China Aoxing Pharmaceutical Company Announces Completion Of Registration Trial Of Its Leading Narcotic Drug For The Treatment Of Cough

Main Category: Flu / Cold / SARS
Article Date: 19 Jun 2009 - 7:00 PDT

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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, announced that it has completed the registration trial with Codeine Phosphate, a compound oral solution for the treatment of acute moderate to severe cough. Top-line results from this trial are expected to be announced by the end of the third quarter of 2009.

Under the regulation of China State Food and Drug Administration ("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. Assuming positive clinical results and timely regulatory approval, the company expects to launch this product in China in 2010.

This registration trial is a randomized, multi-center, double-blind, positive-controlled study designed to evaluate the efficacy of a compound oral solution of codeine phosphate in 215 patient subjects with acute moderate to severe cough.

"We are pleased to report the successful completion of this study, which has demonstrated excellent safety and efficacy among a significant number of patients," said Liying Yang, Vice President of Research of China Aoxing. "As we continue our analysis of the data collected in this study, we look forward to presenting the top-line results by the end of the third quarter of 2009."

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 at approximately $2 billion per year with an annual growth rate of over 10% in China.

Source
China Aoxing Pharmaceutical Company, Inc.