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R & D
ON101 (FESPIXON®) FB825 FB704A OB318 SNS812 SNS851 Research Publication/ Abstract

FESPIXON®
FESPIXON® Cream About Diabetic Foot Ulcers Expanded Access Program Medical Subsidies for low-Income DFU Patients Care for Diabetic Foot The Ph3 Data and the Mechanism of Action of FESPIXON®(ON101) FESPIXON® received International Innovation Awards from Enterprise Asia Media Coverage

Bonvadis®
Bonvadis® Cream

Hospital Location

Health Education
Diabetic Foot Care

FB825

Indications

IgE-related allergic diseases such as atopic dermatitis, allergic asthma, hyper-IgE syndrome, and food allergies

Mechanism of Action

Treats and prevents allergic diseases by inhibiting the B lymphocytes, which express mIgE

Current Status
  1. Completed a phase I clinical trial in the US
  2. Completed a phase IIa clinical trial of atopic dermatitis in the US
  3. A phase IIa clinical trial in allergic asthma in Taiwan is ongoing
  4. A phase II clinical trial of the subcutaneous injection formulation for moderate to severe atopic dermatitis in Taiwan and the United States is ongoing
Product Advantages
  1. Uniqueness: Has a novel drug target and mechanism by inhibiting the source of IgE, i.e., the mIgE B cells.
  2. Safety: Has a specific pharmacological mechanism and limited side effects.
  3. Extensive use: Has a wide range of indications and applies to more allergy and asthma patients than its existing counterparts.
  4. Economy: FB825 has excellent pharmacokinetic properties and a long half-life. It is anticipated to be administered once every 2-3 months. The long-acting advantage provides great convenience to patients and helps reduce medical costs.
Market Potentials

According to analysis reports by Allied Market Research and Coherent Market Insights, the global market size of atopic dermatitis/asthma treatment will reach USD 38 billion in 2027.

R&D Progress
Complete
In Progress
Research Code Therapeutic Area Indication Pre-Clinical Phase I Phase II Phase III NDA Market More
  • FB825
    Dermatology
    Immunology
    Atopic Dermatitis
    Allergic Asthma

    FB825 is a first-in-class antibody targeting IgE B cells for the treatment of allergic diseases. It specifically binds to the CεmX domain on the membrane-bound IgE B cells and induces the apoptosis and ADCC of the targeted cells

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  • FB825 is a humanized monoclonal IgG1 antibody for treating and preventing allergic diseases. It binds only to membrane-bound IgE expressed on human B lymphocytes, not to secrete IgE. This binding triggers a cytotoxic response that kills mIgE B cells, thereby blocking the formation of plasma cells and the production of IgE, which leads to both therapeutic and preventive effects on allergic diseases.
  • FB825 has secured patent approvals in major pharmaceutical markets, including the United States, the European Union, Japan, and China. This establishes a comprehensive framework of global patent protection covering the drug, its therapeutic efficacy, and its antigenic epitopes.
  • FB825 has successfully completed a phase I clinical trial in the United States, establishing its safety for human administration. The U.S. FDA has granted its orphan drug designation for treating Hyper IgE Syndrome and has authorized the initiation of a phase II clinical trials. Furthermore, FB825 has conducted exploratory efficacy trials for atopic dermatitis, demonstrating significant therapeutic benefits. As of 2024, a subcutaneous injection formulation of FB825 has been agreed upon by the Taiwan FDA and the US FDA to proceed with a phase II clinical trial to treat moderate-to-severe atopic dermatitis.
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