The first-ever gene therapy product to treat head and neck squamous cell carcinoma (HNSCC), namely Gendicine (recombinant human p53 adenovirus), was developed by Shenzhen SiBiono GeneTech Co. Ltd. Gendicine entered the commercial market in 2004 following approval by the China Food and Drug Administration (CFDA) a year earlier. The gene discussed is TP53; the disease is head and neck squamous cell carcinoma.