China has approved the sale of GSK's Cervarix HPV vaccine as the first human papillomavirus (HPV) vaccine licensed for use in the country.
The China Food and Drug Administration said the commercial launch of Cervarix is expected in early 2017. Cervarix is registered in China for use in girls and women aged 9-25 years with a three-dose schedule and can help protect the health of millions of women in China at risk of cervical cancer.
HPV is the most common sexually transmitted infection and is transmitted through intimate skin-to-skin contact. A person can acquire HPV by having vaginal, anal or oral sex with someone who has the virus. It is most commonly spread during vaginal or anal sex.
GSK China's Cervarix was approved following a clinical trial conducted in China involving over 6,000 subjects who received Cervarix or a control and were followed for up to six years. The drug demonstrated a high efficacy and favorable benefit risk ratio in preventing certain oncogenic HPV-related cervical diseases, which is consistent with global data.
"We believe that we can work with the relevant authorities to ensure that people in China have increased access to innovative vaccines such as Cervarix," said Hervé Gisserot, senior vice president and general manager, pharmaceuticals and vaccines for GSK China/Hong Kong.
"To achieve this we are ready to explore an innovative pricing approach to support the inclusion of Cervarix into public cervical cancer immunization programs."
Cervical cancer is the second most common cancer in women aged between 15 to 44 years in China, with an estimated 130,000 new cases each year.
China accounts for more than 28 percent of the world's cervical cancer cases every year. Worldwide, a new case of cervical cancer is detected every minute on average, and a woman dies of cervical cancer every two minutes.