At present, innovation has become the development trend
of domestic and foreign pharmaceutical companies.
However, it should be noted that in the case of increasingly difficult to develop new targets and increasing competition for generic drugs, for generic drug companies that cannot undertake innovation and transformation, improved new drugs are obviously gradually becoming the main choice
for many enterprises.
It is understood that improved new drugs refer to drugs that are optimized on the basis of known active ingredients, such as structure, dosage form, prescription process, route of administration, indications, etc.
, and have obvious clinical advantages, and are not listed at home and abroad, and are registered and classified as 2 categories
.
The improved new drug is a marketed drug optimized for the known active ingredient, and the binding target, mechanism of action, pharmacodynamic data, pharmacokinetic data, efficacy evidence and safety characteristics of the improved drug are relatively clear
.
Because compared with generic drugs, improved new drugs, whether it is structural improvement, dosage form improvement, new compound preparation or new indications, have certain technical or patent barriers; And compared with generic drugs, there is a monitoring period of 3 to 4 years, the life cycle is significantly lengthened, the rate of return is also significantly improved, etc.
, so in recent years, the domestic development process is accelerating, but also attracting more and more pharmaceutical companies layout
.
For example, on September 20, Health Yuan issued an announcement that the company recently received the approval of the State Drug Administration to issue the "Drug Clinical Trial Approval Notice" on XYP-001, agreeing to carry out clinical trials
of this product for idiopathic pulmonary fibrosis 。 Health Yuan said that XYP-001 is an improved new drug developed by the company's layout, which was accepted on July 15, 2022, with the acceptance number CXHL2200508, which is intended to be used for the treatment of idiopathic pulmonary fibrosis (IPF), and if successfully developed, it will provide a new and safer drug choice
for patients with idiopathic pulmonary fibrosis.
As of the announcement, the cumulative R&D investment of the Health Dollar XYP-001 is approximately RMB19.
3 million
.
On June 15, Jiudian Pharmaceutical announced that the company recently received the "Drug Clinical Trial Approval Notice" issued by the State Drug Administration for the improved new drug PDX-03, and will carry out clinical trial research
after completing the relevant preparatory work.
According to the data, PDX-03 is a non-steroidal anti-inflammatory drug for external use, and no product is currently in clinical trial stage at home and abroad, and no product has been approved for marketing
at home and abroad.
In addition to the above drugs, according to incomplete statistics, in the nearly 5 years from January 2016 to March 2022, the registration and acceptance of chemical drugs and 2 types of improved new drugs has shown an
increasing trend, and there have been more than 400.
Among them, it will increase significantly in 2021, twice
the total in 2020.
While the number of new drugs continues to grow, in fact, China's improved new drug market as a whole is also showing a rapid growth trend
.
From 2016 to 2020, the size of China's improved new drug market has increased from 261.
39 billion yuan to 323.
99 billion yuan, and it is expected that the market will reach 432.
63 billion yuan
by 2022.
The industry believes that with the drive of national favorable policies and the continuous expansion of the market, the research and development of improved new drugs will accelerate into the fast lane
in the future.
