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2021 is the first year of the "14th Five-Year Plan".
"Insist on innovation-driven development" will become China's core strategy in the next five years and even in the medium and long term
.
In the field of medicine, with the rapid development of science and technology and the advancement of a series of national and local policies, the pace of innovation in China's pharmaceutical industry is accelerating
.
So, entering the era of innovation 2.
0, what opportunities and challenges will pharmaceutical companies face? From the perspective of opportunities, medicine is a rigid demand.
With the increasing aging, the continuous upgrading of consumption, the increase of residents' awareness of health and the growth of payable income, there is still broad room for development in the field of pharmaceutical innovation in the future
.
According to data, the market size of China's pharmaceutical industry has increased from 1,329.
4 billion yuan to 1,791.
9 billion yuan from 2016 to 2020.
According to industry forecasts, China's pharmaceutical market will continue to grow by 2021, and the market size will reach 1,88.
5 billion yuan
.
It is worth mentioning that in recent years, as pharmaceutical companies have joined the innovative drug track one after another, the domestic innovative drug field has gradually emerged the problem of concentrated targets and excessive repetition
.
For example, popular tracks such as PD-(L)1, cell therapy, double antibodies, ADC, etc.
are currently very crowded.
Taking PD-(L)1 as an example, the current domestic approved PD-1/PD-L1 inhibits There are 10 kinds of agents, and the number is still increasing
.
According to data from the Center for Drug Evaluation, as of September this year, it has accepted 276 PD-1 registration applications and a total of 42 applicants
.
According to the forecast of Southwest Securities, 15 PD-1 monoclonal antibodies are expected to be listed in China in the next 2-3 years
.
The track tends to be crowded, product prices continue to drop, and a new round of national medical insurance negotiations is approaching, the market is generally not optimistic about the prospects for the PD-1 track competition
.
In the case of many pharmaceutical companies getting together to enter a certain track, it is not conducive to the healthy development of the industry and the formation of a good competitive landscape in the long run
.
In addition, since my country has been dominated by generic drugs for a long time, it is relatively lacking in R&D investment and R&D experience in innovative drugs.
This also leads to the fact that my country currently has very few innovative drugs that can be independently developed, and many of them are basically from abroad.
Introduce, or pseudo-innovation, that is, to manufacture alternative medicines for a mature target
.
From the perspective of the industry, only a breakthrough from 0 to 1 with a focus on clinical demand as a guide is innovation in the true sense, and can drive China’s new drug creation to a virtuous cycle of research and development.
This is what China’s innovative drug companies need Overcome the problem
.
In July this year, the Center for Drug Evaluation of the State Food and Drug Administration issued a notice for soliciting opinions on the Guidelines for Clinical Research and Development of Anti-tumor Drugs Oriented by Clinical Value
.
The document encourages real new drugs, not me too drugs
.
In the long run, it will help standardize the research and development direction of new anti-cancer drugs, and help the pricing reform of new anti-cancer drugs in China, bringing together more patient populations
.
Some analysts predict that in the near future, not only anti-tumor drugs and anti-cardiovascular drugs, but also other types of chronic disease drugs, will use this principle to define new drugs
.
Once these drugs are included in the guidelines for clinical research and development of new drugs, it means that ordinary new drugs with low value will be returned or increase the difficulty of approval
.
On the contrary, for truly innovative new drug development, the approval speed will be greatly accelerated
.
In addition, the analysis also pointed out that if the company is in the initial stage of the development of a new drug project, the clinical value of its candidate drug is not high, which will cause it to be difficult to deliver when it is finally approved
.
This will mean that investment in new drug research and development companies may be in vain
.
"Insist on innovation-driven development" will become China's core strategy in the next five years and even in the medium and long term
.
In the field of medicine, with the rapid development of science and technology and the advancement of a series of national and local policies, the pace of innovation in China's pharmaceutical industry is accelerating
.
So, entering the era of innovation 2.
0, what opportunities and challenges will pharmaceutical companies face? From the perspective of opportunities, medicine is a rigid demand.
With the increasing aging, the continuous upgrading of consumption, the increase of residents' awareness of health and the growth of payable income, there is still broad room for development in the field of pharmaceutical innovation in the future
.
According to data, the market size of China's pharmaceutical industry has increased from 1,329.
4 billion yuan to 1,791.
9 billion yuan from 2016 to 2020.
According to industry forecasts, China's pharmaceutical market will continue to grow by 2021, and the market size will reach 1,88.
5 billion yuan
.
It is worth mentioning that in recent years, as pharmaceutical companies have joined the innovative drug track one after another, the domestic innovative drug field has gradually emerged the problem of concentrated targets and excessive repetition
.
For example, popular tracks such as PD-(L)1, cell therapy, double antibodies, ADC, etc.
are currently very crowded.
Taking PD-(L)1 as an example, the current domestic approved PD-1/PD-L1 inhibits There are 10 kinds of agents, and the number is still increasing
.
According to data from the Center for Drug Evaluation, as of September this year, it has accepted 276 PD-1 registration applications and a total of 42 applicants
.
According to the forecast of Southwest Securities, 15 PD-1 monoclonal antibodies are expected to be listed in China in the next 2-3 years
.
The track tends to be crowded, product prices continue to drop, and a new round of national medical insurance negotiations is approaching, the market is generally not optimistic about the prospects for the PD-1 track competition
.
In the case of many pharmaceutical companies getting together to enter a certain track, it is not conducive to the healthy development of the industry and the formation of a good competitive landscape in the long run
.
In addition, since my country has been dominated by generic drugs for a long time, it is relatively lacking in R&D investment and R&D experience in innovative drugs.
This also leads to the fact that my country currently has very few innovative drugs that can be independently developed, and many of them are basically from abroad.
Introduce, or pseudo-innovation, that is, to manufacture alternative medicines for a mature target
.
From the perspective of the industry, only a breakthrough from 0 to 1 with a focus on clinical demand as a guide is innovation in the true sense, and can drive China’s new drug creation to a virtuous cycle of research and development.
This is what China’s innovative drug companies need Overcome the problem
.
In July this year, the Center for Drug Evaluation of the State Food and Drug Administration issued a notice for soliciting opinions on the Guidelines for Clinical Research and Development of Anti-tumor Drugs Oriented by Clinical Value
.
The document encourages real new drugs, not me too drugs
.
In the long run, it will help standardize the research and development direction of new anti-cancer drugs, and help the pricing reform of new anti-cancer drugs in China, bringing together more patient populations
.
Some analysts predict that in the near future, not only anti-tumor drugs and anti-cardiovascular drugs, but also other types of chronic disease drugs, will use this principle to define new drugs
.
Once these drugs are included in the guidelines for clinical research and development of new drugs, it means that ordinary new drugs with low value will be returned or increase the difficulty of approval
.
On the contrary, for truly innovative new drug development, the approval speed will be greatly accelerated
.
In addition, the analysis also pointed out that if the company is in the initial stage of the development of a new drug project, the clinical value of its candidate drug is not high, which will cause it to be difficult to deliver when it is finally approved
.
This will mean that investment in new drug research and development companies may be in vain
.
