UNITED LAB(03933): UBT251 Injection obtained clinical trial implied approval for the indication of chronic kidney disease

UNITED LAB (03933) announced that on January 20, 2025, the Phase II clinical trial registration application for the innovative drug UBT251 injection developed independently by its wholly-owned subsidiary Federal Biotechnology (Zhuhai Hengqin) Co., Ltd. for the indication of chronic kidney disease has obtained the Clinical Trial Implication License from the China National Medical Products Administration, with acceptance number CXHL2401227. UBT251 is a long-acting GLP-1 (glucagon-like peptide-1)/GIP (glucose-dependent insulinotropic polypeptide)/GCG (glucagon) tri-target receptor agonist, with potent activity on GLP-1, GIP, and glucagon receptors. Metabolic syndrome caused by obesity, diabetes, etc., damages the kidneys through mechanisms such as changes in hemodynamics, increased glomerular pressure, oxidative stress, and inflammation, leading to a significant increase in the prevalence of chronic kidney disease in recent years. The GLP-1 drug semaglutide has been proven to have therapeutic effects on chronic kidney disease in Phase III clinical trials, and UBT251 has shown better therapeutic effects than semaglutide in relevant preclinical chronic kidney disease animal models. In addition, UBT251 has obtained clinical trial permissions for adult type 2 diabetes indications, overweight or obesity indications, and non-alcoholic fatty liver disease indications in 2023 in China, and the clinical trials are progressing smoothly with its efficacy and safety confirmed. As the first domestically developed chemical synthetic GLP-1R/GIPR/GCGR tri-target receptor agonist drug, UBT251 has helped the company to occupy an important position in the field of this type of drug research. In the future, the company will continue to focus on new product development, and will strive to enhance its competitiveness and creativity in the biopharmaceutical industry, expecting to create greater profits for the company and its shareholders.