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

June 22, 2009

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.

Source: newswire

comments powered by Disqus