SciClone Pharmaceuticals Inc. of San Mateo, Calif., announcedThursday that its lead drug Zadaxin thymosin alpha 1 hasreceived marketing approval from the Ministry of Health of theRepublic of Singapore for the treatment of chronic hepatitis B.
The product license is being issued under comparablecircumstances to the U.S. Food and Drug Administration'saccelerated marketing approval of certain new drugs andbiological products for serious or life-threatening illnesses, withprovision for continued study of the drug's clinical benefits andrestrictions on use if necessary. The license has provisions for asurveillance program.
SciClone's (NASDAQ:SCLN) Thymosin alpha 1 is a naturallyoccurring 28-amino acid peptide originally discovered in thethymus gland, which has been used in clinical trials as animmune modulator for the treatment of hepatitis B.
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