CSPC PHARMA: The new drug application for Idaglutide α injection has been accepted by the National Medical Products Administration
CSPC PHARMA announced that the new drug application for its subsidiary's developed injectable EdaGlutide α has been accepted by the National Medical Products Administration. This product is used for long-term weight management in overweight or obese adults, demonstrating significant effects in reducing weight and improving cardiovascular and metabolic indicators. Clinical trials have shown good safety and tolerability, with a low incidence of adverse events. The Phase III clinical trial for this product is currently ongoing
According to the announcement from CSPC PHARMA (01093), its subsidiary CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. has received acceptance from the National Medical Products Administration of the People's Republic of China for the new drug application of Idaglutide α injection (the product). This product is classified as a Class 1 new drug for therapeutic biological products, indicated for long-term weight management in overweight or obese adults based on dietary control and increased physical activity.
The product is a recombinant human glucagon-like peptide-1 (hGLP-1) Fc fusion protein injection, which patients need to use once a week. It selectively binds to and activates GLP-1 receptors, achieving weight reduction through mechanisms such as appetite suppression and reduced food intake. It can also lower blood glucose levels in a glucose concentration-dependent manner and improve cardiovascular and metabolic indicators.
This new drug application is primarily based on a pivotal Phase III clinical trial, which enrolled overweight adult patients with obesity or at least one weight-related comorbidity. The clinical trial results showed that compared to placebo, the product significantly reduced weight and significantly decreased patients' waist circumference, blood glucose, blood pressure, and blood lipid levels, providing cardiovascular and metabolic benefits to patients. Additionally, the product demonstrated good safety and tolerability. Compared to similar drugs already on the market, the incidence of gastrointestinal adverse events and the rates of treatment interruption or discontinuation due to adverse events are lower, and the dose escalation regimen is faster and simpler, achieving the target maintenance dose in just 4 weeks.
Currently, two Phase III clinical trials of the product in patients with type 2 diabetes are actively underway, aiming to benefit more patients
