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China is a "diabetic country", with more than 140 million people with diabetes, of which about 72.
83 million diabetics have not been diagnosed, and because diabetes requires lifelong medication, the therapeutic drug market is sitting on a huge demand
.
According to the Pharmarong Cloud database, the sales of diabetes chemicals/biopharmaceuticals in China increased from 20 billion yuan in 2014 to 34.
3 billion yuan in 2021, with a compound annual growth rate of 7.
99%.
Hospital sales of diabetes medication
Screenshot database
01 30 billion diabetes drug market, the head effect is obvious
Diabetes mellitus is a metabolic disease characterized by hyperglycemia, and the etiology and pathogenesis are not fully understood
.
Its therapeutic drugs can be divided into two categories: non-insulin hypoglycemic drugs and insulin hypoglycemic drugs, and there can be ten categories
such as biguanides, insulin and its analogues, GLP-1 receptor agonists, sulfonylureas, glitinides, and GKA drugs.
The Frost & Sullivan report shows that China's current anti-diabetic drug market is mainly occupied by traditional drugs, and basically half of it is occupied
by insulin.
According to the statistics of the drug Rongyun database, among the top 10 varieties of diabetes drugs (chemical drugs/biological drugs) in hospital sales in 2021, except for dapagliflozin tablets, sitagliptin phosphate tablets and liraglutide injection, the remaining 7 are insulin and its analogues
.
Insulin aspart 30 injection and insulin glargine injection topped the list with sales of more than 3 billion yuan
.
Diabetes medication (chemical/biological) in 2021
Top 10 varieties in hospital sales
Data source: Yaorong Cloud National Hospital Sales Database
02 New drugs to be launched in 2022 are remarkable
Compared with Hengrui's Henggliflozin, Microchip's siglita, Tanabe Mitsubishi Pharmaceutical's ticogliptin and other new drugs have been approved in China in 2021, there are fewer new drugs approved this year, but they are all remarkable and very eye-catching
.
Hua Medicine Pharmaceutical: Dopagliatin tablets
Hua Medicine Pharmaceutical: Dopagliatin tablets On October 8, Hua Medicine Pharmaceutical's first in class hypoglycemic drug dorzagliatin was officially approved by the NMPA for marketing, trade name: Hua Tangning
.
Two indications for Huatangning ® were approved at one time, namely: monotherapy for the treatment of untreated type 2 diabetes mellitus and the combination with metformin alone for the treatment of adult patients with
type 2 diabetes mellitus when metformin alone has poor glycemic control.
This is the world's first approved glucokinase activator (GKA, Glucokinase Activator), the first innovative drug with a new mechanism in the field of diabetes in the past decade, and the first time to launch the world's first innovative drug
for type 2 diabetes in China.
As a GKA drug, dopagliatin reshapes the body's blood glucose homeostasis by repairing the function of glucose kinase (GK) of blood glucose sensor in patients with type 2 diabetes mellitus to achieve the purpose of
treating type 2 diabetes.
Eli Lilly: Tirzepatide
Eli Lilly: Tirzepatide In May 2022, the FDA approved Eli Lilly's glucose-dependent insulin-stimulating polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor dual agonist tirzepatide (trade name: Mounjaro
).
The drug is the first dual-targeted GLP-1R hypoglycemic drug for the treatment of type 2 diabetes, injected only once a week to supplement diet and exercise to improve glycemic control
in adults with type 2 diabetes.
Current status of Tirzepatide research and development
Screenshot source: Yaorong Cloud Global Drug R&D Database
In China, Lilly first submitted an IND application for tilbotide injection in April 2019, and started clinical trials in August of the same year, and has so far carried out a number of phase III clinical trials for type 2 diabetes, heart failure, and obesity; In September this year, it was declared listed
in China.
Click to view clinical trial details
Screenshot source: Yaorong Cloud China Clinical Trial Database
03 Involution intensified, waiting for the listing of star new drugs
Under the normalization of volume procurement and the consistency evaluation policy of generic drugs, the competition in the domestic diabetes generic drug market is gradually entering a fever pitch, and at the same time, it is also forcing domestic companies to move from generic drugs to Fast-follow and First-in-class
.
Pharmaceutical companies have accelerated their research and development, and many pharmaceutical companies have gathered hot targets and competed for involvement, and a number of new drugs have entered the phase III clinical stage, and some products have submitted marketing applications
in China.
New drugs newly declared for marketing in China
New drugs newly declared for marketing in China In addition to the tilbotide mentioned above, there are currently the following diabetes innovative drugs that have submitted marketing applications that deserve attention
.
Sihuan Pharmaceutical: plus agliflozin tablets
Sihuan Pharmaceutical: plus agliflozin tablets On February 28, Sihuan Pharmaceutical's new drug plus agliflozin tablets was accepted
by CDE.
