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Country of origin : China
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pp-129

Solution for injection

Dossier type
CTD
Dossier status
Under development
Country of origin
China
GMP approvals
China
Comments
Indication: Prevention of RSV lower respiratory tract disease in adults ≥60 years Clinical stage: Phase 2 — ongoing Modality: Biologic (recombinant trimeric RSV-F prefusion protein vaccine; AS03-adjuvanted) Mechanism / Target: Prefusion RSV-F stabilised trimer elicits neutralising antibodies targeting prefusion-specific epitopes (site Ø); broader and stronger immune response than postfusion antigens Route / form: Intramuscular injection Differentiation: Proprietary Trimer-Tag technology provides structural stability; AS03 adjuvant enhances immunogenicity in elderly; low-cost manufacturing potential in China
Manufacturer #39165

Clinical-stage vaccine company specialising in recombinant protein-based vaccines. Uses proprietary Trimer-Tag technology platform to stabilise viral fusion proteins. Developing RSV and other respiratory vaccines for global markets.
 

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