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Research and Development

ibiono has successfully built a R&D platform on viral and non-viral vector for gene therapy drugs, and platforms for the mass production of recombinant adenovirus gene therapy and the quality control of the products thereof. In the process, the world’s first innovative gene therapy drug ‘rAd-p53,Inj’ Gendicine® is marketed. 

Particularly in the area of ‘rAd’ preparation standardization, small scale development and mass production, Sibiono has already had a good head start on setting up ‘rAd’ production technology including large scale cell culture, FPLC 1-step column purification, HPLC analysis, a complete quality control standard, and the operation module SOP document. Those systematic formations are the realization of lab scale to mass production transition for gene therapy in China.

Sibiono has already acquired the invention patents necessary for lab to large scale development technology in gene therapy drugs. With the successful platforms so built and operated, Sibiono has attracted the attention of national and international innovative gene therapy corporations to Shenzhen for the lab-to-industry transition R&D., possibly forming a new global regional center for innovative gene therapy drug.

New Product Development

Sibiono is a pioneer gene therapy in China. Since Gendicine® is in market, we have made the transition from solely a research enterprise to a market-directed one. The R&D is subdivided into R&D dept. for basic sciences, medical dept. for Phase I&II studies, the sales dep. for the promotion of products with academic activity support on clinical research. The R&D activities centered around further in-depth study of Gendicine® while others work on new product research. 

The Gendicine® in-depth research covers the Phase IV clinical trial, ‘off-label-use’ research, and extended clinical use of the drug, while the upgrading of production efficiency and quality improvement research are also included. 

As for the new product development, the Co. has started 2 new products under the ‘Expert Committee of S&T’. They are the ‘ivAdp53’ for iv infusion and ‘dual gene recombinant oncolytic adenovirus for injection’(SBN-3), in addition to 2 invited product: ‘protein A immunoadsorption system and polycation encapsulation of adenovirus’. In Dec 2009, Dr. Gui Gao introduced from the USA the project: ‘protein A immunoadsorption’ was patented in China would benefit the patients with autoimmunity. There is no competitor in China and it would be a new growth point for the Co.. 

Another project: ’polycation encapsulation of adenovirus’ can be coupled with the use of Gendicine® for preventing the adenovirus neutralizating antibody immune response. This measure would raise the transfection rate in multiple dosing for better clinical efficacy. The upgraded product ‘ivAdp53,’ is an improved form of Gendicine® ‘rAd-p53,Inj’. The genetically modified adenovirus vector will be more suitable for iv infusion or even used locally.

 ‘Dual gene oncolytic adenovirus for injection’ (SBN-3) is the upgraded product of Gendicine®. SNB-3 is highly specific for lysing tumor, induces apoptosis and immune response, and synergistic in tumor killing. It has a wide spectrum anti-tumor activity and can be used well by itself.