AstraZeneca Markets an Herbal-Based Remedy to Expand in China

Astra’s willingness to straddle the murky line between drugs and less-regulated supplements illustrates how determined the U.K. company is to push into the world’s second-biggest pharmaceuticals market. Chief Executive Officer Pascal Soriot began pointing to China as a crucial growth market soon after taking the reins in 2012. The focus has paid off: Sales there last quarter surged 21%, outpacing those in all other regions, led by such innovations as the cancer medicine Tagrisso. Now, with the herbal extract called Xuezhikang, Soriot is looking at China as a source of new treatments, not just as a burgeoning market. Astra says it will consider getting the remedy licensed and sold elsewhere, including the U.S. and Europe.

Under Soriot, the company has jettisoned rights to older, off-patent drugs to focus on ­expensive—and profitable—new medicines for cancer. Yet Ruud Dobber, head of the U.K. drugmaker’s biopharmaceutical unit, says the Luye partnership makes sense because it can help Astra maintain its strength in the market for heart drugs in China, where it also sells the blood thinner Brilinta.

Astra is pushing at least one other relatively cheap, older drug in China. It won a contract to sell its cancer treatment Iressa in bulk to a centralized medicine program for 11 major cities there. The arrangement “creates headwinds for older products,” Soriot said in May. But “the good news for us is that we have critical mass in China.”

Xuezhikang is also approved in Taiwan, Singapore, and Malaysia, according to Luye. But red yeast rice compounds have provoked warnings by some health researchers in Europe because of potential side effects patients may not anticipate.

With the Luye agreement, Soriot is linking Astra to an industry favored by Chinese President Xi Jinping, who’s called for promotion of traditional therapies alongside Western medicine. Soriot has professed admiration for Xi. “A group of people, whether it’s a company or a country, has to have that shepherd person,” he says. “He has a vision for China; he has a vision for the world.”

Some traditional Chinese remedies have turned into valuable medical tools, such as ­artemisinin, a malaria treatment derived from the sweet wormwood plant. Yet such examples are rare, and most big drugmakers have shied away from trying to turn such medicines into profitable products, says Craig Hopp, deputy director of extramural research at the division of the U.S. National Institutes of Health that studies alternative treatments.

A supply of 12 capsules of Xuezhikang costs 17 yuan ($2.50) on the website of Chinese online retailer JD.com. Sales were about $26 million in 2018, according to health-care data from IQVIA Holdings Inc., a fraction of the $2.4 billion revenue in China for cholesterol drugs.

Xuezhikang’s packaging materials say it treats hyperlipidemia, a condition where the blood contains high levels of fat particles such as cholesterol, as well as a host of symptoms ranging from dizziness to anorexia. The drug’s effectiveness comes from monacolins, chemicals in red yeast rice that resemble statins—a class of ­cholesterol-lowering drugs that have ranked among the pharma industry’s most profitable. (Astra makes the statin Crestor.)

European drug officials haven’t cleared red yeast rice or the extract, and a body that ­regulates supplements there warns against their use, particularly without consulting a physician. The U.S. Food and Drug Administration says red yeast rice shouldn’t be used as a substitute for standard heart treatments.

Other than the purchase six years ago of a drug based on chemicals in fish oils that hasn’t recorded sales so far, Astra’s focus has been firmly on innovating medicines in the lab. Even Luye, founded in 1994 by Chinese billionaire Liu Dian Bo, is moving toward devising new treatments. Just last month it sought permission from the FDA to sell a drug for schizophrenia and bipolar disorder. Among its more advanced experimental projects is a collaboration with a U.S. biotech on a therapy for programming immune cells to attack cancers.

On its website, Luye calls Xuezhikang “the first evidence-based and internationally recognized Chinese lipid-­adjusting drug which has completed phase II clinical trials required by FDA.” The company points to studies indicating that it reduces cholesterol with greater safety than statins. But the approach isn’t without risk: Monacolins are linked to the same side effects as those widely used medicines, which can include liver damage and rare cases of muscle tissue breakdown.

While China has revamped regulation of conventional medicines, its National Medical Products Administration doesn’t require many traditional therapies to undergo randomized clinical trials for approval. These studies are the standard in the U.S. and Europe for ensuring safety and effectiveness.

Red yeast rice is unusual among supplements in that it contains a documented active substance. “We’re pretty sure we know what’s in it and how it works, which is rare for a botanical dietary supplement,” says Hopp, the NIH scientist.

Still, some scientists have said there’s a lack of reliable research into Xuezhikang. Studies of traditional Chinese treatments are often of poor quality, according to NIH’s National Center for Complementary and Integrative Health. In a 2012 analysis of 22 studies of Xuezhikang for high cholesterol, most failed to show they’d assigned patients randomly to a treatment group, a key step in removing bias. One of the tests was the China Coronary Secondary Prevention Study, which reported positive results. “More rigorous trials with high quality are needed,” the authors concluded, “especially for comparing the effectiveness and safety between Xuezhikang and statins.”

Kirstin Weider was a resident physician at an internal medicine program in the U.S. last year when a 64-year-old woman came to the hospital saying she’d been tired and had lost her appetite. The woman had recently been diagnosed with high cholesterol and, wary of taking a prescription drug, decided to take a supplement: red yeast rice.

Tests showed the woman was suffering severe liver damage. Doctors stopped her from taking the supplement and gave her anti-inflammatory treatment, and she recovered. “We were lucky that we caught it at a good time,” says Weider, who co-wrote a recent article on the episode in BMJ Case Reports. “It could have potentially had a worse outcome.”

Dobber, Astra’s biopharmaceutical unit chief, says the company is following standard safety protocols as it develops Xuezhikang. “All this will be done with the standards of AstraZeneca,” he says. “We’ll never compromise with the safety aspects.” —With Dong Lyu and Tom Metcalf

©2019 Bloomberg L.P.