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

This approval is based on the results of the MIRACLE III Phase trial, in which Benralizumab significantly reduced the annual rate of asthma exacerbations and improved and controlled asthma symptoms in a clinically meaningful way.

August 20, 2024, Shanghai——AstraZeneca announced, Fan Shuzhuo^®(General Name: Benrilizumab Injection) has been officially approved by the China National Medical Products Administration,For the maintenance treatment of severe eosinophilic asthma (SEA) in adults and adolescents aged 12 years and above¹。

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.². The study showed that in patients with severe eosinophilic asthma receiving standard therapy, the annualized asthma exacerbation rate (AAER) was significantly reduced by 74% after treatment with Benralizumab (0.49 in the Benralizumab group vs. 1.88 in the placebo group, hazard ratio 0.26, p<0.0001), demonstrating significant statistical and clinical importance.². Benralizumab met all primary and key secondary endpoints, helping to improve lung function and asthma symptoms.²。

China has approximately 3 million patients with severe eosinophilic asthma.^3-6. The disease has a high incidence rate in China, yet the treatment options are very limited.³, and the misdiagnosis and insufficient treatment of severe asthma still occur frequently. Due to frequent acute attacks, severely limited lung function, and a decline in quality of life, patients face a heavy disease burden.^7-10At the same time, patients with severe asthma have a higher risk of death, and the risk of asthma-related hospitalization is twice that of patients with persistent asthma.^11-13Moreover, medical expenses related to severe asthma account for approximately 50% of the total medical costs for asthma patients, imposing a heavy economic burden on society.¹⁴。

Professor Zhong Nanshan, an academician of the Chinese Academy of Engineering and the international coordinating investigator of the MIRACLE study, stated:"Asthma is a chronic airway inflammatory disease, and the full dose and full course of ICS-LABA are the cornerstone; with the advent of the era of biotargeted therapy, correct 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 results of the MIRACLE trial 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. Studies also indicate its significant efficacy in populations with asthma not well-controlled by medium to high doses of ICS/LABA."

Ruud Dobber, Global 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 marks 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."

Leo Wang, Executive Vice President of AstraZeneca Global, Chairman of International Business and President of China, stated:"Adhering to the core value of 'Patients First,' AstraZeneca has been deeply engaged in the respiratory field globally for over fifty years, boasting a rich product pipeline and extensive layout. With more than thirty years of commitment in China, AstraZeneca has continuously introduced global innovative drugs in the respiratory field to China, supported partners in creating innovative solutions for chronic respiratory diseases, meeting the health needs of Chinese patients with chronic respiratory conditions, and contributing to the achievement of the grand goal of 'Healthy China 2030.'"

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 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 capabilities to bring more innovative therapies with breakthrough significance to benefit patients across China."

Lin Xiao, General Manager of AstraZeneca's Biopharmaceutical Business in China and Head of Hong Kong and Macao Regions, stated:"Innovative biologics have demonstrated significant 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 extremely large population of patients with chronic conditions and widespread health needs. AstraZeneca will continue to focus on accelerating the introduction of innovative drugs for chronic diseases 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.²。

To date, Benralizumab has been approved in more than 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.^15-18. Meanwhile, it has also been approved in the United States and Japan for the treatment of adults and children aged 6 years and above.

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About Severe Asthma

Asthma is a major chronic respiratory disease that affects approximately 300 million people worldwide.²Up to 10% of asthma patients suffer from severe asthma that cannot be effectively controlled.²More than 80% of patients with severe asthma will exhibit eosinophilic inflammation, leading to the eosinophilic phenotype of asthma.². Despite receiving high doses of standard therapeutic medications, patients may still fail to achieve effective control, leading to frequent acute exacerbations, decline in lung function, and a significant reduction in quality of life.^7-10,19。

About the MIRACLE Study

MIRACLE Study is a randomized, double-blind, parallel-group, placebo-controlled Phase III clinical trial of Benralizumab conducted in China, South Korea, and the Philippines, evaluating the efficacy and safety of Benralizumab. A total of 695 asthma patients aged between 12 and 75 years whose conditions were not well controlled received medium-to-high-dose inhaled corticosteroids plus long-acting β2-agonists (ICS-LABA) treatment, with or without oral corticosteroids (OCS) and other asthma control medications.²。

The primary endpoint of the study was the reduction in the annualized asthma exacerbation rate (AAER) over 48 weeks in patients with severe eosinophilic asthma (baseline blood EOS ≥300/μL) treated with 30 mg benralizumab (subcutaneous injection, eight-week dosing regimen) compared to placebo. All patients were randomized 1:1 to either the placebo group or the benralizumab treatment group. Treatment with benralizumab reduced the AAER by 74% (0.49 in the benralizumab group vs. 1.88 in the placebo group, hazard ratio 0.26, p<0.0001), demonstrating significant statistical and clinical importance.²。

In the study, patients were stratified by country/region, age group (adult or adolescent), and baseline peripheral blood eosinophil count at the first visit (<300 or ≥300 cells/μL). The key secondary efficacy endpoints were changes from baseline in pre-bronchodilator (BD) forced expiratory volume in 1 second (pre-BD FEV1) and total asthma symptom score (TASS) at week 48. Other secondary efficacy endpoints included morning and evening peak expiratory flow (PEF), Asthma Control Questionnaire 6 (ACQ-6), St. George's Respiratory Questionnaire (SGRQ), annualized asthma exacerbation rate (AAER) associated with emergency room (ER)/urgent care (UC) visits or hospitalizations, time to first asthma exacerbation, proportion of patients with ≥1 asthma exacerbation, and change from baseline in blood eosinophil levels.²。

About Benralizumab

Benralizumab has been approved in more than 80 countries and regions, including the United States, the European Union, and Japan, and has now been approved in China.^15-18. Currently, the number of patients benefiting from this drug worldwide has exceeded 130,000.²⁰。

AstraZeneca is also developing other indications for Benralizumab, including chronic obstructive pulmonary disease (COPD), chronic rhinosinusitis with nasal polyps (CRSwNP), eosinophilic granulomatosis with polyangiitis (EGPA), and hypereosinophilic syndrome.^21-24 。

Benralizumab was developed by AstraZeneca and introduced through a licensing agreement with BioWa, Inc., a wholly-owned subsidiary of Kyowa Hakko Kirin Co., Ltd. in Japan.

About AstraZeneca's Respiratory and Immunotherapy Field

Respiratory and immunology are important components of AstraZeneca's biopharmaceutical business, and key disease areas the company focuses on, as well as major drivers of business growth.

AstraZeneca is a leader in the respiratory field, with over 50 years of deep engagement in this area, and also boasts an increasingly rich product pipeline in the immunology sector. The company is committed to addressing significant unmet needs in chronic and often debilitating disease areas through the development of its portfolio, which includes inhaled medications, biologics, and new therapies targeting novel pathways. Our goal is to deliver life-changing medicines to patients, helping to prevent exacerbations of COPD and asthma—major causes of mortality—and achieve clinical remission in immune-mediated diseases.

Disclaimer: This article involves products or indications that have not been approved in China. AstraZeneca does not recommend the use of any unapproved drugs.

Source: Press Release (Internal Approval Number: CN-141831)

References:

1.National Medical Products Administration approval, August 2024

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20.AstraZeneca Data on file. 2024. REF-235794.

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