科技重大专项实施成效初显 细节或可改善

 
2009年04月14日
 
    重大新药创制、艾滋病和病毒性肝炎等重大传染病防治两个国家科技重大专项的实施成效初显，业内人士也对细节的改善提出了一些建议。两个重大专项的实施给企业乃至生物医药行业发展带来利好，对促进生物医药行业研发、提高创新水平有极其重大的意义。 
    据中国高新技术产业导报记者  王朝选报道  
    重大新药创制国家科技重大专项实施管理办公室近日发布通知，要求有关单位尽快组织编制该专项２００８年立项课题的２００９、２０１０年度预算；在艾滋病和病毒性肝炎等重大传染病防治国家科技重大专项下，“传染病检测技术平台” 课题近日在青海启动，“慢性乙型肝炎临床转归及相关影响因素的研究”课题日前在重庆启动，“伤寒、痢疾等病原体诊断试剂盒研制”和“慢性乙肝病毒携带者的症候规律及中医药治疗方案研究”项目由深圳的两家单位牵头。由此，重大新药创制、艾滋病和病毒性肝炎等重大传染病防治两个国家科技重大专项已经全面落地。在国家科技重大专项带动下，一些省份设立了自己的重大专项，例如湖南的“新型临床医疗检测产品研制与产业化”、河南的“家禽主要疫病新型诊断技术及新型疫苗研究与开发”。两个国家科技重大专项启动已有一段时间，目前的状况如何？
    成效初步显现
    “作为重大新药创制国家科技重大专项‘十一五’计划第一批课题项目承担企业，微芯生物已正式启动两个拥有全球发明专利的创新药物的临床２期试验和临床３期试验研究。项目承担单位在技术层面上已做好充分准备，且从已有的临床研究结果来看具有极大的潜能，如果国家科技重大专项经费以及地方政府的配套资金能按期拨付，对于如期开展这两个创新药的临床后期试验以及推动产业化和产品上市将起到积极而显著的作用。”深圳微芯生物科技有限公司总裁鲁先平告诉记者，该重大专项对临床前相关技术平台建设、临床研究技术平台建设、各种新药研发的专项技术平台建设和综合技术平台建设的支持力度很大，将在已有基础上初步实现新药创制体系的建设，这对于国内企业开展自主研发或承接国际大型制药企业大量转移的外包研发都会有实质性帮助，并对企业应对当前的国际金融危机起到非常积极的作用。
    东阿阿胶股份有限公司承担了重大新药创制国家科技重大专项中的中药大品种技术改造项目。“应该能达到预期目的，进一步扩大市场规模。”东阿阿胶研究所所长田守生向记者表示，中药是建立在经验基础上的，如果能研究清楚其物质基础和作用机理，有一些理性的科学数据作支撑，从科学的角度对其疗效加以解释，将会使中药得到更多人的认可。此外，通过对物质基础和作用机理的研究，还能发现现有药品的一些新功能。
    辽宁成大生物股份有限公司与其他公司一起承担了艾滋病和病毒性肝炎等重大传染病防治国家科技重大专项的一个项目。该公司研发部部长周荔葆介绍说，在承担项目前已做了两三年的工作，完成了临床前研究，应该可以达到预期目标。她还表示，我国在疫苗的基础研究方面并不差，与国外的差距表现在实验室成果与产业化的对接上，整体工艺与国际领先水平相比有一段距离。不过，目前５０％以上的国内疫苗企业都在引进生物反应器，待这项工作完成后，将是对工艺的一项重大革新，从而接近于国际领先水平。
    细节或可改善
    重大新药创制、艾滋病和病毒性肝炎等重大传染病防治两个国家科技重大专项对促进生物医药行业研发、提高创新水平有着极其重大的意义。一些项目承担企业表示，在实际操作层面，有些细节或许可以进一步改善。
    “艾滋病和病毒性肝炎等重大传染病防治国家科技重大专项承担单位选择面有些窄，应该更公平、更透明地选择项目承担企业。要促进产业升级，单靠国有企业是不够的，还要有民营企业加入，这样才能促进国内企业良性竞争、共同进步，否则不利于行业整体竞争力的提高。因此，应为国有企业、民营企业平等竞争、平等考核创造条件。”浙江天元生物药业股份有限公司总经理丁晓航曾作为专家参与艾滋病和病毒性肝炎等重大传染病防治国家科技重大专项项目评审，他告诉记者，一些项目的可行性研究还不充分，而且绝大部分经费用来购买设备，对软环境建设重视不够，尤其在人才引进方面，这些可能影响重大专项的收效。
    田守生表示，在大品种培育方面，重大新药创制国家科技重大专项在生物药、化学药和中药中各选择了１０个大品种。生物药发展的历史很短，企业数量本就不多，因此竞争并不激烈；而中医药在我国历史悠久，中药企业众多，竞争非常激烈。他建议，中药是我国优势产业，拥有自主知识产权，国家应给予一定的政策倾斜，比如在设置大品种数量时不妨多一些。
    多位接受采访的业内人士都表示，两个国家科技重大专项在选择项目承担单位时，应进一步提高企业尤其是非国有企业的比重。据田守生介绍，在重大新药创制国家科技重大专项的各类项目承担单位中，承担项目比较多的是科研机构，虽然有些品种和平台建设以企业为主体，但承担项目的企业数量比较少。周荔葆也表示，艾滋病和病毒性肝炎等重大传染病防治国家科技重大专项在选择承担单位时倾向于高校和科研院所，经费方面企业得到的也比较少。
    这两个国家科技重大专项的实施给企业乃至生物医药行业发展带来利好，受到企业一致肯定。业内人士表示，重大新药创制科技重大专项涵盖国内新药创新产业链的各个环节，对行业的整体研发能力和技术提升、品种创新甚至企业商业模式都将产生深刻影响；艾滋病和病毒性肝炎等重大传染病防治科技重大专项的实施可以全面提高我国传染病预防、诊断、治疗和控制水平。
     
