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China Sky One Medical (NSDQ: CSKI) said it expects to have final SFDA approval for two more diagnostic kits by the end of 2009. One is a diagnostic test for Human Prostate Specific Antigen, an indicator of prostate related diseases, and the other is a determination kit for Luteinizing Hormone, a diagnosis test for female sterility.

The kits have completed their clinical trials, and they have now also passed examinations conducted by the Chinese National Institute for the Control of Pharmaceutical and Biological Products (ICPBP). China Sky One said the ICPBP examination is the last step in the process before a product is approved.

If, as expected, China Sky One receives the approvals this year, the two tests will begin production in 2010. They will join the company’s relatively new diagnostic testing division, which currently consists of three kits and contributed 6% of the company’s Q3 revenues.

Most of China Sky One’s offerings are OTC products, and many of them use a patch delivery technology. The company has been very aggressive in making acquisitions and adding new products that were developed internally.

In its Q3, China Sky One reported revenues of $43.2 million, a 46% increase year over year. The company reiterated guidance for full-year revenues of $130 million, a 40% jump. Net income is expected to total $39 million, representing a 30% profit margin.

Disclosure: none.

Source: China Sky One Nears Approval on Two Diagnostic Tests