Federal Pharmaceuticals (03933): Application for marketing registration of simeglutide injection accepted

Zhitong Finance App News, Federal Pharmaceutical (03933) issued an announcement. The heavy management indications for simeglutide injections declared by Zhuhai Federal Biomedical Co., Ltd., a wholly-owned subsidiary of the company, were accepted by the China National Drug Administration for marketing registration. The acceptance numbers are CXSS2600179, CXSS2600180, CXSS2600181, CXSS2600182 and CXSS2600183.

Simeglutide injection is a long-acting recombinant human glucagon-like peptide-1 (GLP-1) analog. Clinically, it is mainly used for blood sugar control in patients with type 2 diabetes, long-term weight management in obese or overweight patients, reduction of the risk of major cardiovascular adverse events in obese or overweight patients, and treatment of patients with moderate to severe liver fibrosis (MASH) associated with metabolic steatohepatitis. It is injected subcutaneously once a week to achieve significant weight loss through multiple mechanisms such as suppressing appetite, delaying gastric emptying, regulating energy metabolism, and improving liver histology. At the same time, it also has comprehensive benefits such as reducing the risk of cardiovascular events and treating fatty hepatosis with liver fibrosis, providing an efficient, convenient, and comprehensive long-term weight management plan for obese or overweight patients.

Previously, the company submitted an application for marketing registration of simeglutide injection for diabetes in January 2025 and was accepted. The current marketing registration for weight management indications has further enriched the product's indication layout and is expected to bring clinical benefits to a wider range of patients.

Focusing on the GLP-1 target, the company has laid out a differentiated product pipeline combining innovative drugs and biosimilar drugs, which will help enhance the company's market competitiveness in the biomedical field. In the future, the company will continue to work on new product research and development, which is expected to generate greater benefits for the company and its shareholders.