On August 16, 2022, Semaglutide Injection developed by The United Bio-Technology (Hengqin) Co., Ltd received a clinical registration application acceptance notice issued by the National Drug Administration, with acceptance number CXSL2200379. This is the second variety that the company's clinical application was accepted after the approval of the clinical trial of Degu Mendong Double Insulin Injection by TUL, which marks another major breakthrough and progress in the research and development of diabetes drugs by TUL.
Semaglutide Injection is a long-acting GLP-1 analog that is injected subcutaneously once a week. Semaglutide is a small molecule short peptide composed of 31 amino acids and a long-acting GLP-1 analog that can mimic GLP-1 to significantly reduce blood sugar, promote insulin secretion, and repair pancreatic islets in the human body β Physiological functions such as cells. Structurally, SSemaglutide is a derivative obtained by replacing Lys34 of GLP-1 (7-37) with Arg and connecting a fatty acid side chain with a splitter (AEEA) - (AEEA) - rGlu-C18 diacid) on the Lys26 side chain, while replacing the eighth Ala position on the amino acid sequence with an unnatural amino acid Aib. After the injection of smeglutide, the fatty acid side chain on smeglutide can be connected with human serum albumin through non covalent bond in vivo to form biomacromolecules, which can effectively delay the clearance of kidneys. At the same time, the enzyme digestion site His Ala of DPP-IV has mutated to His Aib, and DPP-IV protease cannot recognize this enzyme digestion site, thus making the half-life of smeglutide much higher than that of GLP-1 analogues (lilalutide, exenatide).
The raw materials and preparations of smeglutide produced by The United Bio-Technology (Hengqin) Co., Ltd were developed in accordance with the requirements of the guiding principles for the research of biosimilar. The head to head pharmaceutical research (structural characterization, influencing factors, stability test, impurity spectrum, etc.) was carried out with the original marketed varieties, and the pharmacological and toxicological research was completed. The research shows that there is no significant difference between the Smeaglutide injection and the original drug in pharmacodynamics, safety pharmacology, single subcutaneous administration toxicity test, repeated administration toxicity test, pharmacokinetics, immunogenicity, allergy test, hemolysis and irritation test, which indicates that this product is effective for the treatment of type 2 diabetes, and there is no doubt about safety, Can achieve the goal of controlling blood sugar by administering medication once a week.
The biopharmaceutics sector of TUL has continued to grow rapidly, and the Group has successfully transformed from antibiotic chemical pharmaceuticals to the dual wheel drive strategy of biopharmaceuticals and chemicals. In the process of transformation, the biopharmaceutical R&D sector of TUL has continued to grow, established a complete product pipeline for diabetes biopharmaceutical development, and established a high-level R&D and production team. The United Bio-Technology (Hengqin) Co., Ltd as the biomedical R&D headquarters of TUL in Hengqin, based on the existing listed product technology and research team, expands biological investment and biological R&D talent introduction, deepens and develops in diabetes drugs, monoclonal antibody drugs, skin drugs, autoimmune diseases and other sectors and fields, from energy metabolism, Developing recombinant protein drugs and nucleic acid regulatory molecules in the fields of inflammation and autoimmune diseases, committed to becoming well-known chronic disease management experts at home and abroad.
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