UNITED LAB (03933): The first trial participant has been dosed with UBT251 injection for a Phase III clinical study of type 2 diabetes in China.

UNITED LAB (03933) announced that its wholly-owned subsidiary, Federal Biotechnology (Zhuhai Hengqin) Co., Ltd. (Federal Biotechnology), has completed the administration to the first trial participant in the Phase III clinical study of its independently developed Class 1 innovative drug UBT251 injection for Type 2 diabetes in China. This study will be conducted as two separate studies: UNIGUIDE-1 and UNIGUIDE-2. UNIGUIDE-1 employs a randomized, double-blind, parallel, placebo-controlled trial design and plans to enroll 360 adult participants with Type 2 diabetes (7.5% HbA1c 10.5%). The aim is to evaluate the efficacy and safety of UBT251 injection in participants with poor blood glucose control after simple dietary and exercise interventions. The primary endpoint of UNIGUIDE-1 is the change in HbA1c from baseline after 40 weeks of treatment. UNIGUIDE-2 utilizes a randomized, open, parallel trial design with semaglutide injection as a control and plans to include 956 adult participants with Type 2 diabetes (7.5% HbA1c 11.0%). This study aims to evaluate the efficacy and safety of UBT251 injection in participants with poor blood glucose control after metformin monotherapy or in combination with sulfonylureas/SGLT2 inhibitors. The primary endpoint of UNIGUIDE-2 is the change in HbA1c from baseline after 40 weeks of treatment, while secondary endpoints include changes in weight, blood pressure, blood lipids, and change in HbA1c from baseline after 52 weeks of treatment.