預(yù)防女性宮頸癌的疫苗被批準(zhǔn)在中國(guó)上市

　　原標(biāo)題：GSK宣布預(yù)防女性宮頸癌的疫苗希瑞適®被批準(zhǔn)在中國(guó)上市

　　-人乳頭狀瘤病毒(HPV)感染是導(dǎo)致宮頸癌的主要誘因，接種 HPV疫苗將為處于 HPV感染風(fēng)險(xiǎn)中的中國(guó)廣大女性提供保護(hù)

　　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(guó)食品藥品監(jiān)督管理總局(CFDA)的上市許可，成為國(guó)內(nèi)獲批的預(yù)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(guó)女性預(yù)防宮頸癌提供更好的手段。希瑞適®在中國(guó)注冊(cè)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(xiàng)在中國(guó)開(kāi)展的長(zhǎng)達(dá)6年的希瑞適®臨床試驗(yàn)入組了6000多名受試者分別接種疫苗和對(duì)照。結(jié)果顯示，該疫苗在預(yù)防某些致癌型HPV相關(guān)的宮頸疾病方面具有很高的保護(hù)效力且具有令人滿意的效益風(fēng)險(xiǎn)比。該結(jié)果與全球臨床研究的數(shù)據(jù)是一致的1。希瑞適®的獲批意味著中國(guó)的女孩和年輕女性將有機(jī)會(huì)通過(guò)接種疫苗來(lái)預(yù)防這一致命性疾病。

　　GSK高級(jí)副總裁，中國(guó)/香港區(qū)處方藥及疫苗部總經(jīng)理季海威先生表示，“提升我們創(chuàng)新藥品和疫苗的可及性是GSK中國(guó)的明確戰(zhàn)略。我們相信通過(guò)與政府相關(guān)部門(mén)的合作，我們將提升中國(guó)人民對(duì)于象希瑞適®這樣的創(chuàng)新疫苗的可及性。為了實(shí)現(xiàn)這一目標(biāo)，我們將探索創(chuàng)新的定價(jià)方式，以支持希瑞適®納入國(guó)家計(jì)劃免疫項(xiàng)目。“

　　除了提升疫苗的可及性，確保疫苗的質(zhì)量也一直是我們的首要工作。GSK中國(guó)全力支持中國(guó)政府近期頒發(fā)的新修訂的疫苗流通和預(yù)防接種管理?xiàng)l例。這不僅符合中國(guó)人民的利益，同時(shí)我們也將踐行“立足中國(guó)、攜手中國(guó)、服務(wù)中國(guó)“的承諾。

　　宮頸癌是中國(guó)15歲至44歲女性中的第二大高發(fā)癌癥，每年約有13萬(wàn)新發(fā)病例。每年, 中國(guó)的宮頸癌病例占全球的28%以上。4在全球范圍內(nèi), 平均每分鐘即檢查出一例新發(fā)病例，2每?jī)煞昼娋陀幸幻�女性死于宮頸癌。2因此，中國(guó)在開(kāi)展宮頸癌篩查項(xiàng)目的同時(shí)引進(jìn)HPV疫苗接種將會(huì)顯著降低宮頸癌和癌前病變的發(fā)病率，從而降低疾病負(fù)擔(dān)。3,5,6

　　希瑞適®在中國(guó)的獲批是GSK踐行“立足中國(guó)、攜手中國(guó)、服務(wù)中國(guó)”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(wèi)生研究所與清華大學(xué)締結(jié)戰(zhàn)略合作備忘錄，共同致力于應(yīng)對(duì)全球公共衛(wèi)生的挑戰(zhàn)。

　　· 2016年6月， 艾滋病治療創(chuàng)新藥物特威凱®正式在中國(guó)上市。

　　· 2016年5月，GSK中國(guó)宣布降低抗慢性乙肝治療藥物在中國(guó)的價(jià)格，降幅高達(dá)67%。這一宣布基于國(guó)家衛(wèi)生計(jì)生委和其他相關(guān)部委公布的首批國(guó)家藥品價(jià)格談判結(jié)果。

　　· 2016年3月，GSK宣布在中國(guó)北京成立傳染病和公共衛(wèi)生研究所，開(kāi)展艾滋病預(yù)防和耐多藥結(jié)核藥物的研發(fā)活動(dòng)。

　　· 自2015 年9月，GSK與國(guó)家衛(wèi)生計(jì)生委合作開(kāi)展涵蓋13，000名乙肝和慢性阻塞性肺病(COPD)的基層醫(yī)生培訓(xùn)項(xiàng)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(chǎn)。

　　· 自2015年5月， GSK中國(guó)實(shí)施新的商業(yè)運(yùn)營(yíng)模式，為患者受益而積極提升與醫(yī)療專業(yè)人士進(jìn)行學(xué)術(shù)交流的質(zhì)量。

　　關(guān)于GSK：

　　

 

　　GSK是全球領(lǐng)先的、以研發(fā)為基礎(chǔ)的藥品和保健品公司，致力于讓人們能夠做到更多、感覺(jué)更舒適、生活更長(zhǎng)久，從而提高人類的生活質(zhì)量。更多信息請(qǐng)瀏覽www.gsk.com。

　　關(guān)于GSK對(duì)中國(guó)的承諾：

　　我們是一家以科學(xué)為導(dǎo)向的全球醫(yī)藥保健公司，研發(fā)并生產(chǎn)多種類的疫苗、消費(fèi)保健品和藥物。我們所做的一切皆以人為核心，致力于將質(zhì)量更高、效果更好的產(chǎn)品帶給有需要的人。在中國(guó)，以及在全世界，我們的使命是幫助人們做到更多，感覺(jué)更舒適，生活更長(zhǎng)久。不斷創(chuàng)新產(chǎn)品，提高產(chǎn)品可及性，這對(duì)完成我們的使命至關(guān)重要，由此我們才能協(xié)助建立更健康、更具活力的社會(huì)。立足中國(guó)，攜手中國(guó)，服務(wù)中國(guó)，是我們不變的承諾。

　　參考文獻(xiàn):

　　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(wèi)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(wèi)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(lái)源： GSK中國(guó)

TAG：預(yù)防女性宮頸癌