United Labs gets FDA nod for CKD drug trial

The United Laboratories International Holdings (HKEX: 3933) announced that its UBT251 injection, a Class 1 innovative drug developed by its subsidiary The United Bio-Technology (Hengqin) Co., Ltd., has been approved by the U.S. Food and Drug Administration (FDA) for a Phase II clinical trial on the indication of chronic kidney disease (CKD). The company said the indication had previously been approved for clinical trials by China National Medical Products Administration. Preclinical data suggests UBT251 demonstrates superior improvement effects compared to Semaglutide in obesity/diabetic nephropathy models. UBT251, a long-acting triple agonist of GLP-1/GIP/GCG, has now secured clinical trial approvals for T2DM, overweight/obesity, and CKD in both China and the U.S.