Box 1. Box 1 Case study: SiBiono Gene Technologies

SiBiono GeneTech, founded in 1998 by Zhaohui Peng, became the first company in the world to develop and market a gene therapy product. Its recombinant human adenovirus-p53 injection, trademarked as Gendicine, was approved after clinical trials by the SFDA in October 2003 for the treatment of head-and-neck cancer, including nasopharyngeal carcinoma, in combination with radiotherapy.

Peng, who is the company's chairman and CEO, states that since Gendicine's launch in early 2004, the gene therapy has been used to treat over 5,000 patients, including 400 foreign patients seeking treatment in China. Although the product is primarily used for nasopharyngeal carcinoma or other head-and-neck cancers, it has also been used off-label for liver, lung and gastric cancers, and other cancers at a very late or terminal stage. Gendicine is normally injected into solid tumors, although intravenous infusion, arterial infusion and intrathoracic/intraperitoneal infusion are also used, especially for sarcomas and metastatic cancers, which cannot be easily treated by conventional methods, such as surgery.

Gendicine comprises a replication-defective adenovirus vector containing the sequence encoding human p53 tumor suppressor gene. SiBiono spent 150 million RMB ($20 million) for its clinical development and construction of a cGMP facility, which was financed by government support (contributing about one-third of total), bank loans and a small investment from a private firm. To date, SiBiono has filed four international Patent Cooperation Treaty (PCT) patents and filed seven patent applications in China. Five of the Chinese patents are currently pending, whereas two (for product invention and manufacture technology) have already been approved.

SiBiono employs 80 full-time personnel and at the time of the survey had plans to more than double its workforce (mostly in the area of sales and marketing) by the end of 2007. Future plans include expanding testing Gendicine into other indications, especially liver cancer (which has a high disease burden in China and a low survival rate) and seeking international partners to help test and market Gendicine in foreign countries. Included in the company's pipeline is a nonviral (peptide-liposome) gene delivery system aimed at increasing the efficiency and targeting of the therapy, as well as a DNA vaccine against HIV/AIDS being developed in collaboration with DNAVEC (Ibaraki, Japan).

SiBiono reached financial breakeven point in 2005, shortly after the launch of Gendicine. In April 2007, the Chinese pharmaceutical company Benda Pharmaceutical (Hubei, China) acquired a majority stake (57.57%) in SiBiono through its 95% owned China-based subsidiary, Hubei Tongji Benda Ebei Pharmaceutical (Hubei).