NEW YORK, April 19 /PRNewswire-FirstCall/ -- China Aoxing Pharmaceutical Company, Inc. , one of the first nongovernmental enterprises to enter the analgesic industry in China, announced today that it received clearance from the China State Food and Drug Administration (“SFDA”) for the clinical study of Tilidine Hydrochloride Tablets and Capsules for the treatment of moderate to severe pain associated with cancer and surgery, as well as other forms of pain. The Tilidine drug is not currently available in China and China Aoxing is currently the only authorized domestic manufacturer of Tilidine tablets and capsules. In 2007 the Company will initiate the clinical study, which includes approximately four hundred patients through several health centers in China, in order to confirm Tilidine’s efficacy and safety in reducing pain levels for Chinese patients.
“We are delighted that the SFDA has cleared China Aoxing for the clinical study of Tilidine (SFDA Certificate 2007L00880 and 2007L00925). Today’s announcement speaks to our commitment to advance analgesic usage for pain management in China. This recognition from the SFDA echoes the significant opportunity we see in China’s pain management industry, which enjoys dedicated government support and enormous room for growth,” stated Zhenjiang Yue, China Aoxing Chairman and CEO. “As the only authorized manufacturer of Tilidine tablets and capsules in China, we are working diligently with doctors and hospitals in China to initiate the clinical trials by mid-year 2007, and we expect to complete the trials by early 2008.”
About Tilidine Hydrochloride
Tilidine is a leading opioid analgesic drug in Europe, currently not available in China, for the treatment of moderate to severe pain associated with cancer and surgery, as well as other forms of pain. Tilidine is widely prescribed in Europe, where Germany, Ireland, Switzerland and Belgium are the major users. In Germany, total sales of Tilidine analgesic was estimated to reach over 300 million Euros in 2005, consuming 91% of worldwide Tilidine supply. In addition, the worldwide consumption of Tilidine has increased at a compounded annual growth rate of approximately 19% between 1993 and 2005.
Although Tilidine is not yet available in China, its usage is expected to increase dramatically when it does become available. China Aoxing is the only government approved domestic manufacturer of Tilidine capsules and tablets.
About China Aoxing Pharmaceutical Group
China Aoxing Pharmaceutical Company, Inc. acquired Hebei Aoxing Pharmaceutical Group Co. Ltd in a reverse merger transaction in April of 2006. Hebei Aoxing Pharmaceutical Group is a corporation organized under the laws of the People’s Republic of China that has developed a patented manufacturing process for a variety of generic analgesic drugs, including Oxycodone, Pholcodine, Naloxone, and Tilidine. Hebei Aoxing is one of only a handful of companies in China to be granted the license to manufacture these drugs and is working closely with the Chinese government to assure their availability throughout China.
China Aoxing Pharmaceutical Group
CONTACT: Dr. Hui Shao, Senior Vice President of China AoxingPharmaceutical, +1-201-420-1075; or Ashley Ammon MacFarlane & Bill Zima ofIntegrated Corporate Relations, Inc., +1-203-682-8200
