The domestic recombinant insulin Qixiong contends for hegemony, the new force launches new challenges!

Medical Network, August 31, July, the National Medical Insurance Bureau held a work symposium to listen to the opinions and suggestions of relevant companies and industry associations on the reform of centralized insulin procurement
.
A few days ago, the industry released the "National Organization of Insulin Centralized Purchase Plan (Draft for Solicitation of Comments)"
.
The national centralized procurement of insulin may be opened, and the future insulin market pattern will face great changes
.
In fierce battle, can local brands win?The Chinese market is very popular.
According to the International Diabetes Federation (IDF) data, in 2019, the number of diabetes patients in the world has reached 463 million, and the number of diabetes patients in China accounted for a quarter of the world, which is about 116 million people.
It is also the number of people with diabetes in the world.
Most countries
.
The annual per capita medical expenses for Chinese diabetic patients exceeds 900 US dollars
.
According to the annual reports of multinational companies, the global insulin market will exceed US$21.
5 billion in 2020, a year-on-year increase of 2.
16%
.
Among them, the three giants in the insulin market-Novo Nordisk, Eli Lilly and Sanofi accounted for 42%, 23.
30% and 21.
86% respectively
.
After new oral glucagon-like peptide-1 receptor agonists (GLP-1RA) entered the market one after another, the growth rate of global insulin sales has slowed by half a beat
.
The core forces driving the growth of the insulin market are Novo Nordisk’s super fast-acting insulin aspart (Fiasp), Degu/Aspart (Ryzodeg), Sanofi’s insulin glargine, Lisnatide (Soliqua), and Glycine The upgraded version of insulin (Toujeo) has become a continuously growing variety
.
    　　According to data from Mi 　　Nei.
com , in 2020, China’s urban public hospitals, county-level public hospitals, urban community centers, and township health centers (referred to as Chinese public medical institutions) will have a total sales of terminal insulin and similar products of nearly 27 billion yuan in 2020, a year-on-year increase.
The annual growth rate was 7.
91% .
  　  
　   　　In 2020, Novo Nordisk, Sanofi and Eli Lilly accounted for 45.
86%, 27.
30% and 11.
25% of the insulin and similar market in public hospitals in key domestic provinces and cities, while Ganli Pharmaceutical, Jiangsu Wanbang, Tonghua Dongbao, Zhuhai Federation and Hefei Tianmai accounted for 15.
37% in total
.
From 2018 to 2020, the proportion of imported brands only dropped by 1.
02 percentage points
.
In the first quarter of 2021, imported insulin still accounted for 84.
44%
.
In the bargaining of the quantity of insulin drugs in Wuhan in 2020 , centralized procurement has promoted the changes in the market structure, reflecting the trend of accelerating the substitution of imported insulin by domestically produced insulin and controlling the excessive growth of medical expenses
.
  　　The domestic recombinant insulin is eye-catching.
At   　　present, the domestic recombinant insulin is competing for hegemony: Tonghua Dongbao, Ganli Pharmaceutical, Beijing Yadong Biopharmaceuticals in the north, Zhuhai Federation in the south, Hefei Tianmai, Jiangsu Wanbang, and Yichang Dongyangguang in the middle
.
From January to July 2021, the NMPA approved 10 insulin production approval documents produced by domestic companies , which is double the number of approvals for the entire year of 2020
.
It is worth mentioning that on February 9, 2021, Shenzhen Kexing’s production approval for protamine human insulin injection and human insulin and its injection have been changed to Beijing Yadong Biopharmaceutical (Anguo)
.
  　　Challenge, what is the chance of success for the new generation? 　　Insulin aspart 7 billion market welcomes new players   　　on May 12, 2020, domestic recombinant insulin aspart was successfully developed by Ganli Pharmaceutical and was approved by the State Food and Drug Administration for listing　    
.
On July 12, 2021, the State Food and Drug Administration approved the production and marketing of Zhuhai United Laboratories’ insulin aspart and insulin aspart 30, thus perfecting the layout of domestic insulin, covering three functional market segments: long-acting, medium-acting, and quick-acting
.
Insulin aspart belongs to the third generation of insulin.
It has the characteristics of short-acting and intermediate-acting insulin.
It was developed by Novo Nordisk under the trade name Novo Rui
.
Novo Rui has launched 3 varieties of Novo Rui, Novo Rui 30 and Novo Rui 50 in the Chinese market
.
According to Novo Nordisk’s 2020 financial report, the sales of insulin aspart injection series in the Chinese market was 6.
688 billion Danish kroner, equivalent to 7.
208 billion yuan, a year-on-year growth rate of 10.
