Human papillomavirus vaccine [types 16, 18](GlaxoSmithKline Plc)

国产二价HPV疫苗上市不过两年多，价格便从最初的两三百一路跌至如今的几十元，不断刷新历史新低，目前是否已到价格战的尾声呢？1多地发布2价HPV疫苗中标，“二连降”至白菜价今年以来，江苏、广东、海南等多地陆续发布了二价HPV疫苗的采购价格，仅仅一个来月疫苗价格就从86元降到63元：3月22日，据江苏政府采购网消息，万泰生物以86元/支的价格中标499206支二价HPV疫苗采购项目，这也是万泰生物继去年以116元/支中标广东采购项目之后创下的新低价，降幅高达74%。值得注意的是，这是国内二价HPV疫苗首次跌破百元大关。4月29日，广东省政府采购中心公布2023年入学适龄女生人乳头瘤病毒（HPV）疫苗第二针采购项目结果，万泰生物的二价HPV疫苗依旧以86元/支的价格中标，2023年2月、2023年7月同款疫苗的中标价格分别是329元、116元。5月8日，海南省政府采购网发布合同公告，沃森生物旗下玉溪泽润生物技术有限公司以63元/支的价格拿下2024年海南省适龄女生HPV疫苗采购项目，采购量为10.7万剂。从跌破百元大关不到2个月，国产二价HPV疫苗价格又从86元降至63元，而相较于其上市之初超300元的单价，目前降价接近80%，堪称“白菜价”。而这一降再降的背后，体现的是市场激烈的竞争，是二价HPV疫苗卖不动的事实。目前，我国已上市的HPV疫苗包括2价、4价和9价。其中，获批上市的2价HPV疫苗的有三款，依次包括2016年7月获批上市的GSK的希瑞适、2019年12月获批上市的万泰生物的馨可宁、以及2022年3月获批上市的玉溪泽润的沃泽惠。此前，国内因9价HPV疫苗供不应求和接种年龄的限制，2价HPV疫苗成为主力军。也是得益于2价HPV疫苗的销售，2020年-2022年间，万泰生物和沃森生物的净利润增速均超过100%，前者2022年净利润达47.36亿元，后者的则达7.29亿元。但到2023年，这两家的业绩开始出现下滑。2023年万泰生物实现营收55.11亿元，同比下降50.73%；归母净利润12.48亿元，同比下降73.65%。这也是公司自2020年上市以来营收、净利出现首降。至于沃森生物，其2023年实现营收41.14亿元，同比下降19.12%；归母净利润为4.19亿元，同比下降42.44%。对此，这两家均在年报中表示，2价HPV疫苗受9价HPV疫苗扩龄以及市场竞争等因素影响，销售不及预期。2024年Q1季度，两家业绩继续下跌。万泰生物营收7.53亿元，同比减少73.93%；净利润1.3亿元，同比大降89.64%。沃森生物营收约6亿元，同比减少28.02%；实现净利约1412.75万元，同比大降91.79%。2国产2价HPV疫苗价格是否还会下降？目前，中国已有广东、海南、福建、西藏、江苏、江西、重庆、浙江和湖北9个省级地区，以及20-30个市、县级地区可以免费为适龄女性儿童接种HPV疫苗。在2价HPV疫苗走向政府采购为主的“薄利”时代的大背景之下，这两家国产厂商的价格战是否还会继续呢？可能会。《财经》记者曾对一些相关专业人士采访咨询过此类问题，一位国产HPV企业前员工表示，“走国家免疫规划的这类疫苗年费用多在50元以下，所以再降多少我都不意外”；一位医药行业分析师则表示，“即便没有纳入国家免疫规划，二价HPV大概率也会出现联盟采购，进一步挤压价格。”彼时，2价HPV疫苗的价格为86元/支。而关于纳入国家免疫规划的问题，据财联社5月18日电，中国疾控中心周报近日公布一项最新调查显示，我国9-45岁女性HPV疫苗接种率逐年增加，但总体接种率低于世界平均水平。中疾控研究团队建议将HPV疫苗纳入国家免疫规划项目。研究团队表示，接种率较低的主要原因是HPV疫苗供应有限，以及属于非免疫规划疫苗，需要自费接种。2019年和2022年，我国推出的国产二价HPV疫苗有助于缓解疫苗供应问题。团队建议，将HPV疫苗纳入国家免疫规划项目。值得注意的是，目前HPV疫苗在接种程序上正逐步朝“减针”方向发展。2022年，WHO更新了HPV接种程序，推荐9-20岁女性（其中9-14岁为最优先接种人群）可接种1剂次的HPV疫苗。而减针次接种研究工作的推进，也意味着免疫接种成本的降低，对企业而言，也进一步压缩了其业绩空间，这对其也是一大挑战。实际上，国内已有一大批HPV疫苗在研中，竞争十分激烈。除了上述提到的2价HPV疫苗企业外，据药时空不完全统计，国内布局2价HPV疫苗的企业还有瑞科生物，而国内9价HPV疫苗已进入III期临床的企业有万泰生物、康乐卫士、瑞科生物、上海泽润、博唯生物、沃森生物6家。此外，国内高价的HPV在研疫苗还有11价、14价、15价及17价，其中国药中生/成都所/北京所的11价HPV疫苗和北京诺宁生物/神州细胞的14价HPV疫苗也均已进入III期临床。相关阅读：128元/支降至88元/支，国药集团率先发动四价流感疫苗价格战！参考资料：[1]价格大跳水！低至几十元.中国新闻网.2024-05-21.[2]HPV疫苗陷入僵局.药智网.2024-04-08.[3]国产疫苗价格雪崩.瞪羚社.2024-05-21.[4]卷王之王！国产二价HPV疫苗采购价降至86元/支.预防界.2024-03-26.[5]HPV疫苗战场转换.财经杂志.2024-04-24.[6]国产二价HPV再降价，单剂次接种成趋势.第一财经.2024-05-19.识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。

HPV vaccines have substantially reduced the prevalence of HPV infections and precancerous lesions. As a new report shows the human papillomavirus vaccine can also protect men and boys, we take a look at HPV vaccines, and their impact on world health Latest global HPV vaccine study The study included an estimated 1.7 million volunteers who were vaccinated against HPV since 2010. Volunteers were aged between nine and 39. There were equal numbers of unvaccinated volunteers. In total, about 44% of those who took part were male. Vaccinated males had lower rates of head and neck cancers in particular. Previously, it was believed smoking was the biggest single cause of head and neck cancers. The study showed that per 100,000 vaccinated patients, 3.4 cases (head) and 2.8 cases (neck) of cancers, compared with 7.5 (head) and 6.3 (neck) per 100,000 of unvaccinated patients. Boys and men can benefit from human papillomavirus ( HPV ) vaccination, which can cut the risk of a range of cancers, a new study shows. The study of around 3.4 million people is one of the first long-term analyses of the vaccine's efficacy on preventing HPV-related cancers of the head and neck, anal areas, penis, vulva, vagina and cervix, Reuters reports. Previous HPV vaccine studies have focused on cervical cancer. The most recent significant research along those