DPP-4 inhibitors have the advantages of good blood sugar control, low risk of hypoglycemia, and no weight impact, and patients are safer
to use.
The data shows that in recent years, the sales of domestic DPP-4 inhibitors have grown rapidly, of which the overall scale of the three major terminal and 6 major markets in 2021 has exceeded 4 billion yuan
.
Analysts said that with the continuous development of domestic brands, the market pattern of DPP-4 inhibitors will usher in great changes
.
It is reported that now domestic pharmaceutical companies are also actively laying out new drugs for DPP-4 inhibitors
.
Taking Hengrui Pharmaceutical as an example, its self-developed class 1 new drug resigliptin phosphate tablets is a DPP-4 inhibitor (dipeptyl peptidase 4 inhibitor) for the treatment of type 2 diabetes, and has submitted a listing application
in September 2020.
The industry said that the probability of the drug being approved before the end of this year is still large, if successfully approved, the new drug is expected to become the first domestic innovative DPP-4 inhibitor, helping Hengrui to show its fists
in the diabetes drug market.
According to the data, Hengrui Pharmaceutical has been laying out diabetes drugs for more than 10 years, and the proline hepagliflozin tablets approved in 2021 are domestic innovative SGLT2 inhibitors, and the approval of the drug marks the opening of a new chapter
in the domestic diabetes drug market of Hengrui Pharmaceutical.
In addition to Hengrui Pharmaceutical, there are a number of DPP-4 inhibitor innovative products in the clinical phase III.
in China, including CSPC's DBPR108, Xinlitai's compound gliliptin, Sheng Tek's Shengglitine and Yuan Dong Bio's eulogicliptin
.
It is worth noting that on August 22 this year, CSPC Pharmaceutical Group issued an announcement that the two key clinical trials of its new class 1 drug "plumagliptin tablets" (DBPR108 tablets) have reached preset endpoints
.
On August 25 this year, Hisco announced that it had completed two Phase 3 clinical trials of its new drug HSK7653 tablets and obtained preliminary statistical analysis results
.
It is reported that more than 900 patients with type 2 diabetes mellitus were enrolled in the two trials of HiSco, and the test results showed good clinical effects and reached a preset endpoint
.
According to public information, HSK7653 is a long-acting DPP-4 inhibitor administered once every two weeks, and Hisco said it will submit a marketing application
to China's State Drug Administration (NMPA) as soon as possible.
In addition, on June 24, Xinlitai issued an announcement that the clinical study of the research and innovation drug benzoate compound glititin tablets phase III has completed the blinding and obtained preliminary statistical analysis results
.
The results showed that whether it was monotherapy or combination metformin treatment of type 2 diabetes patients, after 24 weeks of administration, benzoate compound gliglitin tablets compared with placebo can significantly reduce HbA1c, with obvious hypoglycemic effect
.
According to the "Guidelines for the Prevention and Treatment of Type 2 Diabetes in China", the prevalence of adult diabetes in China has risen to 11.
2%, of which more than 90% are type 2 diabetes
.
Dipeptide peptidase (DPP-4), also known as T cell surface antigen CD26, is a cell surface serine protease, highly expressed in the intestine, in addition, in the liver, pancreas, kidneys, capillary endothelium, etc.
, and immunomodulatory
, signal transduction and apoptosis.
DPP-4 can inactivate inactivate incretin GLP-1 and glucose-dependent insulin-stimulating polypeptide (GIP), while DPP-4 inhibitors can reduce blood glucose by inhibiting DPP-4 enzymes to prolong incretin activity
.
Analysts pointed out that WITH THE LOW INCIDENCE OF HYPOGLYCEMIA AND ORAL CHARACTERISTICS, DPP-4 inhibitors have gradually been fully recognized in clinical guidelines at home and abroad, and their therapeutic status has been continuously improved, and they have gradually become one
of the main forces in the hypoglycemic drug market.
In view of this innovative drug field, domestic pharmaceutical companies are also stepping up their layout
in recent years.
The author has learned that at present, there are also TQ-F3083 of Chia Tai Tianqing in the DPP-4 inhibitors in the clinical phase 2, and domestic pharmaceutical companies such as Xuanzhu Biological, Luye Pharmaceutical, Huadong Pharmaceutical, and Baijidichang also have related products entering the clinical stage
.
