NEW YORK, Nov. 26 /PRNewswire-FirstCall/ -- China Aoxing Pharmaceutical Company, Inc. , which has the largest manufacturing facility and product pipeline for highly regulated narcotic medicines and pain medication in China, today announced that the China State Food & Drug Administration (SFDA) granted the Company the designated manufacturer status to produce Tilidine Tablets and Capsules, a highly regulated narcotic drug, in order to address significant unmet medical needs in cancer pain management in China.
Mr. Zhenjiang Yue, the CEO of CAXG, said: “We are very pleased with the SFDA’s decision on designating the Company as the only drug manufacturer for this highly regulated cancer pain medicine in China. We expect to launch this important and needed cancer pain medicine through CAXG’s integrated 500 person sales force in later 2008. Cancer pain management is a key component in oncology therapy, and becomes the top priority for terminal cancer patients. Cancer has become the first cause of death in China, estimated at 1.5 million victims per year. The number of victims is soaring especially in rural and western China as Western diet and lifestyle becomes prevalent. China’s government and medical community are fully aware that China is woefully behind the rest of world in cancer pain treatment. For example, the consumption of morphine for pain per capita only amounts to 1/3 of other developing countries, more strikingly, almost 0.5% of developed countries. Our mission is to bring multiple effective therapeutic options, including Oxycodone, Tilidine and other promising narcotic pain medicines in our pipeline, to help approximately 20 million cancer patients in China.”
Ms. Liying Yang, the Vice President of R&D, commented, “Today’s approval continues reflecting the trust and support from the China SFDA, and also speaks to our commitment to introducing new narcotic therapeutic paradigms into the China market. SFDA’s decision also solidifies our leading position in narcotic drug business of China. For Tilidine, it sells multi-hundred million Euros per year as a generic in Europe under the aegis of a global top three pharmaceutical manufacturer. Since China Aoxing is the innovator in the China market, the Company under SFDA regulations will have five-year exclusivity in the China market. Based on the regulations set forth by the China SFDA in this sector, currently there are only 13 pharmaceutical companies allowed to be in this business in China. More importantly, the agency designates only 1 or 2 drug companies to be involved in raw material, or active pharmaceutical ingredient (API) production for a particular narcotic drug, and only 1 to 3 companies in the area of associated finished doses of a single product.”
About Tilidine for Cancer Pain Treatment
Tilidine is a prodrug, which, following oral administration, is converted to the active analgesic metabolite, nortilidine. Tilidine is indicated for the relief of acute, moderate to severe pain, and chronic cancer-related pain. Currently Tilidine is not available in China and will be introduced by China Aoxing to the China market. China Aoxing is developing a comprehensive program including clinical study, educational seminars and conferences so the medical community will become aware and positive to the use of Tilidine as an effective narcotic-based cancer pain medication.
About China Aoxing Pharmaceutical Company, Inc.
China Aoxing Pharmaceutical Company, Inc. is a pharmaceutical company in China specializing in research, development, manufacturing and distribution of a variety of narcotics and pain management products. Headquartered in Shijiazhuang City, the pharmaceutical capital of China, outside of Beijing, the Company has the largest product pipeline and largest manufacturing facility (1.2 million sq. ft.) 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 has two drugs on the market and has received China SFDA licenses for research and clinical development of seven more medications such as Oxycodone, Tilidine and Pholcodine. 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.
This news release contains forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements concerning plans, objectives, goals, strategies, future events or performance, and underlying assumptions and other statements that are other than statements of historical facts. These statements are subject to uncertainties and risks including, but not limited to, product and service demand and acceptance, changes in technology, economic conditions, the impact of competition and pricing, government regulation, and other risks contained in statements filed from time to time with the Securities and Exchange Commission. All such forward-looking statements, whether written or oral, and whether made by or on behalf of the company, are expressly qualified by the cautionary statements and any other cautionary statements which may accompany the forward-looking statements. You are urged to read the Company’s filings with the Securities and Exchange Commission, including, but not limited to, the risk factors contained therein. In addition, the Company disclaims any obligation to update any forward-looking statements to reflect events or circumstances after the date hereof.
CONTACT: Dr. Hui Shao, Senior Vice President, China Aoxing Pharmaceutical,
+1-201-420-1075
Web site: http://www.aoxingyaoye.com/
