The history of gene therapy drugs approval on the market

by Alexey Bersenev on December 21, 2011 · 4 comments

in gene transfer

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The history of clinical gene therapy is very exciting, but also very bumpy. Despite many ongoing clinical trials on the late phases, marketing approval was nearly unachievable. The first gene therapy product was approved in 2003 in China. Very recently, the first gene therapy product was approved outside of China. The timeline of gene therapy products approved on the market below.

  1. 2003Gendicine (Shenzhen SiBiono GeneTech, now incorporated into Benda Pharmaceutical, Wuhan, China). Wild-type p53 gene (Ad-p53) for the treatment of head and neck cancer.
  2. 2005Oncorine (Shanghai Sunway Biotech, Shanghai, China). E1B-defective Ad for the treatment of head and neck cancer.
  3. 2011Neovasculogen (Human Stem Cell Institute, Moscow, Russia). VEGF for treatment of peripheral arterial disease (PAD) and its complication critical limb ischemia (CLI).

So, there are only 3 gene therapy products on the market worldwide. About first two Chinese products you can read here and here. About the Russian approval you can read an interview with CEO of the company.

The significance of the recent gene therapy drug approval in Russia:

  • first outside of China
  • first outside of oncology field
  • first gene product approved after long (6 years) break
  • the candidate to be considered as the first gene therapy drug for regenerative medicine

I think, approval of Neovasculogen is the most important event in gene therapy field this year. Unfortunately, despite notable significance, mass media and professional community largely ignored news about Neovasculogen approval.

{ 4 comments… read them below or add one }

Christopher Bravery November 13, 2012 at 4:13 am

About 18 months or so ago I came up with this list:
Gendicine Head and neck cancer SiBiono GeneTech China 2004
Oncorine Head and neck cancer Sunway Biotech Co. China 2006
Rexin-G Metastatic cancers Epeius Biotechnologies Phillapines 2007
Collategene CLI and Buerger’s disease “Vical Incorporated (AnGes MG, Inc.)” Japan Pending

Wonder what happened to Collategene? I seem to recall Rexin-G was difficult to confirm (so may be in doubt).


Christopher Bravery November 13, 2012 at 5:58 am
Alexey Bersenev November 14, 2012 at 1:15 am

Thanks for info Chris!
Any comment on proposed ridiculous cost of Glybera?


Christopher Bravery November 14, 2012 at 4:33 am

Not really, I’ve seen some of the speculation. Bearing in mind this is an exceptional circumstances approval there will be considerable additional commitment to continue development (additional clinical data) which will be costly, so they may well need the money.


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