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歷時18年研發終上市國產二價HPV疫苗五月或可接種
2020-01-11 18:44   来源:  www.luv2lounge.com   评论:0 点击:

歷時18年研發終上市國產二價HPV疫苗五月或可接種近期,随着国家药监局发布“首个国产重组人乳头瘤病毒疫苗

近期,随着国家药监局发布“首个国产重组人乳头瘤病毒疫苗获批上市”的通知,由厦门万泰沧海生物技术有限公司(以下简称:厦门万泰)生产,名为馨可宁的双价人乳头瘤病毒疫苗正式进入大众视野。

Recently, with the state drug administration issued \"the first domestic recombinant human papillomavirus vaccine approved for the market\" notice, by xiamen wantai sea biotechnology co., ltd (hereinafter referred to as xiamen wantai) production, known as xinkangning bivalent human papillomavirus vaccine into the public view.

国家药监局的这份通知显示,馨可宁是首家获批的国产人乳头瘤病毒疫苗(俗称宫颈癌疫苗),适用于9-45岁女性。此次获批的双价人乳头瘤病毒疫苗(以下简称:HPV疫苗)系国内首家申报生产的HPV疫苗,针对HPV16、18型,被纳入国家重大新药创制专项支持。

The National Drug Administration's notice shows that Xin Ke Ning is the first domestic human papillomavirus vaccine (commonly known as the cervical cancer vaccine), suitable for 9-45-year-old women. The approval of the bivalent human papillomavirus vaccine (hereinafter referred to as the HPV vaccine) is the first domestic application for the production of HPV vaccine, for HPV16,18, has been included in the national major new drug creation special support.

据了解,HPV可以有效预防宫颈癌。国家药监局官网显示,宫颈癌是中国15-44岁女性中的第二大高发癌症,仅次于乳腺癌。宫颈癌是目前癌症中唯一病因明确,可早发现早预防的癌症。人乳头状瘤病毒(HPV)感染是引起宫颈癌发生的主要病因。目前预防宫颈癌最直接、最有效的方法即接种HPV疫苗。

It is understood that HPV can effectively prevent cervical cancer. Cervical cancer is the second most common cancer among Chinese women aged 15-44, after breast cancer, according to the official website of the State Drug Administration. Cervical cancer is the only cause of cancer, early detection of early prevention of cancer. Human papillomavirus (HPV) infection is the main cause of cervical cancer. At present, the most direct and effective way to prevent cervical cancer is to inoculate HPV vaccine.

目前市场上已有英国葛兰素史克公司生产的针对HPV型的二价疫苗,美国默沙东公司生产的针对HPV的四价疫苗和九价疫苗。

There are currently two-valent vaccines for HPV produced by GlaxoSmithKline in the UK, and four-valent and nine-valent vaccines for HPV produced by Mercadon in the United States.

如今,国产HPV二价疫苗上市,其免疫效果如何是大众关注的重点之一。对此,人民健康采访了国产二价HPV疫苗研发团队核心成员之一的厦门大学公共卫生学院副院长张军。

Nowadays, domestic HPV bivalent vaccine market, its immune effect is one of the focus of public attention. In response, people's health interviewed Zhang Jun, vice president of Xiamen University School of Public Health, one of the core members of the domestic bivalent HPV vaccine research and development team.

张军告诉人民健康,目前的临床试验数据显示,按推荐程序完整接种国产二价HPV疫苗后,人体可以产生高滴度的中和抗体,与已上市的三种疫苗相似,并且能有效预防疫苗覆盖型别相关的宫颈癌癌前病变、HPV持续性感染的发生。

Zhang told people's health, the current clinical trial data show that according to the recommended procedure to complete the domestic bivalent HPV vaccine, the human body can produce a high titer of neutralizing antibody, similar to the three vaccines listed, and can effectively prevent the vaccine coverage type related cervical cancer precancerous lesions, HPV persistent infection.

“2002年我们开始二价HPV疫苗的研发,历时18年才最终完成了疫苗研发上市。”张军介绍,该疫苗在四个阶段共进行了9989例的临床验证,在中国医学科学院北京协和医学院肿瘤研究所流行病学研究室主任乔友林带领下完成了7372例三期临床试验,充分考虑了全区域覆盖和样本多样性,并通过严谨的国际同行学术评议公开发表于权威学术期刊。

\"In 2002 we started the development of bivalent HPV vaccine and it took us 18 years to complete the vaccine development. A total of 9,989 cases of the vaccine were clinically validated in four stages, and 7,372 clinical trials were completed under the leadership of Qiao Youlin, director of the Epidemiology Research Office of the Institute of Oncology at the Beijing Union Medical College of the Chinese Academy of Sciences.

