Gendicine, The First Approved p53 Gene Therapy Product for Cancer: 20 Years Track Record
Gendicine (recombinant human p53 adenovirus), developed by Shenzhen SiBiono GeneTech Co. Ltd., was approved in 2003 by the China Food and Drug Administration (CFDA) as a first-in-class gene therapy product to treat head and neck cancer, and entered the commercial market in 2004. The global cancer gene therapy market size was valued at USD 1.68 billion in 2021 and is expected to expand at a compound annual growth rate (CAGR) of 20% from 2022 to 2030. The growth of the market is attributed to factors such as the growing demand for gene therapy and an increased incidence of cancer cases across the globe. Gendicine is a biological therapy that is delivered via minimally invasive intratumoral injection, as well as by intracavity or intravascular infusion. The wild-type (wt) p53 protein expressed by Gendicine-transduced cells is a tumor suppressor that is activated by cellular stress, and mediates cell-cycle arrest and DNA repair, or induces apoptosis, senescence, and/or autophagy, dep...