PARIS (AFP) — 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.
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.