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China Pharma Holdings, Inc. to Initiate Clinical Trials For New Antibiotic Combination
Date:10/29/2008

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

(Mohnarin)

(**)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.

Diana Huang

Tel: +86-898-6681-1730

Email: hps@chinapharmaholdings.com

The Ruth Group

Sara Ephraim

Tel: +1-646-536-7002

Email: sephraim@theruthgroup.com


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SOURCE China Pharma Holdings, Inc.
Copyright©2008 PR Newswire.
All rights reserved

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