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In the context of accelerated changes in the development of the pharmaceutical industry, innovation has become the main development trend of global pharmaceutical companies
.
It is worth noting that under the background of the rapid production of Category 1 innovative drugs, its "close relatives" Category 2 improved new drugs have also begun to usher in a research and development climax
.
Improved new drugs are improvements to already marketed drugs, emphasizing "superiority" and having the advantages of high success rate, low risk, and long life cycle
.
In recent years, under the background of the increasing failure rate of new drug R&D, the increasing difficulty of new target development, and the continuous decline of generic drug profits, improved new drugs have become a mainstream on the difficult road of new drug R&D
.
Data show that after the reform of China's drug registration classification, more and more companies are participating in the R&D and production of improved new drugs
.
For example, on April 20, CSPC announced that the cisplatin micelle injection developed by its subsidiary Zhongqi Pharmaceutical Technology (Shijiazhuang) Co.
, Ltd.
has been approved by the State Drug Administration for clinical trials in China
.
The clinical indications approved this time are advanced malignant solid tumors.
The product belongs to Category 2 of the Chinese chemical drug registration classification.
Currently, there is no similar product on the market in the world
.
Coincidentally, according to the information on the CDE website, the clinical application of Qilu Pharmaceutical's 2.
2 improved new drug oseltamivir phosphate oral dissolving film has also been accepted
.
Oseltamivir is a specific inhibitor of neuraminidase, which can inhibit mature influenza virus from leaving host cells, thereby inhibiting the spread of influenza virus in the human body to play a role in the treatment of influenza
.
It is reported that Qilu Pharmaceutical is the first domestic company to develop oseltamivir oral dissolving film
.
It is understood that currently benefiting from the attractiveness of the market prospects, the number of domestic improved new drug applications is increasing, and the number of improved new drugs on the market is also increasing
.
The data shows that 19 new improved chemical drugs have been approved for marketing since 2020, of which 13 will be in 2021
.
So far in 2022, four have been approved
.
At present, many companies are still increasing the layout of improved new drugs
.
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 fact, in recent years, with the improvement of the research and development capabilities of domestic pharmaceutical companies, some high-barrier technologies, such as liposomes, microspheres, oral dissolving 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 the market have shown a trend of skyrocketing in the terminal market every year, and some improved new drugs are still under medical protection, and they have also quickly occupied a high ground in the market
.
In addition, nervous system, systemic anti-infection and anti-tumor are also popular research and development positions for improved dosage forms
.
In this context, the industry expects that the number of applications for improved new drugs will continue to grow in the future, and more improved new drugs will be launched one after another, benefiting more patients
.
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 keep abreast of policy directions when developing new and improved drugs, and enhance their overall view and foresight
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
.
It is worth noting that under the background of the rapid production of Category 1 innovative drugs, its "close relatives" Category 2 improved new drugs have also begun to usher in a research and development climax
.
Improved new drugs are improvements to already marketed drugs, emphasizing "superiority" and having the advantages of high success rate, low risk, and long life cycle
.
In recent years, under the background of the increasing failure rate of new drug R&D, the increasing difficulty of new target development, and the continuous decline of generic drug profits, improved new drugs have become a mainstream on the difficult road of new drug R&D
.
Data show that after the reform of China's drug registration classification, more and more companies are participating in the R&D and production of improved new drugs
.
For example, on April 20, CSPC announced that the cisplatin micelle injection developed by its subsidiary Zhongqi Pharmaceutical Technology (Shijiazhuang) Co.
, Ltd.
has been approved by the State Drug Administration for clinical trials in China
.
The clinical indications approved this time are advanced malignant solid tumors.
The product belongs to Category 2 of the Chinese chemical drug registration classification.
Currently, there is no similar product on the market in the world
.
Coincidentally, according to the information on the CDE website, the clinical application of Qilu Pharmaceutical's 2.
2 improved new drug oseltamivir phosphate oral dissolving film has also been accepted
.
Oseltamivir is a specific inhibitor of neuraminidase, which can inhibit mature influenza virus from leaving host cells, thereby inhibiting the spread of influenza virus in the human body to play a role in the treatment of influenza
.
It is reported that Qilu Pharmaceutical is the first domestic company to develop oseltamivir oral dissolving film
.
It is understood that currently benefiting from the attractiveness of the market prospects, the number of domestic improved new drug applications is increasing, and the number of improved new drugs on the market is also increasing
.
The data shows that 19 new improved chemical drugs have been approved for marketing since 2020, of which 13 will be in 2021
.
So far in 2022, four have been approved
.
At present, many companies are still increasing the layout of improved new drugs
.
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 fact, in recent years, with the improvement of the research and development capabilities of domestic pharmaceutical companies, some high-barrier technologies, such as liposomes, microspheres, oral dissolving 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 the market have shown a trend of skyrocketing in the terminal market every year, and some improved new drugs are still under medical protection, and they have also quickly occupied a high ground in the market
.
In addition, nervous system, systemic anti-infection and anti-tumor are also popular research and development positions for improved dosage forms
.
In this context, the industry expects that the number of applications for improved new drugs will continue to grow in the future, and more improved new drugs will be launched one after another, benefiting more patients
.
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 keep abreast of policy directions when developing new and improved drugs, and enhance their overall view and foresight
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
