True and false innovation, self-discrimination when the Tathagata is indistinguishable

This is not only a problem of disorderly competition and waste of resources.
For patients, ineffective trials may also delay their optimal treatment time
.

In an interventional clinical trial, without withdrawing the informed consent, the subjects must strictly follow the trial protocol to receive treatment, and cannot freely choose the treatment drugs/plans.
Therefore, they should try to provide the subjects with the best clinical practice.
The best treatment methods/drugs should not be used to improve the success rate and efficiency of clinical trials, and should not choose treatments that have uncertain safety and effectiveness or have been replaced by better drugs
.

On the other hand, the research and development of new drugs should provide patients with better treatment options as the highest goal.
When selecting non-optimal treatments as controls, even if the clinical trials reach the preset research goals, it cannot be said that the experimental drugs can meet the clinical needs of patients.
Actual need, or unable to prove the value of the drug to patients
.

Although the "Principles" does not require a "head-to-head" trial, in clinical trials, if a low-standard control is selected to achieve the effective endpoint, it will not be reviewed from the beginning
.

Although the tumor line only occupies a part of pharmaceutical companies, the specific pipeline involved in the document is part of this part, and the overall does not have such a big impact on pharmaceutical companies
.
CRO's stock price plummeted and rose again, which is also a self-regulation after the market overreacted
.
But the "Principles" shows a direction and trend in the future-pharmaceutical companies that focus on the me-too market must achieve transformation and move towards true innovation.
The winner is king and the loser is eliminated
.

"True" innovation is the future trend

On the road to "true innovation", the first change we saw was a change in investment philosophy
.

If risks are not taken into consideration, the average development cost of a single innovative drug is about 1.
5 billion yuan.
If the past investment focuses on operation and revenue, then current investment is more inclined to innovation, that is, enterprise technology and talents
.
Venture capital and private equity investment in China's pharmaceutical and medical field has increased from 12 billion in 2015 to 185 billion in 2020, which has expanded 15 times, with one third of which focused on new drug research and development
.
Refined to enterprises, such as BeiGene, according to the published financial report, its sales revenue in 2020 will total about 300 million US dollars, research and development investment of about 1.
29 billion US dollars, a net loss of 1.
6 billion US dollars, and a total investment of 4.
66 billion US dollars
.

The second is the pipeline layout from pharmaceutical companies
.

When a new drug is attracting investment, it has to be over billions of dollars.
But in fact, it is settled in the terminal market, because various factors such as centralized procurement have to be taken into account.
Maybe the median for everyone in the end can only be It fell to tens of millions
.
This way, it will not support the development of an enterprise for a long time.
What should we do? The current strategy is to increase pipelines
.
This is also a direction for everyone to jump out of the current homogenization competition.
After the investment is settled, they will deploy new targets that are not very crowded on the track to cover more disease directions
.
Baekje had more than 60 pipelines last year, and there will even be 100 pipelines in the future
.
The pioneers in this area are Cinda and Hengrui
.
As far as the antibody layout is concerned, the products on the left are already on the market, and the targets on the right are not on the market.
You can see the forward-looking innovation of Cinda
.
As for the success or failure, it is something later, but the change will make the change, and the general rule will be the long-term truth
.

For the CRO, there may be fluctuations in the number of orders due to policies in the short term, but in the long run, it is undoubtedly positive
.
Because there is still a considerable gap between the R&D investment of Chinese pharmaceutical companies and their international counterparts at present, that is to say, there is still a lot of room for growth in R&D investment, and this growth space will bring considerable profit growth potential to CRO
.

The third is the top-level design
.

Basic research requires long-term government investment.
The ratio of China's total investment in basic research/R&D in 2020 is 6%, while that in the United States and EU countries is generally above 15% during the same period, which has ample room for growth
.
At the same time, clinical research is transformed into actual productivity; the improvement of the regulatory approval system, the elimination of redundant processes, and the acceleration of approval; the protection of related intellectual property rights, and other measures are all measures to support the innovative drug industry
.

In the terminal, the scale of innovative drugs in China is still limited, and there is still a considerable gap between the virtues of the head.
Encouraging innovative drugs is not only an encouragement in terms of investment policies, but also pay attention to the returns of innovative drugs, such as payment and reimbursement.
If problems such as commercial insurance are stuck due to problems such as payment or hospital admission, innovative drugs will not be able to benefit patients extensively, which also violates the sincere heart of focusing on patient needs
.

As Lenin said, history is spiraling.
What is the future? Let the bullets fly for a while
.

reference:

1.
"Guiding Principles for Clinical Research and Development of Anti-tumor Drugs Oriented by Clinical Value (Draft for Solicitation of Comments)"

2.
Researcher Xiaoyi, the new policy is coming! "me-too" drugs may usher in the test of life and death!

3.
Li Jing, the macro trend of China's pharmaceutical market and the restructuring of new drug R&D patterns
.

4.
Building China's pharmaceutical innovation ecosystem-the first in a series of reports: 2015-2020 development review and future prospects
.

5.
Yaodu database