Chiglitazar Sodium

SHENZHEN, China, July 19, 2024 /PRNewswire/ -- On July 19, Shenzhen Chipscreen Biosciences Co., Ltd. (hereinafter referred to as "Chipscreen Biosciences") announced that it has received the Drug Registration Certificate approved and issued by the National Medical Products Administration (NMPA) for Chiglitazar, a noval PPAR (Peroxidase Proliferator Activated Receptor) full agonist developed by the company's independently, combined with Metformin for the treatment of type 2 diabetes. This is a further expansion of the clinical application of Chiglitazar after it was approved as a single agent for the treatment of type 2 diabetes in October 2021, and will provide a noval therapeutic option of combination for type 2 diabetes patients. As of 2021, the number of diabetes patients in China has reached 141 million, ranking first globally. Type 2 diabetes accounts for more than 90% of the total. As a progressive disease, it seriously affects the quality of life of patients and causes a heavy burden on society. As the disease progresses, the probability of monotherapy failure in type 2 diabetic patients gradually increases. Researches have shown that 50% of newly diagnosed T2DM patients require combination therapy after three years of treatment for patients with initial diabetes; After 9 years of treatment, 75% of patients require combination therapy; In addition, for newly treated patients with high blood glucose levels, such as HbA1c>9%, combination therapy is often necessary to achieve good glycemic control. Therefore, combination therapy is essential for diabetes patients. Insulin resistance, as one of the important pathological mechanisms of the occurrence and development of type 2 diabetes, has always been a focus and challenge of drug development and clinical treatment. It will not only cause hyperglycemia but also lead to hyperlipidemia, overweight/obesity, fatty liver, atherosclerotic cardiovascular disease, etc. Now, Chiglitazar has been approved for adjunction to metformin to improve glycemic control in patients with type 2 diabetes with poor blood glucose control after metformin monotherapy. The randomized, double-blind, placebo-controlled pivotal Phase III clinical trial showed that compared with placebo combined with metformin, Chiglitazar combined with metformin can achieve more clinical benefits such as continuous glucose reduction, blood lipid regulation and cardiovascular risk reduction, which shows the promising application of Chiglitazar in combination with diabetes drugs of different mechanisms. Dr. Xianping Lu, chairman of Chipscreen, said: "Although there are multiple drugs available for the treatment of T2DM, the rapid growth of the number of patients with diabetes indicates that there are still significant unmet clinical needs in this field, whether it is monotherapy or combination therapy. As the first PPAR full agonist approved to treat type 2 diabetes in the world, Chiglitazar with a new mechanism of action has broken the long-term dilemma of etiological treatment of insulin resistance, effectively targeted the metabolic syndrome caused by metabolic disorder, opening up a new path for the treatment of type 2 diabetes and providing clinicians and patients with a more flexible and effective combination drug regimen. About Chiglitazar Chiglitazar (Shuangluoping ®/ Bilessglu ®) is a new mechanism hypoglycemic drug independently developed by Shenzhen Chipscreen Biosciences Co., Ltd. As a new chemical molecule，it belongs to a national Class 1 new drug, national "Major New drug creation" special achievement . It is the first PPAR full agonist which approved for the treatment of type 2 diabetes in the world. Chiglitazar can control blood glucose level and ameliorate the lipid and energy metabolic disorders that accompany T2DM, helping to prevent and control cardiovascular complications. This makes Chiglitazar a potentially more comprehensive treatment option for T2DM. Many basic studies have confirmed that insulin resistance is one of the core pathological mechanisms for the occurrence and development of type 2 diabetes, and it is also the common soil for various metabolic abnormalities such as blood sugar and blood lipid. Insulin resistance will not only cause hyperglycemia, but also lead to hyperlipidemia, overweight/obesity, fatty liver, atherosclerotic cardiovascular disease (ASCVD), etc. However, there are relatively few drug options directly targeting the improvement of insulin resistance in clinical practice. Chiglitazar, a PPAR total agonist, can moderately activate three PPAR receptor subtypes with different functions in regulating glucose, lipid and energy metabolism in vivo, and selectively changes a series of gene expressions related to insulin sensitivity, targeting insulin resistance, the core pathological mechanism of the occurrence and development of type 2 diabetes. Through improving the sensitivity of diabetes patients to insulin, regulating blood sugar, improving their complicated lipid metabolism disorder, potentially reducing the occurrence and harm of cardiovascular complications, bringing better efficacy and safety, and achieving comprehensive