Can the Insulin Collective Harvester and Tonghua Dongbao's leader stabilize the three multinational giants? How to break the situation?

The collection of insulin has been firmly established

Prior to this, discussions on the centralized procurement of insulin in the market have been going on for a long time, giving relevant companies a certain amount of preparation time

As early as January 2020, Wuhan City has taken the lead in launching a special volume purchase of insulin on a pilot basis, with nine pharmaceutical companies including Eli Lilly and Novo Nordisk participating

From July 15 to 16, 2020, relevant departments of the National Medical Security Administration held a symposium to listen to expert opinions and suggestions on the centralized procurement of biological products (including insulin) and Chinese patent medicines, study and improve procurement policies in related fields, and promote procurement methods Reform

The "Opinions on Promoting the Normalized and Institutionalized Development of Centralized and Volume Procurement of Drugs" issued at the beginning of 2021 also clearly stated that biosimilar drugs will be included in centralized procurement

As of August 18, the industry has flowed out a letter soliciting opinions on the "National Organization of Insulin Centralized Procurement Plan (Draft for Solicitation of Comments)"

Insulin is the largest anti-sugar drug in the market in China

The centralized procurement is mainly second- and third-generation insulin products

Head Leopard Research Institute report shows that the current global insulin preparation products are in the process of change, the first-generation insulin preparations are rarely used in clinical treatment, the second-generation insulin preparations have a gradual decline in market share, and the third-generation insulin preparations Has become the mainstream of the market, accounting for more than 60% of the global insulin market

The domestic insulin companies are relatively concentrated.

01 Will the competitive landscape of local companies change?

Unlike chemical drugs, there are not many companies involved in insulin companies

Prior to this, Tonghua Dongbao and Ganli Pharmaceutical, both of the leading insulin leaders in China, formed a tacit understanding

However, this tacit understanding was officially broken with the approval of Ganli Pharmaceutical's first second-generation insulin protamine recombinant human insulin injection (premixed 30R) in May this year

Nowadays, Ganli Pharmaceutical Co.

In order to cope with the centralized procurement, Ganli Pharmaceutical is striving to expand its international business

And Tonghua Dongbao's recombinant human insulin (second generation) injection series products will have a revenue of 2.

In addition, the strength of Hefei Tianmai Biology, an important shareholding company of China Resources Pharmaceutical Group, and United Laboratories cannot be underestimated
.
Tianmai Bio was once regarded as the "dark horse" in the insulin field, and it was also one of the winning bidders in Wuhan's centralized insulin procurement
.
Tianmai Biology has successfully developed recombinant human insulin and insulin analog raw materials and preparation products
.
In 2015, Tianmai Biotechnology and its partners jointly launched the oral insulin capsule project to develop and apply new protein-based drugs oral administration technology to fill the international gap
.
Currently, oral insulin capsules have completed phase IIb clinical trials in the United States, and international multi-center phase III clinical trials will soon be conducted in China
.

And United Laboratories is the first domestic company to have both the second-generation and the third-generation insulin production capacity
.
In 2020, United Lab's insulin series revenue totaled 1.
23 billion yuan, a year-on-year increase of 35.
7%
.
Its third-generation insulin glargine injection "Youleling" was successfully approved by China's State Food and Drug Administration in early 2017, and its operating income in 2020 will be approximately 402 million yuan
.
July 21 this year, the Federal insulin excellent times Spirit ® UBLIN ® 30 aspart federal drug approved recently listed 30 Injection (refills) issued the first batch of products from Zhuhai United Laboratories Limited
.

The collection is coming, and the past is the prologue
.
To be sure, this centralized procurement will directly determine the market position and future of relevant companies
.
Whether the former local leader can continue to maintain its existing position and whether Tianmai Bio or other companies will become a dark horse for centralized insulin procurement, the competitive landscape of local companies is still full of variables
.

This special centralized procurement is regarded by many local companies as an opportunity to realize "domestic substitution"
.
Leng Chunsheng, chairman of Tonghua Dongbao, once said at an investment exchange meeting, “As for insulin glargine, I hope that several domestic companies will join hands to gain more market share, but the total is less than 30%.
.
.
.
.
.
I still hope that several domestic manufacturers will work together to increase the proportion of the domestic insulin market.
This is our goal
.
"

02 The "Buddhism" of multinational pharmaceutical companies is no longer?

And the three multinational pharmaceutical companies that have occupied most of the domestic market for a long time, Novo Nordisk, Eli Lilly, and Sanofi, in the national centralized procurement of insulin, will they maintain the "Buddhist system" as other multinational pharmaceutical companies face the centralized procurement of chemical drugs.
"?

There is no doubt that the Chinese market is very important to the global insulin giant Novo Nordisk
.
According to the 2021 mid-year report, Novo Nordisk’s total revenue in the Chinese market is 8.
052 billion Danish kroner ($1.
268 billion), accounting for more than 12% of its global revenue, a year-on-year increase of 10.
5%
.
Among them, insulin preparations revenue is 6.
199 billion Danish kroner (985.
5 million US dollars), accounting for more than 22% of its global insulin revenue, with a growth rate of 8.
39%
.

