The World Health Organization has included ziresovir (10mg), developed by Shanghai Ark Biopharmaceutical Co., Ltd. (ArkBio), in its Paediatric drug optimization for respiratory syncytial virus (PADO-RSV) priority list. This marks the first time WHO has included an anti-RSV drug developed from China in the paediatric drug optimization priority list, and ziresovir stands as the first and only RSV antiviral drug to be included in the list.
Addressing Critical Global Health Need
RSV represents the leading pathogen of lower respiratory tract infections (LRTIs) in infants and young children globally, causing approximately 33 million cases of LRTIs, 3.6 million hospitalizations, and 101,400 deaths annually. Notably, 97% of deaths occur in low- and middle-income countries (LMICs). Despite this severe threat, current specific treatment options for RSV remain extremely limited, creating a clinical urgent need for safe, effective, and child-appropriate innovative drugs.
The PADO-RSV project, initiated by WHO's Global Accelerator for Paediatric formulations (GAP-f), aims to systematically review the global R&D pipeline, clarify R&D priorities, and promote the development and accessibility of RSV prevention and treatment tools more suitable for the paediatric population.
Ziresovir's Clinical Profile and Mechanism
Ziresovir is a novel small-molecule RSV fusion (F) protein inhibitor that binds to the pre-F protein conformation of the virus and prevents viral entry into human cells. The drug can also suppress RSV viral transmission by blocking cell-to-cell fusion through the formation of "syncytia," a characteristic event of RSV infection of host cells.
The drug represents the first oral anti-RSV drug that has completed a phase 3 pivotal clinical study with positive results. These phase 3 results have been published in The New England Journal of Medicine and The Lancet Child & Adolescent Health. Ziresovir has received Breakthrough Therapy designation by the National Medical Products Administration (NMPA) of China.
WHO Recognition and Global Development Plans
WHO pointed out in the report that ziresovir's research results are of great significance to the global RSV treatment field and recommended conducting diverse clinical studies in broader populations to further verify its applicability and effectiveness. With its clear clinical value, child-friendly design, and good safety profile, ziresovir becomes the only product in the antiviral drug category selected for the PADO-RSV priority list, demonstrating its huge potential in the paediatric RSV treatment globally.
ArkBio will actively respond to WHO's advice with a plan to expand ziresovir's clinical development in other countries and regions. By collaborating with international scientific institutions and public health organizations, ArkBio aims to rapidly advance the drug's global registration and accessibility.
Commitment to Global Access
The company is deeply aware of the importance of global public health, particularly concerned about the challenges faced by low- and middle-income countries. ArkBio will formulate drug accessibility plans specifically for these countries to ensure ziresovir can be supplied at reasonable prices globally wherever it is needed, contributing to the prevention and treatment of RSV infection.
"ArkBio has a mission to 'help patients inspire and thrive'," stated Dr. Jim Wu, CEO of ArkBio. "The inclusion of ziresovir in the WHO PADO-RSV priority list is not only an affirmation of the years of effort by ArkBio scientists, but also an inspiration for our corporate mission. The recognition of ziresovir would allow us to expedite its global development and realize the potential on the global stage. We will ensure the innovation can not only benefit patients in China but the very needed patients worldwide. This is not just our goal but our social responsibility."
Company Background
ArkBio is a global biotech company focused on developing innovative therapeutics for respiratory, infectious, and pediatric diseases. Founded in 2014, it has built core technology platforms and a differentiated R&D pipeline through in-house R&D efforts and external collaboration. Key drug assets include ziresovir (AK0529), the first direct-acting RSV antiviral with positive pivotal phase III results, and Azstarys (AK0901), an FDA-approved ADHD therapeutic drug.
The company has established strategic partnerships with several multinational pharmaceutical companies and academic institutes, including Roche, Genentech, the Scripps Research Institute, the Institute of Microbiology of Chinese Academy of Sciences, domestic and international biotechnology companies, as well as venture capital institutions.
