UNITED LAB (03933.HK): UBT251 injection completes first participant dosing in Phase III clinical study for type 2 diabetes in China

NewTimeSpace News: On 7 September 2026, The United Laboratories International Holdings Limited (stock code: 03933) voluntarily announced that UBT251 injection, a Class 1 innovative drug independently developed by its wholly-owned subsidiary United Bio-Tech (Zhuhai Hengqin) Co., Ltd., had completed first participant dosing in its Phase III clinical study for type 2 diabetes in China.

The Phase III study comprises two sub-studies. UNIGUIDE-1 adopts a randomized, double-blind, parallel, placebo-controlled design, planning to enroll 360 adult participants with type 2 diabetes (7.5% ≤ HbA1c ≤ 10.5%) to evaluate the efficacy and safety of UBT251 injection in patients with inadequate glycemic control after diet and exercise intervention alone, with the primary endpoint of change from baseline in HbA1c after 40 weeks of treatment. UNIGUIDE-2 adopts a randomized, open-label, parallel, semaglutide-controlled design, planning to enroll 956 adult participants with type 2 diabetes (7.5% ≤ HbA1c ≤ 11.0%) to evaluate the drug in patients with inadequate glycemic control after metformin monotherapy or combination with sulfonylureas/SGLT2 inhibitors, with the primary endpoint of change from baseline in HbA1c at week 40 and secondary endpoints including changes in body weight, blood pressure, blood lipids and HbA1c at week 52.

UBT251 is a long-acting GLP-1/GIP/GCG triple receptor agonist, which has been approved for clinical research in multiple indications in China and/or the US, including type 2 diabetes, overweight/obesity, chronic kidney disease, metabolic dysfunction-associated steatohepatitis and moderate-to-severe obstructive sleep apnea with obesity. The company stated that it is the first enterprise in China and the second globally to obtain clinical approval for a long-acting GLP-1R/GIPR/GCGR triple agonist prepared by chemical synthesis of peptides. In March 2025, United Bio-Tech and the company entered into an exclusive license agreement with Novo Nordisk A/S in respect of UBT251.

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