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In recent years, in the context of accelerated changes in the development of the pharmaceutical industry, innovation has become the main development trend of global pharmaceutical companies, innovative development
.
In the context of the rapid production of Class 1 innovative drugs, its "close relatives" Class 2 improved new drugs have also begun to usher in a research and development climax
.
It is understood that Category 2 refers to "improved new drugs that have not been marketed at home and abroad, which refer to the optimization of their structure, dosage form, prescription process, route of administration, indications, etc.
on the basis of known active ingredients, and have obvious Drugs of Clinical Advantage"
.
According to data, from 2019 to 2021, the overall trend of registration acceptance of 2 types of improved new drugs for chemical drugs is an upward trend
.
The total number of acceptances has risen from 188 in 2019 to 418 in 2021, with an annual growth rate of nearly 49%; among them, the number of INDs has risen from 141 in 2019 to 304 in 2021, with an annual growth rate Nearly 47%; in addition, in terms of new drug & import classification, it has also increased from nearly flat in 2019 to nearly 2 times, and the number of acceptance numbers of domestic improved new drugs has achieved an annual growth rate of 64%
.
Industry analysts believe that two types of improved new drugs have been approved continuously in recent years, mainly because improved new drugs have the characteristics of high clinical success rate, high profit, and low risk.
Under the background of increasing difficulty and continuous decline of generic drug profits, improved new drugs have become a research hotspot for many generic drug companies
.
Especially under the guidance of national policies, the development momentum of the domestic improved new drug market is getting stronger and stronger
.
It is worth noting that, benefiting from the attraction of market prospects, while the number of domestic improved new drug applications is increasing, the number of companies entering the market is also increasing
.
It is understood that China's current companies that mainly focus on two types of new drugs can be divided into two categories: one is innovative drug companies with a certain scale, represented by Luye and Kelun; the other is new drug DDS platform companies, with transoceanic companies Companies such as medicine and Kexinbicheng are represented
.
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
.
For example, pharmaceutical companies can predict the direction and make arrangements in advance according to the trend
.
In addition, companies also need to take into account future product sales, clinical demand, and market demand, and target improved new drug targets, 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 the R&D personnel of pharmaceutical companies, if they want to seize the opportunity, they need to hurry up the layout
.
.
In the context of the rapid production of Class 1 innovative drugs, its "close relatives" Class 2 improved new drugs have also begun to usher in a research and development climax
.
It is understood that Category 2 refers to "improved new drugs that have not been marketed at home and abroad, which refer to the optimization of their structure, dosage form, prescription process, route of administration, indications, etc.
on the basis of known active ingredients, and have obvious Drugs of Clinical Advantage"
.
According to data, from 2019 to 2021, the overall trend of registration acceptance of 2 types of improved new drugs for chemical drugs is an upward trend
.
The total number of acceptances has risen from 188 in 2019 to 418 in 2021, with an annual growth rate of nearly 49%; among them, the number of INDs has risen from 141 in 2019 to 304 in 2021, with an annual growth rate Nearly 47%; in addition, in terms of new drug & import classification, it has also increased from nearly flat in 2019 to nearly 2 times, and the number of acceptance numbers of domestic improved new drugs has achieved an annual growth rate of 64%
.
Industry analysts believe that two types of improved new drugs have been approved continuously in recent years, mainly because improved new drugs have the characteristics of high clinical success rate, high profit, and low risk.
Under the background of increasing difficulty and continuous decline of generic drug profits, improved new drugs have become a research hotspot for many generic drug companies
.
Especially under the guidance of national policies, the development momentum of the domestic improved new drug market is getting stronger and stronger
.
It is worth noting that, benefiting from the attraction of market prospects, while the number of domestic improved new drug applications is increasing, the number of companies entering the market is also increasing
.
It is understood that China's current companies that mainly focus on two types of new drugs can be divided into two categories: one is innovative drug companies with a certain scale, represented by Luye and Kelun; the other is new drug DDS platform companies, with transoceanic companies Companies such as medicine and Kexinbicheng are represented
.
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
.
For example, pharmaceutical companies can predict the direction and make arrangements in advance according to the trend
.
In addition, companies also need to take into account future product sales, clinical demand, and market demand, and target improved new drug targets, 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 the R&D personnel of pharmaceutical companies, if they want to seize the opportunity, they need to hurry up the layout
.