Astrazeneca PLC Sponsored ADR (AZN.US) has submitted an application for the listing of the asthma triple therapy "Bevespi Aerosphere" in China.

On September 17, according to the CDE website, Astrazeneca PLC Sponsored ADR (AZN.US) has applied for new indications for their budesonide/formoterol inhaler (English brand name: Breztri, Chinese brand name: ) in China. Based on the progress of clinical trials, it is speculated that the indication being applied for this time is for asthma. The budesonide/formoterol inhaler is a fixed-dose triple therapy developed by Astrazeneca PLC Sponsored ADR, containing budesonide (inhaled corticosteroid), glycopyrronium (long-acting muscarinic antagonist), and formoterol (long-acting beta2-adrenergic agonist) as active ingredients. In May of this year, Astrazeneca PLC Sponsored ADR announced that two Phase III studies (KALOS and LOGOS) evaluating the efficacy and safety of the budesonide/formoterol inhaler for treating asthma met their primary endpoints. These studies included a total of 4461 inadequately controlled adult and adolescent asthma patients, comparing the budesonide/formoterol inhaler to the dual therapy Symbicort (budesonide+formoterol) as maintenance therapy. The results showed that patients in the budesonide/formoterol inhaler group had significantly improved forced expiratory volume in 1 second (FEV1) compared to the Symbicort group, and the rate of severe asthma exacerbations was significantly reduced. Detailed data has not been disclosed yet. Asthma is a common chronic respiratory disease characterized by airway inflammation and muscle constriction (bronchoconstriction) that can lead to difficulty breathing. Globally, as many as 262 million people are affected by asthma, and it is estimated that nearly half of patients on dual therapy still have inadequate control, significantly limiting lung function and reducing quality of life.