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赛百诺简介
        

  

     深圳市赛百诺基因技术有限公司,是全球基因治疗领域的开拓者和领军企业。19983月,创建于深圳市高新技术产业园。20031016日,公司自主研发的产品重组人p53腺病毒注射液(今又生/Gendicine®),获得国家食品药品监督管理局颁发的新药证书;2004120日,获得准字号生产批文,2004311日通过药品GMP认证,成为世界上第一个获得批准上市的肿瘤基因治疗新药。多年耕耘在生物基因产业领域,赛百诺终于使基因治疗作为一种新疗法作用于临床成为现实,依靠坚持不懈的创新、发展,为提高人类健康做出了重要贡献。

赛百诺具有强大的研发能力。截至目前,公司对自主创新成果申请并获得相关授权的发明专利共6项,涉及公司产品重组人p53腺病毒注射液的产品发明、生产工艺发明、工程细胞发明、临床用途发明等关键知识产权,已初步形成完善的专利链;围绕基因治疗和今又生的使用,在国内外学术刊物发表的科研论文已达130多篇。 公司还率先在国内建立了重组腺病毒制品大规模生产工艺技术平台和质量控制技术平台,该平台不仅可用于重组腺病毒基因治疗产品生产,还适用于其它重组病毒生产。由公司主要参与制定的中国《人基因治疗研究和制剂质量控制技术指导原则》,已由国家食品药品监督管理局于20033月正式颁布实施,并经SFDA同意,在20045月《Biopharm International》杂志中首次向全世界公开发表了该指导原则的英文版全文,供全球同行参考。

近年来,赛百诺成立了由多位顶级院士为成员的公司科技专家委员会,利用已建立的基因治疗制剂研发平台、产业化平台和市场营销网络,积极引进国内外一批前景较明确的基因治疗制剂在研品种,大力支持、推进其在赛百诺研发大平台上进行产业化和市场化。目前,在中国使用今又生的专家已达1000多名,公司还成立了由300多名三甲医院肿瘤治疗专家组成的临床专家委员会,参与基因肿瘤治疗药物在临床上的合理应用进一步的研究。

    Sibiono  GeneTech Co. Ltd., Shenzhen (Sibiono), is the world's innovator and leader in gene therapy. It was opened at the Shenzhen High-tech Industrial Park in March 1998. In Oct 16, 2003, the innovative product Gendicine®, an adenovirus-based recombinant human p53 for injection (rAd-p53,Inj) was approved by the China Food & Drug Administration (SFDA) with the 'New Drug Certificate. In Jan 20 and Jan 11. 2004, the 'Production Permit' and 'GMP Recognition' were effected respectively, making it he world's first marketable gene therapy new drug. For many years of hard work in biological gene industry, Sibiono finally made gene therapy clinically available a reality. This is all made possible by years of striving for innovative development, targeting at the promotion of human health.  

Sibiono  has a strong team of R&D.Up to now, our Co. owns 6 invention patents, covering p53 adenovirus injection product itself, its production process, related engineered cells and its application in clinical oncology, basically covering gene therapy and the use of Gendicine®. More than 130 research papers were published in national and international scientific journals. Our Co. initiated the Country's first mass production of recombinant adenovirus-related technology and its quality control platforms, which can also be shared by other recombinant virus products. With the significant collaboration of our Co., we helped affirm the introduction of the 'Guidelinefor the production of human gene therapy research and quality control of related pharmaceutics'. The Guideline was publicized for application by the SFDA in March 2003, and approved by SFDA for announcement to the international biotechnology community in the journal: 'Biopharm International' in May 2004.

        
Recently, a scientific panel of Academicians of the Chinese Academy of Sciences was set up. By making use of the existing platforms of experimental gene therapeutics and manufacturing practice with a distribution network, we actively invite potentially c ompetitive gene therapy products under development for further refinement to marketable products. We now have a team of over 1000 specialists employing Gendicine
®, in addition to the 300 oncologists from AAA Hospitals on the panel of clinical specialists, who are in charge of further investigation on cancer gene therapy.