The new drug application (NDA) of Chiglitazar (Bilessglu®) , an innovative new chemical entity (Category 1 of chemical drug) for type 2 diabetes discovered and developed by Shenzhen Chipscreen Biosciences (Stock Symbol: 688321. SH), has been accepted by center for drug evaluation of NMPA on September 19, 2019. The acceptance number is CXHS190032.
Diabetes has become one of the most popular chronic disease in the world. China has been the country with the largest number of diabetes patients. About 110 million people suffer diabetes, with 90 percent those are type 2 diabetes (T2DM). Insulin resistance is the core pathogenesis for T2DM. About 10 percent of T2DM patients have serious insulin resistance, and almost 60 percent of diabetic patients are manifested with metabolic syndrome, usually with poorer therapeutic responses to current medications.
Chiglitazar, a novel non-TZD peroxisome proliferator-activated receptor (PPAR) α/γ/δ pan-agonist with moderate activity, acts as insulin sensitizer with potent insulin-sensitizing effects on T2DM patients. Globally, chiglitazar is the first PPAR pan-agonist that has completed the pivotal phase III clinical trials. The overall results have demonstrated that chiglitazar possesses significant and durable efficacies in glycaemic control and insulin-sensitizing effects with an overall good safety profile, which provide the rationale to bring more clinical benefits to patients with T2DM and metabolic syndrome.