45%, ranking among the best in the domestic market
.
According to data from Minai.
com, in 2020, the sales of terminal insulin aspart injection in public medical institutions in China was 7.
099 billion yuan, an increase of 5.
88% year-on-year.
The main varieties are Novo Rui, Novo Rui 30 and Novo Rui 50.
Refill
.
With the launch of domestic insulin aspart injection and the advancement of the reform of centralized insulin procurement , the market structure is bound to change
.
  　   　　In China, insulin aspart injection is a popular category for declaration
.
According to the statistics of Meinenet MED China Drug Evaluation Database 2.
0, among the new insulin aspart injection drugs undertaken by CDE from 2018 to 2021, Yichang Dongyangyang Yangtze Pharmaceutical, Zhengda Tianqing Pharmaceutical Group, Jiangsu Wanbang Biochemical Pharmaceutical Group, Zhejiang Hisun Pharmaceutical, Beijing Shuanglu Pharmaceutical, Tonghua Dongbao Pharmaceutical, Zhuhai United Laboratories and other seven products have been under review and are expected to be approved for production this year
.
  Insulin glargine 3+1 pattern, the share of domestic drugs rises.
  　　Insulin glargine belongs to the third-generation long-acting insulin, developed by Sanofi, under the trade name Lantus (Lantus), and is a once-a-day long-acting preparation　   　　
.
In 2020, Sanofi's total sales of insulin glargine (Lantus, Toujeo) was 3.
554 billion euros, a year-on-year decline of 8.
75%
.
In order to make up for the loss of competition in the insulin glargine market, Sanofi has launched the new insulin glargine Toujeo, and at the same time, insulin glargine lixisenatide has also emerged in the market
.
In 2002, Sanofi's insulin glargine entered the Chinese market under the trade name Laidushi
.
In 2005, Beijing Ganli Pharmaceutical’s Chang Xiulin was approved for production; Zhuhai Federation’s insulin glargine was approved in 2016 under the trade name You Le Ling; Tonghua Dongbao Pharmaceutical’s insulin glargine was approved at the end of 2019, under the trade name Chang Shu Lin
.
In January 2020, Chang Shulin completed the production and inspection of multiple batches, and began to put on the market in February 2020
.
According to data from Minai.
com, in 2020, the sales of insulin glargine injection in China's public medical institutions will exceed 6.
8 billion yuan, a year-on-year increase of 12.
88%
.
In the past 10 years, insulin glargine injection has maintained a growth trend
.
In the first quarter of 2021 , Sanofi’s Insulin Glargine injection market in public hospitals in key provinces and cities accounted for 73.
02%, Chang Xiulin of Ganli Pharmaceuticals accounted for 25.
18%, and Youlerin of Zhuhai Federation accounted for 1.
81%
.
The share of domestic drugs in the market is increasing year by year
.
  　   　　Ganli Pharmaceutical’s recombinant insulin glargine injection, Chang Xiulin, has been singing in the insulin market all the way, promoting Ganli Pharmaceutical’s official landing on the Shanghai Stock Exchange in 2020
.
In 2020, Chang Xiulin's terminal sales in public medical institutions in China was 2.
559 billion yuan, an increase of 15.
46% year-on-year, and it accounted for more than one-third of the domestic insulin glargine injection market share. .
The company has recombinant insulin lispro (fast-acting), recombinant insulin glargine (long-acting), insulin aspart and protamine zinc, recombinant insulin lispro (25R), insulin aspart 30 and protamine-human insulin mixed (30R), etc.
6 This product has become a leading company in the domestic insulin industry
.
  　　Postscript <<<   　　Since its inception, insulin has experienced the development process from the first generation to the third generation, from animal insulin to human insulin, and then to recombinant human insulin analogues
.
With the decrease in the amount of animal insulin, some manufacturers have revoked production approvals.
In 2020, there are only 9 animal insulin injection approvals, a 58% decrease from 21 in 2013
.
A variety of new varieties have attracted the attention of domestic companies.
At present, the number of manufacturers entering the insulin industry has increased year by year.
The domestic reorganized insulin industry has become a situation where seven heroes are competing for hegemony, and the latecomers are launching new challenges
.
Beijing Shuanglu Pharmaceutical, Chongqing Chen'an Biopharmaceutical, Zhengda Tianqing Pharmaceutical, Zhejiang Hisun Pharmaceutical, Jilin Huisheng Biopharmaceutical, Huaangde Biopharmaceutical, Shandong New Times Pharmaceutical, Lanzhou Biological Products Research Institute, Dongguan New products from 9 companies including Shidong Sunshine Biopharmaceutical R&D are under review and approval
.