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FB825

Indication
Atopic Dermatitis (AD), Allergic Asthma, Hyper IgE Syndrome and Food Allergy.
Product Advantages
1.Novel target, inhibiting the origin of IgE production.
2.Fulfill the unmet need of patients with high IgE (IgE > 1500 IU/mL)
3.Clear Pharmacological mechanism, mild side-effects.
4.Combine with Omalizumab or other anti-allergy drug reducing drug dosage and achieving optimal efficacy.
5.Potential of preventive application in allergy.
6.Broad indications, applicable to various IgE related allergic diseases.
7.Expecting to be administrated once every 2~3 months, improving the convenience of patients and reducing the medical cost.
Status
Phase II clinical trial
Mechanism
FB825 is a humanized monoclonal antibody that binds to the CεmX domain of membrane form IgE, leading to death of IgE+ B lymphocytes by inducing apoptosis and antibody-dependent cellular cytotoxicity (ADCC)
Potential Market
USD 20.8 billion in allergic disease/allergic asthma in 2024
  • FB825, a new generation of therapeutic monoclonal antibody (humanized; IgG1) for allergic disease, specifically binds to the CεmX domain on membrane-bound IgE B cells and induces targeted cells undergoing apoptosis and ADCC. It kills the IgE+ B lymphocytes directly to prevent IgE-plasma cell differentiation and reduce IgE production. FB825 potentially has both therapeutic and preventive effects in allergic disease.
  • FB825 is under global patent protection. Patents have been granted by majority of advanced countries such as US, EU, Japan and China.
  • Phase I clinical study of FB825 has finished in U.S with confirmed safety results in healthy subjects. Orphan Drug Designation of FB825 was granted by US FDA for treatment of Hyper IgE syndrome (HIES). Phase II studies were approved in HIES and allergic asthma. FB825 was also granted the phase II approval in Atopic Dermatitis (AD) by the Taiwan Food and drug Administration (TFDA).


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