China SFDA Approves Clinical Trials To Combat Antibiotic Resistant Infection

Haikou based China Pharma Holdings,has received approval from China's State Food and Drug Administration to start clinical trials of a combination of an antibiotic with a bacterial-enzyme inhibitor.

The company will initiate clinical trials in November 2008 to evaluate this drug, a third generation Cephalosporin antibiotic combined with a bacterial-enzyme inhibitor, for the treatment of antibiotic resistant infections.

China Pharma's CEO and president, Zhilin Li, commented that the company was pleased that the SFDA had given approval for their new antibiotic formula to enter clinical trials. She added that they look forward to initiating and completing these clinical trials over the next two years and hope to confirm previous results that showed significant efficacy in clearing antibiotic resistant bacterial strains.

Microbial antibiotic resistance has emerged as a major public health problem in China and throughout the world. Many Cephalosporins marketed in China, including third generation Cephalosporins, have encountered bacterial resistance. Surveys in China up to 2005 shows that 20% to 70% of certain target pathogen strains may be resistant to one or more third generation Cephalosporins. Despite this drug resistance, China's market for Cephalosporin antibiotics was approximately CNY 25.2 billion in 2006 and is predicted to exceed CNY 38.3 billion in 2008.

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