生物技术药物

生物技术药物以人类体细胞的基因组、转录本组和蛋白质组三个层次生物大分子为目标，基因药物的研究主要针对致病基因的DNA和基因转录本mRNA两类生物大分子。

Biotech drugs are targeting DNAs , transcripts and proteins of disease related genes in human cells , among which gene drugs focus on functional gene duplex DNAs and mRNA transcripts .

中国仓鼠细胞（Chinesehamsterovarycell）及其无血清流加培养是目前包括工程抗体和重组蛋白在内的生物技术药物生产的最为重要的表达系统和工艺技术。

CHO cells ( Chinese hamster ovary cell ) is presently the most important expression systems for engineering antibodies and recombinant protein and serum-free fed-batch culture is also the most important process for biopharmaceuticals production .

通过某些药物的定点突变获得第二代新生物技术药物，如胰岛素、EPO和t-PA的突变体；

Site-directed mutagenesis of some biotech drugs to get second generation biomedicines , such as mutants of EPO , insulin and t-PA.

FDA批准首个治疗癌症的生物技术药物-一种称为利妥昔的单克隆抗体治疗一种淋巴瘤。

First biotechnology product approved by FDA to treat patients with cancer - a monoclonal antibody called rituximab , used to treat one type of lymphoma .

近年来，不断有新的生物技术药物应用于原发性血管炎，包括肿瘤坏死因子抑制剂、重组人干扰素α-2a、抗CD52抗体/抗CD4抗体、抗CD20抗体及抗CD18抗体。

Such biologic agents include anti-tumor necrosis factor agents , interferon alfa-2a , anti-CD52 antibody / anti-CD4 antibody , anti-CD20 antibody and anti-CD18 antibody .

Vical公司致力于基于其DNA传递专利技术的生物技术药物的研发，目的是为了预防和治疗严重的威胁生命的疾病。

Vical researches and develops biopharmaceutical products based on its patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases .

中国批准了27种生物技术药物。

There are 27 biotech drugs approved by SFDA in China .

生物技术药物临床前安全性评价研究进展

Research advances in preclinical safety evaluation of biotechnology derived pharmaceuticals

生物技术药物药代动力学研究的分析方法

Analytical methods used in pharmacokinetics studies for biotechnology drugs

我国生物技术药物研究现状和展望

Research Actuality and Expectation of Biotech Drugs in China

生物技术药物的研究开发与产业化现状及前景

Biopharmaceutical actuality and its development in the future

创新课程生物技术药物药动学的设置

Preliminary Study on the Teaching of Pharmacokinetics of Bio-Technology Derived Drugs as an Innovative Course

欧洲药物管理部门近来开创了一条允许非专利生物技术药物进入市场的通道。

European drug regulators recently created a pathway for generic versions of biotech drugs to come to market .

蛋白质、多肽类药物口服制剂研究是生物技术药物制剂研究的一个重要发展方向。

Studies for oral preparation of protein and polypeptide drugs is an important developing direction of medicine research with biotechnology .

麦凯恩也将推动通用生物技术药物和转移一些照料的任务给护士职业者，华尔街日报说。

McCain will also push for generic biotech drugs and shifting some care to nurse practitioners , the WSJ says .

蛋白质药物作为重要的生物技术药物之一，被广泛的应用于医药治疗与组织工程等领域。

Protein drugs are one of the most important biological drugs in the field of medical treatments and tissue engineering today .

生物技术药物由于自身具有的特点，使得其在体内的药代动力学机制比传统药物更为复杂。

Because of the specialty of the biotechnological drugs , its mechanism of pharmacokinetics is more complex than the traditional drugs .

生物技术药物研发的成功率稍高于小分子药物，但它们距离稳赚不赔的目标仍相距甚远。

Biologics have a somewhat better success rate than small molecule drugs , but they remain far from a sure bet .

既然市场上有很多靶向生物技术药物，那么研究者正开始试验两个靶向药物是否会比一个更好些。

Now that there are several targeted biotech drugs on the market , researchers are starting to test whether two targeted drugs are better than one .

并对我国生物技术药物的发展方向及有关问题提出了建设性意见。可供国家宏观指导部门及生物制药科技工作者决策时参考。

Authors also evaluated the importance of biotechnology in the national economy of China , and illustrated their opinion on the direction of China 's biopharmaceutical industry .

尽管在对“异种移植”的安全性和伦理方面存有疑虑，但生物技术药物公司正在倾注几百万为此而努力，他们的技术水平在稳步提高。

Despite doubts about the safety and ethics of " xenotransplantation ", biotech and pharmaceutical companies are pouring millions into the endeavor , and their technologies are steadily improving .

自20世纪70年代以来，分子生物学家已在物种之间转移基因，一次转移一种基因；他们的工作给我们带来了转基因农作物和生物技术药物。

Molecular biologists have been transferring genes between species , one at a time , since the 1970s ; their work has given us genetically modified crops and biotechnology drugs .

今年，礼来公司进入临床试验的药物一半是生物技术药物。公司计划自2011年起，每年有一个生物技术药物上市。

The company said half of its new drugs entering trials this year will be biologics and it plans to bring a new biotech product to market every year starting in2011 .

新开发的环氧酶2抑制剂及生物技术药物不仅可减少胃肠道副作用，对风湿病的早期治疗有良好疗效，且可减少关节炎引起的功能丧失；

Cyclooxygenase 2 inhibitors and biological products , which were developed recently , have showed higher therapeutic effect and lower incidence of gastrointestinal side effects , reducing functional loss resulted from rheumatoid arthritis .

由于药品是特殊的商品，其研发和生产的各个阶段都需要接受国家药监机构的监管和审批，取得药监机构的批文意味着该生物技术药物研发风险急剧下降，产品价值显著提升。

As drugs are special commodities , the R D , manufacturing and supplying of drugs are supervised and approved by the drug administration . The approval of clinical or manufacturing means a sharp decline in the risk of R D and a significant increase of biopharmaceutical companies ' value .

目前生物技术类药物在临床上应用的剂型大多为注射用溶液或冻干粉针剂。

Nowadays the biopharmaceutical drugs on clinical use are supplied as sterile freeze-dried powder or injectable solutions .

生物技术在药物研制中的应用及我国生物医药发展对策

Discussion on the Application of Biotechnology in Drug Research and the Development of Biomedicine in Our Country

随着蛋白质组学和基因组学计划的逐步深入，越来越多的多肽、蛋白质等生物技术类药物在诊断、治疗或预防等各个方面发挥着十分重要的作用。

More and more peptides and proteins become main and important drugs along with the progress of genomics and proteomics .

现代生命科学和生物技术使药物研制发生了巨大而深刻的革命性的变化。

Modern biological science and biotechnology have made drug research and development to take place enormously and deeply revolutionary changes at present .

它被广泛应用于生物技术、药物动力学、物理、经济、种群动力学、流行病学等领域。

It is widely applied in various domains such as biological technology , medicine dynamics , physics , economy , population dynamics and epidemiology .