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China Sky One Medical, Inc. Obtains Production Approval for Two New Drugs

2009-05-26 18:51 2022

HARBIN, China, May 26 /PRNewswire-Asia/ -- China Sky One Medical, Inc. ("China Sky One Medical" or "the Company") (Nasdaq: CSKI), a leading fully integrated pharmaceutical company in the People's Republic of China ("PRC"), today announced that it recently obtained production approval from the State Food and Drug Administration (SFDA) in China for two of its newly developed drugs.

Acyclovir gel is used to treat the skin infection due to varicella-zoster virus and the herpes simplex virus. Shuanghuanglian suppositories helps relieve cold and flu symptoms such as fever, cough and sore throat pain. It can also be used to treat upper respiratory infections and pneumonia. Both of the products are for common diseases, and should benefit as a result of the rapidly expanded rural health market, especially after China's recent reform of the insurance system. They will be introduced to the market in the third quarter of 2009.

China Sky One Medical started R&D of the two drugs in 2003 and submitted the applications for SFDA approval in early 2007. The document numbers for the drugs are H20093399 and Z20093134. In all, China Sky One Medical has received production approval for 25 products since January 2008, including six new products in 2009. Currently, the Company has over 20 products in the application process under SFDA review.

Recently the Company also received the approval from SFDA for Diclofenac Sodium suppositories to enter the clinical trial, with the document number 2009L02108. This drug is used to treat rheumatoid arthritis and to relieve pain after operations and fever.

"We are excited about our new drug approvals, which are a testament to our outstanding R&D capability and our understanding of the pharmaceutical market in China," said Mr. Yan-Qing Liu, Chairman and CEO of China Sky One Medical. "We will continue to develop exciting new products in the future and are committed to increasing our pipeline and R&D capabilities."

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.skyonemedical.com .

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.

For more information, please contact:

Company Contact:

China Sky One Medical, Inc.

Mr. Stanley Hao, CFO

Tel: +86-451-5399-4069

Email: china_sky_one@yahoo.cn

Investor Relations Contact:

CCG Investor Relations

Mr. Crocker Coulson, President

Tel: +1-646-213-1915

Email: crocker.coulson@ccgir.com

Web: http://www.ccgirasia.com

Source: China Sky One Medical, Inc.
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