本报记者 项铮
■ 给力产学研
记者5月4日自北京万泰药业获悉，万泰药业已经推出最新艾滋病病毒（HIV）口腔黏膜渗出液检测试剂，30分钟内即可观察检测结果。该产品不需要静脉采血，由于唾液的收集简便易行，试剂也有望进入家庭，成为人们自我检测艾滋病的手段。
一般来讲，HIV感染者除血液外，尿液、口腔黏膜渗出液、精液及泪液中均含有HIV抗体。HIV抗体一般在感染后几周逐渐出现，可延续至终生。万泰药业此次推出的试剂盒采用了免疫渗滤技术，可以检测口腔黏膜渗出液中的HIV1+2型抗体，一般用于HIV感染的辅助诊断。目前，在我国采用的HIV诊断试剂都使用血液标本，需要进行侵袭性采样，较为不便，难以满足需求。此次推出的利用人体的唾液标本快速检测的试剂结合常规血液标本检测，未来将成为全球HIV监测工作的主要发展趋势。
北京万泰药业是G20工程入选企业，该试剂盒由北京万泰药业与国家传染病诊断试剂与疫苗工程技术研究中心联合研制，目前已成功通过国家食品药品监督管理局注册审批，获准上市。
北京万泰药业是中国免疫诊断试剂市场的龙头企业，现已成为国内乃至亚洲最大的的免疫诊断试剂生产厂家，年产量超过2亿人份，血源筛查诊断试剂市场占有率列居全国第一位，其中艾滋病、丙型肝炎等免疫诊断试剂的产量连续多年位居国内第一。作为国内最早从事HIV诊断试剂研制的单位之一，公司研发生产的HIV系列诊断试剂，以其灵敏度高，特异性好，质量稳定的优势，连续8年（2003—2010）全国市场占有率第一。
业内人士分析，作为国家生物高技术产业化示范工程基地，近年来万泰公司的高速成长不是偶然的，其发展与我国诊断试剂领域的成长紧密相连，是民族医药产业发展的一个缩影。公司对科研攻关的高度重视和对技术研发的长期投入为其持续发展不竭的能量与动力，形成了基于基础研究与产业化实践的自主创新模式。
万泰药业的研发投入占销售收入比例保持在12%—15%之间，建立了万泰研发中心，拥有科研人员一百余名，形成了由国内一流水平的诊断试剂和疫苗研发专家和技术人员组成的研发团队，拥有价值2000多万元的各类研究开发仪器设备，具有很强的自主研发能力。研发投入比之高是国内药企罕见的。
万泰公司和厦门大学合作已有十多年的历史，双方共建了“国家传染病诊断试剂与疫苗工程技术研究中心”。丰富的科研成果产业化经验和高效成熟的技术转化平台构成了万泰公司的核心竞争力。
在艾滋病病毒抗体诊断试剂领域，万泰药业一直处于国内领先水平。上世纪90年代中期，我国第三代艾滋病诊断试剂依赖进口，国产试剂还停留在第二代的水平。1999年，万泰公司和厦门大学科研人员共同研制出国内唯一一个能完全满足艾滋病毒抗体诊断试剂盒生产要求的艾滋病毒重组抗原，填补了国内的空白。紧接着双方研制出了国内第一个第三代艾滋病毒抗体诊断试剂盒，质量与国际一流产品水平一致，与国产第二代产品相比，在灵敏度和特异性上实现了质的飞跃，2000年获得了国家二类新药证书，结束了外国公司的垄断。同时，公司将科研成果迅速转让给国内科华、华美、新创、金豪等十余家主要诊断试剂厂商和临床单位，使国产艾滋病毒诊断试剂盒在2001年实现全面的更新换代，显著加强了我国的艾滋病毒预防控制能力，并获得“国家科技进步二等奖”。2003—2006年，公司承担了国家发改委高新技术产业化示范工程“艾滋病毒重组抗原与抗体诊断试剂产业化”项目；2008年，国家发改委在授予万泰公司“国家高技术产业化十年成就奖”。2008年万泰药品业推出国内首家上市的国产HIV第四代诊断试剂，进一步提升了我国的艾滋病诊断能力，使国产试剂达到国际领先水平。
(科技日报)
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| 图示∶2010年12月即将出版的《中国特色医疗金鉴》登载的刘君主任及其机构 |
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HIV saliva test kit first listed diagnosis
Published: 2011-05-05 | On: Key Zheng http://www.stdaily.com 2011 年 05 月 05 日 Source: Journal of Science and Technology: Key Zheng
Item Zheng reporter
■ to the power production and research
Reporter May 4 from Beijing Cosmos Pharmaceutical noted that Manhattan Pharmaceutical has launched the latest HIV (HIV) test kit oral exudate, and 30 minutes to observe the test results. The product does not require venous blood, saliva collection is easy because, reagents are expected to enter the home, become a means of self-testing of AIDS.
