On August 20th, AstraZeneca announced that Fanshuzhuo (generic name: Benriizumab 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 and above. This approval is based on the positive results of the Phase III clinical trial MIRACLE, which was conducted in China, South Korea, and the Philippines. Research has shown that severe eosinophilic asthma patients receiving standard treatment have a significantly reduced annual acute attack rate (AAER) of 74% after treatment with pembrolizumab (0.49 in the pembrolizumab treatment group and 1.88 in the placebo group, hazard ratio 0.26, plt; 0.0001), with significant statistical and clinical significance. Benriizumab achieved all primary and key secondary endpoints, which helped improve lung function and asthma symptoms. Severe eosinophilic asthma has a high incidence rate in China, but treatment options are very limited, and severe asthma is often misdiagnosed and inadequately treated. Due to frequent acute attacks, severe lung function limitations, and decreased quality of life, patients face a heavy burden of disease. Meanwhile, patients with severe asthma have a higher risk of mortality, and the risk of asthma related hospitalization is twice that of patients with persistent asthma. In addition, medical expenses related to severe asthma account for about 50% of the total medical costs for asthma patients, bringing a heavy economic burden to society. Zhong Nanshan, an internationally coordinated researcher of MIRACLE research and an academician of the CAE Member, said: "Asthma is a chronic airway inflammatory disease, and ICS-LABA is the cornerstone of full dose and treatment; With the advent of the era of biological targeted therapy, the correct diagnosis and classification of severe asthma patients is crucial. EOS type is the most common biological phenotype in patients with severe asthma, and multiple clinical studies on EOS targeted therapy are currently underway in China. Among them, the MIRACLE test results showed that for severe eosinophilic asthma patients in China, anti-IL-5 receptor monoclonal antibodies can quickly and persistently control asthma symptoms, significantly reducing the annual acute attack rate. The study also showed that its application has significant therapeutic effects in asthma populations with poor control of medium and high doses of ICS/LABA Ruud Dobber, Global Executive Vice President and Head of the Biopharmaceutical Division at AstraZeneca, stated, "Severe asthma troubles millions of patients in China, and the approval of Benrelizumab in China is an important progress in the treatment of severe asthma in China. Chinese patients will soon be able to use this innovative biologic that can accurately target EOS, significantly reducing the risk of acute attacks and bringing significant clinical benefits to Chinese severe asthma patients." Dr. He Jing, Senior Vice President and President of the Global R&D China Center at AstraZeneca, said, "The research results of the MIRACLE Phase III trial fully confirm that anti-IL-5 receptor monoclonal antibody Benrelizumab has good clinical efficacy and is easy to use for the treatment of severe eosinophilic asthma. In the future, we will continue to rely on AstraZeneca's strong research and development advantages to bring more breakthrough innovative therapies to benefit the vast number of Chinese patients Lin Xiao, General Manager of AstraZeneca's Biopharmaceutical Business in China and Head of the Hong Kong and Macau Region, said, "Innovative biologics have shown great potential in the treatment of chronic respiratory diseases. The approval of Benrelizumab in China provides a new treatment option for severe asthma patients in China. Represented by chronic respiratory diseases, China has a huge population of chronic disease patients with extensive health needs. AstraZeneca will continue to focus on accelerating the introduction of innovative drugs in the field of chronic diseases and work with partners to create an innovative 'ecosystem' for chronic disease management to benefit patients." Benrelizumab's safety and tolerability demonstrated in the MIRACLE study are consistent with its currently known drug characteristics. As of now, pembrolizumab has been approved for combination maintenance therapy for severe eosinophilic asthma in over 80 countries and regions, including the United States, Japan, and the European Union. It has now been approved in China. Meanwhile, it has also been approved for the treatment of adults and children and adolescents aged 6 and above in the United States and Japan. (New Society)