title: The application of gene therapy in China.
abstract: Since the 1990s, gene therapy has been broadly applied in the treatment of life-threatening diseases, including infectious disease, cancer, cardiovascular disease and hereditary diseases. China in particular has become a competitive marketplace for the development of biotechnology and gene therapy products. This article provides an overview of the regulatory guidance for gene therapy research, product development and commercialization in China. The first approved gene therapy product, recombinant human adenoviral p53 injection (Gendicine), is highlighted as an example of the innovation occurring in the field in China.
authors.affiliation: Shenzhen SiBiono GeneTech Co Ltd, Langshan Road, Shenzhen Hi-Tech Industrial Park North, Shenzhen 518057, People's Republic of China. sbn518057@hotmail.com
authors.forename: Zhaohui
authors.initials: Z
authors.lastname: Peng
authors.forename: Qing
authors.initials: Q
authors.lastname: Yu
authors.forename: Li
authors.initials: L
authors.lastname: Bao
mesh_terms: D000256:Adenoviridae / Q000235:genetics; D002681:China; D004059:Diffusion of Innovation; D015316:Genetic Therapy / Q000331:legislation & jurisprudence* / Q000639:trends; D005822:Genetic Vectors; D033161:Government Regulation; D006291:Health Policy / Q000639:trends; D006801:Humans; D007880:Legislation, Drug / Q000639:trends; D017410:Practice Guidelines as Topic; D011994:Recombinant Proteins / Q000627:therapeutic use; D016159:Tumor Suppressor Protein p53 / Q000235:genetics / Q000627:therapeutic use
chemical_list: D011994:Recombinant Proteins; C495901:TP53 protein, human; D016159:Tumor Suppressor Protein p53