Gene therapy finds welcoming environment in China
3/1/2006 Beijing, China Hepeng Jia [email protected] Are China's regulations too lax? China in November became the first country to have approved two drugs based on gene therapy. The approvals have fueled quick growth in the field, but they may be a sign that China's drug regulation is too lax, experts caution. China's State Food and Drug Administration in October 2003 approved Gendicine to treat head and neck cancers. The drug uses an adenovirus to deliver the tumor suppressor gene p53 into tumor cells. Ins November 2005, the agency approved Shanghai Sunway Biotech's H101, also an adenovirus, which targets cancer cells that lack p53. More than 50% of all cancers have abnormal expression of p53 (Oncology 13, 148–154; 1999). In the West, the approach to gene therapy has been cautious since the death in 1999 of 18-year-old Jesse Gelsinger in a gene therapy trial at the University of Pennsylvania. More recently, French researchers used the technique to treat ten children with the so-called 'bubble boy' disease, but that trial was put on hold in 2003 after two of the children developed leukemia. In China, however, both the government and the public have embraced the technology. The success of the two approved products has boosted the number of gene therapy trials in China from 5 in late 2003 to 19 in 2006. "The huge numbers of highly cooperative patients, the low cost for research and clinical trials and the positive support from the government has enabled China to lead the world in [...]