This is a glucose-sodium co-transporter 2 (SGLT-2) inhibitor independently developed by Sihuan Pharmaceutical for the treatment of diabetes, which has obtained patents in China, the United States, Europe, Japan and South Korea for the treatment of type 2 diabetes
.
If it can be approved for marketing, it will become the second SGLT-2 inhibitor drug
independently developed in China after Hengrui Proline Hengliflozin Tablets.
Novo Nordisk: semeglutide tablets
Novo Nordisk: semeglutide tablets On May 27, Novo Nordisk's semegluglutide tablet marketing application was accepted
by CDE.
Semeglutide is a GLP-1 receptor agonist, its injection has been approved for marketing in China, tablets have been approved overseas for blood sugar control in adult patients with type 2 diabetes, and is the world's first oral GLP-1 receptor agonist drug (GLP-1RA).
According to the drug Rongyun database, two phase III clinical trials of semeglutide tablets versus placebo or sitagliptin in patients with type 2 diabetes have been completed, and it is speculated that the indicated indication is the treatment of type 2 diabetes
.
Clinical trials carried out in China with semeglutide tablets
Screenshot source: Yaorong Cloud China Clinical Trial Database
Hengrui: repagliptin phosphate tablets
Hengrui: repagliptin phosphate tablets Hengrui's repagliptin phosphate tablets, a DPP-4 inhibitor with a structure similar to the already marketed sitagliptin, is also suitable for type 2 diabetes, and was submitted for marketing in September 2020 and accepted
.
Proline Henggliflozin tablets reported at the same time were approved for marketing on the first day at the end of 2021, becoming the first self-developed SGLT-2 diabetes drug in China, and whether repagliptin can be approved before the end of 2022 is of concern
.
New drugs under development
New drugs under developmentNovo Nordisk: Icodec
Novo Nordisk: Icodec In addition, no weekly insulin preparation product has been approved for marketing in the world, and Novo Nordisk's Icodec insulin is leading
the way.
On October 3, Novo Nordisk announced the positive results of Icodec's Phase IIIa ONWARDS 5 study, and Novo Nordisk also said it expects to apply for regulatory approval
for Icodec in the United States, the European Union and China in the first half of 2023.
Innovent Biologics: Mazdutide (IBI362)
Innovent Biologics: Mazdutide (IBI362) GLP-1 receptor agonists have grown rapidly in recent years and have become the non-insulin diabetes drugs with the highest global market share, with dulaglutide, somaglutide, liraglutide, etc.
being among the leaders
.
GLP-1R multi-target agonists have also become a hot competitive direction
.
Among them, Mazdutide (IBI362), jointly promoted by Innovent and Eli Lilly, is eye-catching
.
This is a GLP-1R/GCGR dual-target agonist whose research on type 2 diabetes has reached the phase II clinical stage
.
On July 19, Innovent announced that a multicenter, randomized, placebo/dulaglutide-controlled phase II clinical study of IBI362 in Chinese patients with type 2 diabetes has reached the primary endpoint, with significant hypoglycemic and weight-reducing effects, which can bring comprehensive benefits
to patients.
On October 4, Innovent announced a phase III clinical trial
of IBI362 for overweight or obesity.
Multiple clinical phase III DPP-4 inhibitors
Multiple clinical phase III DPP-4 inhibitors There are many domestic developers of DPP-4 inhibitors, among which the DBPR108 of CSPC Group, the compound tagliptin of Salubris, the selgliptin of Shengshitai, HSK7653 of Haisco and the yodagliptin of Yuandong Biologics have made rapid progress and have reached the phase III clinical stage
.
CP Tianqing Nanjing Shunxin has laid out two models, TQ-F3083 and TQ05510, adding full horsepower, and the former is already in the phase II clinical stage
.
The same DPP-4 inhibitor, different varieties are also different
.
At present, DPP-4 inhibitors are mostly taken once a day, of which HSK7653 of Haisco Pharma is taken orally every 2 weeks, and Yoldagliptin of Yuandong Biologics and Bogliptin of Baiji Long Pharmaceutical need to be taken once a
week.
Eastern Sunshine Medicine: Jungagliflozin
Eastern Sunshine Medicine: Jungagliflozin SGLT-2 targets are one of the hot targets in the field of hypoglycemic drugs in recent years, and SGLT-2 inhibitors increase glucose excretion and reduce blood sugar levels
by blocking and reducing the reabsorption of glucose by the kidneys, thereby excreting excess glucose through urination.
Among the SGLT-2 inhibitor drugs currently under development, East Sunshine's Jungagliflozin has made the fastest progress and has reached the clinical phase III
.
stage.
Tadagliflozin from Tianjin Institute of Materia Medica, vanagliflozin from Fosun Pharma and elagliflozin from Shanghai Ellis have also entered clinical trials
.
Both insulin and non-insulin drugs are looking forward to early availability and providing more choices
for diabetic patients.
