2022 China's new drug FDA chapter

Entering February 2022, there are various views on the experience of Chinese new drugs going overseas that are hotly discussed in the Chinese pharmaceutical circle, but there are not many views that hit the point, mainly ignoring the essence of the incident

The current status of new drugs in China:

I recently wrote an article on the exploration of the new drug concept of "figuring out what a new drug is", which objectively sorted out the commonly used new drug concepts

The objective reason for this phenomenon is that in the past 100 years, China has not been able to discover any new targets that can be turned into drugs, nor is it the way to find new drugs through HTS to find hits.

It can be seen that under the circumstance that China does not have the two most basic elements for new drugs, the ME COPY new drugs made purely by imitation and structural modification are still considered by a few people as new drugs, so the misunderstanding of the concept of new drugs is subjective.

However, by 2022, most people in the Chinese pharmaceutical industry are already ignorant of what is a real new drug, although they are reluctant to admit that basically no one does not understand that China's new ME COPY drug is really not a new drug

Why do Chinese new drugs go overseas?

China produces the largest number of new drugs in the world every year, but it can only exist in the special market of China, which is not even recognized by Myanmar and Laos

As a new drug of ME COPY, there is no innovation, and there will be no exclusive clinical and commercial opportunities.

In fact, this idea seems very reasonable, but it is of no use.

Therefore, the new ME COPY drugs that go overseas based on the inward pressure in the domestic market are doomed to be hopeless

How can a new drug in China be approved by the FDA?

The basic standard for FDA approval of new drugs has not changed, that is, to address unmet clinical needs in a safe and effective manner

New drugs are commercial science, and the FDA is mainly responsible for scientific evaluations.

The most important part that affects the approval of a new drug is the data of Phase III clinical trials, but the commercial scientific characteristics of new drugs make pharmaceutical companies focus not on the FDA but on the payer when designing Phase III clinical programs, that is, the new drug must be proven through Phase III clinical trials.

At present, China's new ME COPY drugs cannot solve a clinical unmet need, and of course they cannot pass the clinical proof period of pharmaceutical economic value

Secondly, will the entry of new ME COPY drugs into the international market reduce payers' fees to save money for overseas people? Only this idea can be said that the pattern is broken

In fact, in the past, the FDA did not know about the new ME COPY drug from China, and did not understand why it was an analog that was inferior to 505B2, so it must be registered as a new drug.

New ME COPY drugs waste a lot of money and clinical resources in China, because there are not many real new drugs in China at present, so ME COPY new drugs do not pose a threat to real new drugs in China for the time being

So what kind of new Chinese drugs can go overseas and be recognized by the FDA and global payers? It is still necessary to return to the starting point of the new drug.
If this new Chinese drug solves a clinical need that cannot be solved by other drugs in the world, then both the FDA and the global payers must hope to accept this new Chinese drug as soon as possible.
This is the value of the real new drug.
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