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.
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.
“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.
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.
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.
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.
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.
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.”
— With assistance by Daryl Loo