The new domestic hypoglycemic medicine is hot! Over 50 types of Class 1 new drugs are coming, Hengrui, Hausen, Haisco... 3 major tracks are racing

Since the beginning of this year, domestically produced Class 1 new hypoglycemic drugs have ushered in many new developments.
Microchip's Sieglipta has been approved and is known as the first domestic new diabetes drug in China; Hualing's Dozaglietin has been approved for production.
The world’s first innovative drug.
.
.
According to data from Minai.
com, according to incomplete statistics, there are currently more than 50 domestically-made Class 1 hypoglycemic new drugs in the clinical application and above stage, and 14 of them have entered the phase III clinical and above stage.
Focus on the three major targets of DPP-4, GLP-1, and SGLT-2
.

DPP-4, GLP-1, and SGLT-2 have their own characteristics and advantages.
The market prospects are full.
Among them, DPP-4 has the best performance in the domestic market, and GLP-1 and SGLT-2 are also in large quantities
.

With more and more generic drugs on the market, as well as the approval of the first echelon of domestically-developed new drugs under development, and the influence of policies such as centralized procurement and medical insurance negotiations, the domestic diabetes market will continue to be reshuffled

DPP-4 inhibitors: nearly 4 billion market competition is fierce, and the first domestically produced Class 1 new drug will be born

DPP-4 inhibitors: nearly 4 billion market competition is fierce, and the first domestically produced Class 1 new drug will be born

Dipeptidyl peptidase (DPP-4) inhibitors selectively inhibit DPP-4 activity, increase endogenous GLP-1 and GIP levels, promote insulin release from pancreatic β cells, and inhibit the secretion of glucagon from pancreatic α cells.
To achieve the purpose of lowering blood sugar, it has the advantages of good hypoglycemic effect, low incidence of hypoglycemia, and oral administration
.

Including compound preparations, 10 DPP-4 inhibitors have been approved for marketing in China.
In 2020, the sales scale in China (Chinese public medical institutions and Chinese urban physical pharmacies, the same below) will be close to 4 billion yuan, of which SIG The sales of Liliptin exceed 1 billion yuan, and the sales of Saxagliptin are close to 900 million yuan
.

DPP-4 inhibitors listed in China

Note: If less than 50 million yuan is represented by *, the same below

Source: Mi Nei Net Database

The competition for DPP-4 inhibitors is fierce.
Except for saxagliptin, metformin and ticagliptin, the other 8 products have all been approved for the listing of generic drugs and are deemed to have been reviewed
.

Among them, vildagliptin tablets were included in the third batch of centralized procurement.

Currently, no domestically produced DPP-4 inhibitor Class 1 new drug has been approved, but there are already a number of companies deployed
.

According to incomplete statistics, there are currently 13 domestically-made Class 1 new drugs at the stage of clinical approval and above, and the R&D progress of companies such as Hengrui, Haisco, CSPC and Xinlitai is ahead

Some domestic DPP-4 inhibitors under research in China

Note: Only statistics of domestically produced Class 1 new drugs, the same below

Source: China Drug Clinical Trial Publicity Library of Meinenet

Five domestically-made DPP-4 inhibitor Class 1 new drugs have entered Phase III clinical and above stages
.

Hengrui Medicine's Repagliptin has submitted an NDA and is expected to win the first domestically produced DPP-4 inhibitor Class 1 new drug; Haisco's HSK7653 is expected to submit an NDA in 2022 and be approved for listing in 2023

GLP-1 receptor agonists: 2 domestically produced Class 1 new drugs have been approved, and these 5 drugs are expected to be on the market

GLP-1 receptor agonists: 2 domestically produced Class 1 new drugs have been approved, and these 5 drugs are expected to be on the market

Glucagon-like peptide-1 (GLP-1) receptor agonists belong to the class of secretin drugs.
By binding to the GLP-1 receptor and activating the receptor, it promotes the secretion of insulin from pancreatic β-cells in a glucose concentration-dependent manner , And reduce the secretion of glucagon by pancreatic α cells, thereby lowering blood sugar
.

Clinical studies have shown that GLP-1 receptor agonists can not only reduce blood sugar, improve insulin sensitivity and β-cell function, but also reduce body weight, lower lipids, and lower blood pressure

Including compound preparations, there are currently 9 domestic GLP-1 receptor agonists approved for marketing (2 are domestically produced Class 1 new drugs).
In 2020, the domestic sales scale will exceed 1.
5 billion yuan, of which the sales of liraglutide More than 1 billion yuan
.

