Aomaishu® is the commercial brand name of Omalizumab alfa for Injection, developed by Mabpharm. It is a biosimilar humanized monoclonal antibody that selectively binds to free IgE, lowers circulating IgE levels and downregulates FcεRI receptors on mast cells and basophils to suppress allergic inflammatory cascades.
Main Indications
Treatment of adult patients with moderate to severe persistent allergic asthma, who have positive allergen test results and inadequate symptom control with inhaled corticosteroids.
Clinical Research
A phase III head-to-head study confirmed that omalizumab alfa meets biosimilar criteria, with equivalent pharmacokinetics, efficacy and safety compared with reference omalizumab;
The trial in Chinese allergic asthma patients demonstrated reduced asthma exacerbation rates and improved asthma control;
Immunogenicity data showed comparable anti-drug antibody incidence between the biosimilar and reference product.
Common Side Effects
Severe but important risks: Anaphylaxis and severe hypersensitivity reactions, increased risk of parasitic infection;
Common mild adverse reactions: Injection site pain and swelling, headache, upper respiratory tract infection, arthralgia and fatigue.
Approval Status in China
Original drug Aomaishu® (Omalizumab alfa for Injection, specification:150mg per vial) was officially approved for marketing in China in May 2023. It is currently a prescription anti-IgE biosimilar antibody.
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