Guangdong Zhongsheng Pharmaceutical Co., Ltd. (SHE: 002317) announced the enrollment and dosing of the first participant in a Phase 3 clinical trial of onradivir granules for treating simple influenza A in children aged 2‑11 years, expanding the pediatric application of the world’s first PB2‑targeting antiviral approved for adults in May 2025.
Pediatric Advantage: Granule formulation facilitates administration for children and patients with swallowing difficulties
Clinical Development Status
Phase
Status
Key Findings
Phase 2 (Adult & Pediatric)
Completed
Positive efficacy; favorable safety profile
Phase 3 (Pediatric 2‑11)
Initiated
First patient dosed
Phase 3 (Adolescent 12‑17)
Planned
Protocol development underway
Market Context & Outlook
Metric
Value
China Influenza Cases (Annual)
~15‑20 million pediatric cases
Antiviral Market Size (Pediatric)
¥3.5 billion (US$480 million)
Current Standard
Neuraminidase inhibitors (oseltamivir, zanamivir)
Peak Sales Forecast (Onradivir Granules)
¥1.2‑1.8 billion (US$160‑240 million) by 2030
Market Capture Target
25‑30% of pediatric influenza A prescriptions
Competitive Edge: First PB2 inhibitor with pediatric data; potential for Breakthrough Therapy Designation based on novel mechanism
Regulatory Path: Phase 3 data could support NDA filing H2 2027; NRDL inclusion likely given unmet pediatric need
Global Potential: PB2 target validated across influenza A subtypes; U.S. pediatric IND filing possible 2028
Forward‑Looking Statements This brief contains forward‑looking statements regarding onradivir granules’ clinical development, regulatory timeline, and market potential. Actual results may differ materially due to risks including clinical trial outcomes, competitive dynamics, and regulatory review timelines.-Fineline Info & Tech
By Fineline Cube 