China Races to Find Its First Blockbuster Drug

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Li Chen
Li Chen, co-founder and the chief executive officer of Hua Medicine Ltd. Source: Li Chen via Bloomberg

In his quest to create the first original, billion-dollar drug from a Chinese laboratory, Chen Li is zeroing in on one of the world’s fastest-growing patient groups: diabetes sufferers in China.

There were 114 million of them at last count, more than double a 2010 estimate. Numbers are surging because of changing diets and lifestyles, and a genetic susceptibility to the metabolic disease. Once the top scientist in China with Swiss drugmaker Roche Holding AG, Chen is developing a new treatment for diabetes, which he says afflicts Chinese when they’re younger and thinner than Caucasians.

The unique features of China’s epidemic mean new weapons are needed to fight it, according to Chen. He’s part of a growing wave of so-called sea turtle scientists -- Chinese returning home after years studying and working abroad -- developing medicines specifically for their fellow citizens.

“For too long, innovation in China has meant a ‘me too’ drug,” said Chen, who worked at Roche’s New Jersey research labs before returning to his home country in 2004. “China has no choice but to develop novel drugs, and it will need to be for something that attacks the nation in masses like diabetes or cancer.”

Chen’s company, Hua Medicine Ltd., has raised $46 million since 2010 from some of the most prominent U.S. and China biotechnology investors. Venture capitalist Robert Nelsen, who is a co-founder and chairman of Hua, said he wants the company to emulate the success of Receptos Inc., a San Diego-based biotechnology startup that Celgene Corp. bought this month for $7.2 billion.

Glucose Control

Nelsen’s ARCH Venture Partners was one of Receptos’s early investors, he says, and the returns were among his most lucrative. “Receptos is a good comparison to the value that will be created if the drug works in a large market, but we obviously have to wait for the data,” Nelsen said.

One of Hua’s most advanced experimental medicines is HMS5552. The so-called oral glucokinase activator aims to regulate blood-sugar by improving glucose sensitivity for sufferers of type-2 diabetes, the obesity-linked form that accounts for 90 percent of diabetes cases in China.

Hua licensed the compound from Basel, Switzerland-based Roche, and the Chinese company is now starting mid-stage clinical trials in more than 20 cities across China.

Drugs targeting the glucokinase activator mechanism represent a new approach in diabetes, treatments for which Bloomberg Intelligence estimates will reach $55 billion in sales by 2018.

Lilly Rival

Eli Lilly & Co., based in Indianapolis, announced last year a partnership with Shanghai-based Yabao Pharmaceutical Co. to develop its own experimental glucokinase activator in China.

“The collaboration with Yabao is one of the important steps in growing our diabetes footprint,” Lilly spokeswoman Teresa A. Shewman said in an e-mail. Yabao declined to comment.

Early stage-trials showed Hua’s HMS5552 more effectively controlled blood-glucose over 24 hours and improved glucose sensitivity in Chinese type-2 diabetes patients, better than standard therapy with oral medications, Chen said.

Carbohydrate-loaded diets, a growing taste for fatty fast-foods and inherited genetic factors put Chinese at higher risk of diabetes and impaired glucose tolerance than Caucasians, Chen said. Research published in the Journal of the American Medical Association in 2013 found that as many as half of all adults in China may have elevated blood-glucose levels defined as prediabetes.

Inadequate Control

Drugs such as metformin and Sanofi SA’s Lantus, the world’s best selling diabetes drug, are routinely used in North America and Europe. In China, these therapies effectively control the disease in fewer than half of cases, Chen estimates.

Large variations in blood-sugar, especially excessive levels after eating, in diabetes patients increase the risk of complications such as stroke, heart attack and damage to the kidneys, eyes and peripheral nerves.

If successful in China, Hua would seek to make the drug available across Asia, and as a complementary therapy in North America and Europe, he said.

China’s government has invested heavily in biotechnology, and the investments are starting to pay off, said Elizabeth Krutoholow, a biotech analyst at Bloomberg Intelligence in New York. The value of the industry output’s increased 20 percent to 3.16 trillion yuan ($509 billion) in 2014, the official Xinhua News Agency reported last week.

Hua’s drug has been granted “green channel” status by China’s Food and Drug Administration, which is similar to the U.S. FDA’s “fast track” designation and beneficial in a market where approval delays are common, said Frank Yu, founder and Chief Executive Officer of health-care investment-focused Ally Bridge Group, which led a financing round into Hua this January.

Hua Medicine receives grants from the government to support research and development. “We don’t want to be another Western company opening a China office,” Nelsen said. “The government is very interested in seeing Chinese develop drugs that solve Chinese health problems, and to do that would be a huge victory.”

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