24 companies "besieged" AZ's original research drug!

On February 17, the Shanghai Sunshine Pharmaceutical Purchasing Network issued the "Notice on Carrying out the Reporting of Drug Information Related to the Seventh Batch of Centralized Procurement of State-Organized Drugs".
From February 18, 2022, the Joint Procurement Office will carry out the seventh batch of state-organized drugs.
Centralize the filling and reporting of drug information related to procurement
.
After sorting out, the filling and reporting of domestically sourced drugs involves a total of 208 product regulations and 198 enterprises (according to enterprise groups)
.
Among the 29 multinational pharmaceutical companies, Pfizer leads the way with 5 products, followed by Roche and Novartis with 4 products, Merck and AstraZeneca have 3 products; among the 169 local companies, Qilu Pharmaceuticals has the largest number of products.
, involving a total of 16 products, followed by Kelun involving 13 products; companies with 5 or more models also include Chia Tai Tianqing, CSPC, Hengrui Medicine,
etc.
From the perspective of industry insiders, with the normalization of centralized drug procurement, the direction of price reduction for original research drugs that have expired patents has been very clear.
Coupled with the gradual advancement of consistency evaluation, large varieties of over-reviewed generic drugs are increasing day by day, which has also caused huge damage to original research drugs.
Influenced, local pharmaceutical companies are gradually realizing domestic substitution in many aspects and moving towards a broader market
.
18 large varieties of over 1 billion have been included, and up to 24 pharmaceutical companies have been evaluated.
The seventh batch of domestically sourced drugs has involved a total of 58 varieties and 208 product regulations
.
Among them, there are about 18 large varieties with a market size of more than 1 billion yuan, including omeprazole injection, nifedipine sustained-release/controlled-release dosage form, cefixime oral normal-release dosage form, cefmetazole injection, cefminox injection , Bromhexine Injection, Oseltamivir Oral Sustained-Release Formulation,
etc.
Judging from the number of companies that have over-evaluated varieties, the largest variety is omeprazole injection.
A total of 24 generic drugs have passed the consistency evaluation, and the competitive pressure of centralized procurement is high
.
Relevant data show that in 2020, the domestic medical market sales of omeprazole sodium injection will be 5.
21 billion yuan, ranking first in sales of similar injection products for the treatment of peptic ulcer
.
According to the terminal data of Chinese public medical institutions in 2020, Osaikang's market share is 41.
55%, followed by the original pharmaceutical company AstraZeneca with 14.
31%
.
This time, local pharmaceutical companies are expected to take the opportunity of centralized procurement to further expand their market share
.
It is worth mentioning that esomeprazole enteric-coated tablets and enteric-coated capsules, which are clinically similar drugs of omeprazole sodium injection, have been included in the fourth batch of national procurement, and esomeprazole injection has been included in the The fifth batch of national mining
.
According to data from Minet.
com, in 2020, the sales of esomeprazole injection in China's urban public hospitals, county-level public hospitals, urban community centers and township health centers will exceed 3 billion yuan
.
There are more than 30 manufacturers of this product, including AstraZeneca, Chia Tai Tianqing Pharmaceutical Group, Osaikang Pharmaceutical, and Yangzijiang Pharmaceutical Group
.
In recent years, with the development of domestic pharmaceutical companies, AstraZeneca's market share has gradually declined, from monopolizing the market in 2015 to 51% in 2019, and has fallen below 50% in 2020
.
Since the sales channels of injection varieties are mainly in hospitals, it is difficult to expand outside the hospital.
With the promotion of the procurement policy in various provinces, even the original prescription drug products of multinational pharmaceutical companies with strong brands will become increasingly sluggish in the hospital market
.
In addition, tenofovir alafenamide oral normal-release dosage form, clindamycin phosphate injection, cefixime oral normal-release dosage form, and nifedipine sustained-release/controlled-release dosage form have also been reviewed by more than 10 generic pharmaceutical companies
.
Among them, the domestic patent of tenofovir alafenamide oral normal-release dosage form has expired in July 2021, and the original manufacturer Gilead will still monopolize the market in the first half of 2021
.
At present, the products of 12 companies including Guangshengtang, Chengdu Yuandong, Kelun Pharmaceutical, Qilu Pharmaceutical, Chengdu Beite, and Chia Tai Tianqing Pharmaceutical have been reviewed, and the competition for centralized procurement is also very fierce
.
