Researchers ask: Is China the sleeping giant of biotech?

[AlaskaDenise]

China's biotech sector accounts for just a sliver of its pharmaceutical industry and operates under the cloud of a massive review of licenses issued under a regulator executed last year for accepting bribes.

Even so, experts say, Chinese purveyors of genetically engineered drugs and vaccines -- targeting everything from cancer to Alzheimer's -- are growing at a frenzied pace and are likely to become major actors on the world stage.

"There is no question that the sector is established," said Peter Singer of the McLaughlin-Rotman Centre for Global Health in Toronto who was lead researcher of a study published Monday in Nature Biotechnology.

"What we found really surprising is that in an industry that's only 10 years old, China has innovative products on the market," he told AFP.

For their study, Singer and his colleagues selected 22 small- and medium-sized biotech firms from literally thousands operating in the health sector for close scrutiny. They looked for companies that were innovative, both scientifically and in business.

The portrait that emerged is of a dynamic sector that has been growing 30 percent annually over the past decade, reaching a turnover of three billion dollars in the domestic market in 2005.

Yet its activity is dominated by a few big stars and remains dogged by doubts as to its integrity.

It is also a sector led in large measure by "sea turtles" ("hai gui") -- Chinese-born scientists with a decade or two of US or European lab experience under their belts who have come home to found Chinese companies, often with generous backing from the government.

<MEDIA media-type="image"><MEDIA-REFERENCE mime-type="" data-location="#photo1" /></MEDIA>In a market of one billion potential patients, 15 biotech products for health are already on the market, with another 60 in the pipeline, Singer said.

Exhibit A: Gendicine, the first gene therapy product approved after clinical trials anywhere in the world.

A recombinant human adenovirus, Gendicine carries the p53 gene and is administered by injection directly into cancerous tumours in the head and neck, including nasopharyngeal carcinoma.

More than 5,000 patients have received the treatment in combination with radiotherapy, including 400 foreign patients from outside China.

The company became profitable shortly after the launch of the product, approved in 2005 by China's State Drug and Food Administration (SDFA).

That, as it turns out, was not an unimpeachable recommendation.

The SDFA's former director, Zheng Xiaoyu, was executed in July 2007 for accepting bribes in return for issuing drug approvals without proper review.

As a result, a staggering 170,000 licenses granted by the SDFA, especially between 1999 and 2002, are currently under review.

Another company, Shenzhen Beike Technologies, provides a treatment based on umbilical cord and bone marrow stem cells for Alzheimer's, autism, brain trauma, cerebral palsy and spinal cord injury, as well as a dozen other diseases and conditions. The medication is injected directly into the spinal cord of patients.

"There is no need to do clinical trials for this kind of procedure in China," said the study's lead author, Sarah Frew, also a researcher at McLaughlin-Rotman.

"The approach this company is taking is trying the thing on patients rather than doing scientific research," added Singer.

The product has nonetheless been a commercial success, first with Chinese patients and more recently with international patients. When Frew visited the clinic a year ago, there were a dozen foreigners present.

The company's website is filled with glowing testimonials on the effectiveness of the treatment, which costs tens of thousands of dollars.

In most cases the therapies and vaccines developed in China are far less controversial. Indeed, more than 90 percent of products produced in the health biotech sector are biogenerics, with novel products accounting for 3-to-5 percent of the total.

A more recent development are international joint ventures and investment. Shenzhen Chipscreen Biosciences, for example, has developed an anti-cancer drug in cooperation with Huya Bioscience, based in San Diego, California. Once the medication is on the market, the Chinese partner will hold the rights for China, while Huya can lay claim to the rest of the world.

WuXi PharmaTech, which was listed on the New York Stock Exchange in the summer of 2007, is the first biotech service company in China with major foreign clients, including US pharmaceutical giant Merck and Britain's AstraZeneca.

The fact that WuXi has attracted such companies "punctures a little bit the legend that there is no intellectual property in China," said Singer.

Another myth that may soon fall by the wayside is that China can only reproduce what other have done already.

"There is no longer a hegemony on the part of industrialised countries in global biotech innovation," Singer said.

A bottle containing a vaccine against bird flu from Beijing-based pharmaceutical company Sinovac Biotech.

http://www.citizen.co.za/index/Article.aspx?pDesc=1,1,22&Type=top&File=080107202909.h8o32uet.xml

[AlaskaDenise]

Re: Researchers ask: Is China the sleeping giant of biotech?

Experimental drugs flourish in China

BROOKLIN, Ontario, Canada - 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."

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