HARBIN, China, Nov. 26 /PRNewswire-Asia/ -- 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."
About China Sky One Medical, Inc.
China Sky One Medical, Inc., a Nevada corporation, is a holding company. The Company engages in the manufacturing, marketing and distribution of pharmaceutical, medicinal and diagnostic products. Through its wholly-owned subsidiaries, Harbin Tian Di Ren Medical Science and Technology Company ("TDR"), Harbin First Bio-Engineering Company Limited ("First"), Heilongjiang Tianlong Pharmaceutical, Inc. ("Tianlong") and Peng Lai Jin Chuang Pharmaceutical Company ("Jin Chuang") the Company manufactures and distributes over-the-counter pharmaceutical products, which make up its major revenue source. For more information, visit http://www.cski.com.cn .
Safe Harbor Statement
Certain of the statements made in the press release constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by the use of forward- looking terminology such as "believe," "expect," "may," "will," "should," "project," "plan," "seek," "intend," or "anticipate" or the negative thereof or comparable terminology. Such statements typically involve risks and uncertainties and may include financial projections or information regarding the progress of new product development. Actual results could differ materially from the expectations reflected in such forward-looking statements as a result of a variety of factors, including the risks associated with the effect of changing economic conditions in The People's Republic of China, variations in cash flow, reliance on collaborative retail partners and on new product development, variations in new product development, risks associated with rapid technological change, and the potential of introduced or undetected flaws and defects in products, and other risk factors detailed in reports filed with the Securities and Exchange Commission from time to time.
