AstraZeneca Submits New Indication Application in China for Benralizumab in Pediatric Eosinophilic Asthma

May 15, 2024 12:19 CST Updated 12:19

AstraZeneca

Biopharmaceutical Manufacturer

Source: PharmaCube Info

On May 14, the CDE website showed that AstraZeneca'sBenralizumab（benralizumab）The marketing application for a new indication of the injection has been accepted, and the speculated indication is add-on maintenance treatment for eosinophilic asthma patients aged 6-11.June 2023,Benralizumab submitted for marketing approval in China for the first time (Acceptance No.JXSS2300050), ObjectiveIt is currently under review and is expected to be approved for marketing this year.

Benralizumab (Benralizumab/Be那利珠单抗) is an IL-5Rα monoclonal antibody that directly binds to the IL-5 receptor α on eosinophils, attracting natural killer cells to induce apoptosis, resulting in the rapid and nearly complete depletion of eosinophils in the patient's blood and tissues.201In November 7 years ago, benralizumab was approved for the first time in the United States and marketed under the brand name Fasenra. It is used as an add-on maintenance treatment for patients with severe eosinophilic asthma aged 12 years and older.In October 2019, the FDA approved a pre-filled, single-use auto-injector pen (FASENRA Pen™) for patient self-administration.

Eosinophil-related diseases are usually discovered due to the increase of eosinophils in peripheral blood or tissues; they can be roughly divided into inherent diseases mainly characterized by increased eosinophils, such as chronic eosinophilic leukemia, idiopathic hypereosinophilic syndrome, familial eosinophilia, lymphoma, etc., and diseases involving eosinophils, such as parasitic infections, drug and biochemical allergies, collagenous and immune diseases, and eosinophil-related diseases of various systems.

Benralizumab was initially developed by Kyowa Kirin. In December 2006, MedImmune reached an agreement with them to obtain the commercialization rights of benralizumab in the United States, Europe, and other countries. In April 2007, AstraZeneca acquired MedImmune for $15.6 billion, incorporating 45 pipeline products under development.

Since its listing,Benralizumab The market performance is good, with global sales reaching $1.396 billion in 2022. Currently, according to the Insight database, Fasenra is also being developed for other eosinophilic diseases, including atopic dermatitis, bullous pemphigoid, chronic obstructive pulmonary disease, etc.In China,BenralizumabSix Phase III clinical trials for different indications have also been initiated.

BenralizumabPhase III Clinical Trial in China

Since its approval for marketing, the sales of Benralizumab have continued to rise, reaching $1.396 billion in global sales in 2022.

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