Despite the advent of concentrated insulin procurement, Novo Nordisk, which has a lot of hypoglycemic products, has more choices
.
On the one hand, the core power product driving its Chinese market is the GLP-1 agonist, and the global growth rate remains at about 30%
.
Data in the first half of the year showed that its sales in the Chinese market (Mainland China, Hong Kong, Taiwan) increased by 68% year-on-year to 833 million Danish kroner (132.
4 million US dollars), mainly due to the growth of NovoLi (liraglutide) and the new generation GLP-1 preparation Novotel (Simeglutide) was approved for marketing in Taiwan, China
.
Novo Nordisk's GLP-1 products are growing rapidly and insulin products, and sales of such products are expected to surpass insulin in the near future
.

In addition, Zhou Xiaping, senior vice president and president of Greater China of Novo Nordisk, said in an interview with E drug managers that the drug structure in the entire hypoglycemic field is changing, although the current drug market is still dominated by insulin.
With the continuous development of the drug market, the importance of new-type hypoglycemic drugs in treatment is increasing, and the number of drug users is growing rapidly
.
Among them, the proportion of GLP-1 receptor agonists continues to increase
.
Regarding the centralized procurement of insulin in the Chinese market, its CEO stated on his financial conference call that “for mass procurement of biological agents, especially for life-saving drugs like insulin, it is not easy to strike a balance between quantity and quality
.

Eli Lilly’s total revenue in 2020 reached 24.
540 billion yuan, of which diabetes product sales reached 11.
834 billion yuan, accounting for 48.
22% of the total revenue
.
Sales of its diabetes products increased by 8% from the previous year
.
However, the growth of its diabetes products mainly relies on two hypoglycemic drugs, dulaglutide and empagliflozin
.
Regardless of whether it is recombinant insulin lispro, recombinant human insulin or insulin glargine, the sales of insulin products have either limited growth or have declined
.

Moreover, its second-generation insulin market in China is gradually being eaten away by local pharmaceutical companies
.
In 2017, 3SBio and Eli Lilly China reached a cooperation agreement to promote the insulin product Humulin in China.
However, this cooperation has ceased, and Eli Lilly China will also cancel all 3SBio Group Marketing Center Metabolic Therapy Business Units.
Relevant post organization system for forest product promotion
.

Eli Lilly has already begun to look for the next blockbuster insulin product
.
In July, Eli Lilly announced that it would spend US$1 billion (approximately RMB 6.
489 billion) to acquire the biotechnology company Protomer Technologies
.
Through this transaction, Eli Lilly will acquire the drug assets of Protomer's experimental glucose-responsive insulin
.
The company has built a brand-new protein engineering platform that allows therapeutic proteins to bind with specific molecular activators to produce specific reactions, thereby switching the drug function on and off
.
Eli Lilly hopes to develop a brand-new insulin drug through this research and development platform
.

The market competition for Sanofi's insulin products is fraught with crises
.

On July 29, the FDA approved Viatris’ Semglee (generic name insulin glargine-yfgn) as an exchangeable biosimilar for Lantus when Sanofi’s long-acting insulin comes.
This is the first time the FDA has approved an exchangeable biosimilar.
An alternative diabetes biosimilar insulin
.
And Latse's market share in China is declining
.
According to data from Minai.
com, in 2019, the sales of insulin glargine injections in China's public medical institutions exceeded 6 billion yuan, and Sanofi ranked first in market share
.
With the rise of Novo Nordisk, Eli Lilly, Ganli Pharmaceutical, Tonghua Dongbao and other companies, Sanofi's market share is gradually declining, from 71% in 2014 to 61% in 2019
.

In 2015, Sanofi launched a new generation of insulin glargine Laiyoushi ("Insulin Glargine Injection U300")
.
In September 2020, the product was approved in China
.
Sanofi is currently expanding production capacity for the Laiyoushi project
.
The project officially started in 2019, with an investment of 200 million yuan and an increase of 200 million yuan in 2020.
The newly added packaging production line is expected to be put into operation in 2022, and the filling line is expected to be put into operation in 2024
.
After the project is completed, the products produced will not only satisfy the Chinese market, but will also be exported to Australia, Japan and other Asia-Pacific regions
.

The results of the collection in Wuhan showed that Novo Nordisk won the bid for up to 19 varieties, followed by Eli Lilly Suzhou with 6 bids, Eli Lilly France won 2 bids, Sanofi won 2 bids, and Tonghua Dongbao ranked No.
3.
Five varieties were obtained, and two varieties were obtained for Gan Li
.

According to the rules of Wuhan, the weight is based on the magnitude of the drop
.
Whoever cuts the price by a large margin has a higher proportion
.
The price of imported products is high, even if the same rate of reduction as domestic enterprises is adopted, a larger absolute value of the price reduction can be obtained, and thus a larger amount of substitution can be obtained
.
In the centralized insulin procurement organized by Wuhan, Eli Lilly, Novo Nordisk and Sanofi won 29 bids, accounting for 78% of the total
.
The three domestic companies (Tonghua Dongbao, Hefei Tianmai Biology, Ganli Pharmaceutical) have much lower bid standards than foreign companies
.

It can be seen that multinational pharmaceutical companies have become the "winners" in the centralized insulin procurement in Wuhan.
In the larger national insulin procurement, can multinational pharmaceutical companies continue to maintain their existing market share and whether local companies can seize the opportunity A counterattack, a comprehensive innovation of the existing pattern of insulin, is worth looking forward to
.