Medicines (Rx)
Botanical Drugs Target Multiple Sites to Optimize Cancer Treatment
Unlike chemical drugs, botanical new drugs improve symptoms and treat clinical diseases through multi-targeted actions. By adhering to PIC/S GMP-compliant Botanical Active Pharmaceutical Ingredients (API) manufacturing factory guidelines and using the main component's chemical fingerprint maps, botanical new drugs meet the review standards of health authorities. With evidence from basic research and clinical human trials, these drugs help optimize cancer treatment in clinical settings.
Highlights
Botanical New Drug PhytoHealth PG2® Lyo. Injection Included in Taiwan's National Health Insurance Reimbursement List
Multi-targeted effect improves symptoms and treats clinical diseases.
Asia's first PIC/S GMP and US FDA-compliant GMP Botanical Active Pharmaceutical Ingredients (API) manufacturing factory
Precise botanical new drug components and content ratios meet the health authority's review standards
PhytoHealth PG2® Lyo. Injection obtains Taiwan's Ministry of Health and Welfare's first botanical new drug prescription drug marketing approval
Completion of large-scale, multi-center Phase IV clinical human trials, demonstrating clinical safety and efficacy
Assisting Cancer Treatment
Obtaining botanical new drug certification for treating cancer-related fatigue
PhytoHealth, with its high-quality pharmaceutical expertise and technology, has built Asia's first PIC/S GMP (Pharmaceutical Inspection Co-operation Scheme) and US For Phytohealth 57 FDA-compliant GMP "Botanical Active Pharmaceutical Ingredients (API) manufacturing factory" to develop and manufacture PhytoHealth PG2® Lyo. Injection using international standards.
PhytoHealth PG2® Lyo. Injection is made using scientific patented processes to obtain specific molecular weight "rAPS refined Astragalus Polysaccharides," which meet the requirements for human intravenous injection and are manufactured under strict human clinical trials, becoming a prescription botanical new drug for treating cancerrelated fatigue (CRF). The results of its large-scale Phase IV clinical human trials demonstrate that patients with better physical conditions have a higher proportion of achieving better fatigue treatment outcomes, providing clinical evidence for early treatment and better therapeutic effects.
| Guideline | Botanical New Drug |
| R&D Model | Botanical new drugs are based on thousands of years of clinical use experience, confirming that a certain plant medicine (Chinese herbal medicine) has therapeutic effects on a specific disease, and then researched and verified using Western scientific methods. |
| Listing Requirements | Unlike tradtional Chinese medicine, botanical new drugs must complete the most rigorous new drug inspection and registration procedures for Western medicine in order to obtain approval for a drug license, ensuring that the manufacturing process, quality, and efficacy all meet the standards of Western prescription drugs. |
| Product | In 2000, Taiwan's TFDA issued the first botanical new drug license for PhytoHealth PG2® Lyo. Injection, which is currently a commonly prescribed new drug for "cancer-related fatigue" in clinical practice. The main ingredient is "rAPS Refined Astragalus Polysaccharide". |
Optimizing Cancer Treatment
Multi-target action optimizes treatment in cancer adjuvant therapy and combination therapy.
Botanical new drugs are scrutinized based on their main components and chemical fingerprint profiles, precisely controlling the ingredient items and content ratios in the botanical new drugs to meet the review standards of health authorities and comply with the quality requirements of Western science and clinical disease treatment.
Cancer treatment faces challenges such as the inability to effectively eradicate cancer cells, recurrence, and the impact of side effects on treatment completion and prognosis. Numerous research reports indicate that the refined Astragalus For Phytohealth 58 polysaccharide from botanical new drugs, with its multi-target action, can enhance the efficacy of cancer treatment drugs. In addition to treating cancer-related fatigue, improving side effects, and enhancing the quality of life, it also optimizes cancer treatment in adjuvant therapy and combination therapy.
| Category | Botanical New Drug | Chemical Drug |
| Mechanism of treatment | Multi-targeted | Single target |
| Quality | After extensive purification and refinement, the active ingredient has a high purity level. | Chemical compound - highly pure |
| Clinical Validation | Strict human clinical trials must be conducted in accordance with regulations to confirm safety and efficacy. |