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Research History | PU Koreana | Clinical Studies | GMP

Research History

In the 1980s, Dr. B. Blumberg, who won the Nobel Prize for his discovery of the Hepatitis B virus, published numerous papers on Phyllanthus amarus. Inspired and enlightened by his research, Dr. Tai-Ho Chung, managed the “WHO Collaborating Centre for Immunological Research on the Prevention and Control and its related Diseases” to begin investigating the therapeutic properties of Korean herbs, and aggressively focused his attention on dried aqueous extracts of Phyllanthus urinaria Koreana, a close but taxonomically distinct relative of Phyllanthus amarus.

In 1994, working in collaboration with Dr. Blumberg and Dr. B. Tennant at Cornell, Dr. Chung’s group commissioned anti-viral studies on Phyllanthus Urinaria Koreana in woodchucks in the United States. The woodchuck model is generally accepted to be the closest to man for the study of Hepatitis B virus. The results were encouraging and led to formal toxicology studies, and further clinical evaluations in Korea.

Shortly after the Hepaguard Group was formed, Phase II clinical investigations were completed on 30 chronic active Hepatitis B patients. Dr. Chung’s earlier work on Phyllanthus urinaria, and the results of this trial, were the subject of a paper published in Kyungpook University Medical Journal and presented to a WHO Working Group conference on "Prevention and Control of Viral Hepatitis" in Tokyo on December 3rd., 1998.

In May of 2002, a 120 active chronic hepatitis B patients phase III clinical trial was completed, and subsequently, OTC Drug License for Hepaguard® was granted by Korea FDA in April of 2003. Approval for Phase II/III clinical trial commencement was also granted by the Department of Health of Taiwan in the same month. These accomplishments had marked an enormous milestone in HCG.