The recombinant hepatitis B vaccine has received its first regulatory approval in Belgium. SmithKline announced in late October that it had finalized its exclusive licensing agreement with the Institut Pasteur covering the Engerix-B vaccine. Developed and produced by SmithKline's Brussels-based biologicals subsidiary, SmithKline-RIT, Engerix-B has been studied in over 6,000 patients in clinical studies in 15 countries. SmithKline said that Engerix-B is "expected to be approved and marketed in many countries in Europe, Southeast Asia and Africa within the next year".
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