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China Sky One Medical Inc. Gets SFDA Approval for Calcium Folinate Injection

2009-03-03 18:36 1558

- Paeonol Gel and Mei Lu Gel Enter into Clinical Trials -

HARBIN, China, March 3 /PRNewswire-Asia/ -- China Sky One Medical, Inc. ("China Sky One Medical" or "the Company") (Nasdaq: CSKI), a leading fully integrated pharmaceutical company producing over-the-counter drugs in the People’s Republic of China ("PRC"), today announced that it obtained production approval from the State Food and Drug Administration (SFDA) in China for Calcium Folinate Injection. Another two new traditional Chinese medicines, Paeonol gel and Mei Lu gel, were approved by SFDA to enter into clinical trials. All three are all prescription drugs.

Calcium Folinate Injection is a solution for injection intended as an auxiliary therapy for sprue (a disease of the small intestine), malnutrition, pregnancy- or infancy-related megaloblastic anemia, and colonic and rectal cancer. It will be available to consumers around June of 2009.

Paeonol gel is a type of anti-allergic, anti-pyretic and anti-itch medicine that can be used for the treatment of eczema, dermatitis and other kinds of skin diseases caused by insect bites. It can also be used to cure allergic rhinitis as well as for the prevention of colds. Mei Lu gel is used to treat Acne vulgaris and to relieve itching. It can also be used to cure other skin diseases, including eczema and dermatitis solaris, and repel insects. Clinical trials for the two gels will last approximately six months, and management expects to receive final SFDA approvals in 2010.

"We are very pleased to achieve such great progress in developing new drugs," said Mr. Yan-Qing Liu, Chairman and CEO of China Sky One Medical. "All of these products have been developed to meet customers’ needs. We expect them to perform well and to create value for consumers and shareholders alike."

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. Yu-Bo 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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