Genetic Engineering News (GEN)  November 19, 2003

     The State Food and Drug Administration of China granted Shenzhen SiBiono Gene Technologies Co. (Shenzhen, China) approval to produce the world’s first commercially licensed gene therapy, a treatment for head and neck squamous cell carcinoma (HNSCC). The drug license was issued after more than five years of clinical trials. Zhaohui Peng, SiBiono’s founder and CEO, says the drug is marketed under the name Gendicine. SiBiono’s new drug is expected to be commercially launched next January, in what is predicted to be a $100 million market in 2004, adds Peng. SiBiono, founded in 1998, specializes in development of gene therapy products for treatment of a variety of cancers and cardiovascular diseases. The firm operates out of a new 16,000-sq-ft cGMP-compliant facility. This injectable medication, developed using an adenoviral vector, was first produced in roller bottles and parallel-plate reactor systems, before being approved for production using a New Brunswick Scientific Celli-Gene Plus packed-bed perfusion bioreactor, according to officials at the Edison, NJ-based company.
     Genetic Engineering News (GEN), introduced in 1981, was the first publication in the field of biotechnology. It is now the leading and most widely read and largest circulated publication in the biotechnology field worldwide. GEN covers the industrial biotechnology, biopharmaceutical, agricultural, chemical, enzyme, and environmental markets from applied research through commercialization. GEN is the source for news on biotechnology, bioregulation, bioprocess, bioresearch and technology transfer. In addition to news and feature articles, each issue of GEN includes BioProcess Tutorials, New Products, Wall $treet Biobeat, Clinical Trials Update, Collaborations and Agreements, University Gene Beat, People, Calendar and Biotechnology on the World Wide Web.