Taizhou-based monoclonal antibody (mAb) biosimliars specialist MabPharm Ltd (HKG: 2181) has announced that it has attained market approval from the National Medical Products Administration (NMPA) for its CMAB007, a biosimilar version of Roche/Genentech’s anti-IgE dermatology and asthma therapy omalizumab (trade name: Xolair). This approval marks the first home-grown therapeutic biologic for asthma to be made available in China.
CMAB007’s Impact on Asthma Treatment
CMAB007 has been approved for the treatment of immunoglobulin E (IgE)-mediated asthma. The biosimilar can improve the condition of asthma patients and reduce the probability of acute asthma onset with lower doses of inhaled corticosteroids. This development is significant as it provides a more accessible alternative for managing asthma in China.
Clinical Trials and Future Indications
The efficacy and safety of CMAB007 were previously confirmed in four clinical trials. Looking ahead, future indications for the biosimilar are expected to include chronic idiopathic urticaria, seasonal allergic rhinitis, and food allergies, further expanding its potential impact on allergy and respiratory medicine.-Fineline Info & Tech
