SciGen Secures Approval of SciLin™, its Recombinant Human Insulin
in the Peoples Republic of China
21st May 2008: SciGen Limited (ASX:SIE) announces that it has secured the first of three formulation approvals of its Recombinant Human Insulin in the Peoples Republic of
China. Preparations are underway to secure the license for all other formulations from the Chinese Food & Drug Administration (SFDA) and approval is expected shortly.
The product is presently manufactured by Bioton, SciGen’s contract manufacturer and major shareholder, and distributed by Hefei Life Sciences (HSLT), SciGen’s Chinese
distributor. HSLT management has a long and successful track record in marketing Insulin in the Chinese market and is one of SciGen’s partners, together with Bioton, in a
fill & finish facility under construction in Hefei, Hanui Province.
The Insulin market in China is the largest in the Asia Pacific Region with sales of US$500 million dollars in 2007 increasing at the rate of 25 to 30% per year. The WHO
(World Health Organization) estimates that the Chinese Market will exceed US$1 Billion dollars by 2010.
SciGen is now poised to secure a significant share of this market starting in the fourth quarter of this year.
Regards.
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