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Under the normalization of centralized procurement, the competition in the generic drug market has begun to intensify
.
In this context, improved drugs have become a new hot spot, and many companies in the industry have deployed improved drugs
.
According to the regulations, Class 2 drugs refer to improved new drugs that have not been marketed at home and abroad
.
It refers to a drug whose structure, dosage form, prescription process, route of administration, indications, etc.
are optimized on the basis of known active ingredients, and has obvious clinical advantages
.
At present, the most approved modified drugs are drugs with new indications in category 2.
4
.
Statistics 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) accounts for nearly 60%, and Category 2.
2 (new dosage forms).
) followed closely, and there were relatively few categories 2.
1 (modified crystal form) and 2.
3 (new compound preparations)
.
The company with more new indications approved is AstraZeneca, and the company with more new indications approved by domestic manufacturers is Jiangsu Hengrui
.
In addition, more new indications are anti-tumor drugs
.
It is understood that in China, due to the improved new drugs compared with generic drugs, whether it is structural improvement, dosage form improvement, new compound preparations or new indications, there are certain technical or patent barriers, and compared with generic drugs, there are 3 to 4 years.
During the monitoring period, the life cycle has been significantly prolonged, and the rate of return has also increased significantly.
In recent years, the development process of domestic improved new drugs has begun to accelerate significantly.
A large number of domestic pharmaceutical companies, including Luye Pharma, Xuantai Pharmaceutical, and Osaikang, are actively deploying
.
For example, Hengrui Medicine stated on the investor interaction platform on February 15 that in the therapeutic fields of hepatitis and respiratory, new technologies such as PROTAC and siRNA, as well as improved new drug companies such as inhalation and oral dissolving membranes, have already been deployed
.
In November 2021, Shanghai Aokeda Biomedical Technology Co.
, Ltd.
(hereinafter referred to as "Aokeda") completed a financing of over 100 million yuan
.
Haida Investment is the co-lead investor of this round of financing
.
It is understood that Aokeda is a company that develops improved new drugs as well as the first generic and specialty generic drugs. .
The company is good at exploring new therapeutic methods, including new dosage forms, new dosing regimens and new indications, based on existing and proven drug molecules, in order to create new higher-quality products that meet clinical and market needs
.
However, it should be noted that although improved new drugs have the characteristics of high clinical success rate, high benefits, and low risks, this does not mean that the successful development of improved new drugs is an easy task
.
In this regard, industry insiders suggest that pharmaceutical companies need to grasp policies when developing improved new drugs, with a global view and forward-looking
.
In addition, pharmaceutical companies also need to take into account future product sales, clinical demand, market demand, etc.
, and target improved new drug targets in advance, such as sustained and controlled release preparations
.
In general, under the background of accelerated innovation and development of pharmaceutical companies, improved new drugs with obvious clinical advantages and less risk will usher in a "R&D outlet" with policy support
.
Therefore, for pharmaceutical companies, if they want to seize the opportunity, they need to seize the time to deploy
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
.
In this context, improved drugs have become a new hot spot, and many companies in the industry have deployed improved drugs
.
According to the regulations, Class 2 drugs refer to improved new drugs that have not been marketed at home and abroad
.
It refers to a drug whose structure, dosage form, prescription process, route of administration, indications, etc.
are optimized on the basis of known active ingredients, and has obvious clinical advantages
.
At present, the most approved modified drugs are drugs with new indications in category 2.
4
.
Statistics 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) accounts for nearly 60%, and Category 2.
2 (new dosage forms).
) followed closely, and there were relatively few categories 2.
1 (modified crystal form) and 2.
3 (new compound preparations)
.
The company with more new indications approved is AstraZeneca, and the company with more new indications approved by domestic manufacturers is Jiangsu Hengrui
.
In addition, more new indications are anti-tumor drugs
.
It is understood that in China, due to the improved new drugs compared with generic drugs, whether it is structural improvement, dosage form improvement, new compound preparations or new indications, there are certain technical or patent barriers, and compared with generic drugs, there are 3 to 4 years.
During the monitoring period, the life cycle has been significantly prolonged, and the rate of return has also increased significantly.
In recent years, the development process of domestic improved new drugs has begun to accelerate significantly.
A large number of domestic pharmaceutical companies, including Luye Pharma, Xuantai Pharmaceutical, and Osaikang, are actively deploying
.
For example, Hengrui Medicine stated on the investor interaction platform on February 15 that in the therapeutic fields of hepatitis and respiratory, new technologies such as PROTAC and siRNA, as well as improved new drug companies such as inhalation and oral dissolving membranes, have already been deployed
.
In November 2021, Shanghai Aokeda Biomedical Technology Co.
, Ltd.
(hereinafter referred to as "Aokeda") completed a financing of over 100 million yuan
.
Haida Investment is the co-lead investor of this round of financing
.
It is understood that Aokeda is a company that develops improved new drugs as well as the first generic and specialty generic drugs. .
The company is good at exploring new therapeutic methods, including new dosage forms, new dosing regimens and new indications, based on existing and proven drug molecules, in order to create new higher-quality products that meet clinical and market needs
.
However, it should be noted that although improved new drugs have the characteristics of high clinical success rate, high benefits, and low risks, this does not mean that the successful development of improved new drugs is an easy task
.
In this regard, industry insiders suggest that pharmaceutical companies need to grasp policies when developing improved new drugs, with a global view and forward-looking
.
In addition, pharmaceutical companies also need to take into account future product sales, clinical demand, market demand, etc.
, and target improved new drug targets in advance, such as sustained and controlled release preparations
.
In general, under the background of accelerated innovation and development of pharmaceutical companies, improved new drugs with obvious clinical advantages and less risk will usher in a "R&D outlet" with policy support
.
Therefore, for pharmaceutical companies, if they want to seize the opportunity, they need to seize the time to deploy
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
