PD-1 is not new. Which new drug does the approval department prefer?

In the opinion of the approval agency, what kind of new medicine is a good medicine?

Clinical give better treatment, "can no longer provide the homogenization of content, it is of no value"

Give up PD-1

On March 5, 2021, Biotech announced that it would terminate the clinical development of its next two anti-tumor drugs

The reasons for the termination are not the same, all mentioned that "there is a higher risk of clinical development and market

After 3 months, Biotech founder and CEO Li Shengfeng told "Finance·Health", "Our PD-1 drug product line has not kept up and lags behind its peers

The PD-1 craze has faded, and there are hundreds of R&D companies crowded on this track

They are trying intensive farming in this small field.

In the eyes of a drug supervision system person, this is more like a signal released to the outside world

Li Shengfeng believes that a new direction is patients whose PD-1 treatment is ineffective

Lu Shun, director of Shanghai Lung Cancer Clinical Medicine Center, mentioned at the China International Drug Information Conference and the 2021 Drug Information Association (DIA) annual meeting that because the PD-L1 track is very crowded in China, even if a positive result is made later As a result, the value is not great

With the entry of four Chinese PD-1 drugs into the medical insurance list, this new drug battle has come to an end

From a commercial point of view, even if the company is now struggling to get a PD-1 on the market, but there are already seven or eight similar drugs on the market, this may also be a failed business practice

"For companies that do PD-1 R&D now, if the product has not yet been launched, the commercial value may be more difficult to realize

The first PD-1 product in 2019, the expected annual treatment cost is about 187,200 yuan.

At present, 6 domestic PD-1 monoclonal antibody products have been approved, 3 products are applying for marketing, and 7 are in phase III clinical stage

The above-mentioned people in the drug supervision system have learned that there are not a few who have given up Phase III clinical trials

The "door-closing effect" in the approval of innovative drugs

As a lung cancer doctor, Wu Yilong, director of life at Guangdong Provincial People's Hospital, mentioned on more than one occasion, do you need so many similar PD-1 drugs?

In the DIA annual meeting, Wu Yilong believed that after a good new drug was approved in the past, its life cycle in the market would be at least about ten years
.
Now let's see how long the life cycle of the first PD-1 drug in the market is
.
Since the first listing in the previous year, similar drugs are now everywhere, and there may be more approved listings in the future
.

Wu Yilong asked the supervisory authority whether after the third or fourth similar products have been approved, should such similar products be restricted from being launched in the future?

The current domestic approval policy is that if the first product with independent intellectual property rights is approved for listing, then even if there is a domestic substitute
.

The above-mentioned drug supervision system person explained that at this time, the new phase III clinical trials of similar products cannot skip the existing products, and must be better than the existing listed drugs
.
However, if the Phase III clinical trial is already in progress at this time, it should be allowed to continue to be completed and cannot be shut out for this reason
.

This is the "door-closing effect" in the approval of innovative drugs
.

It is equivalent to everyone in the 100-meter race, with the same starting line
.
If the first one runs to the finish line, don't run again if you haven't run yet.
You are already on the track and you are allowed to finish running
.

This strategy is also based on China's existing R&D environment and market considerations
.

In the Drug Administration System view, China is no lack of innovation in drug research and development "over-enthusiastic" person, "PD-1 such projects, sixties and seventies, which is clearly not in line with the objective law"
.

On the new drug development track, the approval department hopes to retain some high-quality players
.
But now a few chemists and a few doctors started companies as soon as they got funding, saying they were innovative drug companies, and doing so was unsustainable
.

In order to retain high-quality players, regulators will continue to raise the threshold to make it both fair and a reasonable transition
.

The above-mentioned drug supervision system person said, “We cannot do it now.
As long as the first similar drug is approved for marketing, the following similar drugs will not be approved
.
Drugs that are undergoing clinical Phase III trials are also cut across the board
.
We need to pass.
The'closing effect' gradually raises technical requirements
.
"

And this kind of "closed door effect" is only for the review thinking of innovative drugs, and does not apply to the previous approval of generic drugs
.

The above-mentioned drug supervision system personnel explained that the goal of generic drugs is not to provide better treatment to the clinic, but to provide the clinic with one more treatment
.
In this case, there is no limit to how many products there are on the market, as long as the quality is the same
.

What's the next step?

In the post-PD-1 era, which type of drug will take the lead in occupying the market and breaking out of the siege?

"Look for differentiation
.
" The above-mentioned drug supervision system person said
.

The different dosage forms of PD-1 is an idea
.
Gong Zhaolong, chairman of Sidi Di, said, "We feel that we need to find a differentiated branch.
There is a difference between intravenous injection and subcutaneous injection
.
" To this end, his company and partners have invested almost 500 million yuan in research and development
.

Gong Zhaolong believes that based on the number of patients in China, the cost will definitely be recovered and it can sell a good number
.

Regarding the change of dosage form, the above-mentioned drug supervision system personnel believe that the change of dosage form such as subcutaneous injection has certain compliance advantages compared with the existing intravenous use
.
However, such advantages are not enough to skip the "door-closing effect" in research and development
.

The ongoing research and development are generally in two directions, one is dual antibody drugs, and the other is combination therapy
.

What kind of drugs will be favored, the above-mentioned drug supervision system people pointed out, the core is "good plus good
.
" To provide better treatment to the clinic, it is not worthwhile to provide homogenized content
.

The original innovative drugs have very large uncertainties, and the risk of failure is high
.
Following innovation, the probability of success is higher
.
"If we do second-hand innovation, we can avoid some detours, while meeting urgent clinical needs, and companies can quickly gain R&D experience, which is also valuable for the future
.
" The above-mentioned drug supervision system person said
.