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FB317

FB317

FB317, a biosimilar of Omalizumab sold 2 billion USD in 2015, inhibits the binding of IgE to the FcεRI on the surface of mast cells and basophils by neutralizing free IgE in the blood.

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Overview
FB317, a biosimilar of omalizumab, inhibits the binding of IgE to the FcεRI on the surface of mast cells and basophils by neutralizing free IgE in the blood. Reduction of surface bound IgE on FcεRI-bearing cells decreases the release of mediators and prevents allergic responses.

Mostly on the clinical treatment with antihistamines, sympathomimetic drugs, corticosteroids and cytomegalovirus inhibitor. With limited therapeutic effect of these anti-allergic drugs, and the defect of need of daily doses for patient; to patients with moderate/severe symptoms were relieved relying on long period of time of high-dose corticosteroids. IgE has been confirmed the disease target of the cause of asthma and allergic. Omalizumab is the sole world approved antibody allergy drug for the treatment of asthma and allergy, which the pathological mechanism is the role of clearing excess of IgE in the blood (see pictures).

IND was approved by CFDA and phase I trial is planning in China.
Application
1. Severe asthma
2. Chronic Urticaria
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