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China approves first gene therapy

Nature Biotechnology volume 22, pages 3–4 (2004)Cite this article

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On October 16, 2003, Shenzhen SiBiono GenTech (Shenzhen, China), obtained a drug license from the State Food and Drug Administration of China (SFDA; Beijing, China) for its recombinant Ad-p53 gene therapy for head and neck squamous cell carcinoma (HNSCC)—a cancer that accounts for about 10% of the 2.5 million annual new cancer patients in China. Sold under the brand name Gendicine, the world's first commercial gene therapy uses an adenoviral vector and cost the company more than RMB 80 ($9.6) million to develop in addition to research grants they received from government.

“We have had more than five years of clinical trials, and the only side effect of Gendicine is self-limited fever,” says Zhaohui Peng, chairman and CEO of SiBiono. After eight weeks of a joint treatment of radiotherapy and weekly gene therapy injections, 64% of late-stage HNSCC tumors experienced complete regression and 32% experienced partial regression.

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  1. Joint reporting from Sue Pearson, Hitchin, UK

    Sue Pearson, Hepeng Jia & Keiko Kandachi

  2. Keiko Kandachi, Tokyo

    Sue Pearson, Hepeng Jia & Keiko Kandachi

  3. Hepeng Jia, Beijing

    Sue Pearson, Hepeng Jia & Keiko Kandachi

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Pearson, S., Jia, H. & Kandachi, K. China approves first gene therapy. Nat Biotechnol 22, 3–4 (2004). https://doi.org/10.1038/nbt0104-3

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