Fasenra (Benralizumab) Approved in China for Maintenance Treatment of Severe Eosinophilic Asthma in Adults and Adolescents Aged 12 and Older

On August 20, AstraZeneca announced that FanShuZhuo (generic name: Benralizumab Injection) has been officially approved by the China National Medical Products Administration for maintenance treatment of severe eosinophilic asthma (SEA) in adults and adolescents aged 12 years and above.

This approval is based on the positive results of the Phase III clinical trial, MIRACLE study, which was conducted in China, South Korea, and the Philippines. The study showed that severe eosinophilic asthma patients receiving standard treatment experienced a significant 74% reduction in annualized asthma exacerbation rate (AAER) after being treated with Benralizumab (0.49 in the Benralizumab group vs. 1.88 in the placebo group, hazard ratio 0.26, p<0.0001), demonstrating both statistically significant and clinically meaningful outcomes. Benralizumab met all primary and key secondary endpoints, contributing to improved lung function and asthma symptoms.

Severe eosinophilic asthma has a high incidence rate in China, yet treatment options are very limited. Moreover, severe asthma is still frequently misdiagnosed or undertreated. Due to frequent acute exacerbations, severely restricted lung function, and reduced quality of life, patients face a heavy disease burden. Additionally, patients with severe asthma have a higher risk of death, and their risk of asthma-related hospitalization is twice that of patients with persistent asthma. Furthermore, medical costs associated with severe asthma account for approximately 50% of the total medical expenses of asthma patients, placing a significant economic burden on society.

MIRACLE Study's International Coordinating Investigator and Chinese Academy of Engineering Academician Zhong Nanshan stated: "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 classification of severe asthma patients are crucial. The EOS phenotype is the most common biological phenotype among severe asthma patients, and currently, multiple clinical studies targeting EOS are underway in China. Among them, the MIRACLE trial results show 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 shows that it has significant efficacy in asthma populations not well-controlled by medium to high doses of ICS/LABA."

Ruud Dobber, Executive Vice President of AstraZeneca and Head of the BioPharmaceuticals Business Unit, stated: "Severe asthma affects millions of patients in China, and the approval of Benralizumab in China is a significant advancement in the treatment of severe asthma. Chinese patients will soon have access to this innovative biologic that precisely targets EOS, significantly reducing the risk of acute exacerbations and bringing substantial clinical benefits to patients with severe asthma in China."

Dr. He Jing, Senior Vice President of AstraZeneca Global and President of AstraZeneca Global R&D China Center, stated: "The results of the MIRACLE III phase trial fully confirm that benralizumab, an anti-IL-5 receptor monoclonal antibody, demonstrates good clinical efficacy in treating severe eosinophilic asthma and is easy to use. In the future, we will continue to leverage AstraZeneca's strong R&D advantages to bring more innovative therapies with breakthrough significance to benefit a wide range of patients in China."

Leon Lin, General Manager of AstraZeneca's BioPharmaceuticals Business in China and Head of Hong Kong and Macao Regions, stated: "Innovative biologics have demonstrated tremendous potential in the treatment of chronic respiratory diseases. The approval of Benralizumab in China provides a new treatment option for patients with severe asthma. Represented by chronic respiratory diseases, China has an enormous population of patients with chronic conditions, presenting extensive healthcare needs. AstraZeneca will continue to focus on accelerating the introduction of innovative drugs in the chronic disease field and, together with partners, will keep building an innovative 'ecosystem' for chronic disease management to benefit patients."

The safety and tolerability of Benralizumab demonstrated in the MIRACLE study are consistent with its currently known drug characteristics.

To date, Benralizumab has been approved in over 80 countries and regions, including the United States, Japan, and the European Union, for the combined maintenance treatment of severe eosinophilic asthma, and has now been approved in China. Additionally, it has also been approved in the United States and Japan for the treatment of adults and children aged 6 years and above.