DC Bead approved by China Food and Drug Administration

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BTG and its partner SciClone Pharmaceuticals have announced that the China Food and Drug Administration has approved the registration of DC Bead for the embolization of malignant hypervascularised tumours.

BTG and SciClone previously entered into an agreement granting SciClone exclusive licensing and distribution rights to DC Bead in China. Under the agreement, SciClone will purchase product from BTG at a specified price for sale in China. Commercial launch plans are now underway.

Louise Makin, chief executive officer at BTG, said: “Approximately half of the world’s liver cancer patients are in China and there is a great interest among Chinese physicians to offer new, differentiated treatment options. Today’s news marks an important step toward bringing our first interventional oncology product, DC Bead, to the Chinese market where we can help address this need.”

DC Bead is a novel treatment for liver cancer which is currently approved in 40 countries worldwide, including Europe. DC Bead is an embolic bead delivered through a minimally invasive, non-surgical procedure to block the blood flow to tumours.

DC Bead is registered in China for the embolization of malignant hypervascularised tumours such as hepatocellular carcinoma (HCC), the most common form of primary liver cancer. The majority of people with HCC have cirrhosis, usually from chronic hepatitis B or hepatitis C infection, or chronic alcoholism.  Because of the country’s high incidence of hepatitis, China accounts for approximately one-half of the world’s liver cancer cases.