PhytoHealth

Herbal substances found in the international medical field often successfully address unmet medical needs. When their clinical safety has been verified and reasonable chemical, manufacturing, and control processes are in place, botanical products that have shown effectiveness through experience will be accepted more readily, which will increase the likelihood of approval for sale in the market. The development of new botanical drugs is based on thousands of years of clinical application experience, driven by a botanical (traditional Chinese herbal) application determined effective in the treatment of certain diseases. Hence, herbal substances take an exclusively treatment-targeted approach, which is also known as the “disease-targeted research model.” This disease-targeted botanical drug development model is vastly different from the “trial and error” development model of pharmaceutical drugs, which, therefore, is accumulating the attention of global pharmaceutical companies.

A few years ago, the FDA approved this new botanical drug testing and it highly regards the research abilities of Taiwan and China in this area. In Taiwan, the FDA already has approved numerous investigational new drug (IND) applications of botanical drugs. The future of botanical drug development appears promising and the government should support the relevant R&D to stay at the forefront of the industry.

In 2010, PhytoHealth acquired Taiwan’s first new drug designation for PHN012® and invested hundreds of millions to build Taiwan’s first GMP sterile botanical drug manufacturing facility that is in compliance with PIC/S (Guide to Good Manufacturing Practice for Medical Products) and FDA regulations. This step symbolizes a milestone in the new injectable botanical drug manufacturing technology in Taiwan’s domestic biotechnology industry. PHN012® hit the market to supply major hospitals in late April 2012. Leveraging on PhytoHealth’s R&D strength and Maywufa’s marketing experience, PHN012® is marketed by the pharmaceutical marketing team under the Maywufa Biopharma Group and is supplied to major hospitals across Taiwan to help alleviate severe and incurable cancer-related fatigue syndrome. The use of PHN012® has been expanded to treat stroke patients, and continued implementation of clinical trials by a stroke specialist Medical Center

In addition, PhytoHealth has been certified for two consecutive years by the Taiwan Intellectual Property Management System (TIPS) under the Ministry of Economic Affairs, making it one of a very few biotech drug development companies to have achieved certification two years in a row. Through its comprehensive global patent portfolio and effective intellectual property management, PhytoHealth continues to accumulate the value of its intangible assets. Because its new drug clinical trials are in progress, many international pharmaceutical companies have approached PhytoHealth to discuss possible business collaborations.

PhytoHealth’s business strategy is to “authorize international pharmaceutical companies to jointly open up the markets in Europe and the US while retaining marketing control in Asian countries (excluding Japan).” In the sixth “Chiang-Chen Meeting” on “cross-strait medical and health cooperation agreement,” Taiwan and China agreed to comply with Good Clinical Practice (GCP) standards and work together to reduce replication of tests, which actively promotes cross-strait clinical trials and the pharmaceutical R&D cooperation policy. Not only has PhytoHealth created Taiwan’s first new botanical drug, PHN012®, that drug was approved by the FDA for four additional clinical trials. With its high industrial standards and numerous award-winning studies, PhytoHealth is certainly the industry leader in the huge botanical drug market of China, which involves limitless business opportunities and potential.

“Asian leader, Global niche’: PhytoHealth has become the leader in botanical drug development in Asia. It is also a bright beacon in Taiwan’s biotechnology and pharmaceutical industry. PhytoHealth is definitely the first choice of many major international pharmaceutical companies when they seek Asian business partners.