Oneness Biotech Co., Ltd. announced that S.C. injection formulation of FB825 has been agreed by US FDA to proceed with Phase 2 clinical trial to treat moderate-to-severe atopic dermatitis. Indication: Treatment for moderate-to-severe atopic dermatitis, allergic asthma and other IgE-mediated allergic diseases. Current development stage: File application/approved/disapproved/Each of clinical trials (include interim analysis): Subcutaneous injection formulation of FB825, anti-CemX antibody, has been agreed by US FDA to proceed with Phase 2 clinical trial.

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. Market situation: Atopic dermatitis is a chronic and heterogeneous skin condition characterized by intense itching and eczematous lesions. It is the most common inflammatory skin disease in developed countries.

According to the Global Report on Atopic Dermatitis 2022 by the International Eczema Council, up to 20% of children and 10% of adults in developed nations suffer from this condition. The market for atopic dermatitis is gradually gaining attention, becoming one of the target indications for pharmaceutical companies. According to a report from Mordor Intelligence, the atopic dermatitis treatment market is estimated to be $10.06 billion in 2024, with a projected compound annual growth rate (CAGR) of 7.18%, reaching $14.23 billion by 2029.

On April 22, 2024, subcutaneous injection formulation of FB825 to treat moderate-to-severe atopic dermatitis was greenlighted by TFDA to proceed with a phase II clinical trial. The trial is jointly conducted with international partner and will be concurrently implemented in multiple medical centers in the United States and Taiwan. According to Guidelines by Taipei Exchange on the Material Information Announced by Listed and OTC Companies, new drug development companies shall make public announcement when filing application for clinical trials to domestic or overseas regulatory authorities, receiving approval or disapproval, obtaining the statistical date of endpoints in each clinical trial (including interim analysis), or receiving approval or disapproval on drug license application.