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omalizumab biosimilar SYN008

Development stage: Phase 3
Lead developer: CSPC Baike Biopharmaceutical
Modality: Monoclonal Antibodies → Antibody-Based Therapeutics
Administration: Subcutaneous

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

Targets

IgE (Immunoglobulin E)

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