Astrazeneca PLC Sponsored ADR (AZN.US) the new indication of benralizumab has been approved and launched

On May 29th, the NMPA official website announced that the new indication for Benralizumab, sponsored by Astrazeneca PLC Sponsored ADR (AZN.US), has been approved for marketing. It is used to treat hypereosinophilic syndrome in adults and adolescents aged 12 and above with no clear non-hematologic secondary cause. Benralizumab is a precision targeted anti-IL-5R biologic for eosinophils (EOS), originally developed by Kylin and Covic Pharmaceuticals. The newly approved indication is for hypereosinophilic syndrome (HES). In the international multicenter Phase III NATRON clinical trial, Astrazeneca PLC Sponsored ADR evaluated the efficacy and safety of Benralizumab in treating HES patients, with the primary endpoint of time to first worsening or relapse for patients. The complete data from the study will be presented for the first time at the 2025 American College of Allergy, Asthma, and Immunology (ACAAI) annual meeting. The results showed that compared to placebo, Benralizumab significantly delayed the time to first HES attack, reducing the risk by 65%. Furthermore, the percentage of patients experiencing disease relapse or dropping out of the trial was lower in the Benralizumab treatment group (22.4% vs 45.5%), and the annual recurrence rate of HES was reduced by 66% compared to the placebo group, with 0.41 times per year and 1.23 times per year respectively.