Gendicine

Gendicine
Clinical data
ATC code	None;
Legal status
Legal status	In general: ℞ (Prescription only);

Gendicine is a gene therapy medication used to treat patients with head and neck squamous cell carcinoma linked to mutations in the TP53 gene. It consists of recombinant adenovirus engineered to code for p53 protein (rAd-p53) and is manufactured by Shenzhen SiBiono GeneTech.

Gendicine was the first gene therapy product to obtain regulatory approval for clinical use in humans^[1] after Chinese State Food and Drug Administration approved it in 2003.^[2] As of 2024, Gendicine has not been approved for use in the United States and the European Union.

^ Zhang WW, Li L, Li D, Liu J, Li X, Li W, et al. (February 2018). "The First Approved Gene Therapy Product for Cancer Ad-p53 (Gendicine): 12 Years in the Clinic". Human Gene Therapy. 29 (2): 160–179. doi:10.1089/hum.2017.218. PMID 29338444.
^ Pearson S, Jia H, Kandachi K (January 2004). "China approves first gene therapy". Nature Biotechnology. 22 (1): 3–4. doi:10.1038/nbt0104-3. PMC 7097065. PMID 14704685.

[1] Zhang WW, Li L, Li D, Liu J, Li X, Li W, et al. (February 2018). "The First Approved Gene Therapy Product for Cancer Ad-p53 (Gendicine): 12 Years in the Clinic". Human Gene Therapy. 29 (2): 160–179. doi:10.1089/hum.2017.218. PMID 29338444.

[Gend-2] Pearson S, Jia H, Kandachi K (January 2004). "China approves first gene therapy". Nature Biotechnology. 22 (1): 3–4. doi:10.1038/nbt0104-3. PMC 7097065. PMID 14704685.

[1]

[2]

Clinical data
ATC code	None
Legal status
Legal status	In general: ℞ (Prescription only)