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Data show that in recent years, Chinese pharmaceutical companies have made great gains in the research and development of improved new drugs.
For example, in 2018, there were 5 chemical drugs in category 2 new drugs (excluding new indications and APIs) that were declared for marketing, and there were 14 in 2019.
There will be 7 in 2020.
.
.
In addition, with the approval of Shanghai Yizhong’s core product Paclitaxel polymer micelles for injection ("paclitaxel micelles") on October 28, 12 new chemical drugs have been improved this year.
.
Paclitaxel is the cornerstone drug for the treatment of tumor diseases and chemotherapy, with a wide range of indications and rich clinical use programs
.
Paclitaxel micelles, as an innovative formulation of paclitaxel, belong to a major national new drug creation project
.
According to the industry, in an environment where volume purchases and innovation are encouraged, the difficulty of research and development of improved new drugs lies between the original innovative drugs and generic drugs.
While bringing substantial returns to pharmaceutical companies, it can also be reduced to a certain extent.
Risk and investment
.
It is understood that the success rate of improved new drugs is 3.
6 times that of innovative drugs, and it can avoid the time and R&D cost risks brought by long-term preclinical research and clinical trials for new drug marketing applications.
Vicious competition
.
Approved improved new drugs can obtain a certain period of market exclusivity (such as 5 years for new chemical entities, 3 years for new dosage forms), and usually have high technical barriers and patent barriers.
With their clinical advantages, they can quickly realize the market exclusivity.
Alternative dosage form
.
Because improved new drugs have the characteristics of high clinical success rate, high returns, and low risks, in recent years, under the background of increasing failure rate of new drug development, increasing difficulty in the development of new targets, and declining profits of generic drugs, improved new drugs have become Research hotspots of many generic drug companies
.
Under the guidance of national policies, the domestic market for improved new drugs is gaining momentum
.
Data show that as of the end of March 2021, CDE has published a total of 787 new drug acceptance numbers for category 2 chemical drugs, of which category 2.
4 (new indications) accounted for nearly 60%, followed by category 2.
2 (new dosage forms) , Class 2.
1 (modified crystal form) and Class 2.
3 (new compound preparation) are less
.
Taking Luye Pharma as an example, it has 9 main improved new drug products under development at different stages of development in China, including 3 anti-tumor drugs and 6 central nervous system drugs
.
Although improved new drugs have the characteristics of high clinical success rate, high benefits, and lower risks, this does not mean that successful development of improved new drugs is an easy task
.
In this regard, some people in the industry suggest that pharmaceutical companies need to grasp policies when developing improved new drugs, and be holistic and forward-looking
.
For example, pharmaceutical companies can predict the direction and make arrangements in advance based on the trend, and they can "change from 1 to 10" when the policy is in place, instead of waiting for the policy to "change from 0 to 1"
.
In addition, companies also need to take into account future product sales, clinical demand, and market demand, and aim for improved new drug targets, such as sustained and controlled release preparations
.
The person further stated that under the background of the continuous increase in R&D investment, innovative drugs are characterized by huge risks and long cycles.
Improved new drugs with obvious clinical advantages can be described as the current "R&D outlets" with the support of policies, and their success The rate is 3-4 times that of innovative drugs, and R&D personnel in pharmaceutical companies should hurry up and deploy
.
It is understood that in recent years, with the improvement of the R&D capabilities of domestic pharmaceutical companies, some high-barrier technologies, such as liposomes, microspheres, oral membranes, micelles, transdermal patches, etc.
, have become the focus of research and development of improved new drugs.
After a short period of cultivation, some products that have been approved for marketing have shown a trend of skyrocketing year after year in the terminal market.
Some improved new drugs are still under medical protection and quickly occupy a high ground in the market
.
In addition, the nervous system, systemic anti-infection and anti-tumor are also popular research and development positions for improved dosage forms
.
For example, in 2018, there were 5 chemical drugs in category 2 new drugs (excluding new indications and APIs) that were declared for marketing, and there were 14 in 2019.
There will be 7 in 2020.
.
.
In addition, with the approval of Shanghai Yizhong’s core product Paclitaxel polymer micelles for injection ("paclitaxel micelles") on October 28, 12 new chemical drugs have been improved this year.
.
Paclitaxel is the cornerstone drug for the treatment of tumor diseases and chemotherapy, with a wide range of indications and rich clinical use programs
.
Paclitaxel micelles, as an innovative formulation of paclitaxel, belong to a major national new drug creation project
.
According to the industry, in an environment where volume purchases and innovation are encouraged, the difficulty of research and development of improved new drugs lies between the original innovative drugs and generic drugs.
While bringing substantial returns to pharmaceutical companies, it can also be reduced to a certain extent.
Risk and investment
.
It is understood that the success rate of improved new drugs is 3.
6 times that of innovative drugs, and it can avoid the time and R&D cost risks brought by long-term preclinical research and clinical trials for new drug marketing applications.
Vicious competition
.
Approved improved new drugs can obtain a certain period of market exclusivity (such as 5 years for new chemical entities, 3 years for new dosage forms), and usually have high technical barriers and patent barriers.
With their clinical advantages, they can quickly realize the market exclusivity.
Alternative dosage form
.
Because improved new drugs have the characteristics of high clinical success rate, high returns, and low risks, in recent years, under the background of increasing failure rate of new drug development, increasing difficulty in the development of new targets, and declining profits of generic drugs, improved new drugs have become Research hotspots of many generic drug companies
.
Under the guidance of national policies, the domestic market for improved new drugs is gaining momentum
.
Data show that as of the end of March 2021, CDE has published a total of 787 new drug acceptance numbers for category 2 chemical drugs, of which category 2.
4 (new indications) accounted for nearly 60%, followed by category 2.
2 (new dosage forms) , Class 2.
1 (modified crystal form) and Class 2.
3 (new compound preparation) are less
.
Taking Luye Pharma as an example, it has 9 main improved new drug products under development at different stages of development in China, including 3 anti-tumor drugs and 6 central nervous system drugs
.
Although improved new drugs have the characteristics of high clinical success rate, high benefits, and lower risks, this does not mean that successful development of improved new drugs is an easy task
.
In this regard, some people in the industry suggest that pharmaceutical companies need to grasp policies when developing improved new drugs, and be holistic and forward-looking
.
For example, pharmaceutical companies can predict the direction and make arrangements in advance based on the trend, and they can "change from 1 to 10" when the policy is in place, instead of waiting for the policy to "change from 0 to 1"
.
In addition, companies also need to take into account future product sales, clinical demand, and market demand, and aim for improved new drug targets, such as sustained and controlled release preparations
.
The person further stated that under the background of the continuous increase in R&D investment, innovative drugs are characterized by huge risks and long cycles.
Improved new drugs with obvious clinical advantages can be described as the current "R&D outlets" with the support of policies, and their success The rate is 3-4 times that of innovative drugs, and R&D personnel in pharmaceutical companies should hurry up and deploy
.
It is understood that in recent years, with the improvement of the R&D capabilities of domestic pharmaceutical companies, some high-barrier technologies, such as liposomes, microspheres, oral membranes, micelles, transdermal patches, etc.
, have become the focus of research and development of improved new drugs.
After a short period of cultivation, some products that have been approved for marketing have shown a trend of skyrocketing year after year in the terminal market.
Some improved new drugs are still under medical protection and quickly occupy a high ground in the market
.
In addition, the nervous system, systemic anti-infection and anti-tumor are also popular research and development positions for improved dosage forms
.
