Brightgene Bio-Medical Technology Co., Ltd. (688166.SH): BGM1812 injection received drug clinical trial approval notice.

Brightgene Bio-Medical Technology Co., Ltd. (688166.SH) announced that its wholly-owned subsidiary, Borui Pharmaceuticals (Suzhou) Co., Ltd. (referred to as "Borui Pharmaceuticals"), recently received the Drug Clinical Trial Approval Notice issued by the National Medical Products Administration, approving Borui Pharmaceuticals' BGM1812 injection for conducting clinical trials on overweight or obese individuals. BGM1812 injection is a newly designed long-acting Amylin analog by the company, with good molecular activity and pharmaceutical stability. Amylin, as a satiety peptide hormone composed of 37 amino acids, is released into the blood by pancreatic cells in conjunction with insulin. It suppresses appetite by activating the satiety pathway in the brain, while also delaying gastric emptying, inhibiting glucagon secretion, and having multiple weight reduction mechanisms. As of the disclosure date of the announcement, the weight reduction indication for BGM1812 injection has obtained FDA drug clinical trial approval in the United States, with the first clinical trial entry completed. As of the disclosure date of the announcement, there are no similar target-specific agents approved for weight reduction on the market globally.