Promotion Association