China Pharma's Candesartan Hypertension Product Passes Bioequivalence Tests and the Company Plans to Apply for NMPA Approval

News provided by

Aug 05, 2021, 09:00 ET

HAIKOU, China, Aug. 5, 2021 /PRNewswire/ -- China Pharma Holdings, Inc. (NYSE American: CPHI) ("China Pharma," the "Company" or "We"), a specialty pharmaceutical company, today announced that its Candesartan hypertension product passed key bioequivalence tests. The Company plans to use the results of the key benchmark tests of consistency evaluation to apply for the National Medical Products Administration's (NMPA) approval. The NMPA is the Chinese agency for regulating drugs and medical devices (formerly the China Food and Drug Administration or CFDA).

Ms. Zhilin Li, China Pharma's Chairman and CEO, commented, "We are very excited about the formal validation that our Candesartan product has passed key bioequivalence tests for consistency evaluation. We plan to use this trial data in our application to the NMPA. We are optimistic based on our experience in this process as we have actively promoted the consistency evaluation process of several key current existing oral products."

Ms. Li continued, "There is a great need for Candesartan among consumers, which we expect will significantly drive increased sales over years to come. Hypertension, or high blood pressure, a leading cause of death worldwide, is estimated to cause billions of dollars of annual economic loss each year and it does not discriminate as it affects both wealthy and poor nations. Unfortunately, the problem is expected to accelerate as many people with hypertension live with it undiagnosed causing further negative health issues and not everyone who has hypertension can access treatment. Our goal is to change that with China Pharma's Candesartan."

China Pharma's Candesartan was developed to treat hypertension, or high blood pressure. Lowering high blood pressure helps prevent strokes, heart attacks and kidney problems. Candesartan belongs to a class of drugs called angiotensin receptor blockers (ARBs). It works by relaxing blood vessels so blood can flow more easily.

According to the World Health Organization ("WHO"), hypertension, or high blood pressure, effects more than 1 billion people worldwide annually and is a leading cause of death. According to China Cardiovascular Health & Disease Report 2020, the China Hypertension Survey (CHS) in 2021-2015 found that the hypertension rate of residents aged 18 or older in China was 39.1%, which means, 435 million Chinese had hypertension.

Nearly half of all adults in the United States, approximately 108 million, have hypertension defined as a systolic blood pressure ≥ 130 mm Hg or a diastolic blood pressure ≥ 80 mm Hg or are taking medication for hypertension. Only about 1 in 4 adults (24%) with hypertension have their condition under control. (Source: www.CDC.gov )

The economic impact is equally dire. The CDC estimates that in the U.S. alone, high blood pressure costs were approximately $131 billion annually from 2003 to 2014.

Background: Consistency Evaluation for Generic Drugs

The "consistency evaluation of generic drugs" refers to the evaluation of generic drugs that were approved for market, for the consistency with the quality and efficacy of the original drug. The goal is for generic drugs to achieve the same level of quality and efficacy as the original drugs and to replace the original drugs in clinical use. This not only saves medical expenses but also improves the development of the pharmaceutical industry, and ensures the safety and effectiveness of drugs.

The State Council of China issued the Pilot Program for the Central Procurement and Use of Drugs by State Organizations (the "Program") on January 17, 2019. The Program calls for the selection of pilot drugs from generics that have passed the "consistency evaluation", and for centralized procurement and use in order to reduce drug prices and patient drug costs. According to documents of the third batch of national centralized procurement issued in July 2020, generic products are required to pass the NMPA's generic drug consistency evaluation to be eligible for procurement.

The NMPA issued an official document on The Implementation of the Evaluation of the Quality and Efficacy of Chemical Injection Generics on May 14, 2020, requiring consistency evaluation for generics of pharmaceutical injections that are already on the market. According to the CPM New Drug Research and Development Monitoring Database, a total of 183 chemical injections passed the consistency evaluation in 2020.

This press release is not intended to substitute for advice given by a physician, pharmacist, or other licensed health-care professional. You should not rely upon this information for self-diagnosis or for self-treatment of a health problem or disease. You should contact your health-care provider immediately if you suspect that you have a medical problem. Information and statements regarding food, health, wellness and dietary supplements have not been evaluated by the Food and Drug Administration and are not intended to diagnose, treat, cure, or prevent any disease or health condition nor is this product intended to diagnose, treat, cure or prevent diseases.

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.

SOURCE China Pharma Holdings, Inc.