By Fineline Cube AIM Vaccine Co., Ltd (HKG: 6660) announced that China’s National Medical Products Administration (NMPA) has approved clinical trials for its 20‑valent pneumococcal conjugate vaccine (PCV20), a next‑generation version of its marketed PCV13 that adds seven serotypes to cover 20 major circulating strains, positioning the company as a domestic challenger to Pfizer’s Prevenar 20 in the world’s largest vaccine market.
Regulatory Milestone
| Item | Detail |
|---|---|
| Company | AIM Vaccine Co., Ltd (6660.HK) |
| Drug | 20‑valent pneumococcal conjugate vaccine (PCV20) |
| Application | Clinical Trial Application (CTA) |
| Agency | NMPA (China) |
| Indication | Prevention of invasive pneumococcal disease (pneumonia, meningitis, bacteremia) |
| Population | Individuals from 2 months of age (≥6 weeks) |
| Approval Date | 15 Jan 2026 |
| Innovation | First PCV20 in China; adds 7 serotypes vs. PCV13; no domestic competitor |
Drug Profile & Development
- Platform: Optimized iteration of AIM’s marketed PCV13 with 7 additional serotypes, covering 20 major circulating pneumococcal strains
- Mechanism: Protein‑polysaccharide conjugate technology induces T‑cell dependent immune response, producing high‑titer, long‑lasting antibodies
- Indication: Broad age range from 6 weeks (2 months) through adulthood, simplifying immunization schedules
- Clinical Need: Invasive pneumococcal disease remains a leading cause of infant mortality in China; MDR serotypes increasing
Market Impact & Competitive Landscape
| Parameter | China | Global |
|---|---|---|
| Annual Births (Target Cohort) | 9.5 million | 135 million |
| PCV Coverage Rate (China) | 35% (2025) | 70‑80% (developed markets) |
| Addressable Market (2030E) | ¥28 billion | $8.5 billion |
| Pfizer Prevenar 20 Status | Not approved in China | Approved in US, EU, Japan |
| AIM PCV20 Peak Share | 18% | 2% |
| Peak Revenue (2032E) | ¥5.0 billion | $170 million |
Key Competitors:
- Pfizer Prevenar 20 – Market leader globally, not yet filed in China (regulatory delay)
- Pfizer Prevenar 13 – Currently dominates Chinese private market (¥4.2 billion sales)
- Domestic PCV13 – 3 local players (Walvax, Minhai, Sinovac) with NRDL pricing (¥600/dose)
- AIM PCV20 – First 20‑valent domestically; potential for premium pricing (¥1,200‑1,500/dose) and NRDL fast‑track
Strategic Positioning
- Manufacturing: AIM’s Changchun facility (capacity 80 million doses/year) can produce PCV20 with minimal retrofit; WHO Pre‑qualification targeted by 2028 for UN procurement
- Clinical Pathway: Phase I/II bridging study vs. Prevenar 20 planned Q2 2026; Phase III superiority trial to demonstrate broader serotype coverage vs. PCV13
- Commercialization: Existing 2,000‑hospital distribution network for PCV13 can be leveraged; private market launch expected 2028, NRDL negotiation in 2029
- Global Ambitions: Ex‑China licensing discussions underway with GSK and Serum Institute for low‑middle income markets
Forward‑Looking Statements
This brief contains forward‑looking statements regarding clinical development timelines, market penetration, and revenue forecasts for PCV20. Actual results may differ due to competitive responses, regulatory delays, and vaccine hesitancy.-Fineline Info & Tech