Golden Biotechnology Corp. (TPEx 4132) ("GoldenBiotech", GBC) announced that it has received notification from its contract research organization (CRO) that the Investigational New Drug (IND) application for the small-molecule drug Antroquinonol (Hocena) has been submitted to and accepted by the U.S. Food and Drug Administration (FDA) for review. The IND application is for a Phase III clinical trial in metastatic pancreatic cancer.

The proposed indication of Antroquinonol (Hocena) is in combination with standard-of-care therapies for the first-line treatment of patients with metastatic pancreatic cancer. The planned development stage under this IND application is Phase III clinical trial.

From a market perspective, according to a market research report published by GlobalData, the pancreatic cancer drug market across the eight major markets—namely the United States, France, Germany, Italy, Spain, the United Kingdom, Japan, and China—was valued at approximately USD 1.8 billion in 2019. The market size is projected to grow to approximately USD 5.4 billion by 2029, representing a compound annual growth rate (CAGR) of approximately 11.5%.