China Biopharmaceuticals Holdings, Inc., a leading Chinese pharmaceutical company focused on the development, manufacturing and distribution of innovative drugs in China, announced that it has completed various progresses in both initiating and completing clinical trials in separate drug indications.

CHBP announced that all required clinical trials for both Torasemide tablets and Injections have been completed, and the Company is waiting for final manufacturing and marketing approval from the State Food and Drug Administration of China (SFDA).

The clinical trials for Torasemide for injections and tablets were conducted in five and six hospitals respectively throughout China. Both trial results will be sent to the SFDA for marketing and manufacturing approval, which is expected to be granted by the third quarter of 2007.

Torasemide is a loop diuretic. It is commonly used in conditions such as heart failure, where the pumping mechanism of the heart is less effective. Torasemide is used to relieve the symptoms of heart failure, such as the shortness of breath seen with fluid on the lungs. At higher doses, the amount of water drawn from the blood into the urine is much greater; therefore Torasemide is also used when there is reduced production of urine in patients with kidney failure, and liver failure.

Diuretics are thought as the first choice of drug treating primary hypertension. Currently, there are 160 million people suffering with hypertension in China, and 10 million people suffering with heart failure, kidney failure, and liver failure. If granted production approval, CHBP will be the one of two pharmaceuticals companies producing Torasemide for injections in China up to 2013, and the one of four pharmaceuticals companies producing Torasemide tablets in China up to 2012, in accordance with Chinese SFDA current policies.

In addition, CHBP announced that it has started the clinical trials for one of its new drugs, Flucloxacillin Magnesium. The trials will be conducted in six hospitals throughout China. All required clinical trials are to be completed within one year.

In China, according to independent sources, the market size for all penicillin products in China is approximately RMB 20 billion Yuan, increasing by approximately 10% per year.

CHBP is the only company approved for clinical trials of this drug in China. If granted production approval, in accordance with Chinese SFDA current policies, CHBP will have at least a 4-year manufacturing rights exclusive for this drug in China.

Source:佚名