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首款国产HPV疫苗低价上市!一针难求局面有望改观
2020-01-08 00:51   来源:  www.getslapt.com   评论:0 点击:

首款国产HPV疫苗低价上市!一针难求局面有望改观[摘要]曾在上海时疾病预防控制中心任职15年的疫苗行业专家

[摘要]曾在上海时疾病预防控制中心任职15年的疫苗行业专家陶黎纳在1月2日接受时代财经采访时表示,"此次国内这款二价宫颈癌疫苗的上市具有里程碑的意义。"

Taurina, a vaccine industry expert who served at the Centers for Disease Control and Prevention in Shanghai for 15 years, said in an interview with Time Financial on Jan. \"

近日,国家药品监督管理局发布公告称,批准厦门万泰沧海生物技术有限公司(以下称“万泰公司”)的双价人乳头瘤病毒疫苗(大肠杆菌)(商品名:馨可宁)上市注射申请。

Recently, the state drug administration issued an announcement that approved xiamen wantai sea biotechnology co., ltd.(hereinafter referred to as \"wantai company \") dual-valent human papillomavirus vaccine (escherichia coli)(trade name: xin koning) market injection application.

据悉,该疫苗为万泰公司与厦门大学联合研发,由万泰实施转化的首款国产宫颈癌疫苗,意味着中国宫颈癌疫苗结束只能依赖进口的历史。

The vaccine, the first domestic cervical cancer vaccine to be converted by wantai, a joint venture between wantai and xiamen university, means china's history of having to rely only on imports.

目前,宫颈癌已成为全球女性中第三大常见癌症。随着大众预防宫颈癌意识的日渐普及,宫颈癌疫苗需求日益增加,全球一年的需求量高达一亿支。但由于技术受限且生产宫颈癌疫苗的企业较少,目前全球供应能力仅为3000万支,不及总需求量的三分之一。资料显示,全球每年新发病例接近60万人,每年有超过30万名妇女死于这种疾病。在中国,宫颈癌每年新发病例约为15万,死亡人数约万,约占全部女性恶性肿瘤死亡人数的%。

At present, cervical cancer has become the third most common cancer among women in the world. With the increasing popularity of cervical cancer prevention awareness, the demand for cervical cancer vaccine is increasing, and the global demand is up to 100 million a year. But with limited technology and fewer companies producing cervical cancer vaccines, the global supply capacity is now just 30 million, less than a third of total demand. Almost 600,000 new cases are reported worldwide each year, with more than 300,000 women dying from the disease each year. In China, the number of new cases of cervical cancer is about 150,000 a year, and the number of deaths is about 10,000, accounting for about% of all deaths from malignant tumors in women.

目前,中国约有4亿人需要接种HPV疫苗。时代财经梳理中国食品药品检定研究院统计的数据发现,2018年国内HPV签发量为700万支,2019年接近900万支。若按照每人全程需注射3针疫苗计算,目前疫苗供应量还远远无法满足国内市场所需,以至于出现一针难求、摇号打针的情况。

At present, about 400 million people in China need to be vaccinated against HPV. Time Finance combed the statistics of the China Institute of Food and Drug Control and Research found that in 2018, the number of domestic HPV issuance was 7 million, and in 2019 it was close to 9 million. At present, the supply of 3 injections per person is far from meeting the needs of the domestic market, resulting in a hard-to-find, rocking situation.

在万泰HPV疫苗正式获批前,全球已上市的HPV疫苗有3种,分别是英国葛兰素史克公司生产的针对HPV16、18型的双价疫苗,美国默沙东公司生产的针对HPV6、11、16、18型的四价疫苗和针对HPV6、11、16、18、31、33、45、52、58型的九价疫苗。

Before the approval of the Wantai HPV vaccine, there were three global HPV vaccines, the two-valent vaccine for HPV16 and 18 produced by GlaxoSmithKline, the four-valent vaccine for HPV6,11,16,18 and the nine-valent vaccine for HPV6,11,16,18,31,33,45,52 and 58.

其中,二价HPV疫苗对2种高危型HPV病毒(HPV-16和HPV-18)有保护作用,而中国人群中超过8成的宫颈癌由这两种病毒引起。

Among them, the bivalent HPV vaccine protects against two high-risk HPV viruses (HPV-16 and HPV-18), and more than 80% of cervical cancer in the Chinese population is caused by these two viruses.

曾在上海时疾病预防控制中心任职15年的疫苗行业专家陶黎纳在1月2日接受时代财经采访时表示,从理论上来讲,二价和四价疫苗的预防率为84%,九价疫苗预防率为92%。“虽然大众普遍认为九价疫苗比二价和四价在预防宫颈癌上效果好很多,但有证据表明,三者在实际效果上并没有明显区别。”

In theory, the prevention rate of bivalent and tetravalent vaccines is 84 percent, and the nine-valent vaccine prevention rate is 92 percent, said Taurina, a vaccine industry expert who served at the Centers for Disease Control and Prevention in Shanghai for 15 years in an interview with Time Finance on Jan. \"Although it is widely accepted that the nine-valent vaccine is much better than bivalent and tetravalent in preventing cervical cancer, there is evidence that the three are not significantly different in practical terms.

