Maxvax Biotech announced today that the China National Medical Products Administration (NMPA) has accepted the registration application for its independently developed recombinant herpes zoster vaccine produced in CHO cells. The vaccine, classified as a Category 1.3 drug, integrates the company’s proprietary MA105 adjuvant system and is the first Chinese vaccine to hold independent intellectual‑property rights for a composite adjuvant platform.
Product Overview
- Technology – Recombinant protein vaccine manufactured in Chinese hamster ovary (CHO) cells.
- Adjuvant – Self‑developed MA105, the first innovative composite adjuvant system in China.
- Indication – Prevention of herpes zoster (shingles) caused by varicella‑zoster virus in adults aged 40 years and older.
- Regulatory Status – Category 1.3 drug; NMPA registration application accepted.
Clinical Evidence
| Study | Participants | Primary Endpoint | Key Findings |
|---|---|---|---|
| Phase 3 | 25,000 adults ≥ 40 years | Protective efficacy ≥ pre‑specified threshold | Demonstrated robust efficacy across all age strata; favorable safety profile with no serious vaccine‑related adverse events. |
Strategic Implications
- First‑Mover Advantage – The MA105 adjuvant gives Maxvax a unique competitive edge in the Chinese vaccine market.
- Market Opportunity – With an aging population, demand for a safe and effective shingles vaccine is projected to grow steadily.
- Expansion Potential – The regulatory approval paves the way for future licensing and global market entry.
About Maxvax Biotech
Maxvax Biotech is a Shanghai‑based biotechnology company focused on the discovery, development and commercialization of innovative recombinant vaccines. The company’s pipeline spans viral, bacterial and parasitic diseases, supported by a strong research, regulatory and manufacturing platform.
Forward‑Looking Statements
This release contains forward‑looking statements regarding regulatory approvals, market potential and future product development. These statements are subject to risks, uncertainties and changes in market conditions.-Fineline Info & Tech
