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R&D Platform for genetic engineering drugs

Genetic engineering drugs refer to those human adapted peptide or protein drugs made by expressing function specific genes or their re-engineered forms into cells via the use of recombinant DNA technology and computer aided design technique for the purpose of disease prevention or treatment. Two technical systems have been established in this platform, one is prokaryotic cell expression system, another is Eukaryotic cell expression system. In this platform, many kinds of technical challenge have been broken through, such as high density ferment and over expression in bacteria or in mammalian cells, protein refolding on large scale, and protein purification technology. Chinese state 863 funds for thematic subject and important subject of lymphotoxin (R&D for new type lymphotoxin 2001AA215051, clinical research for new type lymphotoxin 2002AA2Z3309/2005AA2Z3G10) have been accomplished in this platform as well. The key technical research work of mammalian cell industrialized culture and drug manufacture 2009ZX09503-012, which is one of the Chinese state new drug development subjects, is now being taken in this platform too.

Based on this platform, FDZJ has successfully developed several genetic engineering drugs as below:

recombinant human lymphotoxin α derivative(rhLT28-171, Chinese state 863 fund subject, in clinical phase II research stage)

recombinant human tissue-type plasminogen activator derivative(reteplase, This subject was approved to clinical research by Chinese SFDA in April 2002. It has been transferred to another pharmaceutical company in China, and be approved to market stage by Chinese SFDA in 2007.)

recombinant human parathyroid hormone 1-34(rhPTH1-34, This subject was approved to clinical research by Chinese SFDA in August 2004. Now, the clinical research is being carried.)

recombinant human interleukin-1 receptor antagonist(rhIL-1RA, This subject was approved to clinical research by Chinese SFDA in August 2004. Now, the clinical research is being carried.)

recombinant human TNF receptor p75-Fc fusion protein(Etanercept, This subject was approved to clinical research by Chinese SFDA in May 2005. It has been transferred to two pharmaceutical companies, one is in Shandong province China, another is in Taiwan China. It’s clinical research is being carried now.)

recombinant humanized anti human Her2 monoclonal antibody(Fderceptin, in pre-clinical pharmic research stage.)

recombinant human TNF receptor p75-Fc fusion protein mutant(Hitenercept, the pre-clinical pharmic research work of this subject has been accomplished, and the pre-clinical pharmacology      & pharmacokinetics trials are being carried now.)

Two research papers about recombinant human lymphotoxin α have been published in the Journal of “Cancer Biology & Therapy” recently. One is entitled "Indomethacin enhances the cytotoxicity of recombinant human lymphotoxin α on tumor cells by suppressing NF-κB signaling" Cancer Biology & Therapy 6:9, 1-6, September 2007. And another is named “Platinums sensitize human epithelial tumor cells to lymphotoxin α by inhibiting NFκB-dependent transcription”, Cancer Biology & Therapy 7:9, 1-8, September 2008.

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