Ab&B Bio‑Tech Wins NMPA Approval for First‑Ever Quadrivalent Influenza Subunit Vaccine

Ab&B Bio‑Tech Wins NMPA Approval for First‑Ever Quadrivalent Influenza Subunit Vaccine

Ab&B Bio‑Tech CO., LTD. JS (HKG: 2627) disclosed that its quadrivalent influenza virus subunit vaccine has been cleared by China’s National Medical Products Administration (NMPA) for marketing. The vaccine is specifically indicated for the prevention of influenza in children aged 6 to 35 months.

What Makes This Vaccine Stand Out

  • First of Its Kind in China – The only quadrivalent subunit vaccine approved for all age groups with a full‑dose range.
  • Enhanced Antigen Purity – Utilizes a subunit platform that delivers high‑purity antigenic components, reducing the risk of adverse reactions.
  • Comprehensive Protection – Covers four influenza strains (two A and two B) in a single dose, offering broader immunity than traditional split‑virus formulations.
  • Low Side‑Effect Profile – Early clinical data show minimal reactogenicity, making it suitable for young children.

Regulatory Milestone

  • NMPA Approval – Granted on 3 Sep 2025, marking a significant regulatory achievement for a Chinese‑developed subunit vaccine.
  • Target Population – Exclusively approved for infants and toddlers 6‑35 months, a historically underserved segment for influenza vaccination.

Commercial Implications

  • Market Opportunity – China’s pediatric influenza vaccine market is projected to grow as awareness of early childhood immunization rises.
  • Competitive Edge – The subunit technology positions Ab&B Bio‑Tech ahead of competitors still relying on split‑virus or whole‑virus formulations.
  • Scalability – Full‑dose range and simplified logistics could streamline supply chains and reduce manufacturing costs.-Fineline Info & Tech