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Drug intelligence / Profile preview
omalizumab biosimilar SYN008
- Development stage
- Phase 3
- Lead developer
- CSPC Baike Biopharmaceutical
- Modality
- Monoclonal Antibodies → Antibody-Based Therapeutics
- Administration
- Subcutaneous
01
Overview
SYN008 is a biosimilar of omalizumab developed by Synermore Biologics and CSPC Baike (Shandong) Biopharmaceutical. Omalizumab is a recombinant humanized monoclonal antibody that acts as an IgE receptor antagonist and immunosuppressant. It binds to immunoglobulin E (IgE), preventing its interaction with the high-affinity IgE receptor on mast cells and basophils, thereby inhibiting the allergic inflammatory cascade. SYN008 is being developed primarily for chronic spontaneous urticaria (CSU) and allergic asthma, with clinical trials demonstrating therapeutic equivalence to Xolair (the reference omalizumab product). The drug has reached preregistration for chronic urticaria in China and phase III for allergic asthma[1][3][4].
- Brand names
- Omlyclo
- Other names
- omalizumab biosimilarKelingda
02
Targets
IgE (Immunoglobulin E)FCER1 (Fc epsilon RI receptor)
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