Innovative drug research and development is difficult, and the research and development of first-in-class cannot be blind

According to the FDA's definition, a drug granted first-in-class designation refers to a drug
that uses a completely new and unique mechanism of action to treat a certain disease 。 In recent years, with the rapid development of pharmaceutical technology and the support of favorable pharmaceutical innovation policies, the innovative drug industry has developed rapidly, including PD-L1, CD3, CD19, HER2 and other targets have been fiercely competitive, in order to pursue innovation and improve competitiveness, more and more innovative drug companies try to explore first-in-class research and development from me-too, me-better innovative drug development
model 。 According to incomplete statistics, in the 20 years from 1999 to 2018, the FDA approved a total of 620 new drugs, of which only 194 were granted first-in-class qualification
.
Among them, in 2021, there were only 27 first-in-class drugs
approved by the FDA.
The analysis pointed out that there are many difficulties in the research and development of innovative drugs, and the research and development of an original innovative drug, from R&D project approval to successful market entry, takes a long time and high cost, which are the challenges that pharmaceutical companies need to face, and it is also the reason why First in Class is difficult to
succeed.
According to the data, the average cost of original innovative drug research and development, including silent costs, is already as high as 2.
6 billion US dollars
.
In addition, although in theory, if the technology is in place, the funds and time are sufficient enough, even if the pipeline at the forefront fails, it can develop the first-in-class
in the later stage.
However, from the failure cases, most of the new mechanism drugs have not entered the clinic, or the progress is slow or stagnant soon after entering the clinic, and they are gradually eliminated
by new innovative drugs with better efficacy 。 In this regard, many industry people believe that the research and development of first-in-class can not be blind, although the lack of first-in-class is the status quo of the domestic new drug research and development industry, but compared with the West, the domestic drug research and development capacity gap is still relatively large, short-term to make a large span of original drugs will be more difficult, in the process of new drug research and development, pharmaceutical companies need to keep trying, failure is the norm, only on the basis of scientific research, steady investment in research and development, Only in the future can more First-in-Class be born
.
In addition, from the patient's point of view, the advantage of domestic innovative drugs is that they can reduce the burden on patients and increase the coverage population, which is also a factor
that pharmaceutical companies need to consider.
It is worth affirming that whether it is fast-follow or first-in-class, drug development needs to be patient-centric, clinically value-oriented, and address unmet clinical needs
.
At present, many people in the industry are pinning their hopes on AI pharmaceuticals, believing that there is already artificial intelligence to help drug research and development, artificial intelligence + chemical synthesis + biology, and many original innovative drugs
are expected to appear in the future.
It is understood that the main scenarios of the combination of artificial intelligence and drug research and development include drug target prediction, high-throughput screening, drug design and prediction
of important characteristics such as drug absorption, distribution, metabolism, excretion and toxicity.
The application of artificial intelligence technology to the field of new drug design can not only greatly shorten the development cycle of new drugs, but also effectively improve the success rate and effectively predict
side effects such as drug activity and safety.
In recent years, more and more companies have been involved in the field of AI pharmaceuticals, using artificial intelligence to empower different fields of
drug research and development.
According to statistics, by 2025, the domestic AI pharmaceutical market size will reach about 7.
2 billion yuan, and by 2035, the market size of self-developed pipelines will be about 68 billion yuan, and the market size of foreign cooperation pipeline research and development will be about 135 billion US dollars, plus other related income, the total domestic market size will exceed 200 billion yuan
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice
to anyone.