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**STI-004** is a biosimilar to omalizumab, a recombinant DNA-derived humanized IgG1k monoclonal antibody that specifically binds to free human immunoglobulin E (IgE) on the blood and interstitial fluid and to membrane-bound IgE (mIgE) on the surface of mIgE-expressing B lymphocytes. Unlike ordinary anti-IgE antibodies, it does not bind to IgE already bound to the high-affinity IgE receptor (FcεRI) on mast cells, basophils, and dendritic cells, thereby reducing free IgE levels and inhibiting IgE-mediated allergic responses without triggering mast cell degranulation. Developed primarily by Sorrento Therapeutics in collaboration with Sinomab and MabTech, it has demonstrated comparable safety, efficacy, and immunogenicity to reference omalizumab in phase II/III trials for moderate-to-severe allergic asthma.[1][2][5][7][9][11][12]
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