Jan 7 (IPS) – China’s booming medical biotechnology industry is producing controversial drugs and gene therapy treatment programmes for domestic use, as well as to treat critically ill foreigners seeking potential cures unavailable elsewhere.

China’s Beike Biotechnologies harvests stem cells from the umbilical cord or amniotic membrane and injects them into patient’s spinal region. More than 1,000 patients, including 60 foreigners, have been treated for a variety of conditions including Alzheimer’s disease, autism, brain trauma, cerebral palsy and spinal cord injury, according to a study published Monday in the journal Nature Biotechnology.

“We met foreigners there who were happy with Beike’s treatments,” said Peter Singer of the McLaughlin-Rotman Centre for Global Health at the University of Toronto and co-author of the study.

However, China’s regulatory agency, the State Food and Drug Administration (SFDA), did not require clinical trials, making it difficult to evaluate the efficacy of these therapies, Singer told IPS.

It is an extraordinarily controversial approach and Beike and others in China would be considered “rogue companies” in North America or Europe, he said.

Although less than 10 years old, China’s medical biotech industry has become both an innovator and a place where the world’s biggest pharmaceutical companies contract out their very expensive clinical research and trials. One of China’s largest firms, WuXi PharmaTech, is listed on the New York Stock Exchange and recently acquired a U.S. biologics firm.

“The Chinese biotechnology industry is like a baby dragon, which will grow quickly and soon become hard to ignore,” Singer said.

In 2007, China had sales of 3 billion dollars in biopharmaceuticals, while U.S. biotechnology companies had sales of 59 billion dollars in 2006, according to the accounting firm Ernst & Young LLP.

Singer and colleagues interviewed 22 Chinese companies to obtain the first detailed analysis of developments in the rapidly growing but largely unknown health biotech sector.

Spurred by government investment, China developed the world’s first commercialised gene therapy product called Gendicine. It is used in the treatment of head and neck cancers and more than 5,000 patients have been treated so far, about 400 of them from overseas. The drug is currently undergoing further clinical trials in China for several new indications, including liver, abdominal and pancreatic cancer.

Chinese firms are also developing vaccines to address both local and global needs. They include Shanghai United Cell Biotech, which is manufacturing and marketing one of only two oral cholera vaccines available worldwide (and the only one available in tablet form). Other firms are working on an oral HIV vaccine and novel vaccines against Japanese Encephalitis, SARS and pandemic avian influenza (H5N1 strain).

However, China’s primary focus is on meeting the health needs of its 1.3 billion inhabitants.

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