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Bi-Live
- Development stage
- Unknown
- Lead developer
- Zhejiang Xinlifi Biotechnology
- Modality
- Synthetic Biology Platforms → Engineered Microbial Therapeutics → Microbiome Therapeutics, Fresh FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Yeast Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Bacterial Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Defined Consortia → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Frozen FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Genetically Modified Bacteria → Engineered Microbial Therapeutics → Microbiome Therapeutics, Microbial Metabolites → Microbiome-Derived Products → Microbiome Therapeutics, Microbial Proteins → Microbiome-Derived Products → Microbiome Therapeutics, Complex Communities → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics
- Administration
- Vaginal
01
Overview
Bi-Live (LCV01) is a live biotherapeutic product (LBP) developed by Zhejiang Xinlifi Biotechnology for the treatment and prevention of recurrence of bacterial vaginosis (BV). It contains a specific strain of live *Lactobacillus crispatus*, which is a dominant commensal bacterium in the healthy vaginal microbiome. Bi-Live works by recolonizing the vaginal environment, thereby restoring the natural microbial balance that is typically disrupted in patients with BV. The *L. crispatus* strain produces lactic acid to maintain an acidic vaginal pH (typically < 4.5) and generates antimicrobial substances such as hydrogen peroxide and bacteriocins, which collectively inhibit the overgrowth of anaerobic pathogens like *Gardnerella vaginalis*. The product is formulated as a vaginal capsule and has progressed into late-stage clinical trials in China.
- Brand names
- Bi-Live
- Other names
- Live Lactobacillus crispatus capsule
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