Microchip's Diabetes Class 1 new drug "siglita sodium" will be approved soon!

October 11, 2021

Yaozhi data shows that the new drug listing application of Siglita Sodium, a new class 1 drug for the treatment of diabetes by Microchip Biotechnology, has entered "under approval" and is expected to be approved for listing in the near future.

Source: Yaozhi Data

Chiglitazar Sodium (Chiglitazar Sodium; international common name Carfloglitazar) is a brand-new non-TZD PPAR full agonist independently developed by China Chipcom Biotech. Preliminary comprehensive research results show 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 in a number of exploratory clinical trials. It has a comprehensive regulatory effect on blood sugar and blood lipids in patients with T2DM, and has good safety. In July 2021, Microchip issued a press release stating that Science Bulletin published the results of two confirmatory phase 3 clinical trials, which is also the world's first phase 3 clinical trial of PPAR full agonist for the treatment of type 2 diabetes (T2DM) Test report. The comprehensive results showed that after 24 weeks of treatment with sitaglipta sodium, the absolute value of glycosylated hemoglobin (HbA1c) was reduced by 1.32%~1.52% compared with before treatment. Both doses showed continuous and clinically significant blood glucose control effects. The main efficacy endpoint of the trial showed superior efficacy compared with placebo and non-inferior efficacy compared with the control drug. While effectively controlling HbA1c, the two dose groups of sitaglipta sodium showed superiority in fasting blood glucose, insulin resistance index, 2-hour postprandial blood glucose, free fatty acids, triglycerides and a series of secondary efficacy endpoints. Trends in the efficacy of control drugs. In terms of safety, compared with the placebo and the control group, the two dose groups of sitaglipta sodium are basically consistent in the overall incidence and severity of adverse events. In the two trials, a lower frequency of side effects related to PPARγ activation in the sitaglipta sodium treatment group, such as edema events and weight gain, was observed, but they were significantly lower than those reported by thiazolidinediones. In addition, Microchip Biosciences announced at the end of 2020 that it has reached a strategic cooperation with Hisun Pharmaceuticals, granting Hisun Pharmaceutical the exclusive right to promote Siglitas sodium tablets in 19 provinces and regions in China.

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