Nov 26 2009
China Sky One Medical, Inc. ("China Sky One Medical" or "the Company") (Nasdaq: CSKI), a leading fully integrated pharmaceutical company developing and producing over-the-counter drugs in the People's Republic of China ("PRC"), today announced that the Company recently passed the Chinese National Institute for the Control of Pharmaceutical and Biological Products ("ICPBP") examination for two of its new products: its Diagnostic Kit for Human Prostate Specific Antigen (Colloidal Gold) and its Determination Kit for Luteinizing Hormone (Colloidal Gold).
The clinical trials for both products have been completed earlier. As the examination by ICPBP is usually the last material procedure toward the final production approval for biological testing products, the Company expects to receive the final approval from the State Food and Drug Administration (SFDA) in China for the production of both products by the end of 2009. Formal production for the two new products is expected to begin in 2010.
The Diagnostic Kit for Human Prostate Specific Antigen (Colloidal Gold) can be used in early diagnosis of human prostate disorders, hyperplasia and cancer, because the concentration of Prostate Specific Antigen ("PSA") is an important parameter in clinical treatment of prostate related diseases.
The Determination Kit for Luteinizing Hormone (Colloidal Gold) is used in the diagnosis of female sterility. According to research by World Health Organization, 5%-8% of married couples in developed countries are suffering from the sterility. In China, sterility patients account for nearly 10% of the total population at the age of procreation. This number keeps increasing in China due to various reasons including diseases, conception control and social stress.
"We are excited to have made such great progress in the development of these new products and look forward to receiving SFDA approval for the production of both of them very soon," commented Mr. Yan-qing Liu, Chairman and CEO of China Sky One Medical. "We are fully committed to increasing our drug portfolio by bringing quality new products into domestic as well as international market."
Source:
China Sky One Medical, Inc.