The first imitation in China! United Laboratories' "Somaglutide" clinical trial application accepted

July 05, 2021

On June 29, 2021, Zhuhai United Laboratories Co., Ltd. announced that it had received the Notice of Acceptance of Clinical Registration Application for Semaglutide Injection (Semaglutide Injection) issued by the National Medical Products Administration (Acceptance No.: CXSL2101157). It is worth noting that only two months ago, on April 29th, Novo Nordisk's semaglutide (Semaglutide) had just been approved in China. United Laboratories is the first imitation enterprise in China to apply for clinical trials of somaglutide injection with biosimilars.

Semaglutide Injection is a long-acting GLP-1 analogue, which can imitate GLP-1 in the human body to significantly reduce blood sugar, promote insulin secretion, and repair pancreatic β-cells. Somaglutide injection only needs to be injected once a week to well reduce and control the blood glucose concentration and reduce the weight of patients. It is an ideal medicine for the treatment of type 2 diabetes (T2DM). Structurally, Somaglutide replaces Lys34 of natural GLP-1 (7-37) with Arg, and connects a fatty acid side chain with angle divider to the side chain of Lys26 ((AEEA)-(AEEA) -rGlu-C18 diacid), and the eighth position Ala in the amino acid sequence is replaced with the unnatural amino acid Aib. After injecting Somaglutide injection, the fatty acid side chains on Somaglutide can be connected to human serum albumin through non-covalent bonds in the body to form biological macromolecules, which can effectively delay the renal clearance. At the same time, DPP- The restriction site His-Ala of IV has been mutated to His-Aib. DPP-IV protease cannot recognize this restriction site, which makes the half-life of somaglutide much higher than that of other GLP-1 analogs (such as Lila Lutide, Exenatide). Somaglutide injection is a GLP-1 analogue with significant hypoglycemic effect in the same target drugs currently on the market. The risk of hypoglycemia is low. It only needs to be injected once a week. It has the characteristics of safety, simplicity, and significant efficacy, which significantly improves Patient compliance. Somaglutide injection is under research for multiple indications, including the treatment of type 2 diabetes, weight management (weight loss), NASH (non-alcoholic fatty liver), Alzheimer's disease, etc., and they have all entered the research stage.

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