2015/07/31

GoldenBiotech was granted the Orphan Drug Designation for the use of GHHCC to treat Hepatocellular Carcinoma in July. As a result, GoldenBiotech has received Orphan Drug Designation for three different indications from the US FDA in 2015.

GoldenBiotech, a clinical-stage pharmaceutical company developing drugs for the treatment of cancer and other diseases, announced today that its new drug GHHCC (Antroquinonol) has received Orphan Drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of hepatocellular carcinoma (HCC), the most common form of primary liver cancer. Orphan Drug designation is granted by the FDA Office of Orphan Products Development, which evaluates the scientific and clinical data submissions from sponsors to identify and designate products as promising for rare diseases and to further advance the scientific development of such promising medical products. Orphan Drug designation is granted to therapeutics treating rare diseases affecting less than 200,000 people in the U.S. This designation entitles the sponsor to seven years of market exclusivity as well as opportunities for additional funding, expert protocol assistance, and regulatory benefits.

GoldenBiotech specializes in the research of and development of oncology drugs. Along with the orphan drug designation for the use of new drug GHHCC to treat Hepatocellular Carcinoma, GoldenBiotech has also received orphan drug designation for other indications including the treatment of Pancreatic Cancer as well as Acute Myeloid Leukemia (AML).

Hepatocellular carcinoma (HCC) is the most common primary malignancy of the liver in adults and the third most common cause of fatal cancer diagnosis worldwide. According to National Cancer Institute’s figure, there were 45, 942 patients diagnosed with HCC in the United States, and the figure is expected to increase by 35, 660 patients in 2015; the one year and five year overall survival rates are expected to be 43% and 17% after treatment accordingly.

HCC is a global health problem that is proving to largely affect developing countries as over 80% of diagnosed cases of HCCs have been found to occur in such regions. Over the past two decades, the rates for these cancers have increased in people of all races and genders. Overall mortality rates have been rising on an average of 2.6 percent each year from 2002-2011.

Almost all cases of liver cancer in the United States occur in people with alcohol-related cirrhosis, while other HCC patients in other regions are chronically infected with hepatitis B virus (HBV) or hepatitis C virus (HCV). Obesity, diabetes, and iron storage disease are other risk factors for liver cancer. Standard treatments for liver cancer include surgery, liver transplant, ablation therapy, embolization therapy, radiation therapy, chemotherapy, and targeted therapy.

GHHCC (Antroquinonol) has demonstrated breakthrough clinical effects on cancer treatment along with other multiple indications of new research paths in progress. The Taiwanese’s research demonstrates global competitiveness and continually targets the global markets in hope of acquiring patents for more than 20 indications including NSCLC, Pancreatic Cancer, AML and Hepatocellular Carcinoma in over 103 countries. The approval of these drugs represents a major public health accomplishment toward treating the life-threatening disease of cancer in various forms.