NMPA Approves Chiglitazar-Metformin for Type 2 Diabetes Treatment

SHENZHEN, China, July 19, 2024 -- On July 19, Shenzhen Chipscreen Biosciences Co., Ltd. (referred to as "Chipscreen Biosciences") announced that it has received the Drug Registration Certificate from the National Medical Products Administration (NMPA) for Chiglitazar, a novel PPAR (Peroxidase Proliferator Activated Receptor) full agonist. This drug, when combined with Metformin, is targeted for the treatment of type 2 diabetes. This approval expands the clinical applications of Chiglitazar, which was previously approved as a monotherapy for type 2 diabetes in October 2021, offering a new combination therapeutic option for patients.

As of 2021, China had 141 million diabetes patients, the highest number globally, with type 2 diabetes comprising over 90% of these cases. This progressive disease significantly impacts patients' quality of life and imposes a substantial societal burden. Over time, monotherapy often becomes insufficient for type 2 diabetes patients, necessitating combination therapy. Studies show that 50% of newly diagnosed patients require combination therapy after three years, and 75% after nine years. Additionally, patients with high initial blood glucose levels often need combination therapy to achieve effective glycemic control. Thus, combination therapies are critical in diabetes treatment.

Insulin resistance, a key pathological mechanism in type 2 diabetes, poses challenges in drug development and clinical treatment. It causes hyperglycemia and can lead to conditions like hyperlipidemia, obesity, fatty liver, and cardiovascular diseases. Chiglitazar, now approved for use alongside Metformin, helps improve glycemic control in patients struggling with blood glucose levels despite Metformin monotherapy. A pivotal Phase III clinical trial demonstrated that Chiglitazar, when combined with Metformin, offers significant benefits, including continuous glucose reduction, lipid regulation, and cardiovascular risk reduction, compared to a placebo combined with Metformin.

Dr. Xianping Lu, chairman of Chipscreen Biosciences, highlighted the persistent unmet clinical needs in treating type 2 diabetes despite the availability of multiple drugs. He noted that Chiglitazar, the first PPAR full agonist approved worldwide for type 2 diabetes, introduces a new mechanism of action that effectively addresses insulin resistance. This offers a new avenue for treating metabolic syndrome and provides clinicians and patients with more flexible and effective combination drug regimens.

Chiglitazar (marketed as Shuangluoping®/Bilessglu®) is a hypoglycemic drug developed independently by Chipscreen Biosciences. It is classified as a national Class 1 new drug and has achieved national recognition for major new drug creation. Chiglitazar controls blood glucose levels and ameliorates lipid and energy metabolic disorders associated with type 2 diabetes, helping prevent cardiovascular complications. It targets insulin resistance by moderately activating three PPAR receptor subtypes that regulate glucose, lipid, and energy metabolism, thus addressing the core pathological mechanism of type 2 diabetes.

Chiglitazar enhances insulin sensitivity, regulates blood sugar, and improves lipid metabolism disorders, potentially reducing cardiovascular complications and achieving comprehensive treatment of diabetes and its complications. Besides type 2 diabetes, Chiglitazar is also being explored in compound preparations and as a single drug for nonalcoholic fatty liver steatohepatitis. It was approved for type 2 diabetes treatment in October 2021 and included in the national medical insurance directory in January 2023. In March 2024, it achieved the primary efficacy endpoint in a Phase II clinical trial for non-alcoholic steatohepatitis.

Chipscreen Biosciences is a leading innovative drug company in China, focusing on developing revolutionary drugs with new mechanisms of action to meet pressing clinical needs. The company has a complete industrial chain from discovery to commercialization and has developed first-in-class and best-in-class innovative drugs. With operations in Mainland China, Japan, Taiwan, and the USA, Chipscreen Biosciences has filed over 660 invention patents globally, with more than 180 granted.

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