By Fineline Cube 
CanSino Biologics (HKG: 6185) announced that China’s National Medical Products Administration (NMPA) has approved a supplementary market filing for its ACYW135 Meningococcal Conjugate Vaccine (CRM197) (MCV4, trade name: Menhycia). The approval expands the indicated age range from 3 months to 3 years (47 months) to 3 months to 6 years (83 months), significantly broadening the vaccine’s addressable pediatric population.
Regulatory Milestone
| Item | Detail |
|---|---|
| Company | CanSino Biologics (HKG: 6185) |
| Product | Menhycia (ACYW135 Meningococcal Conjugate Vaccine, CRM197) |
| Vaccine Class | Quadrivalent meningococcal conjugate vaccine (MCV4) |
| Regulatory Action | Supplementary market filing approved |
| Previous Age Range | 3 months to 3 years (47 months) |
| New Age Range | 3 months to 6 years (83 months) |
| Original Approval | December 2021 (China) |
| Indication | Prevention of epidemic cerebrospinal meningitis caused by Neisseria meningitidis A, C, Y, and W135 |
Product Profile – Menhycia
- Vaccine Type: Quadrivalent conjugate vaccine targeting four meningococcal serogroups (A, C, Y, W135)
- Carrier Protein: CRM197 – non‑toxic diphtheria toxin mutant used as conjugate carrier
- Age Expansion Impact: +36 months of additional coverage, extending protection through early childhood
- Disease Prevention: Epidemic cerebrospinal meningitis – a severe bacterial infection with high mortality and morbidity in pediatric populations
Strategic Implications
- Market Expansion: The age range extension doubles the addressable pediatric window, capturing children aged 3–6 years who previously required alternative vaccination strategies or remained unprotected.
- Competitive Positioning: Menhycia strengthens its position in China’s quadrivalent meningococcal vaccine market, competing against domestic and imported MCV4 products.
- Pediatric Vaccine Portfolio: The approval reinforces CanSino’s pediatric infectious disease franchise, complementing its COVID‑19 and other vaccine offerings.
- Public Health Impact: Expanded coverage aligns with China’s National Immunization Program goals to reduce meningococcal disease burden in high‑risk pediatric populations.
Market Context
| Factor | Impact |
|---|---|
| China Meningococcal Disease Burden | Significant public health concern; highest incidence in children under 5 |
| MCV4 Market Growth | Quadrivalent vaccines replacing monovalent/conjugate alternatives due to broader serogroup protection |
| Age Expansion Value | Additional 3‑year coverage window increases vaccination compliance and reduces disease risk in preschool‑age children |
| Revenue Potential | Expanded indication drives volume growth in China’s ~15 million annual birth cohort |
Forward‑Looking Statements
This brief contains forward‑looking statements regarding market uptake, revenue projections, and competitive positioning for Menhycia. Actual results may differ due to risks including pricing pressures, competitive launches, and vaccination program adoption rates.-Fineline Info & Tech