Shanghai Ark Biopharmaceuticals’ (ArkBio) has recently published the Phase III clinical trial results for ziresovir, an oral antiviral drug targeting respiratory syncytial virus (RSV) infection in infants and young children, in The New England Journal of Medicine. 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 GlobalData, a leading data and analytics company.

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.

The Phase III trial conducted in China involved 311 infants and young children aged 1-24 months. The results demonstrated significant efficacy of ziresovir showing a 3.4-point reduction in the Wang bronchiolitis clinical score after 48 hours compared to a 2.7-point reduction for placebo. Ziresovir also demonstrated a 77% greater reduction in RSV viral load after 96 hours compared to placebo. Notably, it exhibited an excellent safety profile, with no serious drug-related adverse events reported.

Chilamula Srija, Pharma Analyst at GlobalData, comments: “RSV remains one of the leading causes of hospitalizations in infants, causing severe respiratory complications such as bronchiolitis and pneumonia. With limited effective treatments approved for children in China, ziresovir’s approval will mark a significant advancement in RSV treatment, addressing a critical unmet need.”

According to GlobalData’s Pharmaceutical Intelligence Center, there are a few other potential competitors in late-stage development. Kexing Biopharm’s GB-05 is a recombinant protein interferon alpha/beta receptor 1 agonist administered via inhalation and currently in Phase III trials. Similarly, Sciwind Biosciences’ XW-001 is a recombinant human interleukin 29 (IL29), also administered via inhalation, which is in Phase II trials. The only other oral therapy in development is VV116, which is in Phase II. VV116 is a derivative of remdesivir, a nucleoside antiviral agent approved for treating COVID-19 in China. ArkBio will lead the RSV treatment landscape in China.

Srija concludes: “Ziresovir could revolutionize RSV management as a potential front-runner in China’s RSV treatment market, offering a more convenient and effective option for infants and young children.”