Domestically marketed GLP-1 receptor agonist

Source: Mi Nei Net Database

Among the short-acting GLP-1 receptor agonists, Novo Nordisk's liraglutide was rapidly increased after being negotiated into medical insurance in 2017.
In recent years, the annual growth rate of the terminal in public medical institutions in China has remained above double digits
.

In 2020, the domestic sales of liraglutide will exceed 1 billion yuan for the first time, and it is expected to reach a new high in 2021.

Among the long-acting GLP-1 receptor agonists, Hausen’s polyethylene glycol loxenatide and Eli Lilly’s dulaglutide will be included in the national medical insurance category B list through negotiations in 2020, and H1 will be listed in Chinese public medical care in 2021.
The growth rate of institutional terminal sales reached 622.
74% and 1465.
61% respectively
.

In addition to the two domestically-made GLP-1 receptor agonists that have been approved for marketing, according to incomplete statistics, there are currently 17 domestically-made Class 1 new drugs in phase I and above
.

Some domestically-developed GLP-1 receptor agonists in China

Source: China Drug Clinical Trial Publicity Library of Meinenet

Five domestically-made GLP-1 receptor agonists have entered a key phase III clinical trial and are expected to be reported for production one after another.
Among them, Hongyun Huaning's recombinant anti-human GLP-1 receptor humanized monoclonal antibody injection is expected to become the world's first ultra-long Effective GLP-1 receptor agonist (2 weeks or even once a month)
.

Among other new drugs under development, the TTP273 tablet of East China is the first small molecule non-peptide oral dosage form, which has a differentiated advantage in dosage form from other products under development; 2 are dual receptor agonists, each from Cinda IBI362 injection (GLP-1/GCGR), Dongyang Pharmaceutical's HEC88473 injection (GLP-1/FGF21)
.

SGLT-2 inhibitors: the market has expanded significantly, Hengrui and Dongyang Sunshine Pharmaceuticals are making great efforts

SGLT-2 inhibitors: the market has expanded significantly, Hengrui and Dongyang Sunshine Pharmaceuticals are making great efforts

Sodium-glucose cotransporter 2 (SGLT-2) inhibitors reduce the reabsorption of filtered glucose by the kidneys by inhibiting SGLT-2, lower the renal threshold of glucose, thereby increasing urinary glucose excretion, and are effective for all stages of type 2 diabetes.
The better treatment effect and the lower incidence of hypoglycemia can reduce the weight of patients and reduce the risk of cardiovascular disease
.

Including compound preparations, currently 5 SGLT-2 inhibitors have been approved for marketing in China.
Due to the late time to market, the market has not yet opened, and the amount of superimposed medical insurance is obvious.
In 2020, the domestic sales of SGLT-2 inhibitors will exceed 1 billion.
It is estimated that it will exceed 2 billion yuan in 2021, of which dapagliflozin will exceed 1 billion yuan
.

Domestic marketed SGLT-2 inhibitor

Source: Mi Nei Net Database

Except for Egliflozin tablets, the other 4 SGLT-2 inhibitors have been approved for the listing of generic drugs and deemed to have been reviewed.
Among them, canagliflozin and empagliflozin have been included in the fourth batch of centralized procurement, due to the late listing , The impact of superimposed centralized procurement has not fully appeared.
The two products will still have a sales growth rate of more than 500% and 200% in the H1 Chinese public medical institution terminal in 2021
.

Currently, no domestically produced SGLT-2 inhibitor Class 1 new drug has been approved, but there are already many companies deployed
.

According to incomplete statistics, there are currently 8 domestically-made Class 1 new drugs at the stage of clinical approval and above, and the research and development progress of Hengrui, Dongyangyang Pharmaceutical and Xuanzhu Pharmaceutical is ahead

Some domestic SGLT-2 inhibitors under development in China

Source: China Drug Clinical Trial Publicity Library of Meinenet

Hengligliflozin of Hengrui Medicine has submitted an NDA and is expected to win the first domestically produced SGLT-2 inhibitor Class 1 new drug; Dongyang Pharmaceutical’s Rongligliflozin is undergoing phase III clinical trials and is expected to complete phase III clinical trials in 2022.