针对国产二价HPV疫苗对国人宫颈癌预防方面的疑问,乔友林表示,宫颈癌疫苗并不是价越高就代表它的成本效益越好。高危型HPV感染是引起宫颈癌的必要条件,全球平均HPV-16和HPV-18引起的宫颈癌占宫颈癌病例的70%以上,对于中国人群来说这个比例更高,在84%以上。

In response to questions about the prevention of cervical cancer in China, Qiao said the higher the price, the more cost-effective the vaccine is. The high-risk type of HPV infection is a necessary condition to cause cervical cancer, with the global average of HPV-16 and HPV-18 causing more than 70% of cervical cancer cases, a higher proportion for the Chinese population, at more than 84%.

据了解,目前国内上市的二价HPV疫苗,适用年龄是9-45岁;九价HPV疫苗适用人群是16岁-26岁女性;而四价HPV疫苗适用年龄是20-45岁。

It is understood that the current domestic listing of bivalent HPV vaccine, the applicable age is 9-45 years old; nine-valent HPV vaccine applicable population is 16-26 years old female; and four-valent HPV vaccine applicable age is 20-45 years old.

HPV病毒感染的主要途径是性传播。国外一项研究显示初次性生活后的5年是HPV感染的高风险期,初次性生活后,46%的女性将在3年内感染上至少1种HPV,刚开始性生活时感染的风险最高,从初次性行为到首次检测出HPV感染的平均时间仅月。我国HPV流行病学研究结果也显示,15-19岁年龄组的HPV感染率已高达%。

The main route of HPV virus infection is sexual transmission. A foreign study showed that five years after the first sex was a high risk period for HPV infection, with 46 percent of women having at least one HPV infection within three years after the first sex, with the highest risk of infection at the beginning of sex, ranging from the first sex to the average time of the first detection of HPV infection in only a month. The results of our country's HPV epidemiological study also show that the HPV infection rate in the 15-19 year old age group is up to%.

因此,有专家建议HPV疫苗接种最好是在女性第一次实质性性接触之前。据发表在《中国科学:生命科学》的相关论文显示,9-14岁女性接种两剂万泰HPV疫苗后血清阳转率达到了100%,且抗体水平高于接种三剂的18-26岁成年女性。9—14岁也正是世界卫生组织推荐的接种HPV疫苗的最佳年龄段。

Therefore, some experts suggest that HPV vaccination is best before a woman's first substantial sexual contact. According to a paper published in Chinese Science: Life Sciences, women aged 9-14 had a 100 percent positive seroconversion rate after receiving two doses of Wantai HPV, and the antibody level was higher than that of adult women aged 18-26 who received three doses. The ages of 9-14 are also the best age group recommended by the World Health Organization for HPV vaccination.

据万泰HPV疫苗说明书显示,9-14岁接种者只需接种两次万泰HPV疫苗即可完成全部接种疗程。这也是国内第一次有宫颈癌疫苗被批准二针法。

According to the Wantai HPV Vaccine Instructions,9-14-year-olds only need to be vaccinated twice to complete the full course of vaccination. This is the first time a cervical cancer vaccine has been approved in China.

在国产HPV疫苗尚未上市前,进口HPV疫苗的价格一直被认为比较高。尽管中国地大物博,但并非人人都能消费得起每针动辄上千元的疫苗。“馨可宁”的问世,则为那些行走在宫颈癌边缘的人带来了福音。

The price of imported HPV vaccine has been considered relatively high before domestic HPV vaccine has been put on the market. Not everyone can afford to spend thousands of dollars a shot, despite China's vast wealth. The advent of \"Xin Ke Ning\" brings good news for those walking on the edge of cervical cancer.

人民健康在北京的几家医院了解到,目前已上市的英国葛兰素史克公司生产的二价HPV疫苗600元/针。对于这一价格,国产二价HPV疫苗329元/针的定价几乎便宜近半。

People's Health learned from several hospitals in Beijing that the bivalent HPV vaccine 600 yuan\/needle produced by the now-listed British company GlaxoSmithKline. For this price, the price of domestic divalent HPV vaccine 329 yuan \/ needle is almost half cheaper.

据悉,福建省药品监督管理局已于2020年1月3日出具GMP检查结果通知书,厦门万泰双价人乳头瘤病毒疫苗(大肠杆菌)检查结果符合《药品生产质量管理规范》。这意味着万泰已经可以正式生产该疫苗。

It is reported that the Fujian Provincial Drug Administration has issued a notice of GMP inspection results on January 3,2020, and the results of Xiamen Wantai dual-valent human papillomavirus vaccine (Escherichia coli) inspection are in accordance with the quality management standard for drug production. That means the vaccine can be officially produced.

