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In recent years, with a series of policies to encourage innovation in medicine and the speeding up of approval and review time, China's innovative drugs ushered in the spring of development.
In addition, three years ago, the Hong Kong Stock Exchange allowed biotech companies with no income and no profits to go public.
It further released the vitality of innovation and opened the golden age of innovative drugs
.
Currently, China's innovative drug R&D momentum is strong.
According to the "Annual Report on the Current Status of Clinical Trials in China's New Drug Registration 2020" published by CDE on November 10, China has registered a total of 2,602 clinical trials in 2020, an overall increase of 9.
1% compared with 2019
.
Among them, clinical trials of innovative drugs accounted for more than half, up to 57%
.
Behind these data is the vigorous promotion of local pharmaceutical companies
.
From the perspective of companies that have applied for clinical innovative drugs, there are 1,142 domestic companies, accounting for 78%, which has changed the situation of overdue foreign-funded pharmaceutical companies monopolizing China's innovation
.
It is worth mentioning that although the progress of China's innovative drugs is obvious to all, the industry has also pointed out a problem.
Compared with the international innovative drug giants, the "quality" of innovation of local innovative drugs needs to be improved
.
At present, China's innovative drug research and development has serious problems of homogeneous competition, which is not conducive to the healthy development of the pharmaceutical innovation industry chain
.
Taking the very popular immunotherapy drugs PD-1/PD-L1 inhibitors in recent years as an example, data shows that as of November 2021, 6 domestically-made PD-1 models have been approved for marketing in China, and 4 models have entered medical insurance
.
At the same time, there are 3 products in the production stage, and there are many products in line behind
.
In 2020 alone, there will be 75 different PD-1 clinical applications
.
In addition to PD-1/PD-L1 inhibitors, in recent years, there are not a few pharmaceutical companies that have carried out clinical trials around popular targets of anti-tumor drugs such as VEGF, EGFR, and HER-2.
In 2020, VEGFR and CYP51A1 targets will be declared.
There are more than 50 varieties
.
The industry predicts that in the future, the R&D situation in these areas will be more prominent, and the market competition will be very fierce
.
In addition, we need to see that local innovative drug companies still have a long way to go before becoming a large-scale pharmaceutical giant with hundreds of billions of dollars.
.
According to data from clinical trials of innovative drugs registered in 2020, only 14.
1% are international multi-center clinical trials.
In addition, nearly 86% of innovative drug clinical trials are mainly carried out in China
.
In this regard, the industry said that innovative drugs not only need to face the domestic market, but only if they are based on the world can they have a broader future
.
The overseas market is also an important stage for local innovative drug companies to work hard to attack in the future
.
From the perspective of the industry, driven by policies, talents and capital factors, pharmaceutical innovation has ushered in a good opportunity that has never been seen before
.
In 2021, the State Food and Drug Administration issued the "Guiding Principles for Oncology Drug Research and Development Based on Clinical Value (Draft for Comment)", which puts forward new requirements for drug R&D strategies and R&D capabilities of pharmaceutical companies, which can further restrict the homogenization of R&D booms The phenomenon of serious competition, while encouraging clinical needs as the starting point, for the purpose of providing patients with clinical value
.
The industry predicts that in the future, it will be clinically value-oriented or implemented throughout the entire chain of innovative R&D, approval, and access
.
In general, while seeing opportunities, Chinese innovative drug companies also need to keep a clear mind, avoid blind "innovation", and continuously improve the quality of innovation, so as to build a more sustainable pharmaceutical ecosystem and promote conceptual changes.
, The mechanism is improved and the capacity is improved
.
In addition, three years ago, the Hong Kong Stock Exchange allowed biotech companies with no income and no profits to go public.
It further released the vitality of innovation and opened the golden age of innovative drugs
.
Currently, China's innovative drug R&D momentum is strong.
According to the "Annual Report on the Current Status of Clinical Trials in China's New Drug Registration 2020" published by CDE on November 10, China has registered a total of 2,602 clinical trials in 2020, an overall increase of 9.
1% compared with 2019
.
Among them, clinical trials of innovative drugs accounted for more than half, up to 57%
.
Behind these data is the vigorous promotion of local pharmaceutical companies
.
From the perspective of companies that have applied for clinical innovative drugs, there are 1,142 domestic companies, accounting for 78%, which has changed the situation of overdue foreign-funded pharmaceutical companies monopolizing China's innovation
.
It is worth mentioning that although the progress of China's innovative drugs is obvious to all, the industry has also pointed out a problem.
Compared with the international innovative drug giants, the "quality" of innovation of local innovative drugs needs to be improved
.
At present, China's innovative drug research and development has serious problems of homogeneous competition, which is not conducive to the healthy development of the pharmaceutical innovation industry chain
.
Taking the very popular immunotherapy drugs PD-1/PD-L1 inhibitors in recent years as an example, data shows that as of November 2021, 6 domestically-made PD-1 models have been approved for marketing in China, and 4 models have entered medical insurance
.
At the same time, there are 3 products in the production stage, and there are many products in line behind
.
In 2020 alone, there will be 75 different PD-1 clinical applications
.
In addition to PD-1/PD-L1 inhibitors, in recent years, there are not a few pharmaceutical companies that have carried out clinical trials around popular targets of anti-tumor drugs such as VEGF, EGFR, and HER-2.
In 2020, VEGFR and CYP51A1 targets will be declared.
There are more than 50 varieties
.
The industry predicts that in the future, the R&D situation in these areas will be more prominent, and the market competition will be very fierce
.
In addition, we need to see that local innovative drug companies still have a long way to go before becoming a large-scale pharmaceutical giant with hundreds of billions of dollars.
.
According to data from clinical trials of innovative drugs registered in 2020, only 14.
1% are international multi-center clinical trials.
In addition, nearly 86% of innovative drug clinical trials are mainly carried out in China
.
In this regard, the industry said that innovative drugs not only need to face the domestic market, but only if they are based on the world can they have a broader future
.
The overseas market is also an important stage for local innovative drug companies to work hard to attack in the future
.
From the perspective of the industry, driven by policies, talents and capital factors, pharmaceutical innovation has ushered in a good opportunity that has never been seen before
.
In 2021, the State Food and Drug Administration issued the "Guiding Principles for Oncology Drug Research and Development Based on Clinical Value (Draft for Comment)", which puts forward new requirements for drug R&D strategies and R&D capabilities of pharmaceutical companies, which can further restrict the homogenization of R&D booms The phenomenon of serious competition, while encouraging clinical needs as the starting point, for the purpose of providing patients with clinical value
.
The industry predicts that in the future, it will be clinically value-oriented or implemented throughout the entire chain of innovative R&D, approval, and access
.
In general, while seeing opportunities, Chinese innovative drug companies also need to keep a clear mind, avoid blind "innovation", and continuously improve the quality of innovation, so as to build a more sustainable pharmaceutical ecosystem and promote conceptual changes.
, The mechanism is improved and the capacity is improved
.
