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news.SciClone Pharmaceuticals and its partner BTG has announced that the China Food and Drug Administration has approved the registration of DC Bead for the embolization of malignant hypervascularized tumors.
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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.
Friedhelm Blobel, SciClone Chief Executive Officer commented: "Together with our partner BTG, we will now focus our efforts on preparing for the introduction of the product in the Chinese market. Oncology is a core business focus for SciClone, and our sales team and academic marketing liaisons have established high quality relationships with the medical professionals and institutions that specialize in cancer treatment. We believe DC Bead has the potential to be a valuable addition to SciClone’s oncology product portfolio."
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 tumors.
DC Bead is registered in China for the embolization of malignant hypervascularized tumors 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. More than 350,000 people dying from primary liver cancer in China annually1.
DC Bead and/or all indications may not be available in all territories. DC Bead is not currently cleared by the FDA for sale or distribution in the USA.