By Bloomberg News
Dec. 12 (Bloomberg) -- The world’s biggest drugmakers are
turning to ancient Chinese remedies to boost product pipelines.
GlaxoSmithKline Plc is testing botanicals -- compounds
extracted from plants -- for immune disorders, Sanofi plans to
turn traditional Chinese medicines into alternative diabetes and
cancer therapies, and Nestle SA teamed last month with
billionaire Li Ka-Shing to develop a drug derived from ancient
Chinese approaches to cure inflammatory bowel disease.
The confluence of China’s growing middle class and
pharmaceutical companies’ need to find new revenue have combined
to give Western drugmakers an increasingly open mind about a
2,500 year-old form of medicine they once scoffed at.
“You have 1.3 billion people, many of whom cannot afford
Western medicines and who believe that traditional Chinese
medicines are good enough,” said Bloomberg Industries analyst
Sam Fazeli. “If they can manufacture it on a meaningful scale,
and do it with the stamp of a Glaxo or a Sanofi on it, perhaps
the consumer will be more interested in buying it than something
that’s boiled up in a vat somewhere.”
China’s market for traditional drugs, excluding raw herbs
and highly purified compounds extracted from herbs, was $13
billion in 2011 and could grow 14 percent annually over the next
five years, according to consultancy McKinsey & Co. Of last
year’s total, $6 billion came from medicines sold over the
counter, accounting for almost half of China’s market for non-
prescription drugs, the consultancy said.

Ancient Recipes

Less stringent U.S. rules for approving plant-based
treatments may give drugmakers a quicker path to creating
medicines, with more than 500 applications to test treatments
lodged with the Food & Drug Administration. Previous attempts to
break down herbal medicines into single ingredients failed to
yield major breakthroughs so Western drugmakers now target
mixtures inspired by ancient recipes to sell globally and in
China, where many are raised to trust traditional methods.
Combining Western science with traditional cures is an
approach that already extends to Glaxo’s research center in
Shanghai. Sick workers can tap an alternative Chinese therapy
using suction cups made of glass, as well as the pharmaceuticals
that generate most of the Brentford, U.K.-based company’s $44
billion of annual sales.

Botanical Treatments

“Traditional medicine has been practiced for thousands of
years but it has always been based on clinical experience and
not so much on clinical evidence like Western medicine,” said
Zang Jingwu, Glaxo’s head of China research and development.
“Our strategy is to integrate existing traditional knowledge of
diseases with modern drug discovery technology.”
The U.S. FDA introduced new guidelines for botanical
treatments in 2004, applying less strict conditions to those
imposed on chemical and biological drugs seeking approval. That
opened up a new avenue for producers to replenish their medical
research pipelines and replace expiring patents.
It’s no longer essential to identify the active
constituents of botanical drugs, while products legally used as
dietary supplements in the U.S. with no known safety issues may
provide “markedly reduced” information on their toxicology,
according to the U.S. regulator.
“Almost all botanicals are complex natural mixtures that
are difficult to have full chemical characterization and will
need flexibility in regulatory approaches,” said Shaw Chen, who
leads the FDA’s botanical review team. The guidelines are
“intended to facilitate more development of new treatments,
especially for unmet medical needs,” he said.

Scaly Skin

The agency has received more than 500 applications to test
drugs under the guidelines, most of which were approved for
human trials, Chen said in an e-mailed response to questions.
Many are in phase three trials, typically the last hurdle to
qualify for approval, with a handful soon to make the final
application to become an allowed drug, he said, declining to be
more precise.
Glaxo’s herbal drugs efforts will focus initially on immune
disorders such as psoriasis, a chronic disease that causes scaly
skin, and drugs that treat inflammation of the digestive system,
according to Zhang Xun, Shanghai-based head of research and
development for the company’s global natural products unit.
“We want to get quickly into the clinical development
stage by collaborating with domestic companies,” said Zhang,
adding that the company will “soon” have a product in
development with a Chinese partner without being more specific.

‘Good Baby’

Sanofi, France’s largest drugmaker, is in talks with the
Hong Kong University of Science and Technology to come up with
“modernized” versions of traditional medicines. These could be
used to treat chronic diseases such as diabetes and cancer, said
Frank Jiang, the company’s head of Asia Pacific research and
development.
The Paris-based company wants to first register new drugs
in China to target local patients before aiming for the global
market through approvals in the U.S.
“If you have a very well-designed clinical trial, with
evidence to show the mixture is better than a placebo in
treating the disease, then in traditional medicine you may have
less issues with getting approved,” Jiang said.
Sanofi has already added traditional Chinese therapies to
its consumer health portfolio after agreeing to buy Beijing-
based BMP Suntone Corp. for $520.6 million in October 2010. The
purchase added the Ha Wa Wa, or Good Baby, brand of children’s
medicines that includes a cough mixture containing ephedra, or
mahuang, a herb that has been boiled into a soup to treat asthma
for thousands of years.

Growing Market

China’s pharmaceuticals market is expected to grow as much
as 18 percent annually to $165 billion by 2016 to make it the
world’s second-largest market after the U.S., according to
consultancy IMS Health Inc. Companies such as Novo Nordisk A/S
and Merck & Co. are spending millions and hiring hundreds of
scientists to study diseases prevalent in China such as diabetes
and cancer.
Initial attempts by Western scientists to develop workable
drugs by extracting single components from herbs failed to yield
major results because much of traditional medicine works as a
mixture of ingredients, said Gao Sihua, president of the Beijing
University of Chinese Medicine.
Combining the scientific standing of western drugmakers
with Chinese methods may overcome consumer doubts about the
value of botanical treatments. The most prominent success came
from artemisinin, which is extracted from sweet wormwood and is
one of the most effective medicines against malaria.

Thunder God

Chinese scientist Tu Youyou received the Lasker Award for
medical research last year for her work with artemisinin.
Novartis AG gained FDA approval to sell the drug in the U.S.
under the brand name Coartem in 2009.
“Western doctors may feel Chinese medicines are not
scientific enough, but we should look at what’s the aim,” said
Gao, who trains aspiring doctors on how to integrate Chinese and
Western practices. “As long as it heals the patient and doesn’t
have strong side effects, then it should be scientific.”
In October, a drug made from a plant known as “thunder god
vine,” or lei gong teng, that has been used in traditional
Chinese medicine, wiped out pancreatic tumors in mice,
researchers at the University of Minnesota’s Masonic Cancer
Center said, and may soon be tested in humans.

50,000 Extracts

Vevey, Switzerland-based Nestle and Hutchison China
Meditech Ltd., a drugmaker controlled by Li Ka-shing, agreed
Nov. 28 to form an alliance to develop gastrointestinal
treatments based on Chinese herbal medicines.
The collaboration gives Nestle’s Health Science unit
exclusive access to Chi-Med’s botanical library of more than
1,500 purified natural products and 50,000 extracts from
medicinal plants.
Chi-Med will begin third phase trials next year for a
herbal extract aimed at treating inflammatory bowel disease.
Tianjin-based Tasly Pharmaceutical Group has already
started the third phase of trials for its Danshen Dripping Pill,
a combination of salvia and notoginseng extracts with synthetic
borneal, according to Henry Sun, Tasly’s vice president. The
drug, used to treat chronic chest pains, passed the second phase
of trials in 2010.
“I don’t think we can make a good impact in the world
until the day we have 10 to 20 different products from
traditional Chinese medicine research, offering clinical
benefits with low toxicity profiles,” Sun said. “By that time,
the image of traditional medicines will be different.”