Shenzhen SiBiono GeneTech Co.,Ltd. is a pioneer in developing gene therapy in China. As the first professional company in gene therapy in China, SiBiono has achieved great success. In October 2003, The Recombinant Human Ad-p53 Injection, trademarked as Gendicine, developed independently by Sibiono successfully obtained the Drug license, Production Approval and GMP Certificate from the China State Food & Drug Administration (SFDA). It is the first commercialized gene therapy product ever approved in the world. Thousands of national and international specialized magazines, newspapers, TV and radio programs, and Internet reported the new technology progress. It was reported that Gendicine is a milestone in the field of gene research and hi-tech bio-technology. It will have an impact on the whole world’s medical and health system, and make important contribution to the course of improving human health.
SiBiono has established a complete set of quality-control assays and production processes for rAd-p53 product following international regulations and standards. Sibiono is also the main participate in drafting the “Points to Consider for Human Gene Therapy and Product Quality Control” which is the national technological legal document and has been published by SFDA in March 2003. At the request of some foreign experts and organizations, the Points to Consider for Human Gene Therapy and Product Quality Control was also published in Biopharm International (May, 2004) for reference.
The Company takes the improvement of human health and life quality as its mission and is committed to developing gene therapy technology and product. Two major technology platforms of Viral Vector Gene Delivery System and Non-Viral Vector Gene Delivery System have been developed focusing on cancer and cardiovascular diseases.
The company has a pool of talents who excel in gene therapy research, development and commercialization. Due to its strength in research and development, the company has undertaken a number of national, provincial projects of research and development, including bio-technology projects of National 863 Plan, key research project of National Tenth Five-Year-Plan, projects in National Innovation Fund, National Key Scientific Development Plan, National Hi-tech Industrialization Projects, key Platform Technology Development Projects for Guangdong Provincial, and hi-tech Industrialization Projects for Shengzhen Municipality.
SiBiono has been equipped with adequate human resources, technology, product and infrastructure, which is very competitive around the world. Upholding the spirit of “Vision, Passion, Innovation and Action”, the company will press ahead in the field of gene therapy.
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