Shenlian Biotech announced that it recently received a “Notice Letter” from participating company Shizhiyuan regarding the progress of phase II clinical research on the UB-221 innovative drug. As of the announcement disclosure date, the project had completed the enrollment of all 145 test subjects. The ongoing clinical trial of UB-221 is a phase II, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of UB-221 in patients with chronic spontaneous urticaria. This clinical trial plans to recruit 144 patients and eventually recruit 145 patients. The patients were randomly assigned to one of the five treatment groups to receive 4 mg/kg UB-221, 2 mg/kg UB-221, 1 mg/kg UB-221, 300 mg Xolair®, or placebo, respectively. The primary endpoint was the percentage of patients with HSS7=0 at week 12. UB-221 was originally developed by United Biomedical Company of the United States, the company's second-largest shareholder. This project is a next-generation product developed by Dr. Zhang Ziwen, the inventor of anti-IgE treatment. It is a humanized promonoclonal antibody in a subcutaneous injectable dosage.

Zhitongcaijing · 08/31/2025 07:41
Shenlian Biotech announced that it recently received a “Notice Letter” from participating company Shizhiyuan regarding the progress of phase II clinical research on the UB-221 innovative drug. As of the announcement disclosure date, the project had completed the enrollment of all 145 test subjects. The ongoing clinical trial of UB-221 is a phase II, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of UB-221 in patients with chronic spontaneous urticaria. This clinical trial plans to recruit 144 patients and eventually recruit 145 patients. The patients were randomly assigned to one of the five treatment groups to receive 4 mg/kg UB-221, 2 mg/kg UB-221, 1 mg/kg UB-221, 300 mg Xolair®, or placebo, respectively. The primary endpoint was the percentage of patients with HSS7=0 at week 12. UB-221 was originally developed by United Biomedical Company of the United States, the company's second-largest shareholder. This project is a next-generation product developed by Dr. Zhang Ziwen, the inventor of anti-IgE treatment. It is a humanized promonoclonal antibody in a subcutaneous injectable dosage.