CSPC Pharmaceutical’s semaglutide injection accepted by NMPA for weight management

CSPC Pharmaceutical Group Limited announced that China's National Medical Products Administration (NMPA) has accepted a second marketing authorization application for its Semaglutide Injection. This application targets long-term weight management in overweight or obese adults, to be used with diet control and increased physical activity. This follows the NMPA's August 2025 acceptance of the product's application for glycemic control in adults with type 2 diabetes.

The Semaglutide Injection, developed by CSPC Baike (Shandong) Biopharmaceutical Co., is a chemically synthesized preparation classified as a Class 2.2 new drug. The company highlights its significant clinical advantages, including avoiding immunogenic substances found in biological fermentation products while maintaining impurity levels comparable to recombinant DNA technology. The drug operates by binding to the GLP-1 receptor, offering comprehensive benefits such as weight reduction, glycemic control, and cardiovascular and renal protection.

The application is supported by Phase III clinical trial results from non-diabetic obese adults. These trials showed significant reductions in body weight and waist circumference, alongside improvements in blood glucose, lipid, and liver enzyme levels. The product demonstrated efficacy highly consistent with Novo Nordisk's semaglutide, a similar safety profile, and good tolerability with a slightly lower incidence of adverse events, underscoring its clinical application value.