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."