原标题:GSK宣布预防女性宫颈癌的疫苗希瑞适®被批准在中国上市
-人乳头状瘤病毒(HPV)感染是导致宫颈癌的主要诱因,接种 HPV疫苗将为处于 HPV感染风险中的中国广大女性提供保护
葛兰素史克(GSK)今日宣布,希瑞适® (人乳头状瘤病毒疫苗[16型和18型])获得中国食品药品监督管理总局(CFDA)的上市许可,成为国内获批的预防宫颈癌的HPV疫苗。HPV疫苗接种和宫颈癌筛查一起,将为中国女性预防宫颈癌提供更好的手段。希瑞适®在中国注册用于9到25岁女性的接种,采用3剂免疫接种程序,并有望在明年年初正式上市。
一项在中国开展的长达6年的希瑞适®临床试验入组了6000多名受试者分别接种疫苗和对照。结果显示,该疫苗在预防某些致癌型HPV相关的宫颈疾病方面具有很高的保护效力且具有令人满意的效益风险比。该结果与全球临床研究的数据是一致的1。希瑞适®的获批意味着中国的女孩和年轻女性将有机会通过接种疫苗来预防这一致命性疾病。
GSK高级副总裁,中国/香港区处方药及疫苗部总经理季海威先生表示,“提升我们创新药品和疫苗的可及性是GSK中国的明确战略。我们相信通过与政府相关部门的合作,我们将提升中国人民对于象希瑞适®这样的创新疫苗的可及性。为了实现这一目标,我们将探索创新的定价方式,以支持希瑞适®纳入国家计划免疫项目。“
除了提升疫苗的可及性,确保疫苗的质量也一直是我们的首要工作。GSK中国全力支持中国政府近期颁发的新修订的疫苗流通和预防接种管理条例。这不仅符合中国人民的利益,同时我们也将践行“立足中国、携手中国、服务中国“的承诺。
宫颈癌是中国15岁至44岁女性中的第二大高发癌症,每年约有13万新发病例。每年, 中国的宫颈癌病例占全球的28%以上。4在全球范围内, 平均每分钟即检查出一例新发病例,2每两分钟就有一名女性死于宫颈癌。2因此,中国在开展宫颈癌筛查项目的同时引进HPV疫苗接种将会显著降低宫颈癌和癌前病变的发病率,从而降低疾病负担。3,5,6
希瑞适®在中国的获批是GSK践行“立足中国、携手中国、服务中国”承诺的又一例证,此前的公告包括:
· 2016年6月,GSK宣布GSK传染病和公共卫生研究所与清华大学缔结战略合作备忘录,共同致力于应对全球公共卫生的挑战。
· 2016年6月, 艾滋病治疗创新药物特威凯®正式在中国上市。
· 2016年5月,GSK中国宣布降低抗慢性乙肝治疗药物在中国的价格,降幅高达67%。这一宣布基于国家卫生计生委和其他相关部委公布的首批国家药品价格谈判结果。
· 2016年3月,GSK宣布在中国北京成立传染病和公共卫生研究所,开展艾滋病预防和耐多药结核药物的研发活动。
· 自2015 年9月,GSK与国家卫生计生委合作开展涵盖13,000名乙肝和慢性阻塞性肺病(COPD)的基层医生培训项目。
· 2015年7月,GSK宣布与上海迪赛诺公司合作,支持艾滋病治疗新药特威凯®原料药在华生产。
· 自2015年5月, GSK中国实施新的商业运营模式,为患者受益而积极提升与医疗专业人士进行学术交流的质量。
关于GSK:
GSK是全球领先的、以研发为基础的药品和保健品公司,致力于让人们能够做到更多、感觉更舒适、生活更长久,从而提高人类的生活质量。更多信息请浏览www.gsk.com。
关于GSK对中国的承诺:
我们是一家以科学为导向的全球医药保健公司,研发并生产多种类的疫苗、消费保健品和药物。我们所做的一切皆以人为核心,致力于将质量更高、效果更好的产品带给有需要的人。在中国,以及在全世界,我们的使命是帮助人们做到更多,感觉更舒适,生活更长久。不断创新产品,提高产品可及性,这对完成我们的使命至关重要,由此我们才能协助建立更健康、更具活力的社会。立足中国,携手中国,服务中国,是我们不变的承诺。
参考文献:
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. 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 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. 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 yearsenrolled in a clinical trial. Int. J. Cancer: 135, 2604–2611 (2014).
来源: GSK中国