United Press International - September 24, 2002
Christian M. Wade, UPI Correspondent

Shanghai Desano Bio-pharmaceutical Co. said it received approval from China's top regulatory body to manufacture and sell Didanosine, also known as ddI, and Stavudine or d4T.

"We expect to begin selling the approved drugs by the end of the year," Zhang Junjie, a spokesman for Desano, told United Press International. "AIDS therapy patients in China will have cheaper alternatives."

Both drugs, developed by New York-based Bristol-Myers Squibb, work by obstructing the building blocks of genetic material and inhibit the human immunodeficiency virus from spreading.

Robert Laverty, spokesman for Bristol-Myers Squibb, said the approved generic versions of ddI and d4T do not infringe on the pharmaceutical company's numerous AIDS drug patents in China.

"As long as the domestic generic companies are in compliance with the international law, they are free to manufacture and market these products," Laverty told United Press International in a telephone interview.

An official with China's State Drug Administration, who only gave his surname Liu, confirmed the agency had given Desano permission to produce the generics but declined to offer details of the approval process.

Zhang said Desano also has applied for permission to produce a third AIDS drug, Nevirapine, which would allow the company to market a generic version of the costly "AIDS cocktail" treatments.

He said the Chinese version of the cocktail therapy would cost around $600 a year per patient, a fraction of the current cost of imported drugs, which range from $3,600 to $12,000 annually.

The move is part of the Chinese government's efforts to reduce medical costs for the country's growing number of HIV/AIDS sufferers by creating more competition for higher-priced imported drugs.

Last month, Northeast Pharmaceutical Group was granted a license by Chinese regulators to sell its generic version of Zidovudine or AZT, another widely used drug that slows the effects of AIDS.

AZT, which was developed by U.S.-based GlaxoSmithKline, had its patent license expire in China. At least a dozen other Chinese drug makers, including Desano, have plans to produce similar AZT drugs.

Like other developing countries, such as India, Brazil and South Africa, China wants drug companies to lower prices for AIDS medication, which often are too expensive for the majority of its 1.3 billion people.

The Chinese government also is considering a plan to reduce import tariffs on AIDS drugs made by foreign pharmaceutical companies, industry officials said.

China's Ministry of Health estimates more than a million people are infected with HIV/AIDS. A report issued by the United Nations earlier this year warned China is on the brink of an AIDS epidemic and could have 10 million infected people by the end of the decade, unless steps are taken to curb its spread.
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