“疫苗治乙肝”有望年底完成临床试验
发布日期：2010-11-08　 来源：健康报

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

慢性艾滋病早期中医药治疗保障生命论证

　　中国工程院院士、疫苗专家赵凯昨日在2010年中国药学大会上介绍说，“十一五”期间， 我国研制出能将HIV感染血清学检测窗口期缩短至两周以内的诊断试剂，自主创新的艾滋病疫苗也将进入二期临床，治疗性乙肝疫苗有望在今年年底完成国际规范的三期临床试验。

　　另外，20多种传染病诊断试剂已获注册并上市销售，引发手足口病的EV（肠道病毒）、EV71（肠道病毒71型）、CA16（柯萨奇A16型病毒）的3个有关诊断试剂已获批准并实现产业化；重组炭疽疫苗和痢疾双价疫苗已开展临床研究；EV71灭活疫苗和F基因型腮腺炎疫苗已申报临床研究。

"Hepatitis B vaccine administration" is expected to be completed by the end of clinical trials
Release Date :2010-11-08 Source: Health News

(Reporter Wang Lemin) "major infectious diseases such as AIDS and viral hepatitis prevention and treatment" technology for more than two years of implementation of major projects, in AIDS, viral hepatitis, the diagnosis of tuberculosis prevention and control technology and related product development stage achieved results, effectively enhance disease prevention and control of our ability.

Chinese Academy of Engineering, vaccine experts yesterday, Zhao Kai, China Pharmaceutical Conference in 2010, said on the "Eleventh Five-Year" period, China developed can detect HIV infection in serological window period shortened to less than two weeks, diagnostic reagents, independent innovation AIDS vaccine will enter Phase II clinical, therapeutic hepatitis B vaccine is expected to be completed by the end of this year Phase III clinical trials to international norms.

In addition, 20 kinds of diagnostic reagents for infectious diseases have been registered and listed for sale, cause hand, foot and mouth disease EV (enterovirus), EV71 (enterovirus 71), CA16 (Coxsackie virus A16) and three related diagnostic reagents have been approved and industrialization; recombinant anthrax vaccine and dysentery bivalent vaccine has been conducting clinical research; EV71 genotype F inactivated vaccine and mumps vaccine clinical studies have been reported.

• 上一篇文章： 报告称艾滋病成为2009年传染病“头号杀手”
   

中美奥达：让中国生物制药走向世界
    时间： 2010-11-08 02:51:18　来源： 京报网 杨汛

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

慢性艾滋病早期中医药治疗保障生命论证

　　一个总投资额超过1亿美元的全球生物制药合同生产项目日前落户北京亦庄，作为项目的主要负责人之一，美国留学归来的北京中美奥达生物技术（北京）有限公司CEO黎志良说，对于我国生物制造产业而言，这一项目的最重要意义是加快中国生物制药走向世界的脚步。

　　创业瞄准制药合同生产

　　“上世纪80年代我在中国疾控中心读硕士，1990年以访问学者身份前往美国进行科研。”黎志良说，赴美后他先在南加州大学做艾滋病诊断试剂研究，随后前往瑞士罗氏制药实验室，先后任科学家、项目经理等职务。十多年的留学和从业生涯，让黎志良积累了大量生物医药方面的尖端技术。

　　而他同时还在为创业做准备。黎志良曾在密歇根大学商学院学习并获MBA学位，也在硅谷创办管理咨询公司。最终黎志良看准CMO，即全球生物制药合同生产。“CMO主要是接受制药公司的委托，提供产品生产时所需要的工艺开发、配方开发、临床试验用药、生物原料药以及制剂生产等服务。”黎志良说，这一低能耗高附加价值的现代工业无疑是最适合的创业方向。

　　遇危机及时调整方向

　　2006年6月，北京中美奥达公司成立，这是我国第一个，也是惟一的专业化生物制药合同生产服务商。学成归国的黎志良不仅被聘为病毒生物技术国家工程研究中心副主任，中美奥达也成为中国生物技术创新服务联盟的骨干成员，先后参与科技部863计划、“十一五”重大专项、卫生部“艾滋病和病毒性肝炎等重大传染病防治”等项目。

　　归国创业看似一帆风顺，但2008年金融危机，让中美奥达也受到资金不足的冲击。

　　“经过慎重考虑，我和合作伙伴们都认为，应该着眼于国内市场。”黎志良开始转变融资方向，而这一改变很快见效：在先后获得各级政府约1000万元人民币的科研资助后，公司与国内外二三十家重要的生物制药公司签订了几十个国内外新药研发服务合同，合同金额超过4000万元人民币。

　　去年，中美奥达在北京设计出我国第一个符合美国FDA-cGMP标准的250升哺乳动物细胞发酵和纯化生产线。该生产线可承接临床前和临床用药的生产，以及中试规模细胞培养工艺的建立和优化。

　　要让中国制药出口欧美

　　今年3月，总投资1.2亿美元的CMO项目落户亦庄，项目由亦庄国际投资发展公司、苏玛基金及中美奥达合资，设立奥达国际生物技术（北京）有限公司，致力于打造我国第一批符合美欧标准的生物新药开发和放大生产线，以及亚洲最大规模的全球生物制药合同生产基地。