treatment of diabetes and its complications. In addition to the indications for type 2 diabetes, Chiglitazar has also carried out clinical exploration of compound preparations of diabetes drugs (metformin-chiglitazar compound, Empagliflozin-chiglitazar compound) and phase II clinical research of single drug treatment of nonalcoholic fatty liver steatohepatitis in China. In October 2021, Chiglitazar was approved by the National Drug Administration (NMPA) to be marketed for the treatment of type 2 diabetes. In January 2023, Chiglitazar was included in the national medical insurance directory. In March 2024, the Phase II clinical trial (CGZ203 study) of Chiglitazar monotherapy for non-alcoholic steatohepatitis achieved the primary efficacy endpoint. In July 2024, the treatment of type 2 diabetes patients with poor blood glucose control after single drug treatment of metformin with Chiglitazar and metformin was approved for marketing by the National Drug Administration (NMPA) of China. About Chipscreen Chipscreen Biosciences is an innovative drug company driven by core technologies with globally competitive pipelines. As a pioneer in drug innovation & development in China, adhering to the concept of "Constant Innovation for Life", we focus on developing revolutionary innovative drugs with new mechanisms of action, to address patients' pressing clinical needs. Chipscreen Biosciences has formed a complete industrial chain covers from early exploratory discovery to commercialization, providing original Chinese new drugs for global patients. Based on the global development strategy of China's early stage research, Chipscreen Biosciences has been able to open the whole process from basic research to clinical transformation with Shenzhen Small Molecule Early R&D Center and Chengdu Small Molecule Early R&D Center bringing together top scientists and teams with senior experience in related fields, and applying the integrated technology platform based on AI-driven design and chemical genomics. We have successfully developed first-in-class and best-in-class innovative drugs. Currently, we have marketed two drugs for four indications in Mainland China, two indications in Japan, and one indication in Taiwan, China. In addition, we have launched a number of R&D projects with differentiated advantages and global competitiveness in the five major areas, including malignant tumors, metabolic diseases, autoimmune diseases, central nervous system diseases, and antivirals. Chipscreen Biosciences has formed a global industrial layout consisting of Shenzhen Head Office/R&D Center/GMP production base, Chengdu Regional Head Office/R&D Center/GMP production base, Beijing Branch, Shanghai Branch, and Chipscreen Biosciences (USA) Co., Ltd. Meanwhile, as one of the first batches of national "innovative drug incubation bases" and national high-tech enterprises, Chipscreen Biosciences has independently undertaken many national "863" plans and national major science and technology projects, such as "10th five-year plan", "11th five-year plan", "12th five-year plan" and "13th five-year plan", and National Science and Technology primary Project for Innovative Drug Development. We have filed over 660 invention patents in China and worldwide, with over 180 granted. SOURCE Shenzhen Chipscreen Biosciences Co., Ltd.

Chiglitazar has already been approved in China as a treatment for type 2 diabetes in addition to diet and exercise, with Chipscreen looking to expand its use in combination with anti-diabetic drug metformin.  Chipscreen Biosciences' metabolic dysfunction-associated steatohepatitis (MASH) candidate reduced patients' liver fat levels, adding further momentum to drugs aimed at the condition. The Shenzhen, China-based biotech says chiglitazar produced “significant and dose-dependent reductions” in liver fat content from baseline compared to placebo during a phase 2 study, according to a Monday press release. The company did not provide data to support the primary endpoint win and said more will be revealed at an upcoming conference or in a medical journal. Chipscreen also reported that patients given chiglitazar “showed significant or dose-dependent trend of improvements” on a number of secondary endpoints. As for safety, Chipscreen kept it short and sweet: “The overall safety is good.”  Chiglitazar has already been approved in China as a treatment for type 2 diabetes in addition to diet and exercise, with Chipscreen looking to expand its use in combination with anti-diabetic drug metformin.  The sampling of phase 2 data teased Monday comes days after Madrigal Pharmaceuticals scored the first-ever FDA approval to treat MASH, which has previously been known as non-alcoholic steatohepatitis (NASH). The much-hyped class of GLP-1 medications have also shown promise as potential MASH treatments. Chipscreen’s metabolic ambitions have grown in parallel with the biotech’s oncology work, centered on its epigenetic modulator, chidamide. The drug is approved in China as a treatment for peripheral T-cell lymphoma and breast cancer, with ongoing trials testing it in patients with diffuse large B cell lymphoma and non-small cell lung cancer.