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Biostar Pharmaceuticals, Inc. Receives the Chinese Military Drug Administration Clearance to Begin Clinical Trial for Zushima Analgesic Aerosol Spray

2009-10-08 22:30 1709

XIANYANG, China, Oct. 7 /PRNewswire-Asia-FirstCall/ -- Biostar Pharmaceuticals, Inc. (OTC Bulletin Board: BSPM) ("Biostar" or "the Company"), a Xianyang-based developer, manufacturer and supplier of pharmaceutical products and medical nutrients addressing a variety of diseases and conditions, today announced that the Chinese Military Drug Administration has granted clearance to begin clinical trials on the Company's new drug application, the Zushima Analgesic Aerosol Spray.

Zushima Analgesic Aerosol Spray is a traditional Chinese herbal product used to relieve pain through a topical application to affected areas or closed wounds. The Zushima spray can also be used in the treatment of certain rheumatic conditions. The product is classified as "Specially Needed Drug" by the Chinese Military Drug Administration but it will also be available to the public. The product is being co-developed by Biostar and Lanzhou Military Medicine and Equipment Institute, which commenced over two years ago, but the intellectual property will be solely owned by Biostar. The Company hosted a seminar to formulate and finalize the Clinical Trial Plan with six Tier 1 hospitals in China to validate efficacy. On September 24, 2009, the Chinese No. 4 Military Medical University's Ethic Committee for the Head of Clinical Trials reviewed and approved the clinical trial eligibility for the Zushima spray. Biostar expects to receive formal product approval by the Chinese Military Drug Administration in the second quarter of 2010. The Zushima Analgesic Aerosol Spray is expected to contribute at least $2 million to 2010 revenues. The gross margin of the product will be in line with average gross margin of Biostar's current portfolio of products. The Company anticipates its initial customers for the product to be the Chinese military and civil hospitals and pharmacies in the Shaanxi province.

"We are very pleased that Zushima spray received approval to commence clinical trials, which is an important milestone to validate its efficacy. We anticipate Zushima will drive incremental revenue growth in 2010 and beyond," said Mr. Wang Ronghua, Chairman and CEO of Biostar Pharmaceuticals, Inc. "Developing new products with high revenue potential will continue to be a key component of our long-term strategy. We expect to immediately launch the Zushima spray in both military and civil markets after the final approval is received in 2010."

About Biostar Pharmaceuticals, Inc.

Biostar Pharmaceuticals, Inc., through its wholly-owned subsidiary in China, develops, manufactures and markets pharmaceutical and medical nutrient products for a variety of diseases and conditions. The Company's most popular product is its Xin Ao Xing Oleanolic Acid Capsule, an over-the-counter ("OTC") medicine for chronic hepatitis B, a disease affecting approximately 10% of the Chinese population. In addition to its hepatitis product, Biostar manufactures two broad-based OTC products, two prescription-based pharmaceuticals and ten nutrients. The Company has adopted international standards and is in the process of applying for two patents.

Safe Harbor

Certain statements in this release concerning our future growth prospects are forward-looking statements, within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended, which involve a number of risks and uncertainties that could cause actual results to differ materially from those in such forward-looking statements. The risks and uncertainties relating to these statements include, but are not limited to, risks and uncertainties regarding the success of our investments, risks and uncertainties regarding fluctuations in earnings, our ability to sustain our previous levels of profitability including on account of our ability to manage growth, intense competition, wage increases in China, our ability to attract and retain highly skilled professionals, time and cost overruns on fixed-price, fixed-time frame contracts, client concentration, our ability to successfully complete and integrate potential acquisitions, withdrawal of governmental fiscal incentives, political instability and regional conflicts and legal restrictions on raising capital or acquiring companies outside China. Additional risks that could affect our future operating results are more fully described in our United States Securities and Exchange Commission filings including our S-1 dated June 27, 2008, our Quarterly Report on Form 10-Q for the quarter ended June 30, 2009, our 10-K for the year ended December 31, 2008, and other recent filings. These filings are available at www.sec.gov. We may, from time to time, make additional written and oral forward-looking statements, including statements contained in our filings with the Securities and Exchange Commission and our reports to shareholders. We do not undertake to update any forward-looking statements that may be made from time to time by or on our behalf.

For further information, contact:

Ms. Elaine Zhao, CFO

Tel: +1-626-456-2789

Email: elaine@biostarpharmaceuticals.com

John Mattio

HC International, Inc.

Tel: US +1-914-669-5340

Email: john.mattio@hcinternational.net

Web: http://www.hcinternational.net

Source: iostar Pharmaceuticals, Inc.
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