1.
Leading the breakthrough in LBPs in China, utilizing NGPs, it is the first orally administered live bacterial drug approved for clinical use in China in over a decade. The NMPA has approved LBP for the first time for IBS/tumor/pediatric medications.
2.
International standards: The first Chinese-originated LBP approved for clinical trials by the FDA, including both live bacteria (UC) and inactivated bacteria (CID), pioneering the development and registration process for both China and the US.
3.
China's first comprehensive development and transformation platform for live biotherapeutics, supporting the development of drugs and next-generation probiotic foods in both China and the US.
4.
Assisting global partners to accelerate the development and implementation of innovative live biotherapeutics and next-generation probiotics, promoting leapfrog development in the biopharmaceutical industry.
5.
China's first comprehensive development and transformation platform for live biotherapeutics, supporting the development of drugs and next-generation probiotic foods in both China and the US.
6.
Zhiyi Bio aids global partners in accelerating the development and implementation of innovative live biotherapeutics and next-generation probiotics, driving the industry's leapfrog development.
Screening and Evaluation of LBP/NGP Candidate Strains
LBP from strains to drugs
Construction and Evaluation of Engineering Bacteria
CMC Integrated Solution
(Based on NMPA、FDA Quality system、Ability to write materials; Record management system; project management system)
LBP/Probiotics Product Co-development/Technical Service Platform
Sample Collection
-Samples provided by customers
-Collection on behalf of customers
Sample Processing
-Anaerobic/aerobic treatment
-Keeping samples highly active
Strain Isolation
-Hundreds of cultivation
-Personalized Filtering
Species Identification
-Rapid identification
-16s rDNA Identification
-Whole genome sequencing
Conservation & Delivery
-Liquid/plate/powder
-Long-term preservation
-Ensure recovery and activity
Fermentation Optimization
-1~10L Cultivation
Fermentation Control
-Obtaining key data
Fermentation Amplification
-30~70L Cultivation
Bacteria Harvesting
-High activity
Lyophilization Optimization
-0.5m² Lyophilizer
Powder Delivery
-100~400g
Viable Bacteria Count
-Multi-bacterial complex samples
-Biological samples
Microbial Limit Test
-Polymicrobial & Aerobic products
qPCR Specificity Analysis
-Multi-bacterial samples
-Biological samples
Quantitative Flow Cytometry Assay
-Fast analysis
-Precise control
Cooperate with pharmaceuticals, food, daily chemicals, pets, and environment business partners
Existing Human Drug Pipeline Authorized/Collaborated on Animal
- Animal/Pet New Drugs
- SK08 (Live Bacteria): 4 approved human drug indications (UC/IBS/Cancer/Pediatric Diarrhea), Phase III clinical trials
- SK10 (Inactivated): 1 approved human drug indication (CID), Phase I clinical trials completed in the US
- AKK (Live Bacteria/Inactivated): Preclinical stage mostly completed
- Engineered Bacteria (Live Bacteria): Intestinal inflammation, preclinical stage
Functional Strain Evaluation
- Database model prediction, functional prediction
- Whole genome sequencing and bioinformatics analysis: Virulence gene analysis, drug resistance gene analysis
- Safety: Drug, hemolysis, toxin production
- Efficacy: Probiotic properties, biochemical properties
- Animal Testing: Toxicity testing, obesity models, IBD models, allergic rhinitis models...
Consumer Product Development
- Possesses a library of tens of thousands of independently isolated probiotic strains
- Probiotic food fermentation, bacterial powder
- Probiotic daily care products, health supplements
- Pet nutritional supplements, milk powder, feed, cat/dog food, fertilizer, environmental protection
Engineered Bacteria (Vector) Technical Services
- Synthetic Biology Technical Services: Homologous recombination system gene editing, CRISPR/Cas platform-based genome modification
- Chassis Organism Modification: Genetic modification technical services for E. coli, lactic acid bacteria, etc.
- Recombinant Probiotics: Dietary supplements, international registration
- Bacterial Vectors: Drug delivery systems
Room 301, Building A, No. 2 Ruitai Road, Huangpu District, Guangzhou, Guangdong, China(510530)
020-82258826
public@zypharm.com.cn