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SciGen Limited announces that it has secured the first of three formulation approvals of its Recombinant Human Insulin in the Peoples Republic of China
Belrose, Australia | May 21, 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.
About SciGen:
SciGen Ltd is a biopharmaceutical company involved in commercializing later stage research. It co-develops and markets biopharmaceutical products for human healthcare. SciGen focuses in the areas of gastroenterology, endocrinology and immunology. Its product portfolio includes vaccines and therapeutics. SciGen acquires rights to manufacture, distribute and market biopharmaceutical products under exclusive licensing arrangements. SciGen’s portfolio currently includes proprietary biotechnology-derived products, and Biosimilar products, which allow for faster entry into the market, as Biosimilar products have undergone much of the clinical development and trials required to bring drugs to market. This minimizes the risks associated with early stage product development. SciGen currently undertakes R&D activities in collaboration with strategic partners and institutions. SciGen’s competitive advantage is in identifying research with commercial potential at an early stage to which it adds its expertise in clinical development, gaining regulatory approval and bringing products to market.
SciGen is a Singaporean biotechnology company, established in 1988 and listed on the Australian Stock Exchange (ASX code SIE). SciGen is headquartered in Singapore, with subsidiary companies in the USA, Australia, S. Korea, Hong Kong, Philippines, Vietnam, Israel and India, a Joint Venture in China, commercial partners in Europe and collaborative partners in the USA and the Netherlands.
SOURCE: SciGen Ltd |
