Oneness Biotech Co., Ltd. announced Subcutaneous injection formulation of FB825 to treat moderate-to-severe atopic dermatitis was greenlighted by TFDA to proceed with a Ph2 study. Date of occurrence of the event: April 22, 2024. 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.

Planned development stages: Phase II clinical trial. Current development stage: File application/approved/disapproved/Each of clinical trials (include interim analysis): Subcutaneous injection formulation of FB825 to treat moderate-to-severe atopic dermatitis was greenlighted by TFDA to proceed with a Ph2 study. 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. Any other matters that need to be specified(the information disclosure also meets the requirements of Article 7, subparagraph 8 of the Securities and Exchange Act Enforcement Rules, which brings forth a significant impact on shareholders rights or the price of the securities on public companies.): On January 30, 2024, an IND application for the phase II clinical trial was submitted to the US FDA. The trial is jointly conducted with international partner and will be concurrently implemented in multiple medical centersin the United States and Taiwan.

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