On Monday, Huya Bioscience International, a San Diego-based biotech company that develops early-stage cancer drugs in China, announced that the Food and Drug Administration will allow the company to test its new cancer compound on humans — the first time that the administration has permitted a drug developed in China to move on to clinical testing.

In my story today, I wrote about Chinese scientists leaving San Diego to work in China’s flourishing biotechnology sector. Huya Bioscience International relies on this trend to identify promising drug candidates in China, and work on bringing them to the global market. I also wrote about concerns over inadequate safety standards for drug production in China.

Huya’s compound is one of thousands of drugs being developed by companies in China who hope to eventually market their products internationally.

Hui Li, principal scientist of medicinal chemistry at Pfizer in San Diego, and president of the Sino-American Biotech & Pharmaceutical Association, which connects Asian professionals working in the Southern California life science industry, said we will probably begin to see a rising number of drugs produced in China and marketed in the United States. But with drug production on the rise in China, Li also warned that regulations need tightening.

“Chinese State Food and Drug Administration doesn’t have the talent, experience, or expertise to do proper monitoring, they don’t know the process as well as the U.S. FDA,” Li said.

“Either SFDA has to recruit more scientists to work in the field, or they have to form solid partnerships with the FDA in order to make sure that safety and regulatory guidelines are implemented to the highest standard in China,” Li said.


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