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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, we took up the responsibility of 'National 973 Project', the 'Tenth 5-year National Major R&D Special Project' and numerous provincial and municipal biotechnological projects. 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 'Guideline for 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, Sibiono is gradually restructuring our originally research-centered enterprise towards an agglomerate structure of R&D and marketing biopharmaceutical enterprise. With the new planning and development blueprint, we target at building a world class leading biopharmaceuticals, putting emphasis on production, management and series. 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 competitive 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. Our goal-orientated innovative development is coupled with accelerated resource allocation for generating a prominent brand product. We advocate full strength R&D in the extension of cancer treatment application and individualized cancer gene therapy center. We take advantage of the national/ provincial support of the biotechnology industry available to strive for a new round of prosperous development.