Pushing biotech boundaries in China

Bruce Einhorn

More news about Chinese doctors pushing the envelope by providing experimental treatment not available in the U.S. I recently wrote a BusinessWeek story about a drug made by a Chinese company, Shenzhen SiBiono, that not only was the first gene-therapy treatment to get the okay in China but also was the first to receive the nod for commercial use anywhere. A U.S. biotech has a similar drug in the works, but the U.S. FDA is rightly concerned about the safety of gene therapy and so progress has been slow.

Now a different Shenzhen company reports what it says is another breakthrough. Beike Biotechnology Co., a joint venture among the Shenzhen city government, the Hong Kong University of Science and Technology, and Peking University (the school in Beijing that still prefers to use the old-fashioned way of Romanizing the city’s name), says that it has successfully been giving stem-cell treatment to an infant from Hungary who suffered a stroke shortly after being born prematurely in July, probably making her the youngest ever stroke victim to receive umbilical stem cells. According to a Beike press release, the baby’s family traveled with her to Shenzhen in October for treatment and now report that she’s making progress back in Hungary. Like SiBiono, Beike is capitalizing on China’s willingness to allow the sort of thing that companies can’t do in the U.S. “Today, treatments for neurological diseases using umbilical cord blood is being taken forward by countries outside the United States, including China, as FDA approval takes longer,” the company reports.

Critics of Chinese medicine have their doubts about the thoroughness of the regulators in the country. Beike's announcement does raise some questions. For instance, it includes an upbeat comment from the baby's doctor back in Hungary, but doesn't mention his or her name. As South Korean stem cell scandal has shown, there are plenty of reasons to be suspicious about sudden breakthroughs. But those doubts haven't stopped hundreds of desperate Westerners from flying to China to get treatments that they hope can save their own lives and lives of family members. With the numbers likely to increase, Chinese companies like SiBiono and Beike are poised to take advantage.

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