China's SFDA Approves Entry into Clinical Trials on Schedule
HAIKOU CITY, China, Oct. 29 /Xinhua-PRNewswire-FirstCall/ -- China Pharma Holdings, Inc. ("China Pharma") (OTC Bulletin Board: CPHI), which develops, manufactures, and markets generic and branded bio-pharmaceutical products in China, announced today that its novel antibiotic combination formula has been granted approval by China's State Food and Drug Administration (SFDA) to enter clinical trials.
The Company will initiate clinical trials in November 2008 to evaluate this drug, a third generation Cephalosporin antibiotic combined with a bacterial-enzyme inhibitor, for the treatment of infections. The development timeline is consistent with the company's predictions.
China Pharma's CEO and president, Ms Zhilin Li, commented, "We are pleased that the SFDA has approved our new antibiotic formula to enter clinical trials within our anticipated timeframe. We look forward to initiating and completing these clinical trials over the next two years and hope to confirm previous results that showed significant efficacy in clearing antibiotic resistant bacterial strains. Antibiotic resistance is a growing global problem that requires the development of more advanced treatment to effectively combat resistant strains. Pending successful clinical development, this therapy could capture market share in China from Cephalosporin antibiotics used to address various infections, including hospital-acquired and respiratory infections, bacterial meningitis, and pneumonia."
Microbial antibiotic resistance has emerged as a major public health
problem in China and throughout the world. Many Cephalosporins marketed in
China, including third generation Cephalosporins, have encountered
bacterial resistance. Surveillance in China up to 2005 shows that 20% to
70% of certain target pathogen strains may be resistant to one or more
third generation Cephalosporins.(*) Despite this drug resistance, China's
market for Cephalosporin antibiotics was approximately CNY 25.2 billion
(USD$3.68 billion) in 2006 and is predicted to exceed CNY 38.3 billion
(USD$5.6 billion) in 2008.(**)
(*)Source: Eur.J.Clin.Microbiol.Infect.Dis. 2008 Aug; 27(8) 697-708. Xiao
YH, Wang J, Li Y. -- Bacterial Resistance Surveillance in China, a
report from the MOH National Antimicrobial Resistance Investigation Net
(**)Source: SFDA information center
About China Pharma Holdings, Inc.
China Pharma Holdings, Inc. is a biopharmaceutical company with rapidly growing profit that develops, manufactures, and markets treatments for a wide range of high incidence and high mortality conditions in China, including cardiovascular, CNS, infectious, and digestive diseases. The Company's cost- effective, high margin business model is driven by market demand and supported by 8 scalable GMP-certified product lines covering the major dosage forms. In addition, the Company has a broad and expanding distribution network across more than 29 provinces, municipalities and autonomous regions. The Company is registered in Delaware, USA. Hainan Helpson Bio-pharmaceutical Co., Ltd (Helpson), located in Haikou City, Hainan Province, China, is a wholly owned subsidiary of China Pharma Holdings, Inc. For more information about China Pharma Holdings, Inc., please visit http://www.chinapharmaholdings.com .
Safe Harbor Statement
Certain statements in this press release and oral statements made by
China Pharma on its conference call in relation to this release, constitute
forward- looking statements for purposes of the safe harbor provisions
under The Private Securities Litigation Reform Act of 1995. Any statements
set forth above that are not historical facts are forward-looking
statements that involve risks and uncertainties that could cause actual
results to differ materially from those in the forward-looking statements,
which may include, but are not limited to, such factors as unanticipated
changes in product demand, increased competition, failure to obtain or
maintain intellectual property protection, downturns in the Chinese
economy, uncompetitive levels of research and development, failure to
obtain regulatory approvals, and other information detailed from time to
time in the Company's filings and future filings with the United States
Securities and Exchange Commission. The forward-looking statements made
herein speak only as of the date of this press release and the Company
undertakes no duty to update any forward-looking statement to conform the
statement to actual results or changes in the company's expectations.
For more information, please contact:
China Pharma Holdings, Inc.
The Ruth Group
|SOURCE China Pharma Holdings, Inc.|
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