In October 2003, China’s State Food and Drug Administration (SFDA) approved a gene therapy product (recombinant human p53 agent) for the treatment of head and neck squamous cell carcinoma (HNSCC).12–14 It can be delivered via numerous routes including intratumoral or intravenous injection, intrapleural and intraperitoneal infusion, intracavity or intravascular infusion, hepatic and lung artery infusion, and endotracheal and intravesical instillation.15

Recombinant human p53 is a replication-incompetent, recombinant, human adenovirus of serotype 5 designed to contain the human wild-type p53 tumor-suppressor gene. It is produced using a cell line that was subcloned from the human embryonic kidney (HEK) cell line 293.12

Over 12 years of commercial use of Gendicine in >30,000 patients, and >30 published clinical studies, it has demonstrated a favorable efficacy and safety profile in HNSCC and other cancer types.13