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China Pharma Holdings, Inc. (NYSEMKT:CPHI) received SFDA approval of a new product, Tiopronin Enteric-Coated Capsules. Tiopronin Tis widely given as a treatment for acute and chronic hepatitis B and to relieve drug-induced liver injury. Because Tipronin can cause stomach irritation, limiting its use, China Pharma has encased its Tiopronin capsules with an enteric coating to decrease stomach mucosal irritation.

Tiopronin is listed in the National Medical Insurance Program, allowing patients to obtain reimbursement for the drug.

China Pharma said that China has 30 million people who suffer from chronic hepatitis B. Almost 10% of the population, approximately 120 million people, carry the virus, one of the highest concentrations in the world. Revenues in China from of liver protection drugs such as Tiopronin, are projected to reach 41 billion RMB ($6 billion) in 2008.

The company did not project revenues for the product.

China Pharma’s main revenue drivers are PuSenOK, a newly approved generic form of Aleve-D; Buflomedil, a treatment for peripheral blood vessel diseases; Roxithromycin dispersible tablet, a macrolide antibiotic; and Bumetanide, a newly approved diuretic that treats edema caused by heart disease and hypertension.

Disclosure: none.

Source: China Pharma Wins Approval of Hepatitis Drug