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中国生物工程杂志

China Biotechnology
China Biotechnology  2020, Vol. 40 Issue (11): 96-101    DOI: 10.13523/j.cb.2006054
    
Market Analysis and Countermeasures of Cervical Cancer Vaccine in China
FENG Xue-jiao1**(),HOU Hai-long2,YU Qiong1,WANG Jun-shu1
1 Institute of Science and Technology Strategy, Jiangxi Academy of Sciences, Nanchang 330096, China
2 School of Management, Nanchang University, Nanchang 330031, China
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Abstract  

As the most common gynecological malignancy, cervical cancer (human papilloma virus, HPV) is the second largest threat to women’s health. Cervical cancer vaccine is an effective way to prevent cervical cancer. Glaxosmithkline (GSK) and Merck (MSD) dominated the global market for cervical cancer vaccines until 2019. Despite the late start of cervical cancer vaccines in China, 20 vaccines have entered the clinical stage driven by domestic innovation policies. In particular, Cecolin, which is developed by INNOVAX and Xiamen University, was approved for market by National Drug Administration in April 2020. It is the first domestically developed cervical cancer vaccine in China and the third in the world. Compared with Europe and the United States and other developed countries, there is still a big gap in the promotion of cervical cancer vaccine in China, the HPV vaccine coverage rate of 9-45 years old women in China is less than 0.05%. In view of the low coverage rate of HPV vaccination, some countermeasures and suggestions were put forward, such as optimizing the review and approval process of HPV vaccine, including HPV vaccine into the national immunization program, and improving women’s understanding of HPV vaccine.



Key wordsHPV vaccine      Cervical cancer      Market analysis     
Received: 29 June 2020      Published: 11 December 2020
ZTFLH:  Q819  
Corresponding Authors: Xue-jiao FENG     E-mail: momoke914@outlook.com
Cite this article:

FENG Xue-jiao,HOU Hai-long,YU Qiong,WANG Jun-shu. Market Analysis and Countermeasures of Cervical Cancer Vaccine in China. China Biotechnology, 2020, 40(11): 96-101.

URL:

https://manu60.magtech.com.cn/biotech/10.13523/j.cb.2006054     OR     https://manu60.magtech.com.cn/biotech/Y2020/V40/I11/96

HPV疫苗 中文名 生产企业 获批年份 批准机构
Gardasil 4 佳达修 4 默沙东,MSD,美国 2006 FDA
Cervarix 2 希瑞适 2 葛兰素史克,GSK,英国 2009 FDA
Gardasil 9 佳达修 9 默沙东,MSD,美国 2014 FDA
Table 1 Human papilloma virus vaccine approved in abroad
分类 HPV疫苗
佳达修 9 佳达修 4 希瑞适 2 馨可宁2
VLP型别 高危病毒HPV16、HPV18型,低危HPV6、HPV11型,HPV31、HPV33、HPV45、HPV52、HPV58 高危病毒HPV16、HPV18型,低危HPV6、HPV11型 高危病毒HPV16、HPV18型 高危病毒HPV16、HPV18型
适用年龄 16~26岁 20~45岁 9~45岁 9~45岁
中标价(元/针) 1 298 798 580 329
生产商 默沙东 默沙东 葛兰素史克 厦门万泰生物
表达系统 酿酒酵母 酿酒酵母 杆状病毒-昆虫细胞 大肠杆菌
免疫程序 0-2-6 0-2-6 0-1-6 0-1-6
Table 2 Comparison of domestic and abroad HPV vaccines
Fig.1 Market size and forecast of global HPV vaccine between 2016 and 2020 Data sources:Annual Report of the Company/China IRR org
Fig.2 Comparison of global HPV vaccine sales for MSD and GSK between 2016 and 2019 (Unit: in US$ 100 million) Data sources:China Reporting Network/Company Annual Report
Fig.3 Pattern of HPV vaccine approval between 2017 and 2019 (units: 10 000) Data source: China Medical Pharmaceutical Material Association/National Institutes for Food and Drug Control
人数
(万人)
中标价
(元/针)
渗透率
(%)
市场规模
(亿人民币)
8 100 1 298 5 157.71
10 315.41
15 473.12
50 1 577.07
Table 3 Market penetration and scale forecast of nine-valent HPV vaccine in China
药物名称 研发进展 研发公司
十四价HPV疫苗(6/11/16/18/31/33/35/
39/45/51/52/56/58/59型)
未公布 北京诺宁生物科技有限公司
十一价HPV疫苗(汉逊酵母) I期 国药中生生物技术研究院有限公司/北京所/成都所
未公布 北京微谷生物医药有限公司
九价HPV疫苗(6/11/16/18/31/33/45/52/58型)(大肠杆菌) III期 上海博唯生物科技有限公司
I期 江苏瑞科生物技术有限公司/
北京安百胜生物科技有限公司
九价HPV疫苗(6/11/16/18/31/33/45/52/58型)(大肠埃希菌) II期 北京康乐卫士生物技术股份有限公司
II期 厦门万泰沧海生物技术有限公司/
厦门大学/北京万泰生物药业股份有限公司/
九价HPV疫苗(6/11/16/18/31/33/45/52/58型)(毕赤酵母) Ⅰ期 上海泽润生物科技有限公司
六价HPV疫苗(6/11/16/18/52/58型) 未公布 成都生物制品研究所有限责任公司
四价HPV疫苗(16/18/52/58型) (毕赤酵母) II期 上海生物制品研究所有限责任公司
暂停 北京双鹭药业股份有限公司
四价HPV疫苗(6/11/16/18型)(汉逊酵母) Ⅲ期 成都生物制品研究所有限责任公司/
北京生物制品研究所有限责任公司
四价HPV疫苗(6/11/16/18型)(汉逊酵母) Ⅲ期 上海博唯生物科技有限公司
三价HPV疫苗(16/18/58型)疫苗(大肠杆菌) II期 北京康乐卫士生物技术股份有限公司/ 泰州天德药业
有限公司/ 黑河小江生物制药有限公司
二价HPV疫苗(16/18型)(汉逊酵母) I期 江苏瑞科生物技术有限公司/
北京安百胜生物科技有限公司
二价HPV疫苗(16/18型)(酵母) III期 上海泽润生物科技有限公司
二价HPV疫苗(6/11型)(大肠杆菌) III期 厦门大学/厦门养生堂生物技术有限公司
III期 厦门万泰沧海生物技术有限公司
Table 4 Clinical trial data of HPV vaccine in China until April 2020
HPV疫苗接种 发达国家 中国
上市疫苗类型 二价、四价、九价 二价、四价、九价
是否纳入NIP
政府推荐
推荐接种年龄 11~15岁 无推荐
付费方式 推荐人群免费(政府支付) 自费
推广方式 主要为校园接种,少数为国家
疾控中心(CDC)接种
CDC接种
接种覆盖率 60% 不足0.05%
Table 5 Comparison of HPV vaccination policies at home and abroad
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