After sharpening the sword for nearly 17 years, the new microchip bio-diabetes drug sitaglipta sodium was approved for marketing today

On October 19, the official website of the National Medical Products Administration announced that it approved the listing of the first-class innovative drug Sieglipta Sodium Tablets (trade name: Shuangluoping/Bilessglu) declared by Microchip Biosciences to improve adults with diet control and exercise2 Blood glucose control in patients with type 2 diabetes
.

 It is reported that Siglipta Sodium is an innovative drug independently researched and developed by China with independent intellectual property rights.
It is also the second product approved for marketing after Sidabenamine by Microchip Biosciences, providing a new product for adult patients with type 2 diabetes.
Treatment options
.

 Type 2 diabetes is a chronic metabolic disease, which usually develops after the age of 35 to 40, accounting for more than 90% of diabetic patients.
At present, the number of patients in China exceeds 100 million
.

The core pathogenesis of these diseases is insulin resistance and subsequent pancreatic islet decompensation.
Therefore, drugs for insulin resistance have an important position and value in clinical applications
.

 Siglipta Sodium is a new generation insulin sensitizer candidate drug independently designed, synthesized, screened and developed by Microchip Biosciences.
It is a peroxisome proliferator activated receptor (PPAR) full agonist and can activate PPAR at the same time.
Three subtype receptors (α, γ and δ), and induce downstream target gene expression related to insulin sensitivity, fatty acid oxidation, energy conversion and lipid transport, and inhibit PPARγ receptor phosphorylation related to insulin resistance
.

 Previous studies have shown that sitaglipta sodium can balance and not excessively activate the three receptor subtypes of PPARα, δ, and γ, has good human pharmacokinetic characteristics, and has been shown to be effective against T2DM in a number of exploratory clinical trials.
The patient's blood sugar and blood lipids have a comprehensive regulating effect, and the safety is good
.

 In July 2021, Microchip Technology announced that the two phase III clinical results of sitaglipta sodium brought by Chinese scholars were published in the journal Science Bulletin (impact factor 11.
780)
.

This is also the first phase III clinical trial report of a PPAR full agonist in T2DM indications
.

 Sitaglipta sodium and placebo control (CMAP) and sitagliptin sodium and sitagliptin control (CMAS) were enrolled in 535 and 739 patients with type 2 diabetes who could not effectively control blood sugar through diet and exercise.
The study observed the comprehensive efficacy and safety of two doses of sitagliptin sodium 32 mg and 48 mg with placebo (CMAP) or with the marketed drug sitagliptin 100 mg (CMAS) after 24 weeks of treatment
.

 The results of the two studies showed that the absolute value of glycosylated hemoglobin (HbA1c) decreased by 1.
32%~1.
52% in patients with type 2 diabetes after being treated with two doses of sitaglipta sodium for 24 weeks.
It has continuous and clinically significant blood sugar control effect
.

Siglipta sodium has overall good efficacy and safety in T2DM patients with poor blood glucose control through life>
.

 According to the Insight database, CDE accepted the clinical application for sitaglipta sodium as early as December 2004.
It was not until 15 years later that the product's marketing application for the treatment of type 2 diabetes was accepted by CDE in 2019
.

Now, this drug, which has been in research and development for nearly 17 years, has finally been approved for marketing, perhaps in response to the long-standing belief of drug developers: Only by accumulation can be thinner, and loneliness can be reaped
.

End reference materials: [1]https:// .
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