Raynovent：Class 1 innovative drug Onradivir Granules included in priority review

Onradivir granules (generic name: Onradivir, research code: ZSP1273) are a Class 1 chemical innovative drug independently developed by Raynovent in Guangdong, China, and represent the world’s first pediatric formulation of an influenza A virus RNA polymerase PB2 inhibitor. On May 22, 2025, Onradivir tablets (adult formulation) was approved for marketing, becoming the world’s first PB2-targeted anti-influenza drug. Its Phase III clinical data were published in The Lancet Respiratory Medicine, receiving international authoritative recognition. The development of a granule formulation for the pediatric population progressed in parallel. On February 9, 2026, the topline data from the Phase III clinical trial of Onradivir granules for the treatment of uncomplicated influenza A in children aged 2–11 years were announced. On May 14, 2026, the New Drug Application (NDA) was accepted by the NMPA.