China Pharma's Candesartan Hypertension Product Passes the Quality and Efficacy Consistency Evaluation of Generic Drugs

Rhea-AI Summary

China Pharma's subsidiary, Helpson, receives approval for its candesartan tablets from NMPA, boosting competitiveness in government procurement.

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• Approval of candesartan tablets enhances competitiveness in government procurement

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• None.

HAIKOU, China, Aug. 9, 2023 /PRNewswire/ -- China Pharma Holdings, Inc. (NYSE American: CPHI) ("China Pharma," the "Company" or "We"), a specialty pharmaceutical company, today announced that its wholly-owned subsidiary Hainan Helpson Medical & Biotechnology Co., Ltd. (hereinafter referred to as "Helpson") has received the "Drug Supplementary Application Approval Notice" for its candesartan tablets by National Medical Products Administration of China (hereinafter referred to as NMPA"), indicating that the Company's candesartan tablets have passed the quality and efficacy consistency evaluation of generic drugs.

The consistency evaluation of generic drugs evaluates approved generic drugs based on the principle that generic drugs need to reach the same level of quality and efficacy as the innovator drug, and can replace the innovator drug in clinical practice. This not only saves medical expenses, but also ensures the safety and effectiveness of public medication.

Candesartan is an angiotensin II antagonist (ARB), suitable for primary hypertension, and is the smallest dose of sartan drugs. The dosage is 4-16mg, once a day. It is the most stable and strongest receptor binding sartan drug. It is tightly bound to four sites of AT1 receptor, with high affinity and slow dissociation characteristics. It is used to maintain stable blood pressure control for 24 hours; reduce the risk of morning spikes caused by blood pressure fluctuations; reduce target organ damage caused by blood pressure fluctuations; help to reduce the hospitalization risk and mortality rate of patients with chronic heart failure, and improve symptoms and exercise ability.

According to the 2023 edition of the China Cardiovascular Disease Report compiled by the National Center for Cardiovascular Disease in China, there are currently 290 million cardiovascular disease patients in China, including 270 million hypertensive patients. According to data from Mi Nei Net, the sales of candesartan tablets in urban, county-level public hospitals, and urban retail pharmacies in China in 2021 were RMB226 million (USD$35 million) and RMB173 million (USD$27 million), respectively.

Ms. Zhilin Li, China Pharma's Chairman and CEO, commented, "Candesartan tablets have long been one of our flagship products. We are excited that it passed generic-drug-consistency-evaluation. Such achievement not only shows that the quality and efficacy of our Candesartan have been recognized by the NMPA, indicating its ability to replace the innovator drug in clinical practice, but also signifies that it has the qualification to participate in China's national centralized procurement, which will greatly enhance our competitiveness in the field of government procurement."

About China Pharma Holdings, Inc.

China Pharma Holdings, Inc. is a specialty pharmaceutical company that develops, manufactures and markets a diversified portfolio of products, focusing on conditions with high incidence and high mortality rates in China, including cardiovascular, CNS, infectious, and digestive diseases. The Company's cost-effective business model is driven by market demand and supported by new GMP-certified product lines covering the major dosage forms. In addition, the Company has a broad and expanding nationwide distribution network across all major cities and provinces in China. The Company's wholly-owned subsidiary, Hainan Helpson Medical & Biotechnology Co., Ltd., is located in Haikou City, Hainan Province. For more information about China Pharma Holdings, Inc., please visit www.chinapharmaholdings.com. The Company routinely posts important information on its website.

Safe Harbor Statement

Certain statements in this press 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. Such risks and uncertainties may include, but are not limited to: the achievability of financial guidance; success of new product development; unanticipated changes in product demand; increased competition; downturns in the Chinese economy; uncompetitive levels of research and development; 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, except as required by applicable law or regulation.

For more information, please contact Investor Relations:

China Pharma Holdings, Inc.
Ms. Diana Na Huang
Phone: +86-898-6681-1730 (China)
Email: hps@chinapharmaholdings.com

 

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SOURCE China Pharma Holdings, Inc.