Singapore, Jun 24, 2009: China Pharma 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, which is deemed one of the most potent cholesterol-lowering medicines available and has been shown to significantly reduce LDL cholesterol. The use of Crestor has translated into a 60 percent decrease in the number of cardiac events and a 17 percent reduction in the risk of stroke. Crestor, discovered and developed by Japan's Shionogi, was first launched in Europe by AstraZeneca in 2002. Global annual sales of Crestor exceeded $2.8 billion in 2007.
China Pharma's CEO and President, Ms Zhilin Li, said, “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 percent 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), Pravastatin and Simvastatin. We anticipate that Rosuvastatin will greatly help to meet the medical needs of Chinese patients suffering from hyperlipidemia and requiring medicine to control cholesterol.”
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