Microchip's Class 1 new drug sitaglipta sodium is about to be approved for type 2 diabetes

On October 9, the NMPA official website showed that the review status of Microchip's new class 1 drug "siglita sodium" has been changed to "under approval" and is expected to be approved in the near future.

Siglipta Sodium (trade name Shuangluoping) is a nuclear receptor peroxisome proliferating receptor (PPAR) full activator independently developed by Shenzhen Chipscreen Biosciences.

According to the Insight database, Siglipta Sodium has initiated 8 clinical trials in China, including 3 phase III clinical trials

Siglipta Sodium Phase 3 Clinical

From Insight database (http://db.

On July 28, 2021, ScienceBulletin published a cover story of Sieglipta Sodium and Placebo Controlled (CMAP) led by Professor Ji Linong from Peking University People’s Hospital, and Siger led by Professor Jia Weiping from the Sixth People’s Hospital Affiliated to Shanghai Jiaotong University.

Both CMAP and CMAS are multi-center, randomized, double-blind, controlled clinical studies.

The comprehensive results of two phase III clinical trials showed that after 24 weeks of treatment with two doses of sitaglipta sodium, the absolute value of HbA1c in T2DM patients was 1.

While effectively controlling HbA1c, compared with sitagliptin, sitagliptin two dose groups, especially the 48mg dose group, have fasting blood glucose, 2 hours postprandial blood glucose, insulin resistance index, triglycerides, and free fatty acids Among a series of secondary efficacy endpoint indicators, all showed a trend of efficacy better than sitagliptin

In terms of safety, compared with the placebo and sitagliptin control groups, the two dose groups of sitagliptin are basically consistent in the overall incidence and severity of adverse events

The results of two phase III clinical trials showed that sitaglipta sodium has an overall good efficacy and safety in T2DM patients with poor blood glucose control through life>

According to the Insight database, the clinical application of siglitata was accepted by CDE in December 2004; in September 2019, the marketing application of siglita sodium for the treatment of type 2 diabetes was accepted by CDE

Timeline of Siglitamine Project

From Insight database (http://db.

On December 16, 2020, Chipset Biosciences and Hisun Pharmaceutical announced a strategic cooperation to grant Hisun Pharmaceutical the exclusive right to promote Siglita sodium tablets (Shuangluoping®) in 19 provinces and regions in China

On this basis, Hisun Pharmaceuticals paid a total of 100 million yuan in exclusive licensing fees to Microchip Biosciences and a sales mileage of no more than 120 million yuan

Public data shows that the market size of diabetes medicines in public medical institutions in China will be approximately 69 billion yuan in 2020

In May 2021, Siglipta Sodium was also approved for Phase II clinical trials for non-alcoholic steatohepatitis (NASH)

From: CDE official website

Reference source: Microchip Technology, ScienceBulletin, Insight database, CDE official website, etc.