Adp53 (Gendicine) 12 Years in Clinic – The First Approved Gene Therapy Product for Cancer

Gendicine (Recombinant Human p53 Adenovirus, AdRSV-p53), developed by Shenzhen SiBiono GeneTech Company, was approved by CFDA in 2003. It has been used in clinical oncology for 12 years since it entered the market in 2004. As the first-in-class product for cancer gene therapy, Gendicine met its expectation and demonstrated with ample clinical data that it is safe and effective for treating cancer. SiBiono manufactured 41 batches in compliant with CFDA QC/QA requirements. Total 169,571 vials (1.0x1012 vector particles per vial) were used in more than 50,000 patients, among them about 5,000 were international form over 50 nations outside China. Comparing with the first-line standard therapies, intratumor injection of Gendicine combined with chemotherapy and radiotherapy resulted in response rate significantly higher than chemo or radiotherapy alone. The approved indication for Gendicine is Head & Neck Cancer, including NPC. However, Gendicine has been successfully applied for various types and at different ...