SCIENCE

Cancer (e.g., liver cancer)

Has multiple working mechanisms, including inhibiting the growth of cancer cells, inhibiting the angiogenesis of cancer cells, and inhibiting the metastasis of cancer cells.

1. Pre-clinical studies were proceeded in accordance with international R&D standards for botanical new drugs (e.g., the corresponding standards published by ICH and the US FDA). All the established techniques and quality met international standards. The anti-cancer activity of the drug has been verified with various cancer cells, and the safety range of the drug has been evaluated by comparing its toxicological study results with those in normal cells and animal studies. The anti-cancer activity of the Antrodia cinnamomea-based new drug has been validated in different in vivo disease models.
2. Greenlighted by the US FDA and TFDA (the Food and Drug Administration, Ministry of Health and Welfare of Taiwan) to proceed with the phase 1 clinical trial. The phase 1 clinical trial in Taiwan started in 2020.
    

1. Safety: 100 times inhibition of cancer cells than in normal cells (in terms of concentration) and therefore has high selectivity
2. Effectiveness: Inhibit the growth of a subcutaneously or orthotopically transplanted malignant cancer significantly
3. Quality assurance: To ensure batch-to-batch consistency of the drug, a proper quality control process has been established for the entire manufacturing process from the raw materials to the finished product.
4. Monopoly: Oneness Biotech has been granted with patents in many countries for the anti-cancer active components, the drug manufacturing process, and the use of the drug. The patent protection of the product lasts at least till 2035.
    

Millions of patients with liver cancer die each year. Hepatocellular carcinoma (HCC) is the most common primary liver cancer and makes up about 90% of all liver cancer cases. As currently available treatment solutions contribute to only a limited increase in the overall survival rate, a new therapy is needed to meet the medical needs in HCC. It is estimated that the market size of liver cancer treatment in 2025 is about USD 5 billion. (Reference: Nature review)