▎WuXi AppTec Content Team Report

Today (August 19),The official website of China's National Medical Products Administration (NMPA) has just announced,AstraZeneca's submissionBenralizumab InjectionThe new drug marketing application has been approved.Public information shows that Benralizumab is a product developed by AstraZeneca.Monoclonal Antibody Targeting IL-5 Receptor, which has previously been approved by the U.S. FDA for the treatment of various types of asthma patients.

Image Source: Screenshot from the NMPA official website

According to the press release issued by AstraZeneca in May this year,BenralizumabThe approved indication this time is forSevere Eosinophilic Asthma (SEA)AstraZeneca simultaneously released the results of a Phase 3 clinical study in Asia (including China) for this indication: compared with placebo, treatment with Benralizumab for 48 weeks...The annualized rate of acute asthma exacerbations was reduced by 74%.In addition, the product also has a convenient dosing regimen,Administered once every four weeks for the first three doses, followed by once every eight weeks, for a treatment period of 48 weeks.。

BenralizumabYesA monoclonal antibody that binds to IL-5Rα expressed on the surface of eosinophils.UnimpededBy binding to IL-5Rα, it is able to recruit natural killer cells and rapidly eliminate these cells by inducing the apoptosis process of eosinophils.

According to AstraZeneca's previously disclosed information, Benralizumab was initially approved by the U.S. FDA in 2017 (brand name: Fasenra), asAdjunctive maintenance treatment for patients 12 years and older with severe eosinophilic asthma (SEA)In April 2024, the drug once again received FDA approval.ApprovalAs an adjunctive maintenance therapy, for the treatment ofSevere asthma patients aged 6 to 11 with an eosinophilic phenotype. In addition, this product treatsRelapsed or Refractory Eosinophilic Granulomatosis with Polyangiitis (EGPA)Patient'sPhase 3 TrialAlso achieved positive results and was published in The New England Journal of Medicine earlier this year.

In May 2024, AstraZeneca announced the results of the Phase 3 MIRACLE trial conducted in several Asian countries, including China. The studyThe efficacy and safety of Benralizumab were evaluated in patients with severe eosinophilic asthma who still could not control their symptoms despite receiving treatment.Studies have shown that, compared with placebo, BenralizumabThe annualized asthma exacerbation rate (AAER) within 48 weeks was reduced by 74%, which is statistically significant and clinically meaningful.Studies have shown that Benralizumab can rapidly and continuously control asthma symptoms, significantly reducing the annual rate of acute exacerbations. Additionally, this product helps improve lung function and asthma symptoms.

According to Dr. He Jing, Senior Vice President and Head of R&D at AstraZeneca China, as stated in the press release, the positive results of MIRACLEBenralizumabTreatment of severe eosinophilic asthma has provided increasing evidence and supports their application to the NMPA as a drug for treating this chronic debilitating disease.

In China, except forMIRACLE Study,AstraZeneca has also launched severalThe clinical research of Benralizumab includes several Phase III clinical studies. It is worth mentioning that, among theseIn the study, Benralizumab was administered via subcutaneous injection.Start with once every 4 weeks for 3 doses, then once every 8 weeks thereafter.

• An ExplorationBenralizumabReduceSevere Eosinophilic AsthmaProspective, Interventional, Multicenter, Single-arm Study of Patient Background MedicationChina Phase 3bResearch.

• OneEvaluationBenralizumab TreatmentPatients with Chronic Eosinophilic Rhinosinusitis with Nasal Polyps (ECRSwNP)International multicenter (including China) Phase 3 study. This study has now completed recruitment.

• An AssessmentBenralizumab100mg TreatmentPatients with moderate to very severe chronic obstructive pulmonary disease (COPD) who have a history of frequent acute exacerbations and elevated peripheral blood eosinophilsInternational Multicenter (including China) Phase 3 Study (RESOLUTE).

• A study inHypereosinophilic Syndrome (HES)Patient EvaluationBenralizumabA Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, 24-week, International Multicenter (including China) Phase 3 Study (with an Open-label Extension Period) of Efficacy and Safety.In this study, Benralizumab was administered via subcutaneous injection once every 4 weeks for a duration of 36 weeks.Adjustments are only permitted in the event of clinical worsening/outbreak of HES or adverse events (AE) caused by background treatment.

ExpectationsThe subsequent clinical research of Benralizumab is proceeding smoothly, benefiting more patients as soon as possible.

References:

[1] Drug Approval Certificate Delivery Information on August 19, 2024. Retrieved Aug 19, 2024, from https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20240819150923195.html