 
 来源：中国高新技术产业导报
 作者：王朝选
 责编：江水

The implementation of major science and technology specific details, or can be improved初显

 
April 14, 2009
 
     Creation of major new drugs, AIDS and viral hepatitis prevention and treatment of infectious diseases and other major national science and technology of two of the implementation of major projects初显, the industry also details a number of recommendations to improve. The implementation of two major projects to the enterprise and even bio-pharmaceutical industry in the development of positive, the promotion of bio-pharmaceutical industry research and development, to raise the level of innovation of great significance.
     According to China's high-tech industry dynasty Herald election coverage
     National science and technology to create a major new drug to implement major projects management office recently issued a circular calling for the relevant units as soon as possible the preparation of the special project in 2008 the annual budget subject 2009,2010; in AIDS and viral hepatitis prevention and treatment of infectious diseases and other major national science and technology of major projects, "infectious disease detection technology platform" issue has to start in Qinghai, "The clinical prognosis of chronic hepatitis B and related factors in the research" subject to start a few days ago in Chongqing, "typhoid fever, dysentery and other pathogens in the development of diagnostic kits" and "chronic hepatitis B the law of the symptoms of HIV and study of traditional Chinese medicine treatment, "the project of two units from Shenzhen to take the lead. Thus, creation of major new drugs, AIDS and viral hepatitis prevention and treatment of infectious diseases and other major national science and technology of two major projects have been full on arrival. Major projects at the national science and technology, led some provinces to set up its own major projects, such as Hunan's "clinical testing of new product development and industrialization", Henan's "major poultry disease diagnostic techniques and new research and development of new vaccines." Two national science and technology to start major projects for some time, how the current situation?
     Preliminary results show
     "As a major new drug to create a major national science and technology special 'Five' plan to issue the first batch of corporate projects, Chipscreen Biosciences has launched two innovative global drug patent 2 clinical trial and clinical study of three tests. assume unit project at the technical level have been fully prepared, and from the existing results of clinical research has great potential, if the national science and technology funding for major projects, as well as matching funds to local governments to allocate time for the scheduled launch of these two innovative drugs in late stage clinical trial and the promotion of industrialization and market will play a positive and significant role. "Shenzhen Chipscreen Biosciences Ltd. Xian-Ping Lu told reporters that the major projects of the pre-clinical platform for the construction of related technologies, clinical research technology platform, a variety of new drug research and development of specific technology platform and integrated technology platform to support the efforts of a large building will have been based on the initial creation of system-building drugs, which carry out independent research and development of domestic enterprises or undertake international large-scale transfer a large number of pharmaceutical companies outsourcing R & D, there will be substantive help, and businesses in response to the current international financial crisis, play a very active role.
     Co., Ltd. Dong-Ejiao assumed a major national science and technology to create a major new drug of special varieties of Chinese medicine major technical innovation projects. "Should be able to achieve the desired objective to further expand the size of the market." Ejiao Dong-Shou Tian, director of the Institute of Health told reporters that Chinese medicine is built on the basis of experience, and if we can study the material basis and its mechanism of action, there are some rational scientific data for support, from a scientific point of view to explain its effect will be to make traditional Chinese medicine has been recognized by more people. In addition, the material basis of the mechanism and role of research, but also found a number of existing drugs with new features.
