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GC Biopharma¡¯s Hunterase approved after 11yrs

By Chon, Seung-Hyun | translator Kim, Jung-Ju

23.11.16 09:51:37

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Received conditional approval under the condition of conducting a Phase III trial in 2012

Completed phase three trial and received official marketing authorization

GC Biopharma¡¯s rare disease treatment ¡®Hunterase¡¯ was granted official marketing authorization 11 years after receiving conditional approval.


On the 16th, GC Biopharma announced that it had completed the Phase III trial for its Hunterase on the 14th and changed its license from conditional approval to final marketing authorization.

Hunterase, which was approved in 2012 in Korea, is the world¡¯s second treatment for developed Hunter syndrome, which is also known as ¡®Mucopolysaccharidosis type II (MPS II),¡¯ is a rare disease that is known to occur in roughly 1 in 100,000 to 150,000 male live births. As a congenital, hereditary metabolic disorder, Hunter syndrome shows various unpredic

Chon, Seung-Hyun(1000@dailypharm.com)
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