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China Drug Approvals | 2024 | iPharmaCenter

January 02, 2023

Beyfortus was approved in China for Preventing RSV Disease in Infants

AstraZeneca and Sanofi's Beyfortus (nirsevimab), a long-acting monoclonal antibody, has received official approval in China for its role in preventing lower respiratory tract infection (LRTI) caused by the respiratory syncytial virus (RSV) in newborns and infants. This approval encompasses infants entering or during their initial RSV season, and Beyfortus is expected to be accessible in the forthcoming 2024-2025 RSV season.

Beyfortus marks a significant breakthrough as the first preventive solution approved to safeguard a broad infant population from RSV. This includes protection for healthy term-born infants, preterm infants, and those with specific health conditions that make them susceptible to severe RSV disease.

The nod of approval from The National Medical Products Administration (NMPA) is grounded in the results of three pivotal late-stage clinical trials of Beyfortus and an extensive local clinical development initiative. Across all clinical endpoints, a single dose of Beyfortus consistently demonstrated efficacy against RSV lower respiratory tract disease (LRTD) for five months, aligning with the typical RSV season.

RSV is a prevalent and highly transmissible seasonal virus and stands as the leading cause of LRTD, including bronchiolitis and pneumonia, in infants. It is also a major contributor to hospitalizations among all infants, with a significant portion of hospital admissions for RSV affecting healthy term-born infants. China, identified as a country with elevated RSV infection rates, underscores the significance of Beyfortus approval in this region.

Before securing approval in China, Beyfortus gained regulatory clearance in the European Union in October 2022 for preventing RSV LRTD in newborns and infants during their initial RSV season. The United States Food and Drug Administration approved it in July 2023, backed by the unanimous recommendation from the Antimicrobial Drugs Advisory Committee in June 2023. Ongoing reviews of regulatory applications are also underway in Japan and various other nations.

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