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YH35324 is a long-acting fusion protein drug under development for the treatment of immunoglobulin E (IgE)-mediated allergic diseases. It is an Fc fusion protein that combines the extracellular domain of the high-affinity IgE receptor (FcεRIα) with a hybrid Fc region. The primary mechanism of action involves binding to free human IgE with high affinity, thereby preventing serum IgE from interacting with its receptors on mast cells and basophils. This inhibition blocks histamine release and degranulation in response to allergens and also suppresses autoantibody-dependent effector cell activation by blocking anti-FcεRIα autoantibodies[1][2][3][4][6]. Unlike existing therapies such as omalizumab (Xolair), YH35324 can effectively reduce free IgE levels even in patients with very high total IgE or those who are non-responsive to current anti-IgE antibodies[6]. It does not bind to Fcγ receptors, which may lower the risk of anaphylaxis compared to other antibody-based treatments[6]. Developed by Yuhan Corporation, it is being investigated for various allergic conditions including chronic urticaria (chronic spontaneous urticaria and chronic inducible urticaria), atopic dermatitis, allergic asthma, food allergies, ranula, cold urticaria, and anaphylaxis[4][5].
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