CSPC PHARMA (01093) announced that the new drug application for Idaglutide Alpha Injection developed by its subsidiary, CSPC Baike (Shandong) Biopharmaceutical Co., Ltd., has been accepted by the National Medical Products Administration of the People's Republic of China.

The product has been filed as a Category 1 new biological therapeutic drug, with an indication for long-term weight management in overweight or obese adults as an adjunct to a reduced-calorie diet and increased physical activity.

The product is a recombinant human glucagon-like peptide-1 (hGLP-1) Fc fusion protein injection that requires once-weekly administration. It can selectively bind to and activate GLP-1 receptors, achieving weight reduction through mechanisms including appetite suppression and reduced food intake. Additionally, it can achieve glucose-dependent blood sugar reduction and improve cardiovascular and metabolic parameters.

The new drug application is primarily based on a pivotal Phase III clinical trial that enrolled obese adults or overweight adults with at least one weight-related comorbidity. Clinical trial results demonstrated that compared to placebo, the product significantly reduced body weight and significantly improved patients' waist circumference, blood glucose, blood pressure, and lipid profiles, providing comprehensive cardiovascular and metabolic benefits to patients. The product also showed good safety and tolerability.

Compared to similar marketed drugs, this product showed lower incidence rates of gastrointestinal adverse events and lower rates of treatment interruption or discontinuation due to adverse events. Furthermore, its dose escalation regimen is faster and more convenient, requiring only 4 weeks to reach the target maintenance dose.

Currently, two Phase III clinical trials of this product in Type 2 diabetes patients are actively progressing, with the aim of benefiting more patients.