GSK announces Cervarix? approved in China to help protect women from cervical cancer

?Access to human papillomavirus (HPV) vaccination could help to protect the health of millions of women in China at risk from exposure to Human Papillomavirus, the major cause of cervical cancer?

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GSK China today announced that Cervarix? (Human Papillomavirus (Types 16, 18) Vaccine, Adsorbed) ) has been approved by the China Food and Drug Administration (CFDA) as the first human papillomavirus (HPV) vaccine licensed for use in China, helping to prevent cervical cancer. Together with the cervical cancer screening programme, HPV vaccination will provide a better solution for Chinese women to fight against cervical cancer. Cervarix is registered in China for use in girls and women aged 9-25 years with a 3 dose schedule. The commercial launch of Cervarix is expected in early 2017.

A clinical trial conducted in China, involving more than 6000 subjects who received Cervarix or (Al (OH)3 control and were followed for up to 6 years, demonstrated a high efficacy and favourable benefit risk ratio in preventing certain oncogenic HPV-related cervical diseases, which is consistent with global data.1 The approval of Cervarix means that girls and young women in China will now have the chance to have access to a preventive vaccine against this deadly disease.

Hervé Gisserot, Senior Vice President and General Manager, Pharmaceuticals and Vaccines, GSK China/Hong Kong, said, “Increasing access to our innovative medicines and vaccines is a clear strategy for GSK China. 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.?To achieve this we are ready to explore an innovative pricing approach to support the inclusion of Cervarix into public cervical cancer immunisation programmes”.?

In addition to improving access, the quality of our vaccines has always been of utmost importance. GSK China fully supports the new regulations on the administration of vaccines distribution recentlyissued by the Chinese government. This not only benefits the people of China, it also fulfils our commitment to be ‘in China, with China, for China’.

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. Every year, China accounts for more than 28% of the world’s cervical cancer cases.4 Worldwide, a new case of cervical cancer is detected every minute on average,2 and a woman dies of cervical cancer every 2 minutes.2The introduction of HPV vaccination alongside China’s cervical cancer screening programme has the potential to substantially reduce the incidence of cervical cancer and pre-cancer, and the burden of disease in China.3, 5,6

The approval of Cervarix is the latest example of GSK delivering on its publically stated commitment to be “in China, with China, for China”. Previous announcements include:

  • Announced a Memorandum of Understanding between the GSK Institute for Infectious Diseases and Public Health and Tsinghua University to tackle global public health challenges in June 2016.
  • Launched Tivicay, an innovative HIV drug, in June 2016.
  • Participated in the national price negotiation pilot and announced a price reduction of our first line chronic hepatitis B treatment, Viread, by up to 67% in May 2016.
  • Announced a Beijing-based Institute for Infectious Disease and Public Health to conduct local development programs for pivotal HIV and TB R&D assets in March 2016.
  • Partnered with the National Health and Family Planning Commission on a multi-year program to fund independent training programs in Hepatitis and COPD for over 13,000 healthcare professionals from September 2015.
  • Formalised a partnership with Shanghai-based Desano Pharmaceuticals to locally manufacture the Active Pharmaceutical Ingredient for Tivicay (dolutegravir) in July 2015.
  • Transformed our commercial operating model to actively contribute to improving the quality of scientific exchanges with healthcare professionals for the benefit of patients since May 2015.

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GSK – one of the world's leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.? For further information please visit www.gsk.com.

GSK commitment to China

We are a science-led global healthcare company. We research, develop and manufacture a wide range of medicines, vaccines and consumer healthcare products. People are at the heart of what we do. We strive to bring high quality, high performing products to everyone who needs them. Creating innovative products and improving access to them is critical to our mission, allowing us to help build stronger, healthier communities. In China, and around the world, we are on a mission to help people do more, feel better, live longer. We are in China, with China, for China, and our commitment remains unwavering.

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Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D 'Risk factors' in the company's Annual Report on Form 20-F for 2015.

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References

1.Fengcai Zhu et al.,Efficacy and safety of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine in Chinese women: event-triggered analysis of a randomized trial. 10th Asia-Pacific Congress of Medical Virology (APCMV) October 15–18, 2015, Taipei, Taiwan.

2.WHO International Agency for Research on Cancer (2013). Press release No. 223, 12 December 2013. Latest world cancer statistics. Available from: http://www.iarc.fr/en/media-centre/pr/2013/pdfs/pr223_E.pdf (accessed June 2015).

3.World Health Organization (March 2015). Human Papillomavirus (HPV) and Cervical Cancer. Fact sheet 380. Available from: http://www.who.int/mediacentre/factsheets/fs380/en/# (accessed June 2015).

4.卫生部宫颈癌诊疗指南(2013年版)

5.En-Qi Wu ? Bin Liu ? Jian-Feng Cui ? Wen Chen ? Jian-Bing Wang ?Liang Lu ? Mayineur Niyazi ? Chao Zhao ? Sheng-Da Ren ? Chang-Qing Li ?Xiang-Zhen Gong ? Jennifer S. Smith ? Jerome L. Belinson ? Kai-Li Liaw ?Christine Velicer ? You-Lin Qiao Prevalence of type-specific human papillomavirus and pap results in Chinese women: a multi-center, population-based cross-sectional study Cancer Causes Control (2013) 24:795–803

6.Fang-Hui Zhao1, Feng-Cai Zhu2, Wen Chen1, Juan Li3, Yue-Mei Hu2, Ying Hong4, Yi-Ju Zhang2, Qin-Jing Pan1, Jia-Hong Zhu, Xun Zhang1, Yong Chen6, Haiwen Tang7, Helen Zhang8, Christelle Durand9, Sanjoy K. Datta9, Frank Struyf, Dan Bi9, for the HPV-039 study group baseline prevalence and type distribution of human papillomavirus in healthy Chinese women aged 18–25 years enrolled in a clinical trial. Int. J. Cancer: 135, 2604–2611