• 1/9/2008
  • Brooklin, Ontario, Canada
  • staff
  • CancerPage.com

China’s booming medical biotechnology industry is producing controversial drugs and gene therapy treatment programs that are being sought out by 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 Center 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 said. It is a 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 US 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 US$3 billion in biopharmaceuticals, dwarfed by the $59 billion in sales by US biotechnology companies 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 commercialized 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.

“China is not just a low-cost manufacturer. It is investing in drug research and development,” said co-author Sarah Frew, a research associate at the McLaughlin Rotman Center for Global Health. “There are many innovative products either on the market or close to being marketed.”

Shanghai’s Sunway Biotech Company has developed a gene therapy treatment for cancer called H101, which is licensed by Onyx Pharmaceuticals Inc of California. Sunway did all of the clinical development and trials and brought the product to market far faster and less expensively than Onyx could have, she said.

Experts note that China is the world leader in gene therapy simply because US and European companies have much tougher safety and efficacy requirements.

Gene therapies use genetically engineered viruses to transport genetic material into the nucleus of cells that are malfunctioning. No such therapy has been approved by US regulators as safe and effective. Human testing has been temporarily stopped several times in the US and Europe because of patient deaths.

“Regulations to protect patients in China are considerably weaker than in the US,” said Peter Laurie, deputy director of Public Citizen’s health research group, a Washington-based non-profit watchdog group.

A few years ago, US researchers working in China deliberately infected Chinese AIDS patients with malaria in hopes the resulting malarial fever would destroy the AIDS virus. Such experiments are illegal in the US, and widely considered dangerous and unethical, Laurie said.

“Any foreign company doing clinical trials or clinical research in China is ethically suspect unless it’s doing so to improve the health of people there,” he said.

International standards for drug testing are rigorous, time-consuming and expensive, but they are crucial to protect patients, he added.

Frew says China’s drug safety regulator, the SFDA, is modeled on the US Food and Drug Administration. “The standards are quite high but enforcement has been tainted by corruption,” she said.

Last July, Zheng Xiaoyu, the head of the SFDA, was executed for taking bribes from companies to approve their products, including an antibiotic that killed several people. Since that scandal, the SFDA has been much stricter and more serious about rebuilding its credibility, said Frew.

However, China’s researchers do not always follow international standards and are unlikely to be able to export their products or therapies to the developed world in the near future. That’s one reason why China’s medical biotech hasn’t grown faster.

The study notes that international investors see enormous potential in the sector to become the world’s pharmacy for generic drugs and the next generation of drug and treatment blockbusters. But there has been little outside investment thanks to poorly enforced regulations and China’s uncertain financial system, rigid restrictions on the export of capital and continuing doubts about the Chinese government’s protection of intellectual property rights.

“China still has one foot in the closed society of the past,” said Singer. “For the sake of both national and global health, we hope China will embrace the financial and regulatory reforms needed to attract the venture capital required for sustained innovation in the health biotech sector.”