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China Pharma Holdings, Inc. Announces SFDA Approval for Rosuvastatin Clinical Trials

2009-06-19 07:38 927

Company to Enter Phase I and Phase II Clinical Trials for Generic Crestor(R)

HAIKOU CITY, China, June 22 /PRNewswire-Asia-FirstCall/ -- China Pharma Holdings, Inc. ("China Pharma") (OTC Bulletin Board: CPHI), which develops, manufactures, and markets specialty pharmaceutical products in China, today announced that it has received official approval from China's State Food and Drug Administration ("SFDA") to enter Phase I and Phase II clinical trials to test the efficacy of its cholesterol-lowering drug, Rosuvastatin. The Company plans to begin the trials in the first half of 2009, and estimates that it will receive a production license by the end of 2010.

Rosuvastatin is the generic version of Crestor(R), which is deemed one of the most potent cholesterol-lowering medicines available and has been shown to significantly reduce LDL cholesterol (so-called "bad cholesterol"). The use of Crestor(R) has translated into a 60% decrease in the number of cardiac events (heart attack, sudden cardiac death) and a 17% reduction in the risk of stroke(1). Crestor(R), discovered and developed by Shionogi & Co., Ltd., was first launched in Europe by AstraZeneca in 2002. Global annual sales of Crestor(R) exceeded USD$2.8 billion in 2007(2).

China Pharma's CEO and President, Ms. Zhilin Li, commented, "We are very pleased that the SFDA has approved China Pharma to pursue clinical trials for Rosuvastatin. Hyperlipidemia and high blood cholesterol are becoming serious problems as a result of aging in the Chinese population, as well as due to significant changes in dietary structure and lifestyle. In China, the prevalence of hyperlipidemia is estimated at 7% to 8% of the population, and at least an additional 100 million people require treatment to control high cholesterol levels. Rosuvastatin is a well known statin product which has shown favorable results in international clinical comparisons with other leading statins, such as Atorvastatin (Lipitor(R)), Pravastatin and Simvastatin(3). We anticipate that Rosuvastatin will greatly help to meet the medical needs of Chinese patients suffering from hyperlipidemia and requiring medicine to control cholesterol."

Ms. Li continued, "China Pharma is experienced in bringing world leading medicines to the Chinese market. We believe that Rosuvastatin provides us with an exciting opportunity to extend our product portfolio, and expect it to create value for patients and our shareholders over time."

(1) Source: BMJ 2003 June: 326 (7404):1423. Law MR et al. "Quantifying effect of statins on low density lipoprotein cholesterol, ischaemic heart disease, and stroke: systematic review and meta-analysis."

(2) Source: AstraZeneca 2007 Annual Report and Form 20-F Information

(3) Source: Am J Cardiol. 2003 July 15;91(5A):20C-23C; Jones PH et al. "Comparison of the efficacy and safety of rosuvastatin versus atorvastatin, simvastatin, and pravastatin across doses (STELLAR* Trial)."

About China Pharma Holdings, Inc.

China Pharma Holdings, Inc. is a specialty pharmaceutical company with rapidly growing profit that develops, manufactures, and markets treatments for a wide range of high incidence and high mortality conditions in China, including cardiovascular, CNS, infectious, and digestive diseases. The Company's cost-effective, high margin business model is driven by market demand and supported by eight scalable GMP-certified product lines covering the major dosage forms. In addition, the Company has a broad and expanding distribution network across 30 provinces, municipalities and autonomous regions. The Company is registered in Delaware, USA. Hainan Helpson Medical & Biotechnology Co., Ltd. (Helpson), located in Haikou City, Hainan Province, China, is a wholly owned subsidiary of China Pharma Holdings, Inc. For more information about China Pharma Holdings, Inc., please visit http://www.chinapharmaholdings.com .

Safe Harbor Statement

Certain statements in this press release and oral statements made by China Pharma on its conference call in relation to this release, constitute

forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Any statements set forth above that are not historical facts are forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements, which may include, but are not limited to, such factors as unanticipated changes in product demand, increased competition, failure to obtain or maintain intellectual property protection, downturns in the Chinese economy, uncompetitive levels of research and development, failure to obtain regulatory approvals, and other information detailed from time to time in the Company's filings and future filings with the United States Securities and Exchange Commission. The forward-looking statements made herein speak only as of the date of this press release and the Company undertakes no duty to update any forward-looking statement to conform the statement to actual results or changes in the company's expectations.

Source: China Pharma Holdings, Inc.
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