Chinese approval for drug-eluting beads delayed
This article was originally published in Clinica
The Chinese State FDA has delayed the approval of Biocompatibles International's DC Bead for the treatment of liver cancer. SciClone Pharmaceuticals, Biocompatibles' distribution partner for China, has been told by the agency that it must conduct a small local trial to supplement data obtained from a previous study of the drug-coated beads performed in Hong Kong. If the trial, which is planned to commence this quarter, is successful, Biocompatibles (Farnham, UK) expects to receive Chinese regulatory approval for DC Bead in the second half of 2010 – the firm had hoped to launch the product in China this year. DC Bead is approved in 40 countries worldwide, including the US, where it is marketed as LC Bead, and Europe.
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