On March 25, CSPC Pharmaceutical Group (1093.HK) announced that the semaglutide injection developed by the group has been approved by the National Medical Products Administration of the People’s Republic of China to conduct the clinical trial in China for weight management indication in overweight or obese adult patients on the basis of calorie diet reduction and increased physical activity. It is also the second indication for this product to be approved for clinical trials after blood sugar control in adults with type 2 diabetes.

Semaglutide injection is currently the most significant product in the field of weight loss and is still growing rapidly with broad market prospects. The raw materials used in this product are completely prepared through chemical synthesis, using advanced synthesis, purification and characterization technologies. The raw materials prepared are of higher purity, avoiding host proteins and other immunogenic substances introduced during the biological fermentation process, and ensuring the level of impurities is no higher than semaglutide prepared by DNA recombinant technology. Comparative study results of impurity profiles show that compared with semaglutide injection prepared by DNA recombinant technology, this product has lower impurity levels and no new impurities are produced under long-term storage conditions of 2-8°C.

Pre-clinical research results show that this product has similar biological activity and weight loss effects to semaglutide injection prepared by DNA recombinant technology; it has consistent metabolic characteristics and safety in cynomolgus monkeys, and has no systemic active allergic reactions It is well tolerated locally.

This product belongs to Category 2.2 in the Chinese Chemical Drug Registration Classification. Currently, there is no chemically synthesized semaglutide product on the global market, and it is of great clinical development value.

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