Sinovac's (北京科興) bacterial vaccine platform creates pneumococcal, HIB and meningitis vaccines
Sinovac Biotech seeks SFDA approval to begin human trial for its proprietary Pneumococcal Polysaccharides Vaccines
Beijing Wednesday, February 02, 2011, Sinovac Biotech Ltd. a leading provider of biopharmaceutical products in China, announced the submission of the applications to commence human clinical trials for its 23-valent and 24-valent Pneumococcal Polysaccharides Vaccines to the Chinese State Food Drug Administration (SFDA) on January 31, 2011. The preclinical studies were completed and showed good safety and efficacy profile in animal models. Sinovac independently developed the Pneumococcal Polysaccharides Vaccines (PPV) and will retain full commercialization rights to the vaccine upon approval. The supplied quantity of PPV was doubled in China over the past three years demonstrating the consistent increasing market demand. And the gap between demand and supply in Chinese market still exists. PPV remains relatively expensive in China due to the limited available products. The target population of PPV is children over 2 years old and adults in all age groups, especially the elderly over 65 years old. The current available 23-valent PPV have shown good protection effects after launching into the market. But due to the different epidemic characteristics of pneumococcal diseases in China, we also developed the 24-valent PPV to cover one more serotype of pneumococcus, which is one of the top three most prevalent pneumococcus bacteria in China, and therefore has the potential to provide more extensive vaccine protection to the Chinese population. Dr Weidong Yin, chairman & CEO, commented, "PPV is the first bacterial vaccine for which the Company has submitted the clinical trial application to the SFDA, representing our expansion of our R&D capabilities to include both bacterial and virus vaccines. The establishment of our bacterial vaccine development platform will accelerate the R&D for the pneumococcal conjugate vaccine and other types of bacterial vaccines in our pipeline, such as the HIB and meningitis vaccines. We consistently advance our R&D strategy to provide a greater number of high quality vaccine products aimed at preventing diseases in children and adults around the world." Pneumococcal diseases are a major public health problem all over the world. The etiological agent, Streptococcus pneumoniae (the pneumococcus) is surrounded by a polysaccharide capsule. Differences in the composition of this capsule permit serological differentiation between about 90 capsular types, some of which are frequently associated with pneumococcal disease, others rarely. Invasive pneumococcal infections include pneumonia, meningitis and febrile bacteraemia; among the common non-invasive manifestations are otitis media, sinusitis and bronchitis. At least 1 million children die of pneumococcal disease every year, most of these being young children in developing countries. In the developed world, elderly persons carry the major disease burden. Conditions associated with increased risk of serious pneumococcal disease include HIV infection, sickle-cell anaemia and a variety of chronic organ failures. Vaccination is the only available tool to prevent pneumococcal disease. The recent development of widespread microbial resistance to essential antibiotics underlines the urgent need for more efficient pneumococcal vaccines. Pneumococcal Polysaccharide Vaccine (PPV), is a vaccine used to prevent Streptococcus pneumoniae (pneumococcus) infections such as pneumonia and septicaemia. In the United States, PPV is recommended for adults 65 years of age or older, adults with serious long-term health problems, smokers, and children older than 2 years with serious long-term health problems. The World Health Organization recommendations are similar. The safety of the current polysaccharide vaccines in older children and non-pregnant adults is well documented. Sinovac's 23-valent PPV contains 23 different purified capsular polysaccharides prepared from the most prevalent and invasive strains of Streptococcus Pneumoniae, including serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F and 33F. 24-valent PPV contains 24 different purified capsular polysaccharides prepared from the most prevalent and invasive strains of Streptococcus Pneumoniae, including serotypes 1, 2, 3, 4, 5, 6A , 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F and 33F. Sinovac Biotech Ltd. is a China-based biopharmaceutical company that focuses on the research, development, manufacture and commercialization of vaccines that protect against human infectious diseases including hepatitis A, seasonal influenza, H5N1 (bird flu) pandemic influenza and H1N1 influenza and is developing a number of new vaccine products, including vaccines for pneumococcal conjugate, enterovirus 71 (EV71) (against Hand, Foot & Mouth Disease), Japanese Encephalitis, animal and human rabies, HIB and epidemic meningitis, chickenpox, mumps and rubella.
北京科興生物製品有限公司（SINOVAC BIOTECH CO.,LTD.）是由科興控股（香港）有限公司（Sinovac Biotech (Hong Kong) Ltd.）、北京北大未名生物工程集團有限責任公司合資組建的生物高科技企業。公司于2001年在北京中關村國家自主創新示範區註冊成立，註冊資本1.336億元人民幣。目前北京科興通過其控股公司在納斯達克全球市場上市（NASDAQ：SVA），是唯一一家在北美上市的中國疫苗企業。作為一家專業從事人用疫苗的研究、開發、生産和銷售的企業，並正在開創"讓世界兒童用上中國生産的疫苗"的新紀元。北京科興自成立之初就推出了我國第1支甲型肝炎滅活疫苗，填補了國內空白，緊接著全球第1支SARS病毒滅活疫苗，中國第1支、全球第2支甲型乙型肝炎聯合疫苗，中國第1支與全球同步的大流行流感疫苗（人用禽流感疫苗），唯一不含防腐劑的國産流感病毒裂解疫苗以及全球第1支甲型H1N1流感疫苗相繼問世，且都擁有自主知識産權，為我國防治重大突發傳染病貢獻了巨大力量，其驕人成就世界矚目。在北京科興成立的短短數年間，胡錦濤、溫家寶、賈慶林、李克強、王岐山、回良玉、劉淇、吳儀、陳至立、郭金龍及國家相關委辦局領導都曾先後親臨視察，詳細了解北京科興的疫苗研發、生産、質量控制情況，傾聽疫苗研發進展。2009年北京科興被列入首批中關村國家自主創新示範區創新型企業，"科興"也被評為中關村十大品牌之一。北京科興憑藉持續的盈利能力和高速增長已經連續兩年入選德勤高科技、高成長中國50強（2008年44位，2009年37位），亞太區500強（2008年189位，2009年104位）和《福布斯》中國最具潛力中小企業榜200強（2009年52位，2010年23位，2011年24位），併入選2009中國最具競爭力境外上市公司10強。
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