China Pharma Holdings, Inc. Announces Successful Completion of Clinical Trials of the Cholesterol-Lowering Drug, Rosuvastatin
HAIKOU CITY, China, Dec. 6, 2010 /PRNewswire-Asia-FirstCall/ — China Pharma Holdings, Inc. (“China Pharma”) (NYSE Amex: CPHI), which develops, manufactures, and markets specialty pharmaceutical products in China, today announced the completion of clinical trials of the cholesterol-lowering drug, rosuvastatin (generic version of Crestor), which the Company intends to commercialize in the large and expanding Chinese healthcare market.
Rosuvastatin helps reduce low-density lipoprotein cholesterol (LDL-C, or “bad cholesterol”) and raise high-density lipoprotein cholesterol (HDL-C, or “good cholesterol”). In the Company’s clinical trials, rosuvastatin demonstrated better effect in lowering LDL-C compared to control groups using atorvastatin (Lipitor). A 10 mg dose of rosuvastatin lowered LDL-C by 45% and helped 82% of all subjects reach LDL-C treatment target levels.
According to Chinese State Food and Drug Administration (SFDA) information center, the market size for cholesterol-lowering drugs in China reached RMB 7.9 billion (approximately USD$1.1 billion) in 2008, and more than RMB 9.0 billion (approximately USD $1.3 billion) in 2009. Rising disposable income among Chinese consumers has coincided with unhealthy changes in lifestyle and eating habits, leading to a growing incidence of obesity and high cholesterol in the country. Rosuvastatin (generic Crestor) is a prescription drug belonging to a group of medicines called statins, which are frontline drugs used to treat high cholesterol. Due to its significant position among cholesterol-lowering drugs, rosuvastatin has been listed in the 2009 National Insurance Catalogue (NIC) in China.
Sales of Crestor reached USD$4.5 billion(1) globally in 2009. The U.S. Food and Drug Administration (FDA) recently approved Crestor (rosuvastatin) to be prescribed for reducing the risk of heart attack and stroke in people without known heart disease but with increased risk of the getting the disease. The US approval could be a harbinger of similar, expanded indications for rosuvastatin in China, which would add to the Company’s market opportunity.
The Company is actively preparing to enter the SFDA production approval process, and will update shareholders when final milestones have been met to allow China Pharma to commercialize this exciting global product in China. The Company believes this product will be one of the first versions of generic Crestor on the Chinese market and expects it to contribute meaningfully to the Company’s overall revenues over the next few years, beginning in 2011.
China Pharma’s CEO and President, Ms. Zhilin Li, commented, “We are thrilled to announce the completion of clinical trials of the cholesterol-lowering drug rosuvastatin. Rosuvastatin is safer and has fewer liver related side-effects compared to other statins, an important advantage given China’s high incidence rate of liver disease, which impacts approximately 20% of the population. We look forward to introducing this advanced product to improve the lives of hyperlipidemia patients throughout China.”
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 .
(1) AstraZeneca 2009 Annual Report
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SOURCE China Pharma Holdings, Inc.