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中国HPV疫苗诞生记科研团队18年磨一剑
2020-01-07 23:42  www.equintos.com

  【解说】中国国家药监局近日批准首个国产双价人乳头瘤病毒疫苗(商品名为馨可宁)的上市注册申请,该疫苗的上市意味着中国成为全球继美国和英国后第三个成功研发生产HPV疫苗的国家。

Explanation [] China's State Drug Administration recently approved its first domestic listing application for a dual-valent human papillomavirus vaccine, known as Xin Ke Ning, which means China has become the third country in the world to successfully develop and produce HPV vaccines after the US and the UK.

  【解说】HPV即人乳头瘤病毒的英文简称,%的宫颈癌都是因感染HPV造成的。此次国产HPV疫苗由中国国家传染病诊断试剂与疫苗工程技术研究中心(厦门大学夏宁邵团队)和厦门万泰共同研发,采用基于大肠杆菌的疫苗制作体系,具有完全自主知识产权,适用于9至45岁女性。该研究中心副主任张军在接受中新社记者专访时表示,从立项研制到如今上市,历经约18年时间。

HPV is the abbreviation of human papillomavirus.% of cervical cancer is caused by HPV infection. the domestic hpv vaccine was jointly developed by china national infectious disease diagnostic reagent and vaccine engineering technology research center (xia ning shao team of xiamen university) and xiamen wantai, using a vaccine production system based on e. coli, with fully autonomous intellectual property rights, suitable for women aged 9 to 45. Zhang Jun, deputy director of the research center, said in an interview with China News Agency reporters that it took about 18 years from project development to listing today.

  我们采用了一个独立全新的疫苗生产体系,这个来说是之前我们自己实验室在戊型肝炎疫苗的研制上面来说,已经有了初步成功的经验,然后我们拓展到宫颈癌疫苗上,而这一条路因为国外来说他们从来没有尝试成功过,所以来说在这一个(研发)过程当中也是受到了很多方面的这个,不能说质疑至少来说大家半信半疑,那么我们需要来说更坚实的科学数据去说服大家。

We have adopted an independent new vaccine production system, this is to say that our own laboratory in the development of hepatitis e vaccine has had a preliminary successful experience, and then we expand to cervical cancer vaccine, and this road because they have never tried to succeed abroad, so in this (research) process is also a lot of aspects of this, cannot say that at least we need to be more solid scientific data to convince everyone.

  【解说】与仿制药走捷径不同,原创体系只能从零开始,困难重重。18年来,该团队在国产HPV疫苗研制过程中,至少有两千人参与研发,从青丝到白发,历经数千次实验,克服多项技术难点才最终成功。

Unlike generic drug shortcuts, the original system can only start from scratch, with many difficulties. Over the past 18 years, at least 2,000 people have been involved in the development of domestic HPV vaccines, from blue to white hair, after thousands of experiments to overcome many technical difficulties.

  (研发)会有很多的困难在里面,所以当时还是想办法(解决问题),甚至做到有的学生真的是(实验)做到哭了,哭了我们擦干眼泪继续往下做,反正基本上用这样的方式,所以一步一个脚印的解决各个技术问题,这里面有特别多的技术问题,但得一个一个去解决,有一些大家已经告诉我们不行,但我们怎么绕过去,所以这里面有很多这种巧妙的或者说是一些比较重要的突破在里面。

(R