In general, HIV infection than in the blood, urine, oral mucosal exudate, semen and tears contain HIV antibodies. HIV antibodies usually appear gradually several weeks after infection and can be extended to life. The launch of Cosmos Pharmaceutical kit using immunogold filtration technology can detect oral mucosal exudate in HIV1 +2 antibody, generally used for HIV infection diagnosis. At present, China's HIV diagnostic reagents are used with blood samples, the need for invasive sampling, the more inconvenient, difficult to meet the demand. The launch of the use of human saliva samples in combination with conventional reagents for rapid detection of blood specimens, the future will become the world's HIV monitoring major trends.
Beijing is the G20 works selected Cosmos Pharmaceutical companies, the kit and the State by Beijing Cosmos Pharmaceutical Diagnostics Infectious Diseases and Vaccine Research Center, jointly developed, has successfully passed the State Food and Drug Administration for regulatory approval, be allowed to market .
Beijing Cosmos Pharmaceutical immune diagnostic reagents is market leader, has now become immune as well as Asia's largest manufacturer of diagnostic reagents, copies of annual output of more than 200 million people, blood screening diagnostics market share out the nation The first, in which AIDS, hepatitis C and other immunodiagnostic reagent production for many years among the first. As the first HIV diagnostic reagents developed in one of the units, the company developed the production of HIV diagnostic reagents series, with its high sensitivity, specificity and quality advantages, for 8 consecutive years (2003-2010) the national market share of the first .
Analysis of the industry, bio-tech industry as a national demonstration project base, the company's rapid growth in recent years, Manhattan is not accidental, its development and growth of the field of diagnostic reagents closely linked to the development of national pharmaceutical industry in microcosm. The company attaches great importance to scientific research and technology R & D investment for the long-term sustainable development of inexhaustible energy and power, formed the basic research and industry based on independent innovation in the practice mode.
Cosmos Pharmaceutical R & D investment proportion of total revenue remained at 12% -15%, and the establishment of a Manhattan research and development center, with a hundred researchers, formed by the first class of diagnostic reagents and vaccines research and development experts and R & D team composed of technical staff, has a value of more than 2000 million research and development of various types of equipment, with strong R & D capabilities. High R & D investment is the pharmaceutical companies than rare.
Wan Tai Company and Xiamen University to more than ten years of history, the two sides to build a "national epidemic of Diagnostics and Vaccine Research Center." Rich experience and efficient industrialization of research findings into a mature technology platform to form the Manhattan company's core competitiveness.
HIV antibody diagnostic reagents in the field of medicine has been in Manhattan the leading domestic level. The mid-90s of last century, China's third generation of diagnostic reagents for HIV dependence on imports, domestic agents still remain in the second generation level. In 1999, the Manhattan Company and Xiamen University researchers co-developed the only one able to fully meet the diagnostic kit for HIV antibody production requirements of HIV recombinant antigen, to fill the domestic blank. Then the two sides in the domestic first developed the third generation of HIV diagnostic kits, the level of quality and world-class product line, and made the second generation compared to the sensitivity and specificity to achieve a qualitative leap in 2000 was the national second-class new drug certificate, ending the monopoly of foreign companies. At the same time, the company will quickly transfer to the domestic research subjects China, China and the United States, the new record, Jin Hao, more than ten major manufacturers of diagnostic reagents and clinical units, so that HIV diagnostic kits made in 2001 to achieve a comprehensive upgrading, significantly enhancing China's ability to control HIV prevention, and won the "National Science and Technology Progress Award." 2003-2006, National Development and Reform Commission undertook a high-tech industrialization demonstration project "HIV recombinant antigen and antibody diagnostic reagent industry" project; 2008, the National Development and Reform Commission in Manhattan granted the company "national high-tech industry Decade Award. " Cosmos 2008, launched the first domestic pharmaceutical industry in the domestic market fourth generation of diagnostic reagents for HIV, and further enhance the ability of China's AIDS diagnosis, so that domestic agents to reach international advanced level.
(Science and Technology Daily)
