{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,22]],"date-time":"2026-10-22T12:18:06Z","timestamp":1792671486656,"version":"4.5.0"},"reference-count":199,"publisher":"SAGE Publications","issue":"2","license":[{"start":{"date-parts":[[2018,2,1]],"date-time":"2018-02-01T00:00:00Z","timestamp":1517443200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Human Gene Therapy"],"published-print":{"date-parts":[[2018,2]]},"abstract":"<jats:p>\n                    Gendicine (recombinant human\n                    <jats:italic toggle=\"yes\">p53<\/jats:italic>\n                    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. 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, depending upon cellular stress conditions. Based on 12 years of commercial use in &gt;30,000 patients, and &gt;30 published clinical studies, Gendicine has exhibited an exemplary safety record, and when combined with chemotherapy and radiotherapy has demonstrated significantly higher response rates than for standard therapies alone. In addition to head and neck cancer, Gendicine has been successfully applied to treat various other cancer types and different stages of disease. Thirteen published studies that include long-term survival data showed that Gendicine combination regimens yield progression-free survival times that are significantly longer than standard therapies alone. Although the\n                    <jats:italic toggle=\"yes\">p53<\/jats:italic>\n                    gene is mutated in &gt;50% of all human cancers,\n                    <jats:italic toggle=\"yes\">p53<\/jats:italic>\n                    mutation status did not significantly influence efficacy outcomes and long-term survival rate for Ad-\n                    <jats:italic toggle=\"yes\">p53<\/jats:italic>\n                    -treated patients. To date, Shenzhen SiBiono GeneTech has manufactured 41 batches of Gendicine in compliance with CFDA QC\/QA requirements, and 169,571 vials (1.0\u2009\u00d7\u200910\n                    <jats:sup>12<\/jats:sup>\n                    vector particles per vial) have been used to treat patients. No serious adverse events have been reported, except for vector-associated transient fever, which occurred in 50\u201360% of patients and persisted for only a few hours. The manufacturing accomplishments and clinical experience with Gendicine, as well as the understanding of its cellular mechanisms of action and implications, could provide valuable insights for the international gene therapy community and add valuable data to promote further developments and advancements in the gene therapy field.\n                  <\/jats:p>","DOI":"10.1089\/hum.2017.218","type":"journal-article","created":{"date-parts":[[2018,1,17]],"date-time":"2018-01-17T01:04:55Z","timestamp":1516151095000},"page":"160-179","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":307,"title":["The First Approved Gene Therapy Product for Cancer Ad-\n                    <i>p53<\/i>\n                    (Gendicine): 12 Years in the Clinic"],"prefix":"10.1177","volume":"29","author":[{"given":"Wei-Wei","family":"Zhang","sequence":"first","affiliation":[{"name":"LifeTech Biosciences Group, Hong Kong."},{"name":"Angionetics, Inc., San Diego, California."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Longjiang","family":"Li","sequence":"additional","affiliation":[{"name":"State Key Laboratory of Oral Disease, West China Hospital of Stomatology, Sichuan University, Chengdu, China."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dinggang","family":"Li","sequence":"additional","affiliation":[{"name":"Beijing Haidian Hospital Center for Cancer Gene Therapy, Beijing, China."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jiliang","family":"Liu","sequence":"additional","affiliation":[{"name":"Shenzhen Hengsheng Hospital Cancer Center, Shenzhen, China."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiuqin","family":"Li","sequence":"additional","affiliation":[{"name":"China Medical University Shengjing Hospital Department of Obstetrics and Gynecology, Shenyang, China."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wei","family":"Li","sequence":"additional","affiliation":[{"name":"Shenzhen SiBiono GeneTech Co. 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Ltd., Shenzhen, China."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wei","family":"Xu","sequence":"additional","affiliation":[{"name":"Shenzhen SiBiono GeneTech Co. Ltd., Shenzhen, China."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dominic Man-Kit","family":"Lam","sequence":"additional","affiliation":[{"name":"LifeTech Biosciences Group, Hong Kong."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2018,2]]},"reference":[{"key":"e_1_3_3_2_2","unstructured":"Brief Report First gene therapy medication approved. (Gendicine developed by Shenzhen SiBiono Gene Technologies). 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