Gendicine

{{Short description|Gene therapy medication}}

{{Use dmy dates|date=June 2023}}

{{Primary sources|date=June 2018}}

{{Infobox drug

| drug_name =

| INN =

| type =

| image =

| width =

| alt =

| caption =

| gt_target_gene =

| gt_vector =

| gt_nucleic_acid_type =

| gt_editing_method =

| gt_delivery_method =

| pronounce =

| tradename =

| Drugs.com =

| MedlinePlus =

| licence_CA =

| licence_EU =

| DailyMedID =

| licence_US =

| pregnancy_AU =

| pregnancy_AU_comment =

| pregnancy_category =

| dependency_liability =

| addiction_liability =

| routes_of_administration =

| class =

| ATCvet =

| ATC_prefix = None

| ATC_suffix =

| ATC_supplemental =

| biosimilars =

| legal_AU =

| legal_AU_comment =

| legal_BR =

| legal_BR_comment =

| legal_CA =

| legal_CA_comment =

| legal_DE =

| legal_DE_comment =

| legal_NZ =

| legal_NZ_comment =

| legal_UK =

| legal_UK_comment =

| legal_US =

| legal_US_comment =

| legal_EU =

| legal_EU_comment =

| legal_UN =

| legal_UN_comment =

| legal_status = Rx-only

| bioavailability =

| protein_bound =

| metabolism =

| metabolites =

| onset =

| elimination_half-life =

| duration_of_action =

| excretion =

| CAS_number =

| CAS_supplemental =

| PubChem =

| IUPHAR_ligand =

| DrugBank =

| ChemSpiderID =

| UNII =

| KEGG =

| ChEBI =

| ChEMBL =

| NIAID_ChemDB =

| PDB_ligand =

| synonyms =

| IUPAC_name =

| chemical_formula_ref =

| chemical_formula =

| C= | H= | Ag= | Al= | As= | Au= | B= | Bi= | Br= | Ca= | Cl= | Co= | F= | Fe= | Gd= | I=

| K= | Li= | Mg= | Mn= | N= | Na= | O= | P= | Pt= | S= | Sb= | Se= | Sr= | Tc= | Zn= | charge=

| molecular_weight =

| molecular_weight_comment =

| SMILES =

| StdInChI =

| StdInChI_comment =

| StdInChIKey =

| density =

| density_notes =

| melting_point =

| melting_high =

| melting_notes =

| boiling_point =

| boiling_notes =

| solubility =

| sol_units =

| specific_rotation =

}}

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{{cite journal | vauthors = Zhang WW, Li L, Li D, Liu J, Li X, Li W, Xu X, Zhang MJ, Chandler LA, Lin H, Hu A, Xu W, Lam DM | display-authors = 6 | title = The First Approved Gene Therapy Product for Cancer Ad-p53 (Gendicine): 12 Years in the Clinic | journal = Human Gene Therapy | volume = 29 | issue = 2 | pages = 160–179 | date = February 2018 | pmid = 29338444 | doi = 10.1089/hum.2017.218 | doi-access = free }} after Chinese State Food and Drug Administration approved it in 2003.{{cite journal | vauthors = Pearson S, Jia H, Kandachi K | title = China approves first gene therapy | journal = Nature Biotechnology | volume = 22 | issue = 1 | pages = 3–4 | date = January 2004 | pmid = 14704685 | pmc = 7097065 | doi = 10.1038/nbt0104-3 }} As of 2024, Gendicine has not been approved for use in the United States and the European Union.

__TOC__