According to incomplete statistics by China Securities Journal and China Securities Taurus reporter, 39 innovative drugs have been approved by the State Food and Drug Administration for listing this year, and more than 20 in the first half of only, which has exceeded that of last year.
In terms of treatment, approved drugs mainly involve drugs for diseases such as tumor, autoimmune system, virus and infection. Among the new drugs approved for listing, in addition to biopharmaceuticals, 11 new traditional Chinese medicine drugs are also included. Source: compiled by China Securities Journal, China Securities Taurus reporter
speed up the listing of innovative drugs
Among the innovative drugs approved this year, there are drugs independently developed by many Chinese pharmaceutical enterprises, such as Yasheng medicine, Rongchang biology, Shenzhen Chipscreen Biosciences Co.Ltd(688321) , real biology and so on.
Many vaccines and drugs involving covid-19 prevention and treatment were approved this year. In the first half of the year, three covid-19 vaccines and "tripartite" related traditional Chinese medicine varieties (Qingfei Paidu granules, Huashi Baidu granules and Xuanfei Baidu granules) were approved for listing. In addition, the State Food and Drug Administration recently approved the registration application of Tengsheng Huachuang covid-19 virus neutralizing antibody combination therapy drug, a subsidiary of Tengsheng boyao, which is the first covid-19 virus neutralizing antibody combination therapy drug approved with independent intellectual property rights in China.
In recent years, China has ushered in a gale of drug innovation. Guosheng Securities believes that policy promotion, superimposed with the help of science and innovation board and registration system, the capital of innovative medicine racing track swarmed, the financing of innovative medicine enterprises accelerated, and China's innovative medicine investment entered the era of gale mouth. At present, domestic innovative drugs have entered the harvest period one after another, and more heavy innovative products will be approved and listed in China in the next few years.
encourage source innovation
In November this year, the annual report on the current situation of clinical trials of new drug registration in China (2020) released by the drug evaluation center of the State Food and drug administration showed that in 2020, the total number of clinical trials registered by the drug clinical trial registration and information publicity platform increased by 9.1% compared with 2019, and the Chinese sponsors accounted for more than 70%.
Zhou Siyuan, deputy director of the drug evaluation center of the State Food and drug administration, said that in the past two years, the number of approved innovative drugs has increased rapidly, and innovative drugs have begun the process of quantitative change. "However, we should also see the gap. For example, compared with the 160 innovative drugs approved by fda2018-2020, there are not many first in class new drugs approved in China. The varieties are mainly concentrated in antitumor drugs, antiviral and anti infection drugs and analgesics, and there are not many new drugs in other fields."
In November this year, the guiding principles for clinical research and development of antitumor drugs guided by clinical value issued by the drug evaluation center of the State Food and drug administration was officially implemented, which made it clear that pharmaceutical enterprises should implement the research and development concept of clinical value oriented and patient centered from determining the research and development direction to carrying out clinical trials.
Industry analysts believe that the tightening of clinical and listing requirements for cancer drugs reflects the guidance of the regulatory level in encouraging source innovation in policy guidance and encouraging enterprises to study new targets, new mechanisms and new indications.
(China Securities Journal)
