The board of directors of CSPC Pharmaceutical Group Limited announced that the Semaglutide Injection developed by the Group has obtained clinical trial approval granted by the National Medical Products Administration of the People's Republic of China to conduct clinical trials in China for weight management in overweight adults or obese patients, along with a reduced calorie diet and increased physical activity. It is also the second indication for clinical trial approved for the Product following its indication for the glycemic control in adult patients with type 2 diabetes. Semaglutide injection is the single largest product in the field of weight loss and is developing rapidly with a huge market potential.

The active pharmaceutical ingredient API used in the Product is produced completely through chemical synthesis. The use of advanced synthesis, purification and characterisation techniques enables a higher purity of the API produced, avoiding the introduction of immunogenic substances such as host protein in the process of biological fermentation, and ensuring that the impurity level is not higher than that of semaglutide prepared by DNA recombinant technology. The comparative study of impurity profile demonstrated that compared with semaglutide injection prepared by DNA recombinant technology, the impurity level of the Product is lower with no new impurities produced under long-term storage at 2-8°C. Preclinical studies demonstrated that the Product has similar biological activities and weight loss effect as those of semaglutide injection prepared by DNA recombinant technology, and has consistent metabolic characteristics and safety in cynomolgus monkeys, with no active systemic allergic reactions and good local tolerability.

The Product is a Class 2.2 chemical drug in China. Currently there is no chemically synthesised semaglutide product available in the global market, providing a promising clinical development value.