Gendicine, the first approved gene therapy product (adenovirus p53)
Gendicine, primer producto de terapia génica aprobado (adenovirus p53)
- Date
- 2003 · confidence high
- Place
- Shenzhen, Guangdong, China
- Credited to
- Peng Zhaohui and Shenzhen SiBiono GeneTech
- Field
- Life & health
⚠️ Disputed: the sources disagree.
What it is
Recombinant adenoviral vector carrying the tumour-suppressor gene p53, injected into head and neck tumours. China's SFDA approved it in October 2003, the first gene therapy drug authorised for clinical use in the world.
Approved by the SFDA without randomised phase III trials to Western standards; its efficacy and safety have been questioned and it was never approved by the FDA or EMA. It is cited as the first by date of authorisation, not by strength of evidence.
What it led to
- gene therapies approved in the EU (Glybera, 2012) and the US (Luxturna, 2017)
- adenoviral oncolytics (Oncorine, China, 2005)
- debate on approval standards and efficacy