China Aoxing Pharmaceutical Company Receives SFDA Approval for Clinical Trial of Abuse Resistant Opioid Drug
17 September 2009 - 10:00PM
Marketwired
China Aoxing Pharmaceutical Company, Inc. (OTCBB: CAXG) ("China
Aoxing"), a China-based pharmaceutical company specializing in
research, development, manufacturing and distribution of narcotic
and pain-management products, today announced that its Clinical
Trial Application ("CTA") for Tilidine/Naloxone Capsules, an opioid
drug with abuse resistance property, was officially approved by the
China State Food and Drug Administration ("SFDA"). CTA approval is
a key SFDA requirement prior to pursuing a clinical trial and,
ultimately, commercialization of a pharmaceutical product in China.
The company hopes to begin the clinical trial by the end of this
year, and estimates that receipt of a market license could occur
sometime in 2011. The drug is designated as a Class III New
Medicine with approximately at least three-year market exclusivity
protection upon marketing clearance by the China SFDA.
Tilidine/Naloxone Capsules were developed with China Aoxing's
proprietary technology, which combines Tilidine, an effective
opioid agonist, with Naloxone, an opioid antagonist, to address
moderate to severe pain, such as cancer pain and post-operative
pains. Based on clinical trials in Europe, when Tilidine/Naloxone
Capsules were taken as directed, pain relief was provided and
Naloxone passed through the body without observed clinical effect.
If the Capsules is crushed or dissolved in alcohol, which are
common approaches abusers use to tamper with an opioid product in
order to gain euphoria, both Tilidine and the Naloxone are
released, and the euphoric effect of Tilidine was significantly
reduced.
"Today's announcement speaks to our unique capability to
commercialize narcotic pharmaceutical products in the Chinese
market," stated Zhenjiang Yue, Chairman and CEO of China Aoxing.
"CTA acceptance is one key step toward reaching marketability. To
the best of our knowledge, we could be the first pharmaceutical
company to bring Tilidine/Naloxone Capsules to China. This is a
great example of our ability to target under-penetrated areas with
drugs that improve the overall health of the population. We remain
excited about the growth prospects for abuse resistant painkiller
in China, which just becomes a new therapeutic paradigm in
developed countries. We intend to continue to bring high value,
niche-focused prescription drugs, with rigor and prudence, to the
growing Chinese healthcare market."
About China Aoxing Pharmaceutical Company, Inc.
China Aoxing Pharmaceutical Company, Inc. (OTCBB: CAXG) is a
pharmaceutical company located in China 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) to develop
and market various narcotic drugs in China. 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-KSB for the year ended
June 30, 2008, 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 China Aoxing Pharmaceutical Company, Inc.
Email: chinaaoxing@gmail.com Telephone: 646-367-1747 Website:
www.chinapainmed.com
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