CSPC PHARMA (01093): The new drug application for the injection of Idecagrptide Alpha has been accepted by the National Medical Products Administration.

CSPC PHARMA (01093) announced that the new drug marketing application for the injectable exenatide developed by its subsidiary company CSPC PHARMA Baike (Shandong) Biopharmaceutical Co., Ltd. has been accepted by the National Medical Products Administration of the People's Republic of China. The product is filed as a class 1 new drug for therapeutic biologics, indicated for long-term weight management in overweight or obese adults on a controlled diet and increased exercise. The product is a recombinant human glucagon-like peptide-1 (hGLP-1) Fc fusion protein injection, to be used once a week by patients. It selectively binds and activates GLP-1 receptors, reducing weight by suppressing appetite, decreasing food intake, and lowering blood sugar in a glucose-dependent manner to improve cardiovascular and metabolic indicators. The new drug marketing application is mainly based on a pivotal Phase III clinical trial involving obese or overweight adults with at least one weight-related comorbidity. Results showed that compared to placebo, the product significantly reduced weight, waist circumference, blood sugar, blood pressure, and blood lipids in patients, providing cardiovascular and metabolic benefits. The product also demonstrated good safety and tolerability. Compared to similar marketed drugs, it had lower rates of gastrointestinal adverse events and discontinuation due to adverse events, with a quicker and simpler dose escalation plan reaching maintenance dose in just 4 weeks. Currently, two Phase III clinical trials in type 2 diabetes patients are actively ongoing with the goal of benefiting more patients.