On January 16, China Biopharmaceutical announced that the Group has initiated a Phase III clinical study of Semaglutide Injection in China for the indication of type 2 diabetes mellitus.

Semaglutide is a long-acting glucagon-like peptide-1 (GLP-1) analog with 94% sequence homology to human GLP-1, a peptide secreted by small intestinal L-cells, which is known for its ability to increase insulin synthesis and secretion, inhibit appetite, and delay gastric emptying. Semaglutide reduces blood glucose by stimulating insulin secretion and decreasing glucagon secretion.

Semaglutide is the first weekly GLP-1 formulation in China with both hypoglycemic and cardiovascular indications, and its effects in lowering blood glucose, reducing body weight, and cardiovascular protection in diabetes have been well proven. Compared with the previous generation of glucose-lowering drugs, Semaglutide's outstanding advantage is its longer half-life, which allows it to be administered once a week, greatly improving patient compliance. Currently, Semaglutide has become one of the best-selling hypoglycemic drugs in the world, with global sales in 2022 exceeding USD 10 billion.

The Phase III clinical study, conducted by Professor Zhu Dalong of Gulou Hospital, Nanjing University School of Medicine, enrolls 492 patients and aims to evaluate the efficacy and safety of Semaglutide injection in patients with type 2 diabetes mellitus, with the primary endpoint being the value of glycosylated hemoglobin (HbA1c) after 32 weeks of treatment, and the secondary endpoints of the study including lipids, fasting glucose, body weight, and drug safety. Secondary endpoints included lipids, fasting glucose, body weight, and drug safety.

In addition to Semaglutide injection, China Biopharm's GMA106 (GIPR antagonist/GLP-1R agonist) has been submitted to the Center for Drug Evaluation of the State Drug Administration of the People's Republic of China (the "CDE") for Phase Ib/II clinical trials and has been accepted, which is expected to bring more choices of medication to patients.

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