　　亦庄CMO项目初定产能规模为20000升，约8到10条生产线，囊括了小试、中试及大规模生产等环节。目前，250升生产线的设备已采购到位，等待进厂安装。小试生产线年内可投产运行，中试生产线将于明年建成。

　　“中国生物制药技术水平低，与企业研发能力及研发投入低有关，这成为行业的普遍性问题。”黎志良说。“我希望用10年时间，让10%的世界生物制药产能转移到中国来。10年后，‘10%’将是一块不小的蛋糕，估计将达到100亿美元。”

U.S. Oda: China to the world pharmaceutical
    Time: 2010-11-08 02:51:18 Source: Beijing, Nov Yangxunqiao
    Keywords: biopharmaceutical Oda U.S. FDA-cGMP Li Zhiliang
        Abstract: Li Zhiliang business venture reflections find their own direction when, pre-emptive is very important. At present, bio-pharmaceutical production chain is forming a strong impulse to outsourcing, it spotted the opportunity and only in the United States Oda made biopharmaceutical industry, contract opportunities. Last year, the United States Oda design in Beijing China's first line with the U.S. FDA-cGMP standards of 250 liters of fermentation and purification of mammalian cell lines.
Li Zhiliang entrepreneurs find their own reflections when the direction of business, pre-emptive is very important. At present, bio-pharmaceutical production chain is forming a strong impulse to outsourcing, it spotted the opportunity and only in the United States Oda made biopharmaceutical industry, contract opportunities.

A total investment of more than 100 million U.S. dollars in the global biopharmaceutical contract manufacturing project recently settled in Beijing Yizhuang, as the one primarily responsible for the project, the United States returned to Beijing to study China and the U.S. Oda Biotechnology (Beijing) Co., Ltd., said CEO Li Zhiliang For the purposes of bio-manufacturing industry, the most important significance of this project is to speed up the pace of biopharmaceuticals to the world.

Aimed at pharmaceutical contract manufacturing business

"I am 80 years of last century in China, Master CDC in 1990 as a visiting scholar to the United States for scientific research." Lizhi Liang said, the United States after his University of Southern California first AIDS diagnostic reagents to do research, then went to Switzerland, Roche pharmaceutical laboratories has been the head scientists, project managers and other positions. Ten years of study and career practitioners, so that Li Zhiliang accumulated a lot of cutting-edge technology of biological medicine.

And he also prepare for the start. Li Zhiliang in the University of Michigan Business School and received MBA degrees, is also founder of management consulting firm in Silicon Valley. Li Zhiliang eventually spotted CMO, the world's biopharmaceutical contract manufacturing. "CMO major pharmaceutical companies is to accept the commission, to provide products needed for production process development, formulation development, clinical trial drugs, bulk drugs and formulations of biological production services." Lizhi Liang said that the power consumption of high value-added modern industry is undoubtedly the most suitable business opportunity.

Opportunities to adjust the direction of the crisis

June 2006, Beijing Sino-US Oda established, and this is the first and only specialized biopharmaceutical contract manufacturing service providers. Li Zhiliang returning studies was hired as the virus not only biotechnology, deputy director of National Engineering Research Center, U.S. Oda biotechnology innovation has become a key member Service Alliance, has been involved in 863 plans, "Eleventh Five" major projects, the Ministry of Health, "AIDS and viral hepatitis and other major infectious diseases," and other projects.

Returned seemingly smooth start, but the 2008 financial crisis, so that Sino-US Oda has also been the impact of insufficient funding.

"After careful consideration, I believe that partners should focus on the domestic market." Lizhi Liang began to change the financing direction, and this change will soon bear fruit: in all levels of government has received about 10 million yuan after the research funding , twenty or thirty domestic and foreign companies and major pharmaceutical companies have signed dozens of domestic and international drug development services contract, the contract value more than 40 million yuan.

Last year, the United States Oda design in Beijing China's first U.S. FDA-cGMP standards consistent with the 250 l fermentation and purification of mammalian cell lines. The production line can undertake pre-clinical and clinical drug production, and pilot-scale cell culture process of the establishment and optimization.

China's pharmaceutical exports in Europe and America to make

March of this year, a total investment of 120 million U.S. dollars of CMO projects to settle Yizhuang, the project by the Serious and International Investment Development Corporation, Soma Fund and the American Otter joint venture, the establishment of Oda International Biotechnology (Beijing) Co., Ltd., to build China's first meet the standards of a group of U.S. and European drug development and amplification of biological production, as well as Asia's largest production base of global biopharmaceutical contract.

Serious and CMO project an initial production scale of 20,000 liters, about 8-10 lines, to include small scale, pilot and large-scale production and other areas. Currently, 250 l production line equipment have been procured in place, waiting for installation into the plant. Small scale production line can be put into operation during the year, pilot production line will be completed next year.

"China's low level of bio-pharmaceutical technology, and research and development capabilities and low R & D investment related to the universality of this problem the industry." Lizhi Liang said. "I hope in 10 years, so that 10% of world pharmaceutical production transfer to China. 10 years later, the '10% 'is not a small piece of cake, it is estimated will reach 100 billion."

• 上一篇文章： 一名“小姐”艾滋病血检呈阳性