Avian flu medicine ready for trial runs

By Cai Wenjun
2009-1-14

A BIRD flu medicine for humans that is being brought to the domestic market by Shanghai scientists and two pharmaceutical firms in Jiangsu Province has received approval for clinical tests from the State Food and Drug Administration.

Test procedures for the drug zanamivir are still being decided. If the trials prove successful, zanamivir would be one of only two domestically produced medicines capable of treating the deadly disease.

The drug is being manufactured by the Shanghai Institute of Materia Medica under the Chinese Academy of Sciences, Nanjing Simcere Dongyuan Pharmaceutical Co Ltd and Nanjing EffactPharm Drug Development Corp. The production is being carried out under a licensing agreement with the drug's developer, GlaxoSmithKline, a health care giant based in the United Kingdom.

Approval for clinical tests was issued on November 7, but the local institute announced the breakthrough only recently. The final medicine will be an inhalable powder. Its projected market date was not disclosed.

Zanamivir is an antiviral medicine that can block the action of influenza A and influenza B, the two most common types of flu. Zanamivir and another drug called oseltamivir are the only known medicines that can be used to combat bird flu in humans, experts said.

Zanamivir was first marketed commercially by GlaxoSmithKline under the trade name Relenza, which hasn't been sold in China.

In 2006, GSK signed a licensing agreement with Simcere Pharmaceutical Group of Nanjing, granting it the right to manufacture and sell zanamivir in China, Indonesia, Thailand, Vietnam and other developing countries.

The agreement with Simcere is intended to expand supplies of zanamivir in areas of the world that may be on the front line of a possible influenza pandemic.

Simcere officials said domestic production of zanamivir may help reduce its price in China and other countries covered by the deal.

Oseltamivir is produced by the Roche pharmaceutical company under the trade name Tamiflu. The Swiss firm has granted sub-licenses for the production of the generic drug to the Shanghai Pharmaceutical Group and Shenzhen-based HEC Group.

As of January 7, 393 human cases of bird flu involving 248 deaths have been reported around the globe, according to the World Health Organization. In China, there have been 31 cases and 21 deaths, the latest a Beijing woman who died on January 5.