Chinese Government Approves Sale of a Domestic AIDS Drug

The Chinese government approved for the first time production and sale of an AIDS drug by a domestic company, potentially making cheaper HIV drugs available in China. Northeast General Pharmaceutical Factory, a state-owned drug manufacturer, said last week that the State Drug Administration approved production and sale of AZT in China.

AZT was the first approved AIDS drug in the United States and is now used along with other drugs in a cocktail to treat patients. "We think there is a real portion of patients who will use this medicine, and we have faith that sales will go well," said Shi Yanling, an executive in the company's information department.

China has lagged behind developing nations such as Brazil and India in pushing for reduced prices for medicines to treat HIV. The approval of the AZT drug is the first in what Beijing maintains will be fast-track approval for drugs to treat AIDS. It is expected that the approval may spark China's burgeoning generic drug industry to make a broader range of drugs available at affordable prices. Other drug manufacturers have received government approval to waive clinical trials and one, Shanghai Desano Biopharmaceutical Co., has been approved to generically produce and sell the AIDS drug ddI.

The production of AZT sidesteps the sticky issue of patent violation because the patent protection in China for AZT, which was developed by GlaxoSmithKline PLC, expired at the end of last year. Other drugs whose patent protections are in effect may run into more complicated hurdles with the world's pharmaceutical giants.

China has 800,000 to 1.5 million people with HIV, according to the UN. Many of them are rural dwellers who contracted the disease through sharing needles or selling blood to unlicensed blood collection stations.

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