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FB317

Indication
Moderate-to-severe allergic asthma and chronic idiopathic urticaria (CIU)
Ingredient
Omalizumab, anti-IgE-humanized monoclonal antibody
Dosage
150 mg
Product Advantages
1.FB317, a biosimilar of Omalizumab, is a new option for the treatment of IgE-mediated allergic diseases.
2.FB317 has similar efficacy as Omalizumab in neutralizing free serum IgE.
Status
Phase I clinical trial
Mechanism
Omalizumab is a humanized monoclonal antibody that specifically interacts with an antigenic epitope on IgE, preventing its binding to Fc?RI on mast cells and basophils.
Potential Market
2017 global sales exceeded 2.7 billion, thus the market is expected to amplify with more indications approved.
  • Omalizumab (Xolair) is a humanized monoclonal antibody that specifically interacts with an antigenic epitope on IgE, preventing its binding to Fc?RI on mast cells and basophils, thus relieves allergic reactions. Xolair has been approved for allergic asthma and chronic idiopathic urticarial. Other indications, such as food allergy, are still under investigation. More indications for Xolair are expected to increase. The patents on Xolair already expired in 2017 (both in US and Europe), but only few bio-similar drugs are in development. Xoliar was on the China market in the late 2017, indicating that FB317 still has allergy market potential in China. FB317 has received the IND approval from the CFDA and is currently in preparation for phase I study in China.


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