Cervarix, first vaccine for cervical cancer prevention in mainland China, has officially launched

GSK announced today that Cervarix, the first approved vaccine for cervical cancer prevention in mainland China, has been officially launched in the market. The first imported batch of Cervarix has passed inspections by quality inspection authority, and can now be supplied to the market. This addresses the current high level of unmet medical needs of a great amount of Chinese women within the appropriate age group for a vaccine that can help prevent cervical cancer. Like other vaccines, Cervarix can be vaccinated at community hospitals and health service centres where available.

Professor Youlin Qiao, Head of Epidemilology Department, Cancer Institute and Hospital, Chinese Academy of Medical Sciences (CICAMS) and Peking Union Medical College, said, “Cervical cancer is a common form of malignant tumor that severely threatens the health of women. There are 100,000 new cases of cervical cancer in China each year, and over 30,000 deaths due to the disease. It is the third most common cancer amongst women from the ages of 15 to 44. For this reason, cervical cancer vaccination together with cervical cancer screening will significantly reduce the incidence of cervical cancer and pre-cancerous lesions, thus reducing the burden of this disease”.

Thomas Willemsen, General Manager, GSK China Pharmaceuticals and Vaccines, said, “Increasing access to our innovative medicines and vaccines is a clear strategy for GSK to be in China, with China, for China. We are happy to announce that Cervarix is now available to help protect young girls and women against the threat of cervical cancer. We are undertaking a series of initiatives, including public disease awareness education, a complementary platform for adult vaccination, and professional training for HCPs, to enable more Chinese females to benefit from protection against cervical cancer via vaccination”.

In July 2016, Cervarix was approved by the China Food and Drug Administration (CFDA) as the first vaccine to prevent cervical cancer in mainland China. Cervical cancer is caused by oncogenic HPV (human papillomavirus) infection. A four-year international large-scale clinical study, which enrolled over 18,000 subjects, showed that the efficacy of Cervarix against CIN3+ related to HPV 16 and 18 in naive population was 100%. With cross-protection for other oncogenic strains, the overall protection of Cervarix against CIN3+ related to any oncogenic HPV types is 93.2%1.

Cervarix has been registered in 132 countries and regions (including mainland China), and more than 69 million doses of Cervarix have been provided to the worldwide market. 70 countries have included HPV vaccines in their national immunisation programmes. 

As part of the ‘in China, with China, for China’ strategy, GSK China has:

  • Announced the collaboration programme to aid hepatitis prevention and treatment in poverty-stricken areas of the western region in July 2017.
  • Announced Seroxat CR and Tykerb on 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.
  • Announced Viread, Arixtra, Requip and Mivacron included in the “2017 National Reimbursement Drug List” in Mar 2017.
  • Joined hands with the Home of Red Ribbon to combat HIV/AIDS, unveiling plan to support people living with HIV in Nov 2016.
  • Announced the strategic partnership with China Preventive Medicine Association (CPMA) to address major public health challenges in China in Nov 2016.
  • Announced the approval of Cervarix in China to help protect women from cervical cancer in July 2016.
  • 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 programmes for pivotal HIV and TB R&D assets in March 2016.
  • Partnered with the National Health and Family Planning Commission on a multi-year programme to fund independent training programmes 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.

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.

GSK enquiries:

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

Reference:

  1. Lehtinen M, Paavonen J, Wheeler CM, et al. Overall efficacy of HPV16/18 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. 

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