China's Food and Drug Administration Approves GlaxoSmithKline's Cervarix

BEIJING--China's Food and Drug Administration approved GlaxoSmithKline PLC's (GSK) Cervarix, the first vaccine against human papilloma virus to be licensed for use in China for the prevention of cervical cancer.

The approval is expected to boost the sales of the U.K.-based drug company in China after its business there was severely hit by a bribery scandal three years ago.

Glaxo said Cervarix was tested on 6,000 subjects for a span of six years in China. It is registered in China for use in girls and women between nine and 25 years old. The commercial launch of Cervarix is expected in early 2017.

Details of Cervarix's pricing in China have yet to be announced. Herve Gisserot, general manager of pharmaceuticals and vaccines for Glaxo's China and Hong Kong operations, said the company is ready to explore an innovative pricing approach to support the inclusion of Cervarix into public immunization programs.

Glaxo's latest moves have indicated a strong intention to restore the relationship with China. The company was fined $490 million by Chinese authorities in 2014, and the British former general manager and top Chinese executives all received suspended prison sentences over the bribery allegations. In May, Glaxo slashed the price of its hepatitis B treatment Viread by 67% in China's pilot program for price negotiation.

China reports an estimated 130,000 new cases of cervical cancer every year, which accounts for more than 28% of the total new cases world-wide, according to the guidelines issued by China's Ministry of Health in 2013. The World Health Organization recommends the inclusion of human-papilloma-virus vaccines in all immunization programs.

U.S. drug maker Merck & Co. (MRK), which is known as MSD outside the U.S. and Canada, has conducted testing of its cervical cancer vaccine Gardasil in China, according to public records.

--Fanfan Wang

(END) Dow Jones Newswires

July 18, 2016 01:55 ET (05:55 GMT)

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