“万泰已于3日下午开始正式生产国产HPV二价疫苗。疫苗生产出来后,还要待药品监管部门批签发后才能放行,预计5月份可以正式铺向市场。不过,如按照新药品法的相关规定,也有可能春节前少量疫苗可以上市。”张军表示,国产二价HPV疫苗对9~14岁女性可以选择两剂次接种程序,于0、6月分别接种1剂次(间隔不小于5个月)。对于15-45岁的女性,推荐于0、1和6月分别接种1剂次,共接种3剂,其中第2剂可在第1剂之后的1~2月内接种,第3剂可在第1剂后的第5~8月内接种。

\"Wantai on the afternoon of the 3rd began the production of domestic HPV divalent vaccine. After the vaccine is produced, it will not be released until it is approved by the drug regulator and is expected to be officially marketed in May. However, in accordance with the relevant provisions of the new drug law, it is also possible that a small number of vaccines can be listed before the Spring Festival. Zhang said that domestic bivalent HPV vaccine for 9-14-year-old women can choose two doses of the vaccination program, in 0, June, respectively, one dose (not less than five months interval). For 15-45-year-old women, it is recommended to inoculate 1 dose in 0,1 and 6 months respectively, a total of 3 doses, of which the second dose can be inoculated within 1 to 2 months after the first dose, and the third dose can be inoculated within 5 to 8 months after the first dose.

国产二价HPV疫苗接种在望,有人甚至算出了国内HPV疫苗的市场缺口约是10亿。面对如此大的市场空间,张军表示,目前的厂房设计产能为3000万剂/年,第一年可以实现年产800万剂,如果市场需求旺盛,企业会及时安排产能扩大,保障疫苗及时供给。

Domestic bivalent HPV vaccinations are in sight, and some have even calculated that the market gap for domestic HPV vaccines is about 1 billion. Faced with such a large market space, Zhang said that the current plant design capacity of 30 million doses per year, the first year can achieve annual production of 8 million doses, if the market demand is strong, enterprises will timely arrange capacity expansion to ensure the timely supply of vaccines.

“疫苗在国内覆盖各省、自治区、直辖市,一般设有疫苗接种点的社区医院、卫生服务中心、妇幼医院就能接种到。”张军说。

\"Vaccines cover the provinces, autonomous regions and municipalities directly under the Central Government, and are commonly available in community hospitals, health service centers and maternal and child hospitals with vaccination sites. said Zhang Jun.

如今,在国产二价疫苗投产的同时,厦门万泰母公司北京万泰生物药业股份有限公司(下称“万泰生物”)也顺利通过IPO审核,拟登陆上交所主板。

Now, at the same time as domestic bivalent vaccine production, xiamen wantai parent company beijing wantai biopharmaceutical co., ltd.(hereinafter referred to as \"wantai biological \") also successfully passed the ipo audit, to land on the main board of the shang.

据天眼查显示,万泰生物隶属于养生堂有限公司,是从事生物诊断试剂与疫苗研发及生产的高新技术企业。除疫苗产业外,万泰生物还涉及体外诊断试剂与体外诊断仪器的研发、生产及销售。(王国菁)

According to the sky eye inspection, Wantai Bio belongs to the health hall limited company, is engaged in biological diagnostic reagent and vaccine research and production of high-tech enterprises. In addition to the vaccine industry, Wantai Bio is involved in the development, production and marketing of in vitro diagnostic reagents and in vitro diagnostic instruments. (King Kong)

冬季上火大多是饮食不当!养生应该这样吃冬季温度低、气候干燥。从中医角度讲,冬季上火,多是由于饮食不当所致。那么,冬季如何饮食才能养生呢?

Winter fire is mostly bad diet! Health should eat this low winter temperature, dry climate. From the point of view of traditional Chinese medicine, winter fire, mostly due to improper diet. So, how to eat in winter to keep healthy?

上了年纪,耳朵听不清?教你6招防老年耳聋衰老虽是自然规律,但老年性耳聋发病年龄和进展速度却因人而异,生活中不少百岁老人依然耳聪目明。那么,该如何预防或推迟老年性耳聋发生呢?

When you're old, you can't hear me? Although it is a natural rule to prevent deafness and aging, the age and speed of onset of deafness vary from person to person, and many centenarians still have ears and eyes in their lives. So how to prevent or delay the occurrence of senile deafness?

日常保健五大要穴推荐缓解腰痛最佳动作中医养生保健学历史悠久,其中穴位养生越来越受到重视。你知道吗?身上的5个穴位对养生保健、强身健体有重要作用。

Five main points of daily health care recommended to relieve the best action of low back pain traditional Chinese medicine health care has a long history, among which acupoint health care has been paid more and more attention. You know what? The body of 5 acupoints to health care, physical fitness has an important role.


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