Worldwide Biotech & Pharmaceutical Company Obtains Chinese FDA Regulation Approval For Its Product 'Diagnostic Kit To Hepatitis C Antibody (ELISA)
Yangling Daiying Biotech & Pharmaceutical Group Co., Ltd. (''Yangling''), 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.
''This transition is a critical milestone of our growth strategy to become the leading figure in the research & development of HCV diagnostics and therapeutics,'' said Wenxia Guo, CEO and President of WWBP, ''Our ability to release a highly sensitive and accurate HCV diagnostic product based on the intact HCV virus, that we cultured, strongly enhances the leading position of our company in HCV research.''
About Worldwide Biotech and Pharmaceutical Company
Worldwide Biotech & Pharmaceutical Co. (''WWBP'') is a hi-tech biotech company with top-ranking pharmaceutical R&D abilities, Good Manufacturing Practices (GMP) licensed manufacturing facilities and a well-established marketing network in China and Southeast Asia. The product range of WWBP covers Hepatitis C Virus (HCV) products, diagnostic medicines and Over-The- Counter (OTC) drugs. WWBP currently possesses 101,240 square meters of land and 24,175 square meters of GMP standard facilities. With strong pharmaceutical R&D abilities especially in the HCV field, WWBP has been known as the first biotech company in the world to hold the technology of culturing intact HCV in vitro by cell culture. Its principle project ''The intact hepatitis C virus (HCV) and method for culturing HCV in vitro by cell culture'' was awarded a Chinese Patent by the China Patent Bureau and the prestigious China Patent Gold Medal by the World Intellectual Property Organization and China Patent Bureau. The medal is the only one issued for achievement in the biomedical sciences during the past 10 years. WWBP has achieved a GMP production scale level of 10,000 ml for concentrated HCV material and 10 grams HCV antigen per month, which is expected to provide enough HCV materials for its research and production. WWBP has successfully two pharmaceutical companies in China in January 2006. The acquisitions will strengthen WWBP's R&D abilities and production scale, as well as extend its marketing network throughout China and Southeast Asia. WWBP has been working closely with pharmaceutical research institutes, and has established connections with both central & local governments.
About HCV diagnostics
HCV is listed together with HBV and HIV as one of the three most dangerous blood-borne virus', and it accounts for the majority of hepatitis virus' in the US and worldwide. About 1.3-2.5% of the worldwide population is infected with the virus. There is neither any medication available that can cure HCV infection or any vaccine for prevention, and existing diagnostics suffer from poor sensitivity and specificity. The development of reliable diagnostic methods and treatment for HCV is delayed due to the inability to produce and propagate HCV in vitro. Scientists at WWBP achieved a technological breakthrough for successfully culturing and propagated HCV in vitro, making it the first to overcome the main hurdle to HCV research and product development. From this Rosetta stone, WWBP has developed a new generation of HCV diagnostic reagent based on intact HCV virus cultured in vitro, which has passed the large-scale clinical sanction by SFDA. It has been shown that this HCV diagnostic product has higher sensitivity and specificity than other HCV diagnostics currently on the market and successfully solves the problems of low accuracy and high misdiagnosis rate of current products.
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Source: Worldwide Biotech and Pharmaceutical Company