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China Aoxing Pharmaceutical Corp. (CAXG) Announces Successful Completion of Phase III Registration Clinical Study of Tilidine for Moderate to Severe Pain


1/25/2010 11:32:52 AM

NEW YORK, NY--(Marketwire - January 25, 2010) -

China Aoxing Pharmaceutical Company, Inc. (OTCBB: CAXG) ("China Aoxing"), a pharmaceutical company specializing in research, development, manufacturing and distribution of narcotic and pain-management products, today announced that it completed Phase III clinical study for Tilidine tablets, a novel drug in China to treat acute and chronic moderate to severe pain, including post-operative and cancer pain in adult patients. The drug is designated as a Class III New Medicine with approximately at least four-year market exclusivity protection upon marketing clearance by the China SFDA.

"Reaching this pivotal milestone is an important event for the development of our Tilidine franchise, and will enable a complete analysis of the trial results and a timely submission of new drug application (NDA) to the China SFDA. We believe that Tilidine has the potential to become a major player in the underserved pain market in China," said Mr. Zhenjiang Yue, CEO and Chairman of China Aoxing. "Also, we are looking forward to reporting the top-line results in the coming weeks."

The Phase III clinical study was a multi-center, randomized, double-blind and active-control study which covers two pivotal trials, (1) a trial of 200 patients with post-operative pain for the indication of acute moderate to severe pain; (2) a trial of 120 patients with cancer pain for the indication of chronic moderate to severe pain. The study was conducted at 9 metropolitan hospitals in China. The primary endpoints used to evaluate the efficacy were the sum of pain score differences, measured by Pain Intensity Difference (PID). The size of the trials per protocol was not powered to achieve statistical significance between the treatment arms versus control arms.

In China it is estimated that there are at least 50 million operation procedures performed in hospital and clinical centers every year, and 50% of these procedures require acute post-operative pain treatment. On the other hand there are estimated to be over 2.2 million newly diagnosed cancer patients every year, and 60% of them are unable to receive necessary pain management under current treatment paradigm. Cancer has become the No. 1 cause and attribute to 20% of adult death in China based on the New England Journal of Medicine.

About Tilidine

Tilidine hydrochloride is an orally-absorbed synthetic narcotic analgesic in 50mg or 100mg dosage strength for relief of acute, moderate to severe pain, and chronic cancer-related pain. It is mainly used in European countries, including Germany, Belgium, Ireland, Italy, Switzerland, and etc. It is not available in China at the moment.

Based on the Annual Report of International Narcotics Control Board in 2008, global consumption reached a record level in 2007 and global Tilidine manufacture also reached a peak of 62.2 tons in 2007, twice the level reported in 2002, or at CAGR of 15% during the last five year period.

About China Aoxing Pharmaceutical Company, Inc.

China Aoxing Pharmaceutical Company, Inc. (OTCBB: CAXG) is a pharmaceutical company specializing in research, development, manufacturing and distribution of a variety of narcotics and pain-management products. It has a strategic alliance with American Oriental Bioengineering, Inc. (NYSE: AOB). Headquartered in Shijiazhuang City, the pharmaceutical capital of China, outside of Beijing, China Aoxing has China's largest and the most advanced manufacturing facility for highly regulated narcotic medicines, addressing a very under-served and fast-growing market in China. Its facility is one of the few GMP facilities licensed for narcotics medicines. The Company is working closely with the Chinese government and SFDA to assure the strictly regulated availability to medical professionals of its narcotic drugs and pain medicines throughout China.

Statements made in this press release are forward-looking and are made pursuant to the safe harbor provisions of the Securities Litigation Reform Act of 1995. Such statements involve risks and uncertainties that may cause actual results to differ materially from those set forth in these statements. The economic, competitive, governmental, technological and other risk factors identified in the Company's filings with the Securities and Exchange Commission, including the Form 10-K for the year ended June 30, 2009, may cause actual results or events to differ materially from those described in the forward looking statements in this press release. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether because of new information, future events, or otherwise.


Contact:

Wei Zhang
Vice President
China Aoxing Pharmaceutical Company, Inc.
Email: chinaaoxing@gmail.com
Telephone: 646 - 367-1747
Website: www.chinapainmed.com



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