On March 25, Federal Pharmaceuticals (03933) issued an announcement stating that its wholly-owned subsidiary, Federal Biotechnology (Zhuhai Hengqin) Co., Ltd., has independently developed a Class 1 innovative drug UBT251 injection has completed a Phase II clinical trial in Chinese patients with type 2 diabetes.

This study included 211 patients with a baseline mean HbA1c of 8.12%, a baseline weight of 80.1 kg, and a baseline BMI of 29.1 kg/m². Results showed that after 24 weeks of treatment, the UBT251 treatment group achieved the highest mean HbA1c reduction of 2.16%, significantly better than the 1.77% reduction in the semaglutide group and the 0.66% reduction in the placebo group. Simultaneously, the UBT251 treatment group achieved the highest mean weight reduction of 9.8%, compared to 4.8% in the semaglutide group and only 1.4% in the placebo group.

This study also demonstrated that UBT251 showed improvements in key secondary endpoints such as waist circumference, blood pressure, and blood lipids, and exhibited good safety and tolerability. The study has met its expected objectives and supports UBT251's advancement to the next phase, Phase III clinical trials. Federal Pharmaceuticals will initiate Phase III clinical trials in Chinese patients with type 2 diabetes as soon as possible. Furthermore, UBT251 has been approved for clinical trials in China and/or the United States for multiple indications, including adult type 2 diabetes, overweight/obesity, and chronic kidney disease.

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