Oneness Biotech Co., Ltd. announced submission of a phase II clinical trial protocol to Taiwan FDA for subcutaneous injection formulation of FB825 in patients with moderate-to-severe atopic dermatitis. New drug name or code: FB825. Indication: Treatment for moderate-to-severe atopic dermatitis, allergic asthma and other IgE-mediated allergic diseases; Information Website: has not submitted to Taiwan Clinical Trial Information System.

Current development stage: FB825 has successfully developed a subcutaneous injection formulation and completed the enrollment of a bridging trial involving both intravenous and subcutaneous formulations among healthy subjects in the United States. Initial findings have affirmed the safety of the subcutaneous injection formulation. A phase II clinical trial application for the subcutaneous injection formulation of FB825 in patients with moderate-to-severe atopic dermatitis has been submitted via IND to the Taiwan FDA.

The primary objectives of this study are to investigate the efficacy, safety, and pharmacokinetics associated with FB825's subcutaneous injection formulation in moderate-to-severe atopic dermatitis patients. (1)File application/approved/disapproved/Each of clinical trials (include interim analysis): Submit an IND to Taiwan FDA for a phase II clinical trial of the subcutaneous injection formulation of FB825 in patients with moderate-to-severe atopic dermatitis; (2) Once disapproved by competent authority or each of clinical trials (include interim analysis) results less than statistically significant sense, the risks and the associated measures the Company may occur: Not applicable; (3)After obtaining official approval or the results (include interim analysis) of statistically significant sense, the future strategy: Not applicable; (4)Accumulated investment expenditure incurred: No disclosure of investment expenditure at the moment in consideration of future marketing strategies and to protect the interests of the company and investors.