Shenzhen Chipscreen Biosciences Co., Ltd. Receives NMPA Approval for Chiglitazar-Metformin Combination Therapy for Type 2 Diabetes
Saturday, July 20, 2024
Shenzhen Chipscreen Biosciences Co., Ltd. (Chipscreen Biosciences) has announced that the National Medical Products Administration (NMPA) has granted a Drug Registration Certificate for Chiglitazar, a novel Peroxidase Proliferator Activated Receptor (PPAR) full agonist. Developed independently by Chipscreen Biosciences, Chiglitazar in combination with Metformin has been approved for the treatment of type 2 diabetes. This follows its approval as a monotherapy for type 2 diabetes in October 2021, adding a new combination therapy option for patients.
China had 141 million diabetes patients in 2021, the highest number globally, with over 90% having type 2 diabetes. This progressive disease significantly impacts patient quality of life and imposes a substantial societal burden. The progression often leads to monotherapy failure, necessitating combination therapy. Research indicates that 50% of newly diagnosed type 2 diabetes mellitus (T2DM) patients require combination therapy after three years, and 75% after nine years. Additionally, patients with high blood glucose levels (HbA1c>9%) at the time of diagnosis often need combination therapy for effective glycemic control. Therefore, combination therapy is essential for effective diabetes management.
Insulin resistance is a critical pathological mechanism in type 2 diabetes, leading to hyperglycemia, hyperlipidemia, overweight/obesity, fatty liver, and atherosclerotic cardiovascular disease. Chiglitazar, now approved for use with metformin, aims to improve glycemic control in patients who have not achieved adequate control with metformin alone. A pivotal Phase III clinical trial demonstrated that Chiglitazar combined with metformin offers significant clinical benefits, including continuous glucose reduction, lipid regulation, and cardiovascular risk reduction, compared to placebo combined with metformin.
Chipscreen Biosciences, stated, "Despite the availability of multiple drugs for T2DM, the rapid increase in diabetes patients indicates significant unmet clinical needs in both monotherapy and combination therapy. As the first PPAR full agonist approved globally for type 2 diabetes, Chiglitazar, with its novel mechanism, addresses the challenge of insulin resistance, targeting the metabolic syndrome associated with this disorder. This approval provides clinicians and patients with a more flexible and effective treatment option."
Chiglitazar (Shuangluoping®/Bilessglu®) is a novel hypoglycemic drug developed by Shenzhen Chipscreen Biosciences Co., Ltd. It is classified as a national Class 1 new drug and a significant achievement in the national "Major New Drug Creation" initiative. Chiglitazar is the first PPAR full agonist approved for type 2 diabetes treatment worldwide.
Chiglitazar regulates blood glucose levels and improves lipid and energy metabolism disorders associated with T2DM, helping prevent cardiovascular complications. This makes Chiglitazar a potentially comprehensive treatment option for T2DM.
Insulin resistance, a core pathological mechanism in type 2 diabetes, leads to hyperglycemia, hyperlipidemia, obesity, fatty liver, and atherosclerotic cardiovascular disease (ASCVD). Few drugs target insulin resistance directly. Chiglitazar, a PPAR full agonist, activates three PPAR receptor subtypes, regulating glucose, lipid, and energy metabolism. It selectively alters gene expressions related to insulin sensitivity, addressing insulin resistance and its complications. By improving insulin sensitivity, regulating blood sugar, and addressing lipid metabolism disorders, Chiglitazar potentially reduces cardiovascular complications, offering better efficacy and safety for comprehensive diabetes treatment.
Besides type 2 diabetes, Chiglitazar is also being explored for combination preparations with other diabetes drugs (e.g., metformin-chiglitazar, empagliflozin-chiglitazar) and phase II clinical research for treating nonalcoholic fatty liver steatohepatitis in China.
Source: prnewswire.com
