
Biopharmaceutical Manufacturer
ShanghaiSeptember 9, 2023PR Newswire -- AstraZeneca will present the latest real-world clinical research data on its leading inhaled agents, biologics, and early-stage respiratory portfolio at the 2023 European Respiratory Society (ERS) International Congress, held from September 9 to 13, 2023, in Milan, Italy. At the conference, AstraZeneca will unveil 93 abstracts, including 18 oral presentations, focusing on unmet needs in severe asthma, chronic obstructive pulmonary disease (COPD), and other acute respiratory conditions.
Ruud Dobber, Executive Vice President of AstraZeneca Global and Head of the BioPharmaceuticals Business Unit, stated: "Unlike many other immune-mediated diseases, 'remission' is not an established goal in asthma treatment. The key data presented at ERS demonstratesFasenra(Common name:benralizumab) andTezspire(Common name:tezepelumab) has tremendous potential in alleviating asthma, improving medical standards, and further enhancing patients' quality of life. Based on this data, we can see the significant progress AstraZeneca has made in the treatment of asthma, chronic obstructive pulmonary disease (COPD), and other respiratory conditions."
Clinical remission is a higher treatment goal for severe asthma, typically including: no acute exacerbations; not receiving maintenance therapy with oral corticosteroids (OCS); stable lung function; and long-term absence of significant asthma symptoms.[1]。
Multiple clinical studies have shown that biologicsbenralizumabFor the treatment of severe eosinophilic asthma(SEA)Leading Therapies in Biologics[2]
Multiple clinical studies have shown,tezepelumabMay provide sustained relief for a broad population of patients with severe asthma
Emphasizing the Urgency of Preventing COPD Exacerbations Through New Real-World Data on Cardiopulmonary Risks
Scientific Progress in the Early Pipeline
Disclaimer: The data provided in this article does not involve any head-to-head comparisons. This article involves products or indications that have not yet been approved in China, and AstraZeneca does not recommend the use of any unapproved drugs.
About Severe Asthma
Severe asthma is often debilitating and can even lead to death in serious cases. The global number of patients is as high as 26 million.[17-20]. Despite receiving high doses of standard-of-care medications, patients may still not be adequately controlled, leading to frequent acute exacerbations, significantly reduced lung function, and decreased quality of life.[17,19-21]。
About Chronic Obstructive Pulmonary Disease
Chronic obstructive pulmonary disease (COPD) refers to a group of lung diseases that cause airflow obstruction and breathing-related problems, including chronic bronchitis and emphysema.[12]. Approximately 391 million people worldwide are affected by this disease, which is the third leading cause of death globally.[22,23]。
Aboutbenralizumab
benralizumabIt is a monoclonal antibody that directly binds to IL-5Rα on eosinophils and attracts NK cells, leading to nearly complete depletion of eosinophils through apoptosis (programmed cell death), and the depletion process is rapid.[24]。benralizumabIt is AstraZeneca's first biologic for respiratory conditions, currently approved in the United States, the European Union, Japan, and several other regions as an add-on maintenance treatment for severe eosinophilic asthma. Based on the excellent results of the MIRACLE Phase III trial, China's National Medical Products Administration (NMPA) has officially accepted the application.benralizumabApplication for the Marketing of a New Drug to Treat Severe Asthma
benralizumabDeveloped by AstraZeneca and licensed by BioWa, Inc., a wholly-owned subsidiary of Kyowa Kirin Co., Ltd.
Abouttezepelumab
tezepelumabDeveloped in collaboration by AstraZeneca and Amgen, it is a first-in-class anti-TSLP monoclonal antibody that inhibits the action of TSLP. TSLP is a key epithelial cytokine situated at the top of multiple inflammatory cascade reactions and is crucial in the initiation and persistence of allergic, eosinophilic, and other types of airway inflammation (including airway hyperresponsiveness) associated with severe asthma.[25,26]. Currently,tezepelumabApproved by the United States, the European Union, Japan and other countries for the treatment of severe asthma[27-29]。
About the Collaboration between AstraZeneca and Amgen
In 2020, Amgen and AstraZeneca updated regardingtezepelumab 2012 Cooperation Agreement. After AstraZeneca pays Amgen a mid-single-digit royalty as the inventor's fee, the two companies will continue to share costs and profits equally. AstraZeneca will continue to lead in research and development, while Amgen will continue to lead in production. All aspects of the cooperation are supervised by a joint management body. According to the revised agreement, Amgen and AstraZeneca will jointly promote the product in North America.TezspireCommercialization. Amgen will record product sales in the United States, and AstraZeneca will record its share of profits in the U.S. as "collaboration revenue." Outside the United States, AstraZeneca will record product sales, and Amgen will record its share of profits as "other/collaboration revenue."
About Beizherui®LingChang®/Trixeo
Budigefu Inhalation Aerosol, registered trademark approved in China as Beizerui® Lingchang®, trade name approved in the EU asTrixeo, a fixed-dose triple combination inhaler, utilizes an innovative aerosol device to deliver a combination of three drug components: budesonide (inhaled corticosteroid, ICS), glycopyrronium bromide (long-acting muscarinic antagonist, LAMA), and formoterol fumarate (long-acting beta2-adrenergic agonist, LABA). It provides an important treatment option for appropriate patients with chronic obstructive pulmonary disease (COPD) and offers a convenient and innovative method of medication administration. Bevespi Aerosphere® has been approved in over 50 countries worldwide for the treatment of COPD, including the United States, the European Union, China, and Japan. Phase III clinical trials for asthma are currently ongoing.
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