     Biological Co., Ltd. Liaoning Cheng Kung University, together with other companies to assume the AIDS and viral hepatitis prevention and treatment of infectious diseases and other major national science and technology as a major special projects. Minister for the company's research and development, said Zhou Li-bao, the commitments made in 2023 before the work was completed pre-clinical studies, should be able to achieve the desired objective. She also said that the basis of our country in vaccine research is not bad, and the performance gap with foreign countries in the laboratory results and the industrialization of the docking, the overall process compared with the international advanced level for some distance. However, more than 50% of the domestic vaccine companies on the introduction of bio-reactor, when the work is completed, will be a major process innovation, and thus closer to the international advanced level.
     Details, or can be improved
     Creation of major new drugs, AIDS and viral hepatitis prevention and treatment of infectious diseases and other major national science and technology of two major projects for the promotion of bio-pharmaceutical industry research and development, to raise the level of innovation has a great significance. Corporate a number of projects that, in practice the operational level, some details may be further improved. 
     "AIDS and viral hepatitis prevention and treatment of infectious diseases and other major national science and technology to bear a special unit of the major choices in some narrow, it should be more equitable, more transparent corporate options. To promote industrial upgrading, the state-owned enterprises alone is not enough, we should also have private enterprises to join, so that domestic enterprises can promote healthy competition and common progress, or not conducive to the industry's overall competitiveness. Therefore, for state-owned enterprises, private enterprises to compete on an equal footing, the creation of equal conditions for examination. "Zhejiang Tianyuan Bio Pharmaceutical Company Limited Ding, general manager of aviation experts to participate as AIDS and viral hepatitis prevention and treatment of infectious diseases and other major national science and technology assessment of a major special project, he told reporters that the feasibility study on a number of projects not yet fully, but the vast majority of funds used to purchase equipment insufficient attention to the soft environment, in particular the introduction of talents, which are major projects that may affect the results.
     Tian Shou-sheng said the species in cultivation, the major new drugs to create a special major national S & T in bio-medicine, chemical medicine and Chinese medicine in the choice of the 10 major species. History of the development of biological drugs is very short, not more than the number of enterprises, the environment is not highly competitive; and Chinese medicine has a long history in China, many Chinese enterprises, competitive. He suggested that Chinese medicine is the dominant industries in China, with independent intellectual property rights, the State should be given some preferential policies, such as in setting the number of large species may be a little more time.
     Interviewed a number of people in the industry said that the two major national science and technology to bear a special unit in the selection of projects, should further enhance the enterprises, especially the proportion of non-state-owned enterprises. According to Tian Shou-sheng, the creation of new drugs in a major national science and technology a major commitment to special projects of various types of units, the project is a relatively large number of research institutions, although some species and platform to enterprises as the mainstay, but the number of firms in the project is relatively small. Zhou Bao-Li also said that AIDS and viral hepatitis prevention and treatment of infectious diseases and other major national science and technology a major commitment in the choice of special units tend to universities and research institutes, and funding of enterprises is also relatively small.
     The two major projects of national science and technology to the enterprise as well as the implementation of bio-pharmaceutical industry in the development of positive, unanimously endorsed by the enterprise. Industry point out that science and technology to create significant new drugs to cover specific domestic drug major innovation in all aspects of the industry chain, the industry's overall R & D capability and technology upgrading of enterprises and even varieties of innovative business models will have a profound impact; AIDS and viral hepatitis infection and other major disease prevention and control technology for the implementation of major projects to improve China's comprehensive infectious disease prevention, diagnosis, treatment and control.
      
  
  Source: China High-tech Industry Herald
  Authors: Wang election
  In charge of: water