China's Food and Drug Administration Approves GlaxoSmithKline's Cervarix
July 18 2016 - 2:10AM
Dow Jones News
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)
Copyright (c) 2016 Dow Jones & Company, Inc.
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