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12/22/2024 09:45:54 pm

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China's FDA Approves use of GlaxoSmithKline's Cervarix Vaccine

China Food and Drug Administration approved use of GSK HPV vaccine Cervarix.

(Photo : Getty Images) China Food and Drug Administration has approved the use of GSK's HPV vaccine Cervarix.

China's Food and Drug Administration has approved the use of GlaxoSmithKline (GSK) Plc's human papillomavirus (HPV) vaccine Cervarix to help women in the country fight cervical cancer, the drug maker announced on Monday.

According to GSK's China, Cervarix is the first HPV vaccine licensed for use and is expected to be launched as early as next year.

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China, which accounts for over a quarter (28 percent) of the world's cervical cancer cases, would give both girls and women between 9 and 25 years old access to the anti-cervical cancer vaccine. GSK said the Cervarix has been tested on 6,000 subjects for six years in China.

A representative from China's Food and Drug Administration announced that it has already given GSK's application a go signal for an import registration of the vaccine.

GSK has struggled to rebuild its sales after being penalized by nearly half a billion dollars in 2014 for bribing Chinese doctors. The company has said that it will work with Chinese officials to make sure that all Chinese netizens will have increased access to the vaccines.

"To achieve this we are ready to explore an innovative pricing approach to support the inclusion of Cervarix into public cervical cancer immunisation programmes," Hervé Gisserot, senior vice president of pharmaceuticals and vaccines GSK China/Hong Kong, said in a statement. Details of the price of the drug, however, is yet to be announced.

China records about 130,000 new cervical cancer cases each year, according to China's Ministry of Health in 2013, and the World Health Organization has recommended the inclusion of HPV vaccines in all immunization programs.

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