The eighth batch of national varieties of drugs is a big conjecture

0+4 or 1+3 has become a new basis for entering the country, and the competition pattern of 95 drug markets has met the original research + evaluation enterprises≥4, in addition, the biological drug market also has a certain scale, and the conditions for full competition have been reached
.
What varieties will be introduced in the eighth batch of national harvesting, it is worth looking forward to!

On July 18, the National Joint Procurement Office announced the results of the seventh batch of national drug centralized procurement, and clarified that it will be officially implemented
in November 2022.

According to the statistics of the Pharmaceutical Cloud Studio, 15 provinces (cities) have issued documents to land the results of the seventh batch of national procurement, of which 5 provinces have clarified the specific implementation time
.

Henan: From November 1, 2022

Gansu: November 15, 2022

Xinjiang: November 2022

Hainan: around the end of November 2022

Shanghai: Expected in late November

As the dust settles on the seventh batch of national mining, industry insiders predict that the news of the eighth batch of national mining will come out
in November.
As for whether the threshold for inclusion will be raised, some people in the industry believe that the eighth batch may meet 4+1/5+0 or 5+1/6+0 before it can be included
.

Previously, some official media issued an article saying that since the second batch of national procurement, the trigger threshold has been 3, and since the seventh batch has been adjusted to ≥4, the competition pattern continues to open
.
With the increase in the number of rated companies, the maximum number of shortlisted companies will increase
accordingly.
In the long run, market stability and supply are more assured
.

What the entry threshold of Article 8 looks like depends on the final procurement documents
.
But in the current competitive landscape, 5+1/6+0 should not be very
likely.

In terms of chemical drugs, according to the statistics of the Pharmaceutical Cloud Studio, as of October 23, 2022, there are 4 ≥ of 95 varieties of original research + evaluation enterprises among the varieties not included in the national collective procurement, and 53 varieties
are also collected by 5 enterprises.

Of course, not all of these 95 varieties are suitable for inclusion in national collective procurement, and for some special varieties, such as anti-epidemic and national reserve drugs, they are generally not suitable for inclusion in collective procurement
.
It is usually included in national reserves and is not easily collected
.

In addition, like amlodipine atova, ivabradine, because they are new drugs on the market, the current market sales are not large, not tested by the market, considering the quality factors are uncontrollable, may not be included in the national centralized procurement
so quickly.

There are also oral rehydration salt powders that are included in the "List of Chemicals with Clear Clinical Value and Cannot Recommend Reference Preparations (First Batch)" (Publicity), as well as products such as alogliptin and sitagliptin whose patents have not expired, are also not suitable for inclusion in national centralized procurement
.

In addition to chemical drugs, the call for biosimilars to be included in national procurement in recent years is also very high
.
The National Health Insurance Administration has also issued news many times, intending to release "biosimilars into centralized procurement"
.
At present, after insulin has been explored and practiced in Wuhan, the national special organization has collected and gained certain experience
.

Although biosimilars started late in China, progress has accelerated
in recent years.
Adalimumab analogues have been approved for marketing by 6 companies, including Bio-Thera, Hisun Pharmaceutical, Innovent Corporation, Henlius, CP Tianqing, and Junshi Biologics; Bevacizumab analogues have been approved by 8 companies including Qilu Pharmaceutical, Innovent Biologics, and Luye Pharmaceutical, and the first biosimilar of trastuzumab has also been approved for marketing
.

In addition, in addition to the above-mentioned enterprises, more than 10 pharmaceutical companies such as Hengrui and Luye are applying for listing or entering the clinical trial stage, and biosimilars will appear in the next few years, forming a more full competitive state and meeting the basic premise of
volume procurement.
From the perspective of the competition pattern of the domestic biosimilar market, it has reached sufficient competition conditions, and it has also reached a certain scale
from the perspective of market size.

For PD-1/L1 products, the medical insurance payment standard is currently determined through national price reduction, and the purpose of price reduction has been achieved
at least during the 2-year agreement period of medical insurance.
At present, the competition of PD-1 itself is still very fierce, and there are still a large number of similar drugs that have entered the clinical stage after the price reduction, and such drugs can achieve price formation through market competition, so the industry believes that it is of little significance to be included in the national centralized procurement
.