另外,厦门大学公共卫生学院副院长张军曾接受媒体采访时表示,相较于葛兰素史克公司的二价HPV疫苗使用昆虫细胞生产体系,以及默沙东公司的HPV使用的重组酿酒酵母生产体系,此次获批的双价人乳头瘤病毒疫苗使用的是大肠杆菌生产体系,“其直接生产成本低,更利于未来产能的放大。”

In addition, Zhang Jun, vice president of Xiamen University's School of Public Health, said in a media interview that the approved double-valent human papillomavirus vaccine used an E. coli production system, which is less costly and more conducive to the expansion of future production capacity, compared with GlaxoSmithKline's two-valent HPV vaccine using insect cell production systems and the recombinant Saccharomyces cerevisiae production system used by Mercadon.

时代财经注意到,目前进口HPV疫苗的价格普遍偏高。据北京市疾控中心公布的价格,进口九价疫苗为1298元(人民币)/针,全程费用大约在4000元左右。进口二价疫苗为580元/针,全程也需近2000元。

Time Finance noted that the current import of HPV vaccine prices are generally high. According to the price announced by the CDC in Beijing, the imported nine-valent vaccine is 1298 yuan (RMB)\/pin, and the full cost is about 4000 yuan. The imported bivalent vaccine is 580 yuan \/ needle, and the whole process also needs nearly 2000 yuan.

万泰公司透露的信息显示,其HPV疫苗定价为329元/针,9-14岁小龄组全程658元,大龄组全程987元。该价格约为进口二价疫苗价格的一半。

According to the company's information, its HPV vaccine is priced at 329 yuan \/ needle,9-14 years of age group full 658 yuan, older group full 987 yuan. The price is about half the price of imported bivalent vaccines.

尽管陶黎纳认为此次国内二价宫颈癌疫苗的上市具有“里程碑式”的意义,但他认为,若单纯从技术上来说,这款国产疫苗“只能算中规中矩,并没有特殊的亮点。”

Despite tao lina's belief that the domestic listing of bivalent cervical cancer vaccine is a \"landmark \", he said that if purely technical, the domestic vaccine\" can only be counted as moderate, and there is no special bright spot.\"

据其介绍,葛兰素史克公司的二价HPV疫苗运用了全新的佐剂技术,而该技术的原理曾获得过诺贝尔奖,且在针对2种高危型HPV病毒(HPV-16和HPV-18)产生的抗体更高。陶黎纳认为,目前的国产疫苗与进口疫苗相比,“并不具备关键性的优势。”

GlaxoSmithKline's bivalent HPV vaccine uses a new adjuvant technology that has won a Nobel Prize for its principles and produces higher antibodies against two high-risk HPV viruses (HPV-16 and HPV-18), it said. Tao believes that the current domestic vaccine compared to imported vaccines,\" does not have a key advantage.\"

陶黎纳认为,关键在于企业如何在国内市场推广这款疫苗。在他看来,这款国产疫苗在一线城市的推广较为困难,一方面较之进口疫苗,国产疫苗只具备价格上的优势竞争力还不够;另一方面,一线城市大众普遍对宫颈癌疫苗的了解程度较深,且对九价疫苗更为认可。

The key, he says, is how companies promote the vaccine in the domestic market. In his view, the promotion of this domestic vaccine in first-tier cities is more difficult, on the one hand, the imported vaccine, domestic vaccine has only a price advantage competitiveness is not enough; on the other hand, the first-tier cities generally know more about cervical cancer vaccine, and the nine-valent vaccine is more recognized.

但他认为,相较于一线城市,二、三线城市的受众相对会更容易接受国产疫苗,“如果部分地区政府采购政策可以实现,那国产疫苗大概率会成为政府优先考虑的对象。”

But he argues that second- and third-tier cities will be more receptive to home-made vaccines than first-tier cities,\" if some regional government procurement policies can be achieved, then the high probability of home-made vaccines will be a priority for the government.\"

据最新研究发现,青少年群体只需注射一剂宫颈癌疫苗也可以达到预防效果。在注射次数少、价格减少的情况下,国内实现青少年免费接种的概率也会进一步加大。有业界人士认为,在众多发达国家已将宫颈癌疫苗纳入免费接种的行列的背景下,中国实现该类疫苗的免费接种或只是时间的问题。

The latest study found that a single dose of cervical cancer vaccine could be used to prevent the disease. In the case of fewer injections and lower prices, the probability of achieving free vaccination for adolescents in China will be further increased. Industry insiders believe it is only a matter of time before a vaccine for cervical cancer is given free of charge in china, in a context where many developed countries have included it.

时代财经注意到,2019年9月9日,万泰公司已与葛兰素史克共同签署了一项合作协议,双方将基于万泰公司的创新抗原技术与葛兰素史克的佐剂系统联合研发新一代的人乳头瘤病毒疫苗。

Time notes that on September 9,2019, Wantai has signed a cooperation agreement with GlaxoSmithKline to jointly develop a new generation of human papillomavirus vaccine based on Wantai's innovative antigen technology with Glaxo's adjuvant system.


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