Cervarix is approved for cervical cancer prevention in female population aged 9-45 years in mainland China

The age limit of Cervarix is approved to extend to 45 years, thereby benefiting more Chinese women

GSK announced today the age limit of its HPV vaccine Cervarix has been approved to extend to 45 years according to the results of technical review from the Center of Drug Evaluation, China National Drug Administration (CNDA)*.  With the approval, it has become currently the only vaccine for cervical cancer prevention in female population aged 9-45 years in mainland China.

The incidence and disease burden of cervical cancer are not optimistic

Cervical cancer is caused by persistent high-risk human papillomavirus (HPV) infection in female genital tract. The incidence and mortality rate of cervical cancer ranks the highest of all malignant tumors in the female reproductive system in China1, with about 100,000 new cases and 30,000 cases of death per year 2.

HPV16 and HPV18 are the most common high-risk HPV types in cervical cancer. In China, more than 84.5% cases of squamous carcinoma of cervix are related with persistent infection of the two high-risk HPV types2. The first peak is 15-24 years and the second peak is 40-44 years for high-risk HPV infection in Chinese women 3.  

While conducting screening for cervical cancer, vaccination of HPV vaccine in the female population at appropriate ages will significantly reduce the morbidity of cervical cancer and precancerous lesions, thereby reducing the burden of disease4,5,6.

Cervarix is developed for prevention of cervical cancer, helping to protect millions of women in China

As the vaccine was specifically developed for prevention of cervical cancer, with vaccine antigen targeting HPV16/18, and adopting AS04 patented adjuvant system, it significantly stimulates the immune system to produce a strong and persistent immune response. With cross-protection for other high-risk types, the clinical study showed an overall protective efficacy of 93.2% for Cervarix in the cervical precancerous lesions (CIN3+) caused by irrespective high-risk HPV types among HPV negative population 7.

Dr. Thomas Breuer, Senior Vice President and Chief Medical Officer of GSK Vaccines, said: “Thanks to scientific progress, cervical cancer has become a vaccine-preventable disease. It is great news that Cervarix, which was specifically developed for prevention of cervical cancer, has now received approval for a label extension for women aged 26 to 45 years in China, allowing more women to access our vaccine. Cervarix can now be given to women from age 9 up to the age of 45, making it the HPV vaccine with the broadest age indication in China.”

Thomas Willemsen, General Manager, GSK China Pharmaceuticals and Vaccines, said, “Achieving the age limit extension of Cervarix is another demonstration of GSK’s commitment to increasing access to our innovative vaccines. GSK will continue to carry out public disease awareness education, enhance the complementary platform for adult vaccination consultation, and professional training for vaccination healthcare professionals, to enable more Chinese females to benefit from prevention solutions against cervical cancer.”

 

*Former CFDA

 

References:

1. Chen W, Zheng R, Baade PD, et al. Cancer statistics in China, 2015. CA Cancer J Clin 2016; 66(2): 115-32

2. Comprehensive prevention and control guidelines for cervical cancer by The Women's Health Branch of Chinese Preventive Medicine Association. Beijing: People's Medical Publishing House. 2017

3. Zhao FH, Lewkowitz AK, Hu SY, et al. Prevalence of human papillomavirus and cervical intraepithelial neoplasia in China: a pooled analysis of 17 population-based studies. Int J Cancer 2012; 131(12): 2929-38.

4. World Health Organization (March 2015). Human Papillomavirus (HPV) and Cervical Cancer. Fact sheet 380. Available from: http://www.who.int/en/news-room/fact-sheets/detail/human-papillomavirus-(hpv)-and-cervical-cancer.

5. Wu EQ, Liu B, Cui JF, et al. 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(4): 795-803

6. Zhao FH, Zhu FC, Chen W, et al. Baseline prevalence and type distribution of human papillomavirus in healthy Chinese women aged 18-25 years enrolled in a clinical trial. Int J Cancer 2014; 135(11): 2604-11.

7. Lehtinen M, Paavonen J, Wheeler CM, et al. Overall efficacy of HPV-16/18 AS04-adjuvanted vaccine against grade 3 or greater cervical intraepithelial neoplasia: 4-year end-of-study analysis of the randomised, double-blind PATRICIA trial. Lancet Oncol 2012; 13(1): 89-99.

 

GSK in China with China for China

GSK is committed to supporting the healthcare reform of the Chinese government and to ensuring that Chinese patients can access our innovative treatments targeting their specific needs. As part of our strategy to be "in China, with China, for China", we have achieved the following milestones in recent years:

  • GSK Flixotide Nebules launched in mainland China for acute exacerbations of childhood asthma in May 2018.
  • The Chinese Association of STD and AIDS Prevention and Control and GSK China sign MOU for AIDS prevention and control through online physician education in May 2018.
  • GSK China partners with JD to drive “Internet + Healthcare” to improve patient experience and access to healthcare in May 2018.
  • Anoro Ellipta, a new once-daily dual bronchodilators treatment for COPD, was approved in March 2018.
  • Our innovative antiretroviral Single Tablet Regimen (STR) Triumeq was officially launched in January 2018.
  • Supported the launch of “New Respiration and Frequent Care” online management platform for asthma patients in December 2017.
  • Supported the launch of the UK-China Health and Economy Partnership in November 2017.
  • Supported the launch of "Happy Breath" COPD Tiered Diagnosis and Treatment Project across China in November 2017.
  • Flixotide Nebules received approval for the treatment of children asthma in September 2017.
  • Announced partnership with Ali Health to launch innovative online service platform to improve adult vaccination consultation experience in August 2017.
  • Innovative antiretroviral Single Tablet Regimen (STR) Triumeq received approval in China in August 2017.
  • Cervarix, the first vaccine for cervical cancer prevention in mainland China, was officially launched in July 2017.
  • Announced collaboration programme to aid hepatitis prevention and treatment in poverty-stricken areas of the western region in July 2017.
  • Seroxat CR and Tykerb were included into the list of reimbursed drugs as results of the national health insurance negotiations in July 2017.
  • Announced a strategic partnership with academia to co-develop health big-data system and upgrade the management of respiratory diseases in June 2017.
  • Aided the National Preventive Vaccination Services and Management Training Programme, helmed by the Chinese Preventive Medicine Association under the guidance of the National Health and Family Planning Commission, with the support of the China Centre for Disease Control and Prevention that officially kicked off in June 2017.
  • Viread, Arixtra, Requip and Mivacron were included in the “2017 National Reimbursement Drug List” in March 2017.

 

GSK – a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com.

  

GSK media enquiries:

Joanna Zhu     Joanna.x.zhu@gsk.com         (China)

Susan Song    susan.s.song@gsk.com         (China)

 

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 'Principal risks and uncertainties' in the company's Annual Report on Form 20-F for 2016.