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In recent years, with the advancement of the reform of the review and approval system of the pharmaceutical industry, the enthusiasm for innovation of domestic pharmaceutical companies has been ignited, and a large number of companies have begun to devote themselves to the research and development of innovative drugs
.
According to the "Annual Report 2020 on the Current Status of Clinical Trials of New Drug Registration in China" 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, as high as 57%
.
The homogeneity of domestic innovative drugs is serious (picture source: Pharmaceutical Network).
However, it should be noted that while domestic pharmaceutical innovation continues to accelerate, the phenomenon of "involution" has also begun to emerge
.
It is reported that some popular tracks, such as ADC drugs and PD-1 products, have become quite fierce in the context of more and more companies entering the game and higher and higher fund-raising and financing quotas
.
Taking PD-1 product as an example, as an epoch-making anti-tumor drug, by mobilizing the body's own immune function, it can achieve anti-tumor effects with good curative effect and high safety, and it has a wide range of indications and other advantages.
In recent years It is getting more and more attention from domestic pharmaceutical companies
.
According to statistics, as of November 2021, 6 domestically produced PD-1 models have been approved for listing in China, and 4 models have already entered medical insurance
.
At the same time, there are 3 products in the production stage
.
In addition, according to incomplete statistics, there are currently 657 registrations of PD-1/PD-L1 clinical trials in China, involving more than 150 companies
.
However, it is worth noting that, as far as the author knows, there are 183 products in the phase 3 clinical stage that are not differentiated significantly, and most of the targets are the same
.
Then, under the over-repetition of new drug research and serious homogeneity, as well as the pressure of centralized procurement, how should domestic related companies find a way out? Industry analysis believes that firstly, domestic pharmaceutical companies should actively develop new indications and targets; secondly, develop joint drugs; in addition, it may be a good way to choose to cooperate with multinational pharmaceutical companies for development and promotion.
.
The reason for this recommendation is that the status quo of "involving innovation" in some innovative drug tracks is mainly due to the low risk of research and development of popular tracks and higher benefits, and the insufficient investment of local pharmaceutical companies in the research and development of high-end innovative drugs.
And so on
.
Therefore, pharmaceutical companies should increase the intensity of R&D investment, make differentiated innovations, and find new indications, instead of squeezing into the "shortcut" track
.
It is understood that, in fact, in July this year, the National Center for Drug Evaluation issued the "Guidelines for Clinical Value-Oriented Anti-tumor Drug Clinical Research and Development" for soliciting comments.
Compare it with the best drug in the existing scheme, otherwise it cannot be marketed.
The document is actually fighting against ineffective innovation
.
In addition to making competitive, differentiated, and valuable products, the industry believes that domestic innovative companies should also set their sights on overseas markets
.
It is understood that in the field of PD-1 drugs, "going abroad" has become a new choice for this type of product to expand the market
.
At present, Junshi Biotech, BeiGene, Cinda Biotech, Hengrui Pharmaceuticals, etc.
are all using cooperation with foreign pharmaceutical companies to license their products to overseas, actively exploring overseas markets and enhancing competitiveness
.
Generally speaking, driven by policies, talents, and capital factors, pharmaceutical innovation is ushering in a good opportunity that has never been seen before
.
But if you want to truly make innovative drugs and usher in a broader market, pharmaceutical companies need to be updated, faster, or differentiated, and have more clinical value, in order to occupy a place in the market
.
.
According to the "Annual Report 2020 on the Current Status of Clinical Trials of New Drug Registration in China" 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, as high as 57%
.
The homogeneity of domestic innovative drugs is serious (picture source: Pharmaceutical Network).
However, it should be noted that while domestic pharmaceutical innovation continues to accelerate, the phenomenon of "involution" has also begun to emerge
.
It is reported that some popular tracks, such as ADC drugs and PD-1 products, have become quite fierce in the context of more and more companies entering the game and higher and higher fund-raising and financing quotas
.
Taking PD-1 product as an example, as an epoch-making anti-tumor drug, by mobilizing the body's own immune function, it can achieve anti-tumor effects with good curative effect and high safety, and it has a wide range of indications and other advantages.
In recent years It is getting more and more attention from domestic pharmaceutical companies
.
According to statistics, as of November 2021, 6 domestically produced PD-1 models have been approved for listing in China, and 4 models have already entered medical insurance
.
At the same time, there are 3 products in the production stage
.
In addition, according to incomplete statistics, there are currently 657 registrations of PD-1/PD-L1 clinical trials in China, involving more than 150 companies
.
However, it is worth noting that, as far as the author knows, there are 183 products in the phase 3 clinical stage that are not differentiated significantly, and most of the targets are the same
.
Then, under the over-repetition of new drug research and serious homogeneity, as well as the pressure of centralized procurement, how should domestic related companies find a way out? Industry analysis believes that firstly, domestic pharmaceutical companies should actively develop new indications and targets; secondly, develop joint drugs; in addition, it may be a good way to choose to cooperate with multinational pharmaceutical companies for development and promotion.
.
The reason for this recommendation is that the status quo of "involving innovation" in some innovative drug tracks is mainly due to the low risk of research and development of popular tracks and higher benefits, and the insufficient investment of local pharmaceutical companies in the research and development of high-end innovative drugs.
And so on
.
Therefore, pharmaceutical companies should increase the intensity of R&D investment, make differentiated innovations, and find new indications, instead of squeezing into the "shortcut" track
.
It is understood that, in fact, in July this year, the National Center for Drug Evaluation issued the "Guidelines for Clinical Value-Oriented Anti-tumor Drug Clinical Research and Development" for soliciting comments.
Compare it with the best drug in the existing scheme, otherwise it cannot be marketed.
The document is actually fighting against ineffective innovation
.
In addition to making competitive, differentiated, and valuable products, the industry believes that domestic innovative companies should also set their sights on overseas markets
.
It is understood that in the field of PD-1 drugs, "going abroad" has become a new choice for this type of product to expand the market
.
At present, Junshi Biotech, BeiGene, Cinda Biotech, Hengrui Pharmaceuticals, etc.
are all using cooperation with foreign pharmaceutical companies to license their products to overseas, actively exploring overseas markets and enhancing competitiveness
.
Generally speaking, driven by policies, talents, and capital factors, pharmaceutical innovation is ushering in a good opportunity that has never been seen before
.
But if you want to truly make innovative drugs and usher in a broader market, pharmaceutical companies need to be updated, faster, or differentiated, and have more clinical value, in order to occupy a place in the market
.
