The Chinese National Medical Products Administration has granted approval for AstraZeneca and Sanofi’s monoclonal antibody, Beyfortus (nirsevimab), to prevent respiratory syncytial virus (RSV) in neonates and infants.
The antibody will be available for the upcoming 2024-2025 RSV season.
It is a single-dose long-acting antibody developed using AstraZeneca’s YTE technology.
The approval is based on data from three late-stage clinical trials and a complete local clinical development programme.
A single Beyfortus dose demonstrated efficacy against lower respiratory tract disease associated with RSV for up to five months.
AstraZeneca Vaccines and Immune Therapies executive vice-president Iskra Reic stated: “Beyfortus represents the first opportunity to prevent serious respiratory disease due to RSV for all infants in China.
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“The science that Beyfortus is built on demonstrates AstraZeneca’s leadership in addressing the needs of the most vulnerable populations and reducing the infectious disease burden on healthcare systems.”
Beyfortus received approval in the European Union in October 2022 for usage in newborns and infants during their first RSV season, and from the US Food and Drug Administration in July 2023.
Regulators in Japan and other regions are currently reviewing applications for the drug.
The latest development comes after AstraZeneca entered a definitive deal for the acquisition of China-based Gracell Biotechnologies for $1.2bn.
This deal expands the chimeric antigen receptor (CAR) T-cell therapy portfolio of AstraZeneca. It is anticipated to close in the first quarter of the financial year 2024.
A lead asset of Gracell, GC01F is a dual B cell maturation antigen and CD19 targeting CAR-T cell therapy.
This drug is being analysed for indications including multiple myeloma and systemic lupus erythematosus.