China Aoxing submits an NDA to the China SFDA for its Codeine Phosphate

Sep 3 2009

China Aoxing Pharmaceutical Company, Inc. (OTCBB: CAXG) ("China Aoxing"), a pharmaceutical company specializing in research, development, manufacturing and marketing of narcotic and pain-management products, today announced that it has submitted a new drug application (NDA) to the China State Food and Drug Administration (SFDA) for its Codeine Phosphate, a compound oral solution for the treatment of acute moderate to severe cough.

Under the regulation of the China SFDA, this drug is designated as a Class III New Medicine, or the first drug to be launched in China while already selling in other regulated territories. As a result, the product is expected to receive at least three-year market exclusivity protection after marketing clearance by the China SFDA. In June 2009, China Aoxing announced that it had completed the clinical studies required for an NDA by the China SFDA. Assuming timely regulatory approval, the company expects to launch this product in China in 2010. China Aoxing believes that this product will give physicians a more effective option to the conventional drugs for the treatment of acute moderate to severe cough in China.

"This is a major achievement of our company. We believe that this drug will address a growing and presently unserved need in the marketplace, and we are very hopeful that the SFDA will find our submission acceptable for final production approval. We believe that we have adhered to the requirements we agreed upon with the SFDA at our pre-NDA meeting. We are also very pleased with the tremendous team effort, great planning and execution by our own staff," said Zhenjiang Yue, the Chairman and the CEO of China Aoxing.

The prevalence rate of cough condition is approximately at 15% in China. It is estimated that over 50 million Chinese patients are seeking cough treatment, mainly caused by respiratory disorders. The market size of pharmaceutical product to address cough condition is estimated approximately $2 billion per year with an annual growth rate of over 10% in China.