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In recent years, under the multiple favorable resonances such as the frequent introduction of policies, the influx of talents, the increase in research and development, and the increase in capital, China's innovative drug industry has developed rapidly
.
At the same time, the industry is also facing stricter supervision.
For example, CDE requires "pseudo-innovation" and "true innovation"
.
The industry believes that in 2022, China's innovative drugs may enter a stage of elimination.
In this context, there are 4 types of companies that are optimistic
.
First, companies with original innovation capabilities and solid basic research on technology platforms and targets
.
The threshold for innovative drug research and development is high, and there are high requirements for the technology platform, basic research experience, and research and development investment of enterprises.
Enterprises with original innovation capabilities can focus more on cutting-edge technology development and accelerate the development of first-in-class drugs.
.
However, at present, there are still relatively few pharmaceutical companies in China that can realize the original innovation ability.
It is necessary for enterprises to increase investment in talents, R&D investment and other aspects in order to achieve the improvement of innovation ability
.
Second, on the basis of self-research, companies that flexibly adopt multiple models and means to expand their pipelines (such as introduction/equity cooperation/platform cooperation, etc.
)
.
On the basis of the R&D capabilities of pharmaceutical companies themselves, cooperative development between companies is also considered to be another way for pharmaceutical companies to innovate well.
This model can clarify the division of labor between companies and reduce the development of similar drugs.
Quantity and optimize the competitive landscape
.
In fact, licensing cooperation has also become a model that local pharmaceutical companies are very familiar with
.
As of mid-December 2021, at least 20 innovative drugs developed by Chinese companies have reached authorized cooperation with overseas companies, involving CAR-T therapy, antibody conjugated drug (ADC), BTK inhibitor, third-generation EGFR-TKI , anti-PD-1 antibody and other popular new drug research and development fields
.
Third, companies that innovate with marginal thinking and have breakthroughs in clinical benefits (clinical benefits include effectiveness/safety/drug price/convenience of administration, etc.
)
.
It is understood that in July 2020, the Drug Evaluation Center of the State Food and Drug Administration proposed the breakthrough treatment drug review process, which means that the Chinese version of "breakthrough therapy" officially came out
.
In the past year or so, many domestic drugs have also been identified as breakthrough treatment drugs, involving products such as Hengrui Medicine, Kangfang Bio, Keji Bio, Wanchun Brin, and Rongchang Bio
.
Among them, Vidicitumumab of Rongchang Bio is the first ADC drug that has been double-recognized as breakthrough therapy in the United States and China, and the first domestic ADC drug that has received FDA breakthrough therapy designation so far.
A milestone in the development of innovative biopharmaceuticals
.
Fourth, in the commercialization stage, there are companies with medical insurance support/good indications competition/perfect sales team layout
.
The medical insurance negotiation is held once a year.
At present, the time for innovative drugs to be included in medical insurance from the market has been greatly shortened.
Although the price of innovative drugs entering medical insurance will decrease, it will significantly accelerate the commercialization to seize market share
.
The industry pointed out that commercialization is an upcoming major challenge for R&D biomedical technology companies
.
Especially for drugs with intense racing track, accelerated entry into medical insurance is expected to achieve heavy volume
.
For pharmaceutical companies that fail to enter medical insurance or do not plan to enter medical insurance, they need to have a strong sales team and do a good job in the layout of the out-of-hospital market in order to seize market share and maintain profit growth
.
.
At the same time, the industry is also facing stricter supervision.
For example, CDE requires "pseudo-innovation" and "true innovation"
.
The industry believes that in 2022, China's innovative drugs may enter a stage of elimination.
In this context, there are 4 types of companies that are optimistic
.
First, companies with original innovation capabilities and solid basic research on technology platforms and targets
.
The threshold for innovative drug research and development is high, and there are high requirements for the technology platform, basic research experience, and research and development investment of enterprises.
Enterprises with original innovation capabilities can focus more on cutting-edge technology development and accelerate the development of first-in-class drugs.
.
However, at present, there are still relatively few pharmaceutical companies in China that can realize the original innovation ability.
It is necessary for enterprises to increase investment in talents, R&D investment and other aspects in order to achieve the improvement of innovation ability
.
Second, on the basis of self-research, companies that flexibly adopt multiple models and means to expand their pipelines (such as introduction/equity cooperation/platform cooperation, etc.
)
.
On the basis of the R&D capabilities of pharmaceutical companies themselves, cooperative development between companies is also considered to be another way for pharmaceutical companies to innovate well.
This model can clarify the division of labor between companies and reduce the development of similar drugs.
Quantity and optimize the competitive landscape
.
In fact, licensing cooperation has also become a model that local pharmaceutical companies are very familiar with
.
As of mid-December 2021, at least 20 innovative drugs developed by Chinese companies have reached authorized cooperation with overseas companies, involving CAR-T therapy, antibody conjugated drug (ADC), BTK inhibitor, third-generation EGFR-TKI , anti-PD-1 antibody and other popular new drug research and development fields
.
Third, companies that innovate with marginal thinking and have breakthroughs in clinical benefits (clinical benefits include effectiveness/safety/drug price/convenience of administration, etc.
)
.
It is understood that in July 2020, the Drug Evaluation Center of the State Food and Drug Administration proposed the breakthrough treatment drug review process, which means that the Chinese version of "breakthrough therapy" officially came out
.
In the past year or so, many domestic drugs have also been identified as breakthrough treatment drugs, involving products such as Hengrui Medicine, Kangfang Bio, Keji Bio, Wanchun Brin, and Rongchang Bio
.
Among them, Vidicitumumab of Rongchang Bio is the first ADC drug that has been double-recognized as breakthrough therapy in the United States and China, and the first domestic ADC drug that has received FDA breakthrough therapy designation so far.
A milestone in the development of innovative biopharmaceuticals
.
Fourth, in the commercialization stage, there are companies with medical insurance support/good indications competition/perfect sales team layout
.
The medical insurance negotiation is held once a year.
At present, the time for innovative drugs to be included in medical insurance from the market has been greatly shortened.
Although the price of innovative drugs entering medical insurance will decrease, it will significantly accelerate the commercialization to seize market share
.
The industry pointed out that commercialization is an upcoming major challenge for R&D biomedical technology companies
.
Especially for drugs with intense racing track, accelerated entry into medical insurance is expected to achieve heavy volume
.
For pharmaceutical companies that fail to enter medical insurance or do not plan to enter medical insurance, they need to have a strong sales team and do a good job in the layout of the out-of-hospital market in order to seize market share and maintain profit growth
.
