SOURCE: China Aoxing Pharmaceutical Co., Inc.

January 05, 2010 08:30 ET

China Aoxing Pharmaceutical Company Announces Successful Completion of Phase II Clinical Study of Novel Menstrual Pain Drug

A Milestone Reached to Commercialize a Leading Oral Drug to Treat Primary Dysmenorrhea

NEW YORK, NY--(Marketwire - January 5, 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 II clinical study for oral TJSL capsules, a novel investigational drug to treat primary dysmenorrhea ("PD") , or menstrual pain, in adult women. Top-line results from this study are expected to be announced in the coming weeks.

The Phase II clinical study was a 12-week, multi-center, randomized, double-blind and placebo-controlled study to evaluate the safety and efficacy of TJSL capsules among 240 patients with primary dysmenorrheal. Subjects were between 18 and 35 years old enrolled at four leading university teaching hospitals in metropolitan areas of China. Subjects received TJSL capsules or placebos, three times a day for ten days, starting at one week prior to each menstrual cycle or period. The primary endpoints used to evaluate the efficacy were the sum of pain score differences, measured by visual analogue scale ("VAS"), as well as symptom improvement during menstruation over three menstrual cycles. The size of the trials was powered to achieve statistical significance between the treatment arm versus control arm.

"We are very pleased with the results to date and the progress made in TJSL program since we acquired the product last year," stated Zhenjiang Yue, Chairman and the CEO of China Aoxing. "We look forward to announcing the results of this trial and initiating Phase III clinical study in the coming weeks. We believe that TJSL has the potential to become a major player in the treatment of menstrual pain and enables us to serve yet another greatly underserved market segment in pain management."

TJSL is a capsule form of selected herbal medicines. Its mechanism of action deserves further investigation, but appears to be its capability of reversing the effects of endometrial prostaglandin, reducing the frequency and strength of uterine contraction as well as providing pain relief, based on in vivo study.

The prevalence rates of PD among women are from 60 to 90 percent. It is estimated that 64% of women in China purchase menstrual pain drugs on a regular basis. The market size of a healthcare product to address menstrual pain is estimated at $3 billion per year in China.

About Primary Dysmenorrhea ("PD")

Primary dysmenorrhea is defined as recurrent, cramping pain in the lower abdomen occurring just before or during menstruation, in the absence of demonstrable pelvic disease, such as endometriosis. Prevalence rates are as high as 90 percent. Initial presentation of PD typically occurs in adolescence. It is a common cause of absenteeism and reduced quality of life in women. Women with PD have increased production of endometrial prostaglandin, resulting in increased uterine tone and stronger, more frequent uterine contractions.

Pharmacological interventions available in the market include non-steroidal anti-inflammatory drugs (NSAIDs), hormonal contraceptives, levonorgestrel intrauterine contraception and tocolytics.

About TJSL Capsules

TJSL was originated by Professor X. Tian, a well known gynecologist in China. The drug is composed of several herbal medicines optimized based on her 40 years of medical research in treating PD. The drug has been used empirically by over 1,000 patients who suffered from PD. From in vivo studies, the drug was capable of reversing the effects of endometrial prostaglandin, reducing the frequency and strength of uterine contraction as well as providing pain relief.

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-KSB 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.

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