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Drug intelligence / Profile preview
recombinant hepatitis B vaccine (hansenula polymorpha, CpG and aluminum adjuvant)
- Development stage
- Phase 2
- Lead developer
- Grandway SaviXin Life Sciences
- Modality
- Vaccines & Immunotherapeutics, Recombinant Proteins and Enzymes
- Administration
- Intramuscular
01
Overview
This is a recombinant protein subunit vaccine designed for the prevention of Hepatitis B virus (HBV) infection. The vaccine utilizes the Hepatitis B surface antigen (HBsAg) expressed in the methylotrophic yeast *Hansenula polymorpha*. A key feature of this formulation is its dual-adjuvant system, combining a synthetic CpG oligodeoxynucleotide (specifically CpG-QCX1), which acts as a Toll-like receptor 9 (TLR9) agonist to stimulate cellular immunity, with a traditional aluminum-based adjuvant to enhance the humoral response. Developed by Grandway SaviXin Life Sciences (Nanjing) Co., Ltd., the vaccine is currently in Phase II clinical trials to evaluate its safety and immunogenicity, particularly focusing on optimized adjuvant ratios and immunization schedules in adults.
- Other names
- Recombinant Hepatitis B Vaccine (Hansenula Polymorpha, CpG and Aluminum Adjuvant)
02
Targets
HBsAg-specific BCR (HBsAg-specific B-cell receptor)NLRP3 (Nod-like receptor family pyrin domain-containing protein 3)Hepatitis B surface antigen-specific T-cell receptorT-cell receptor recognizing Hepatitis B surface antigen-derived peptide–MHC class II complexesTLR9 (Toll-like receptor 9)
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