lines was conducted in Sweden in 2020, and showed cervical cancer rates were 47 for every 100,000 vaccinated women and 94 per 100,000 in unvaccinated women. The latest study will be presented to the upcoming American Society of Clinical Oncology ( ASCO ) meeting in Chicago, which takes place from May 31 to June 2. ASCO President Dr Lynn Schuchter says the new study “extends what we know and shows that preventing infection with the vaccine helps prevent these additional HPV-related cancers”. In light of the HPV vaccine study findings, we take an in depth look at the evolution of the vaccine, the pharmaceutical companies involved, and how HPV vaccination programmes play out in different territories. Merck & GSK in HPV vaccine vanguard Merck's HPV vaccine was approved in 2006 for girls and women ages 9 to 26 and in 2009 for boys and men in that age group. The most recent version, Gardasil 9, has been approved in the U.S. since 2018 for use in children and adults ages 9 through 45. A separate study to be presented at the ASCO meeting found that between 2011 and March 2020, U.S. uptake of the HPV vaccine rose from 23.3% to 43.0% of the eligible population, improving from 7.8% to 36.4% in males and from 37.7% to 49.4% among females. HPV vaccines help ease the significant global healthcare burden that these diseases pose. Cervical cancer is the third most common cancer globally, and the second most frequent cause of cancer deaths among women aged between 15 and 44 years. Vaccines for HPV first became available in the early 2000s, after research by pharmaceutical companies including Merck and GlaxoSmithKline (GSK). Merck's Gardasil, approved in 2006, and GSK’s Cervarix (2009) were the first vaccines to target strains of HPV responsible for cervical cancer and genital warts . Merck's vaccine is for girls and women ages nine to 26 and in 2009 for boys and men in the same age group. The most recent version, Gardasil 9, was approved for use in the US in 2018 for use in children and adults ages Nine to 45. Gardasil 9 protects against nine HPV strains responsible for cervical, vulvar, vaginal and anal cancers. In terms of sales, Merck and GSK enjoy significant revenue from their HPV vaccine portfolios, with earnings estimates suggesting Merck's Gardasil franchise and GKS’s Cervarix generate billions of (US) dollars annually for the companies. HPV vaccine uptake affected by socioeconomic conditions The introduction of HPV vaccines has led to a substantial reduction in the prevalence of HPV infections and precancerous lesions in countries with high vaccination coverage rates. In North America, where HPV vaccination programs have been in place for over a decade, there has been a noticeable decline (by 51%) in cervical cancer rates among women aged 20-24. Similar trends have been reported in Canada, and also in European countries with HPV vaccination programs. In total, as of November 2022, 38 of 53 countries in the WHO European Region have introduced the HPV vaccine. In the Asia-Pacific (APAC) region, the uptake of HPV vaccines has been uneven, with varying levels of implementation across countries. Australia introduced a national HPV vaccination program in 2007, and has reported a substantial decline in HPV infections and precancerous lesions among vaccinated age groups. But in the developing world, especially Africa, HPV vaccine uptake is adversely influenced by factors such as poor healthcare infrastructure, lack of awareness campaigns and unfavourable socioeconomic conditions. Leading the way in Africa is Nigeria, which in 2023 ran a vaccination programme reaching 7.7 million girls, the largest number in a single round of HPV vaccination on the continent.