Chipscreen Biosciences Announces NMPA New Drug Approval of Bilessglu® (Chiglitazar Sodium tablets) for ( Type 2 Diabetes) in China

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Shenzhen Chipscreen Biosciences, Ltd.

Oct 19, 2021, 07:00 ET

SHENZHEN, China, Oct. 19, 2021 /PRNewswire/ -- SHENZHEN CHIPSCREEN BIOSCIENCES CO., LTD. (hereinafter referred to as: CHIPSCREEN), a China headquartered biopharmaceutical company developing and marketing novel drugs based on its unique technology of Chemical Genomics Drug discovery platform, today announces that Bilessglu® (Chiglitazar Sodium tablets), a globally first PPAR pan-agonist discovered and developed independently by Chipscreen, has been officially approved by the National Medical Products Administration (NMPA) of China for the treatment of Type 2 Diabetes (T2DM) .

Bilessglu® (Chiglitazar Sodium tablets) is Chipscreen 's second drug approved by the NMPA following Epidaza ® (Chidamide). The approval of Bilessglu® (Chiglitazar Sodium tablets) marks the expansion of Chipscreen Biosciences 's marketed products into the non-oncology field.

Diabetes has become one of the commonest chronic disease in the world. China has been the country with the largest number of diabetes patients whom often associated with dyslipidemia among them. About 110 million people suffer diabetes, with 90 percent of which are T2DM. Insulin resistance is the core pathogenesis of T2DM. About 70 percent of T2DM patients have serious insulin resistance, usually with poorer therapeutic responses to current medications.

The approval was based on two phase III clinical trials with placebo and Sitagliptin as controls. The trial was conducted in 525 and 740 patients with type 2 diabetes, respectively. The results showed that glycated hemoglobin (HbA1c) level was reduced significantly by 24 weeks, and the decrease was 1.52% at 52 weeks. In terms of secondary efficacy indicators, Bilessglu® showed the effect of long-term continuous reduction of fasting blood glucose and 2-hour postprandial blood glucose, and no secondary failure of response was found in 52-week treatment period. In both experiments, Bilessglu® showed significant long-term hypoglycemic effect and good safety while demonstrated potential therapeutic value in preservation of β Islet cell function and blood lipid regulation. It can prevent and treat T2DM together with disease complications in an all-round way. This product is considered as an innovative insulin sensitizer with optimal efficacy/safety ration for T2DM patients which significantly improves patients' quality of life.

Dr. Lu Xianping, Chairman and President of Chipscreen said, "Since its establishment, Chipscreen has committed to pharmaceutical innovations encountering with disease challenges. China needs innovative drugs. The ecological chain of pharmaceutical industry will never be satisfied if no one push forward the innovation because of the serious difficulties and challenges. Chipscreen is forging ahead in the road of pharmaceutical innovations in China that is the significance of our effort in the urgent needs of disease treatment and improvement of human health. "

Dr. Ji Linong, professor of Peking University People's Hospital, Lead Investigator of Bilessglu® clinical trial, commented, "I'm delighted to see the Approval of Bilessglu® in China. Insulin resistance has always been the focus of clinical treatment of T2DM, and is also a difficult point in the relevant drug development. Chipscreen has developed such an effective and safe blockbuster product, which is a historic breakthrough of original diabetes drugs. From zero to one, this progress represents the strength of Chinese innovative drug research and development. The launch of Bilessglu® will help more patients of T2DM, and improve their quality of life in China."

Dr. Jia Weiping, professor of The Sixth People's Hospital Affiliated to Shanghai Jiaotong University, Co-Lead Investigator of Bilessglu®'s clinical trial, commented, "The existing approaches to insulin resistance are either indirect or with safety concerns, and there is an urgent need to develop an efficacious and safe insulin sensitizer. The efficacy and safety of Bilessglu® in T2DM have been confirmed in clinical trials. The approval of Bilessglu® will bring a new treatment to Chinese T2DM patients.

About Bilessglu®

Bilessglu® (Chiglitazar Sodium tablets), a novel non-TZD structure and configuration-restricted peroxisome proliferator-activated receptor (PPAR) α/γ/δ pan-agonist with moderate activity, acts as insulin sensitizers with potent insulin-sensitizing effect for T2DM. Bilessglu® is the first PPAR pan-agonist globally which finished the confirmative phase III clinical trials and been approved. The clinical results showed Bilessglu® had significant and durable improvements in glycaemic control and insulin-sensitizing effects whilst regulates lipid metabolism and associated energy homeostasis with potential liver protective effects.

About CHIPSCREEN BIOSCIENCES

Shenzhen Chipscreen Biosciences Co., Ltd. (Chipscreen Biosciences, Stock Symbol: 688321.SH) was founded in Shenzhen in 2001, specializing in the research and development of novel small molecule drugs. Within house-built proprietary chemical genomics-based drug discovery and early evaluation platform as its core competitiveness, integrated Chipscreen Biosciences has now become one of China's leading innovative drug enterprises, forming a modern biopharmaceutical group company in Shenzhen, as its headquarter, research and development center and GMP production base, Chengdu, as a regional headquarter, second research and development center, and a large scale GMP production base for both drug substances and products, Beijing clinical research center, Shanghai commercial center, and CHIPSCREEN BIOSCIENCES (United State) Limited. At present, the company has developed several original new drug product lines for oncology, metabolic diseases, autoimmune diseases, central nervous diseases, and antiviral diseases.

Contacts
Shenzhen Chipscreen Biosciences
Jiawen Zhang
Business Development Director, Based in Shanghai
[email protected]

Chipscreen Biosciences (United State) Limited
Stephen Xue
Director of Operation
[email protected]

SOURCE Shenzhen Chipscreen Biosciences, Ltd.