The leading Company, Worldwide Biotech & Pharmaceutical Company obtained Chinese FDA regulation approval for its product ''Diagnostic Kit to Hepatitis C Antibody (ELISA)''; the only HCV diagnostic kit developed from intact HCV virus on the market. The project was also awarded ''Outstanding Project Derived from Chinese Patent'' by the Chinese state government.
Yangling Daiying Biotech & Pharmaceutical Group Co., Ltd., a wholly owned subsidiary of WWBP, obtained regulation approval from the State Food and Drug Administration (''SFDA'') for its product ''Diagnostic Kit to Hepatitis C Antibody (ELISA)'', which is the first product from the Company's HCV research pipeline ever to be released on the market.
Different than other HCV antibody detection kits, the antigen for producing this kit is purified directly from the intact HCV virus particles instead of using recombinant HCV proteins or synthesized polypeptides as with other HCV diagnostics currently on the market. The antigens from intact HCV virus have better epitopes, which could be more specifically recognized by the HCV antibody. This new generation of ELISA diagnostic kits for HCV antibody detection dramatically improves the accuracy of the HCV diagnostics, and significantly advances the diagnostic window of HCV infection.
The Hepatitis C virus infection is the most common chromic blood-borne infection in the United States. According to the Center of Disease Control in the U.S. (''CDC''), a conservative estimate of 1.8% of the U.S. population -- about 4 million individuals -- have become infected with HCV; about 3 million are chronically infected. HCV is transmitted primarily through contact with blood or blood products; a majority of infections (about 90%) produces few or no symptoms to prompt early diagnosis although they are highly infectious. HCV screen testing is necessary for all in-patients at most hospitals, as well as follow-up tests for HCV infected patients, and blood sample screening at all major blood centers. By releasing this new generation of HCV diagnostic product into the market, WWBP will compete vigorously in the 500 million US dollar Hepatitis clinical diagnostics market.
The production line for ''Diagnostic Kit to Hepatitis C Antibody (ELISA)'' meets the Good Manufacturing Practice (GMP) guidelines certified by the SFDA. The certificate was issued on December 6, 2006. The large-scale production and sale of this HCV diagnostic product has already commenced.
Source:未知