From Experience-based Practices to Evidence-based Medicines
Yiviva is learning from the ancient wisdom of traditional medicines by combining the latest advances in metabolomics, systems biology and bioinformatics to accelerate drug discovery.
US FDA and China FDA’s Botanical Drug Regulatory Pathways Creates New Opportunities
All modern medicines, including botanical, biologics, and small molecules drugs, are evaluated based on safety, efficacy and quality control.
The US FDA evaluates the “totality of evidence” of botanical drugs, with flexibility on certain requirements for quality control, preclinical and clinical studies – which may accelerate research and development. See here to learn more about the US FDA Botanical Drug Guidance.
Botanical Drugs May Lead to New Breakthroughs for Patients via Systems Biology Approach
Conventional drugs, with a single chemical entity targeting a single pathway, can be limited in its efficacy. It may take a cocktail of conventional drugs, with the risk of their inherent side-effects, to have a multi-target effect.
A single sophisticated botanical drug that is poly-chemical and multi-target in nature, can be designed to treat humans holistically – targeting multiple tissues and mechanisms of action, including in the:
- Tumor microenvironment
- Gastrointestinal microenvironment
- Interactions across organs
Yiviva is pioneering first-in-class botanical drugs to address unmet medical needs.
Quality Medicines – Creating value from farm to bedside
Yiviva has solved key challenges to modernize botanical medicines:
- Yiviva has pioneered a proprietary Mechanism-based Quality Control (MeQC) platform for developing complex mixtures
- Yiviva follows Good Agricultural and Collection Practices (GACP) and Good Manufacturing Practices to develop batch-to-batch consistent products that meet FDA guidances
- Yiviva partners with leading manufacturers, including co-founder Sun Ten Pharmaceuticals.
Yiviva is establishing a long-term global competitive advantage.