AstraZeneca Launches First Respiratory Biologic in China for Maintenance Treatment of Severe Eosinophilic Asthma

China Finance Network, March 24th: Today, AstraZeneca announced the official commercial launch in China of Fasenra (Benralizumab Injection), an innovative targeted biologic for the treatment of Severe Eosinophilic Asthma (SEA). It is indicated for maintenance treatment in adults and adolescents aged 12 years and above with severe eosinophilic asthma.

Benralizumab is an innovative biologic that precisely targets eosinophils (EOS) by acting as an anti-IL-5R agent. A pooled analysis study showed that in patients with baseline bEOS ≥ 300/μL, benralizumab rapidly improved asthma symptoms within 3 days of treatment compared to the placebo group. The PONENTE and SHAMAL studies demonstrated that over 90% of severe asthma patients reduced their use of oral corticosteroids (OCS) and inhaled corticosteroids (ICS-formoterol) compared to baseline, with long-term treatment showing good safety.

In August 2024, Benralizumab was approved in China based on the positive results of the Phase III clinical trial MIRACLE study. This study was conducted in China, South Korea, and the Philippines. The study showed that the MIRACLE study achieved all primary endpoints and key secondary endpoints. Severe eosinophilic asthma patients (baseline blood EOS ≥300/μL) receiving standard treatment experienced a significant 74% reduction in annual asthma exacerbation rate (AAER) after being treated with Benralizumab compared to the placebo group (AAER 0.49 in the Benralizumab group vs. 1.88 in the placebo group, hazard ratio 0.26, p<0.0001). Benralizumab helps improve lung function and asthma symptoms.

Data shows that China has approximately 3 million patients with severe eosinophilic asthma, and cases of misdiagnosis and under-treatment of severe asthma still frequently occur. Due to frequent acute exacerbations, severely limited lung function, and a decline in quality of life, patients face a heavy disease burden. Eosinophils (EOS) are key effector cells in type 2 inflammation in severe asthma, serving as both an important biomarker and a critical therapeutic target. Benralizumab directly targets the IL-5R on the surface of eosinophils, not only blocking the binding of IL-5 to eosinophils but also rapidly clearing eosinophils through antibody-dependent cellular cytotoxicity while efficiently inhibiting related inflammatory cycles. This reduces acute exacerbations of severe asthma, improves lung function, and decreases corticosteroid use. Additionally, during the maintenance phase, only six injections per year are required, offering convenience and clinical benefits for patients.

MIRACLE Study's International Coordinating Investigator, Academician of the Chinese Academy of Engineering, Zhong Nanshan, stated that asthma is a chronic airway inflammatory disease, and the full-dose and full-course treatment with ICS-LABA is the cornerstone; with the advent of the biotargeted therapy era, accurate diagnosis and phenotyping of severe asthma patients are crucial. "The EOS phenotype is the most common in severe asthma patients. Among them, the MIRACLE trial results showed that for Chinese patients with severe eosinophilic asthma, anti-IL-5 receptor monoclonal antibodies can rapidly and durably control asthma symptoms and significantly reduce the annual exacerbation rate. The study also demonstrated significant efficacy in asthma populations poorly controlled by medium to high doses of ICS/LABA."

"Respiratory chronic diseases represented by asthma face challenges in China, such as a large number of affected individuals, low public awareness, and low rates of treatment and diagnosis. There is a significant unmet treatment need for patients," said Lin Xiao, General Manager of AstraZeneca China and General Manager of China's Biopharmaceuticals Business. He expressed hope that the application of Benralizumab in China could help patients achieve disease control and free them from the constraints of severe asthma as soon as possible. Meanwhile, AstraZeneca will continue to collaborate with multiple parties to reshape the landscape of chronic disease treatment, ensuring that the health needs of patients with respiratory chronic diseases in China are continuously met.

"Benralizumab's successful launch in China marks AstraZeneca’s first biologic in the respiratory field and signifies that the treatment of severe asthma in China has entered the era of precision targeted therapy," said Chen Xi, Vice President of AstraZeneca China, and Head of the Respiratory, Autoimmune Biopharmaceuticals, Vaccines, and Immunotherapy Division. Currently, AstraZeneca's products available in China encompass a complete portfolio and solutions ranging from mild to moderate to severe asthma, meeting the full-course management needs of patients with different asthma phenotypes.