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FB825

合一生技股份有限公司 / SCIENCE / R & D / FB825

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

FB825-en

Ongoing
Completed
Research Code Therapeutic Area Indication Development Region Pre-Clinical Phase I Phase II Phase III NDA Market More
FB825
 Dermatology, Immunology Atopic Dermatitis, Allergic Asthma
Taiwan
US / Taiwan(SC formulation)
  • 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.