Improved new drugs become a new "blue ocean", and there will be three major trends in future development

Improved new drugs refer to drugs whose structure, dosage form, prescription technology, route of administration, indications, etc.
are optimized on the basis of known active ingredients, and have obvious clinical advantages, and are not marketed at home or abroad
.
Compared with new molecular entities, improved new drugs have lower R&D risks and lower investment costs
.
Compared with generic drugs, improved new drugs have high technology or patent barriers, long life cycles and high return rates
.
Relying on the above advantages, in recent years, as the development of new targets has become more difficult and the competition for generic drugs has become increasingly fierce, for pharmaceutical companies that cannot afford the huge cost of original innovation, improved new drugs are becoming a new hot spot for their research and development
.
According to data, as of October 2019, there have been 329 improved new drug applications (including APIs, counted by acceptance number), involving 129 active ingredients and 159 companies
.
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) has more acceptance numbers, accounting for nearly 60%; followed by category 2.
2 (new dosage forms) ; Class 2.
1 (modified crystal form) and Class 2.
3 (new compound preparation)
.
From the data point of view, the industry believes that China's innovative preparation technology is catching up and continuously narrowing the gap with foreign countries
.
It is reported that there was a big gap between the level of preparation innovation in China and foreign countries in the past
.
Except for some follow-up innovations (such as freeze-dried orally disintegrating tablets), there is a large gap in preparation technology innovation compared with foreign levels
.
However, at present, the number of improved new drugs is increasing year by year, and the number of companies entering the market is also increasing.
China's innovative formulation technology is catching up, innovative formulation platforms have begun to be established, and a variety of formulations are in the pipeline
.
It is reported that China Biopharmaceuticals, Luye Pharmaceuticals, Hengrui Pharmaceuticals, Fosun Pharma, CSPC and other companies have already begun to actively deploy the improved drug market
.
Among them, sustained and controlled-release oral solid preparations, oral mucosal administration and new injections are gradually becoming the new focus of research and development.

.
The analysis believes that by judging the current domestic development trends, benchmarking overseas, and taking into account the scientific nature, in the future domestic improved new drug research and development, China's improved new drug will usher in the blue ocean of development, but there is also a huge room for development
.
Therefore, in the future, we need to continue to develop more improved new drugs based on clinical needs; second, we must carry out a differentiated layout and explore in multiple directions to avoid increased R&D risks due to too fierce competition; third, do not limit to a pure drug delivery system (DDS) improvement, but also to improve the synthesis and improvement capabilities of new APIs, which can not only achieve high-quality improvement and innovation, but also lay the foundation for innovation and transformation at the source
.
In general, improved new drugs have low R&D costs and short time due to improvements on the basis of original drugs, as well as significant product features and clinical advantages, and they have greater advantages in market competition
.
Therefore, under the current situation that it is becoming more and more difficult to develop new targets, improved new drugs may become a very good choice for generic drug companies that cannot undertake innovation and transformation
.