The competition situation of some of the original research drugs in the seventh batch of national procurement As far as the structure of the varieties involved in centralized procurement is concerned, the situation of the seventh batch of national procurement is most similar to that of the fifth batch.
The injections involved in these two batches are not only large in quantity, but also account for a large proportion.

.
Looking back at the past national procurement, one to three batches only included oral dosage forms, the fourth batch included injections for the first time, and then the fifth batch began to tilt towards injections, with the proportion of injections reaching 48%, the sixth batch was special centralized procurement of insulin, and the seventh batch From the perspective of filling in the catalogue, the proportion of injections reached 46.
5%
.
It is expected that with the advancement of the consistency evaluation of injections, the pace of centralized procurement of injections will be accelerated
.
Industry insiders predict that because injections are mainly sold in hospitals, the out-of-hospital market is almost negligible.
If they are not selected, they will give up most of the market.
Therefore, foreign companies have to participate in national procurement because they are not willing to give up the in-hospital market
.
From the perspective of the fifth batch of national procurement, a total of 58 products from foreign companies were involved, of which 53 participated in the quotation, with a participation rate of 91%.
In the end, 11 products from 10 multinational pharmaceutical companies were selected, the largest number of national procurement ever
.
The seventh batch of national procurement has begun, and the choice of multinational pharmaceutical companies is still the main focus
.
Domestic substitution greatly accelerates the normalization of centralized procurement and the normalization of multinational pharmaceutical companies "do not advance or retreat" With the continuous improvement of the quality of generic drugs in China, the continuous progress of the consistency evaluation work, and the normalization of centralized procurement, the market competition of original research drugs with expired patents The power is gradually weakened, and the substitution of generic drugs is accelerating
.
Previously, the China Medical Insurance Research Association compared the centralized procurement results for 9 drugs, including atorvastatin oral normal-release dosage form, amlodipine oral normal-release dosage form, and entecavir oral normal-release dosage form, based on incomplete statistics on the national situation.
Changes in prices and purchases from one year to the next
.
The study shows that the “substitution effect” of the selected generic drugs on the unselected original research drugs is obvious.
One year after the implementation of the centralized procurement results, the total national annual purchase volume of the unselected original research drugs decreased by an average of 46% compared with the year before the implementation of the centralized procurement results.
Generic drug purchases fell even more, by more than 80%
.
The total annual purchase volume of selected generic drugs increased by 265.
2%, of which omeprazole oral normal-release formulation increased the most, reaching 522.
6%; followed by amlodipine oral normal-release formulation, which increased by 506.
5%; imatinib has the smallest increase.
Oral normal release agent, also reached 54.
5%
.
At the same time, the total annual purchase volume of 9 drugs by generic name increased by 23%
.
In terms of the proportion of the total annual purchases of drugs with the same generic name in the country, the original research drugs dropped from 28.
9% in the year before the implementation to 12.
7%
.
With the advancement of centralized procurement, the enthusiasm of foreign companies to participate has also continued to increase
.
On December 6, 2018, the "4+7" centralized procurement pilot was launched.
Among the 25 selected varieties, AstraZeneca became one of the few original pharmaceutical companies that won the bid, and was finally selected at a price of 547 yuan, a drop of more than 76%
.
In the fifth batch of national procurement, 11 products from 10 foreign companies were selected.
Compared with the previous number of winning bids, there were only about 2 to 4.
The participation of foreign companies has increased significantly, and some pharmaceutical companies have reduced prices by more than 70%
.
For example, on the colon cancer drug oxaliplatin injection, Sanofi offered a price of 310.
51 yuan per box, a drop of as much as 82%; GlaxoSmithKline's dutasteride soft capsule was priced at 3.
1 yuan per tablet, also lower than The generic drug company Shengdi Pharmaceutical’s price is 3.
31 yuan per tablet
.
With the normalization of centralized procurement, the era of long-term high premiums for original drugs with expired patents in China is coming to an end
.
On the one hand, the attitude of multinational pharmaceutical companies towards purchasing with volume has gradually changed from wait-and-see to proactive, and more and more original research drugs have been added to purchasing with volume
.
On the other hand, bulk purchases give the reviewed drugs and the original research drugs a fair chance to compete, and promote the replacement of the original research by imitations
.