High success rate, fast return, new hot spot for research and development of improved new drugs

Improved new drugs are improved on the basis of the original drugs and have a certain clinical basis.
Most products do not require complete clinical trials and have a greater advantage in market competition
.
At present, as the global failure rate of new drug R&D is getting higher and higher and the development of new targets is getting harder and harder, for companies that cannot undertake innovation and transformation, improved new drugs have become the main choice for new drug R&D
.
In China, with the continuous advancement of medical reform, under the influence of factors such as the normalization and standardization of national procurement and provincial centralized procurement, and the increasing pressure on the generic drug market, improved new drugs have also become a hot trend in domestic new drug research and development
.
It is worth noting that this mainstream trend is still accelerating brewing, judging from the declarations made by domestic pharmaceutical companies in recent years
.
According to data, as of the end of March 2021, CDE has announced 787 new drug acceptance numbers for category 2 chemical drugs, of which category 2.
4 (new indications) accounted for the majority, accounting for nearly 60%; followed by category 2.
2 ( New dosage form); Class 2.
1 (modified crystal form) and Class 2.
3 (new compound preparation)
.
In addition, over 1 billion large varieties of modified dosage forms are even more popular
.
In this regard, the industry believes that there are two main reasons for this phenomenon
.
On the one hand, these large varieties have been on the market for many years, the clinical safety and effectiveness have been recognized, and the market foundation is strong.
The new dosage form will have more advantages in similar products, and it will be easier to quickly obtain the approval of doctors and patients after the market; on the other hand; It is because, in the general atmosphere of centralized procurement, some large-variety generic drug manufacturers have completed one or more rounds of shuffling, freeing up more space for new drugs (including improved new drugs) for cultivation
.
Therefore, thanks to the above benefits, the number of domestic improved new drug declarations is still increasing, and at the same time, the number of companies entering the market is also increasing
.
It is understood that my country’s current companies focusing 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 a new drug DDS platform company, with overseas Pharmaceuticals, Kexin Bicheng and other companies are represented
.
The analysis believes that compared with generic drugs, improved new drugs have a monitoring period of 3-4 years, their life cycle is significantly longer, and the rate of return has also increased significantly.
Therefore, as more and more pharmaceutical companies enter this field in the future, domestic improved new drugs The development process will also continue to accelerate
.
In general, 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 development of improved new drugs.
The point is that some products that have been approved for marketing have been cultivated for a short period of time, and the terminal market is also showing a trend of skyrocketing year after year
.
In the future, under this background, more and more companies are expected to regard improved innovation as the key to future development
.
However, it is worth noting that in some popular areas, such as the nervous system, systemic anti-infection and anti-tumor drugs, the competition between pharmaceutical companies may become more and more fierce
.