Shanghai Ark Biopharmaceuticals (ArkBio) has recently released the Phase III clinical trial results for ziresovir, an oral antiviral drug targeting respiratory syncytial virus (RSV) infection in infants and young children.
The positive data support ziresovir's potential to be a game-changer in pediatric RSV treatment, with the drug expected to be the first direct-acting antiviral to receive approval in China, says pharma analytics company GlobalData.
The current treatment options for RSV are limited. Ribavirin remains the only approved RSV treatment globally. Ziresovir is the first non-oncology investigational product to receive Breakthrough Therapy designation by the National Medical Products Administration (NMPA) of China and is currently under regulatory review. ArkBio acquired rights to the drug from Swiss pharma major Roche (ROG: SIX) in 2014.
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