China Pharma's Candesartan Hypertension Product Clears Generic Drug Evaluation

10 August 2023 | Thursday | News

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.
Image Source | Public Domain

Image Source | Public Domain

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."

 

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