China's medicines authority (China State Food & Drug Administration, SDFA) approved the cancer therapy after it achieved promising results in a clinical trial on October 16, 2003. The treatment, called Gendicine, has been launched commercially by SiBiono GeneTech Co. of Shenzhen, Guangdong province. Gendicine was approved for the treatment of head and neck squamous cell carcinoma. The gene therapy product is an adenovirus vector carrying the p53 tumour-suppressor gene. Gendicine is similar to Advexin developed by the Texas-based Introgen Therapeutics. Advexin is still waiting for FDA approval.
The results of the Gendicine clinical trial are published in Human Gene Therapy, says Zhaohui Peng, the SiBiono company's founder and head. Gendicine's approval was announced earlier but has gone largely unnoticed outside China (see also China approves first gene therapy. There were concerns about the approval among researchers elsewhere in the world as to quality of the trials performed and thereby the safety and efficacy of the treatment (Controversial Chinese gene-therapy drug entering unfamiliar territory). The available clinical data and conclusions drawn were obtained from a relatively small number of patients in clinical trials. There have been more patients treated, but the clinical data of these patients are hard to access, partly due to the fact that they were published only in Chinese journals. Furthermore, it seemed that approval had been made on the basis of tumour shrinkage rather than extension of patient lifetime (An update on gene therapy in China). Despite these concerns, patients have flown to China to undergo therapy (see Medical Tourism)
Shanghai Sunway Biotech Co. Ltd. announced in November 2005 that the SFDA has approved Oncorine (H101), an oncolytic adenovirus, to be used in combination with chemotherapy as a treatment for patients with late stage refractory nasopharyngeal cancer. This marks the first oncolytic viral therapy approved by any regulatory agency in the world and this is the second commercial gene therapy product. H101 is essentially a modified version of Onyx-015, initially developed by Onyx Pharmaceuticals. Besides Oncorine, Shanghai Sunway Biotech develops a tumor-targeted recombinant adenovirus injection (H102) and an oncolytic recombinant adenovirus injection (H103) for treatment of cancer. H102 specifically targets primary hepatocellular carcinoma. H103 adenoviruses lyses the tumor cells and expresses Hsp70 that can potently stimulate an antitumor immune response.
See the following reviews regarding the developments of gene therapy in China:
- Current status of gene therapy in Asia
- Gene medicine for cancer treatment: commercially available medicine and accumulated clinical data in China
- Gene Therapy in China - From a Dutch perspective (2010). This study was initiated by The Netherlands Commission on Genetic Modification (COGEM) to retrieve information from Chinese sources, esp. Chinese literature databases, Chinese scientists, scientific meetings in China, on gene therapy developments and risk assessment.