AstraZeneca Submits NDA for IL-5Rα Monoclonal Antibody Benralizumab in China

On June 29, the marketing application for AstraZeneca's Benralizumab Injection was accepted by the National Medical Products Administration.

Benralizumab is an IL-5Rα monoclonal antibody that directly binds to the IL-5 receptor α on eosinophils and attracts natural killer cells to induce rapid and nearly complete depletion of eosinophils through apoptosis (programmed cell death). In November 2017, benralizumab was first approved for marketing in the United States under the brand name Fasenra for add-on maintenance treatment in patients 12 years and older with severe eosinophilic asthma. In October 2019, the FDA approved a pre-filled, single-use auto-injector pen (FASENRA Pen™) for self-administration by patients.

Benralizumab was initially developed by Kyowa Kirin. In December 2006, MedImmune reached an agreement with Kyowa Kirin 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. In October 2016, AstraZeneca expanded the commercialization rights of benralizumab to Japan. In March 2019, AstraZeneca entered into a new licensing agreement with Kyowa Kirin to obtain the development and commercialization rights of benralizumab in Asia as well as global commercialization rights.

In addition to being approved by regulatory agencies such as the FDA and EMA for the treatment of eosinophilic asthma, benralizumab is also being developed for the treatment of eosinophilic esophagitis, chronic rhinosinusitis with nasal polyps, and allergic granulomatous vasculitis.

Source: PharmaCube NextPharma

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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