-- Company Submits Production Application to SFDA --
HAIKOU CITY, China, Jan. 21 /PRNewswire-Asia/ -- China Pharma Holdings, Inc. ("China Pharma") (NYSE Amex: CPHI), which develops, manufactures, and markets specialty pharmaceutical products in China, today announced that the Company has completed clinical trials for Candesartan, an anti-hypertension drug, and submitted the generic drug production application to the SFDA.
Analysis of the clinical trial results shows that Candesartan Cilexetil is a prodrug of Candesartan. It is 10-fold stronger in effect than Losartan, has good selectivity (Candesartan has much greater affinity (>10,000-fold) for the AT1 receptor than for the AT2 receptor), and has long effective time (one administration per day in low dosage). As a prodrug, it also enables smooth release via an oral solution, which makes it an ideal hypertension drug.
Candesartan, the leading anti-hypertension drug, is an angiotensin II receptor antagonist for which 2007 worldwide sales exceeded $2.5 billion (1). Discovered and originally synthesized by Takeda Pharmaceutical Company Limited, Candesartan was jointly developed by Takeda and AstraZeneca Pharmaceuticals for the treatment of hypertension, chronic heart failure, and left ventricular systolic dysfunction.
In China, nearly 60% of all urban adults aged 65 years and over suffer from hypertension, and prevalence in urban areas is expected to reach 100 million by 2011 (2). Candesartan is listed in the China's National (Medical) Insurance Catalog ("NIC"), allowing patients to be reimbursed by the government.
China Pharma's CEO and president, Ms. Zhilin Li, commented, "We are pleased to announce the satisfactory completion of clinical trials for Candesartan, a multi-billion dollar revenue-generating drug, ahead of schedule. Hypertension is a serious problem linked to an increased incidence of other diseases, particularly brain edema, coronary heart disease and diabetes. Candesartan is a well-established and well-tolerated anti-hypertension drug with an excellent safety record and is known to be particularly suitable for cardiovascular and diabetic patients."
Ms. Li continued, "According to the Chinese government, ninety percent of China's citizens will be covered by a universal healthcare system by the end of calendar 2010. Candesartan's presence in the NIC allows users to receive reimbursement and will provide effective treatment for a high number of Chinese patients whose medication needs are seriously unmet. We see great potential in the target market and are excited to have an opportunity to provide this excellent anti-hypertension drug to individuals suffering from hypertension in China."
About China Pharma Holdings, Inc.
China Pharma Holdings, Inc. is a specialty pharmaceutical 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 eight scalable GMP-certified product lines covering the major dosage forms. In addition, the Company has a broad and expanding distribution network across 30 provinces, municipalities and autonomous regions. The Company is registered in Delaware, USA. Hainan Helpson Medical & Biotechnology 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.
(1): Takeda Pharmaceutical Company Ltd., Annual Report 2008;
(2): Nature Reviews, Drug Discovery: 2008 May; 7 383-384.
For more information, please contact:
China Pharma Holdings, Inc.
Tel: +86-898-6681-1730
Email: hps@chinapharmaholdings.com
ICR, Inc.
Christine Duan
Tel: +1-203-682-8200
