Biotech Cancer Therapy Gets Approval in China
Posted on: Sunday, 20 November 2005, 12:00 CST
By Andrew Pollack
A cancer therapy using a virus that attacks tumor cells but not healthy ones has been approved in China, the first regulatory approval for this type of treatment anywhere in the world, according to the company that developed the treatment.
The drug is essentially a copy of one developed and then abandoned by an American biotechnology company. The move in China is an example of how some therapies can win quick approval there, perhaps because regulatory hurdles are lower. China is also the only country so far to have given regulatory approval to any gene therapy.
The Chinese company, Shanghai Sunway Biotech, received clearance to sell its drug, H101, in China as a treatment for a type of head and neck cancer, according to a news release prepared by Sunway that it was expected to issue soon.
H101 uses a type of cold virus that has been genetically engineered so that it attacks only cells with a particular genetic defect typical of cancer cells. It is a modified version of Onyx- 015, a treatment initially designed and tested in early clinical trials by Onyx Pharmaceuticals, a biotechnology company in Emeryville, California.
Although the approach generated excitement among scientists, there were some problems putting it into practice. Onyx dropped Onyx- 015 in 2003, in part to devote its resources to a more conventional drug that is awaiting approval from the U.S. Food and Drug Administration.
Onyx was not aware at the time, however, that scientists at Sunway had duplicated the approach on the basis of a paper published by Onyx scientists, according to Sunway executives and to Frank McCormick, Onyx's founder and the main inventor of the technology.
Because Onyx had no patent in China, Sunway was not infringing. But earlier this year, after revealing itself to Onyx, Sunway licensed worldwide rights to Onyx-015. It said it wanted to conduct clinical trials aimed at winning approval for the drug in the United States and Europe.
Source: International Herald Tribune
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