Enyitan® is the commercial brand name of Omalizumab for Injection, a biosimilar humanized monoclonal antibody developed by CSPC. It binds selectively to free IgE in circulation, reduces IgE levels and downregulates FcεRI receptors on mast cells and basophils, thereby suppressing allergic inflammatory responses.
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 clinical trial confirmed that CSPC’s omalizumab biosimilar has equivalent pharmacokinetics, efficacy and safety compared with the reference product;
The trial in Chinese patients with allergic asthma demonstrated reduction in asthma exacerbation frequency and improvement of asthma control;
Immunogenicity assessment showed comparable incidence of anti-drug antibodies between the biosimilar and reference drug.
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 Enyitan® (Omalizumab for Injection, specification:150mg per vial) was officially approved for marketing in China in 2024. It is currently a prescription anti-IgE biosimilar antibody.
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