Chipscreen Biosciences's Oringinal New Drug Bilessglu® (for Type 2 Diabetes): Commercialization Application Accepted
SHENZHEN, China, Sept. 19, 2019 /PRNewswire/ -- The new drug application (NDA) of Chiglitazar (Bilessglu®), an innovative new chemical entity (Category 1 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.
About Chipscreen Biosciences
In 2001, Chipscreen Biosciences was founded in Shenzhen, specializing in the research and development of original small molecule drugs. With the self-created "integrated drug discovery and early evaluation platform based on chemical genetics" as its core competitiveness, Chipscreen Biosciences has now become one of China's leading innovative drug enterprises, forming a modern biomedicine group company in Shenzhen, as its headquarters / research and development center / GMP production base, Chengdu, as a regional headquarter / research and development center / GMP production base, Beijing clinical research center and Shanghai commercial center. At present, the company has developed a number of original new drug product lines for tumors, diabetes, and endocrine and autoimmune diseases. In December 2014, the original anti-tumor new drug Chidamide was approved by the China Food and Drug Administration for marketing.
SOURCE Shenzhen Chipscreen Biosciences Co., Ltd.