原標題：GSK宣布預防女性宮頸癌的疫苗希瑞適®被批準在中國上市

　　-人乳頭狀瘤病毒(HPV)感染是導致宮頸癌的主要誘因，接種 HPV疫苗將為處于 HPV感染風險中的中國廣大女性提供保護

　　葛蘭素史克(GSK)今日宣布，希瑞適® (人乳頭狀瘤病毒疫苗[16型和18型])獲得中國食品藥品監督管理總局(CFDA)的上市許可，成為國內獲批的預防宮頸癌的HPV疫苗。HPV疫苗接種和宮頸癌篩查一起，將為中國女性預防宮頸癌提供更好的手段。希瑞適®在中國注冊用于9到25歲女性的接種，采用3劑免疫接種程序，并有望在明年年初正式上市。

　　一項在中國開展的長達6年的希瑞適®臨床試驗入組了6000多名受試者分別接種疫苗和對照。結果顯示，該疫苗在預防某些致癌型HPV相關的宮頸疾病方面具有很高的保護效力且具有令人滿意的效益風險比。該結果與全球臨床研究的數據是一致的1。希瑞適®的獲批意味著中國的女孩和年輕女性將有機會通過接種疫苗來預防這一致命性疾病。

　　GSK高級副總裁，中國/香港區處方藥及疫苗部總經理季海威先生表示，“提升我們創新藥品和疫苗的可及性是GSK中國的明確戰略。我們相信通過與政府相關部門的合作，我們將提升中國人民對于象希瑞適®這樣的創新疫苗的可及性。為了實現這一目標，我們將探索創新的定價方式，以支持希瑞適®納入國家計劃免疫項目。“

　　除了提升疫苗的可及性，確保疫苗的質量也一直是我們的首要工作。GSK中國全力支持中國政府近期頒發的新修訂的疫苗流通和預防接種管理條例。這不僅符合中國人民的利益，同時我們也將踐行“立足中國、攜手中國、服務中國“的承諾。

　　宮頸癌是中國15歲至44歲女性中的第二大高發癌癥，每年約有13萬新發病例。每年, 中國的宮頸癌病例占全球的28%以上。4在全球范圍內, 平均每分鐘即檢查出一例新發病例，2每兩分鐘就有一名女性死于宮頸癌。2因此，中國在開展宮頸癌篩查項目的同時引進HPV疫苗接種將會顯著降低宮頸癌和癌前病變的發病率，從而降低疾病負擔。3,5,6

　　希瑞適®在中國的獲批是GSK踐行“立足中國、攜手中國、服務中國”承諾的又一例證，此前的公告包括：

　　· 2016年6月，GSK宣布GSK傳染病和公共衛生研究所與清華大學締結戰略合作備忘錄，共同致力于應對全球公共衛生的挑戰。

　　· 2016年6月， 艾滋病治療創新藥物特威凱®正式在中國上市。

　　· 2016年5月，GSK中國宣布降低抗慢性乙肝治療藥物在中國的價格，降幅高達67%。這一宣布基于國家衛生計生委和其他相關部委公布的首批國家藥品價格談判結果。

　　· 2016年3月，GSK宣布在中國北京成立傳染病和公共衛生研究所，開展艾滋病預防和耐多藥結核藥物的研發活動。

　　· 自2015 年9月，GSK與國家衛生計生委合作開展涵蓋13，000名乙肝和慢性阻塞性肺病(COPD)的基層醫生培訓項目。

　　· 2015年7月，GSK宣布與上海迪賽諾公司合作，支持艾滋病治療新藥特威凱®原料藥在華生產。

　　· 自2015年5月， GSK中國實施新的商業運營模式，為患者受益而積極提升與醫療專業人士進行學術交流的質量。

　　關于GSK：

　　

 

　　GSK是全球領先的、以研發為基礎的藥品和保健品公司，致力于讓人們能夠做到更多、感覺更舒適、生活更長久，從而提高人類的生活質量。更多信息請瀏覽www.gsk.com。

　　關于GSK對中國的承諾：

　　我們是一家以科學為導向的全球醫藥保健公司，研發并生產多種類的疫苗、消費保健品和藥物。我們所做的一切皆以人為核心，致力于將質量更高、效果更好的產品帶給有需要的人。在中國，以及在全世界，我們的使命是幫助人們做到更多，感覺更舒適，生活更長久。不斷創新產品，提高產品可及性，這對完成我們的使命至關重要，由此我們才能協助建立更健康、更具活力的社會。立足中國，攜手中國，服務中國，是我們不變的承諾。

　　參考文獻:

　　1. Fengcai Zhu etal.,Efficacy and safety of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine in Chinese women: event-triggered analysis of a randomized trial. 10thAsia-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 June2015).

　　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. 衛生部宮頸癌診療指南(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 yearsenrolled in a clinical trial. Int. J. Cancer: 135, 2604–2611 (2014)

　　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 riskfrom exposure to Human Papillomavirus, the major cause of cervical cancer

　　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 recently issued 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.2 The 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.

　　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 peopledo more, feel better, live longer. We are in China, with China, for China, and our commitment remains unwavering.

　　Reference:

　　1. Fengcai Zhu etal.,Efficacy and safety of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine in Chinese women: event-triggered analysis of a randomized trial. 10thAsia-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 June2015).

　　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. 衛生部宮頸癌診療指南(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 yearsenrolled in a clinical trial. Int. J. Cancer: 135, 2604–2611 (2014).

　　來源： GSK中國

TAG：預防女性宮頸癌