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SK10 (Zhiyi Pharmaceutics)
- Development stage
- Preclinical
- Lead developer
- Zhiyi Pharmaceutics
- 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
- Oral
01
Overview
SK10 is an investigational live biotherapeutic product (LBP) being developed by Zhiyi Biotechnology for the treatment of Crohn's Disease (CD). It is categorized as a biological product without prior human use, indicating that it utilizes a novel bacterial strain or microbial consortium not previously established in clinical practice. The drug is currently in the IND-enabling stage for submission to the U.S. Food and Drug Administration (FDA). As an LBP, SK10 is designed to address the underlying pathophysiology of Crohn's Disease by modulating the intestinal microbiota and host immune responses to reduce inflammation and restore gut homeostasis.
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