HARBIN, China, Nov. 25 China Sky OneMedical, Inc. ("China Sky One Medical" or "the Company") (Nasdaq: CSKI), aleading fully integrated pharmaceutical company developing and producingover-the-counter drugs in the People's Republic of China ("PRC"), todayannounced that the Company recently passed the Chinese National Institute forthe Control of Pharmaceutical and Biological Products ("ICPBP") examinationfor two of its new products: its Diagnostic Kit for Human Prostate SpecificAntigen (Colloidal Gold) and its Determination Kit for Luteinizing Hormone(Colloidal Gold).
The clinical trials for both products have been completed earlier. As theexamination by ICPBP is usually the last material procedure toward the finalproduction approval for biological testing products, the Company expects toreceive the final approval from the State Food and Drug Administration (SFDA)in China for the production of both products by the end of 2009. Formalproduction 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 andcancer, because the concentration of Prostate Specific Antigen ("PSA") is animportant parameter in clinical treatment of prostate related diseases.
The Determination Kit for Luteinizing Hormone (Colloidal Gold) is used inthe diagnosis of female sterility. According to research by World HealthOrganization, 5%-8% of married couples in developed countries are sufferingfrom the sterility. In China, sterility patients account for nearly 10% of thetotal population at the age of procreation. This number keeps increasing inChina due to various reasons including diseases, conception control and socialstress.
"We are excited to have made such great progress in the development ofthese new products and look forward to receiving SFDA approval for theproduction of both of them very soon," commented Mr. Yan-qing Liu, Chairmanand CEO of China Sky One Medical. "We are fully committed to increasing ourdrug portfolio by bringing quality new products into domestic as well asinternational 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 ofpharmaceutical, medicinal and diagnostic products. Through its wholly-ownedsubsidiaries, Harbin Tian Di Ren Medical Science and Technology Company("TDR"), Harbin First Bio-Engineering Company Limited ("First"), HeilongjiangTianlong Pharmaceutical, Inc. ("Tianlong") and Peng Lai Jin ChuangPharmaceutical Company ("Jin Chuang") the Company manufactures and distributesover-the-counter pharmaceutical products, which make up its major revenuesource. For more information, visit http://www.cski.com.cn .
Safe Harbor Statement
Certain of the statements made in the press release constituteforward-looking statements within the meaning of the Private SecuritiesLitigation Reform Act of 1995. These statements can be identified by the useof forward- looking terminology such as "believe," "expect," "may," "will,""should," "project," "plan," "seek," "intend," or "anticipate" or the negativethereof or comparable terminology. Such statements typically involve risks anduncertainties and may include financial projections or information regardingthe progress of new product development. Actual results could differmaterially from the expectations reflected in such forward-looking statementsas a result of a variety of factors, including the risks associated with theeffect of changing economic conditions in The People's Republic of China,variations in cash flow, reliance on collaborative retail partners and on newproduct development, variations in new product development, risks associatedwith rapid technological change, and the potential of introduced or undetectedflaws and defects in products, and other risk factors detailed in reportsfiled with the Securities and Exchange Commission from time to time.For more information, please contact: Company Contact: China Sky One Medical, Inc. Mr. Stanley Hao, CFO Tel: +86-0451-5399-4069 Email: [email protected]
Investor Relations Contact: CCG Investor Relations Mr. Crocker Coulson, President Tel: +1-646-213-1915 Email: [email protected]
SOURCE China Sky One Medical, Inc.