CSPC PHARMA (01093): The second application for the listing of Idecaglutide injection has been accepted by the National Medical Products Administration.

CSPC PHARMA (01093) announced that its subsidiary CSPC PHARMA Baike (Shandong) Biopharmaceutical Co., Ltd. has had the second application for the listing of its product, Ideglira peptide injection solution (trade name: Shanmeining), accepted by the China National Medical Products Administration (NMPA). This product is classified as a Class 1 new drug for biologics in the treatment of type 2 diabetes in adults. Previously, the application for the listing of this product for the indication of long-term weight management in overweight or obese adults was accepted by the NMPA in October 2025. This product is a recombinant human glucagon-like peptide-1 (hGLP-1) Fc fusion protein injection solution, administered once weekly. It selectively binds and activates the GLP-1 receptor to promote insulin secretion in a glucose-dependent manner, inhibit glucagon release, thereby steadily lowering blood sugar levels; it also suppresses appetite, reduces food intake, regulates weight, and improves cardiovascular and metabolic parameters. The application for listing is based on two key Phase III clinical studies conducted in Chinese type 2 diabetes patients, which confirmed the efficacy and safety of this product as monotherapy and in combination with metformin. The results of the two pivotal Phase III clinical studies consistently demonstrated that this product comprehensively reduces blood sugar, promotes weight loss, and improves multiple metabolic parameters; it shows rapid onset of action, with a significant reduction in HbA1c observed after 4 weeks of treatment, and the efficacy can be maintained for up to 52 weeks. When used in combination with metformin, the product demonstrated better long-term blood sugar control compared to exenatide. For patients with higher baseline HbA1c levels, the product effectively reduced HbA1c by over 2%. In addition to improving blood sugar levels, the product also improves lipid levels, blood pressure, weight, and other cardiovascular risk factors, with benefits increasing over time, providing integrated metabolic management advantages for patients. The product is well tolerated and safe, with lower rates of gastrointestinal adverse events and discontinuation due to adverse events compared to similar products on the market, and a faster and simpler dose titration regimen to reach maintenance target dose within 4 weeks. Given its advantages in efficacy and safety, this product has significant clinical value and is expected to become a new option for the treatment of type 2 diabetes.