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康希诺生物13价肺炎球菌多糖结合疫苗获新药临床试验批准

发布者:康希诺生物公众号浏览次数:

康希诺生物股份公司(康希诺生物,6185.HK)今天宣布,其研制的“13价肺炎球菌多糖结合疫苗”PCV13i于2019年4月19日获得国家药品监督管理局临床试验批准。

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这是迄今为止康希诺生物在肺炎球菌疫苗领域获得的第二个临床试验批件,意味着公司在产品商业化进程中取得又一进步。在此之前,公司一款“重组肺炎球菌蛋白疫苗”PBPV,已于2018年10月获得临床试验批准。

 

PCV13i是康希诺生物采用自主技术研制的肺炎球菌新型疫苗产品,包含13个肺炎球菌血清型,2017年发布的“肺炎球菌性疾病免疫预防专家共识显示,这13个血清型覆盖了我国5岁以下儿童80%以上的侵入性肺炎球菌疾病。

 

与国内现有和潜在的肺炎球菌结合疫苗不同,PCV13i使用白喉毒素无毒突变体(CRM197)和破伤风类毒素(TT)两种蛋白载体与13个肺炎球菌致病血清型共价结合,可有效避免使用单一载体过量可能导致的不良反应。

 

肺炎球菌性疾病是导致5岁以下儿童发病甚至死亡的主要原因之一,世界卫生组织报告显示,2008年全球约有46万5岁以下儿童死于肺炎球菌引起的相关疾病,其中,2岁以下婴幼儿占绝大部分。

 

康希诺生物成立于2009年,致力于创新疫苗的研发、生产和商业化,为中国乃至全球公共卫生健康安全做出贡献。公司现有四个创新疫苗平台技术,包括腺病毒载体疫苗技术、结合技术、蛋白设计与重组技术、制剂技术。在此基础上,公司已经研发出15个创新疫苗候选产品,覆盖12个疾病领域,其中埃博拉病毒病疫苗已率先于2017年获批上市。康希诺生物是香港联交所主板上市公司,股票代码:6185.HK

 

 

CanSinoBIOreceives approval for its 13-valent penumococcal conjugate vaccine to startclinical trials

 

April 19,2019, CanSino Biologics Inc. (CanSinoBIO, 6185.HK) announces that it received theNational Medical Products Administration’s (NMPA) permission for its PCV13i, a candidate 13-valent pneumococcalconjugate vaccine, by to start human clinical trials. 

 

This is the second approval CanSinoBIO has been granted as of today for clinical trials of its novel pneumococcal vaccines, showcasing another step forward in the company’s commercialization commitment. A novel protein-based pneumococcal vaccine (PBPV) candidate was approved for clinical trials in October 2018.

 

PCV13i  is the company’s proprietary vaccine candidate under development for protection against invasive pneumococcal disease (IPD). It contains capsular polysaccharides from 13 pneumococcal serotypes that are responsible for over 80% of the IPD among children under five years of age in China, according to Expert Consensus on Immunization for Prevention of Pneumococcal Disease in China published in 2017.

 

Each of these antigens are individually conjugated to one of the two carrier proteins, CRM197, a non-toxic variant of diphtheria toxin, and a tetanus toxoid (TT), which makePCV13i  unique to other pneumococcal conjugate vaccines currently available and under development in China. Using two carrier proteins will minimize the potential negative effects caused by using excessive single carrier protein.

 

Pneumococcal infections remain a leading cause of mortality and morbidity among children under five globally. WHO reported an estimated death of 460,000 children under five in 2008, with infants under two contributing disproportionately to the pneumococcal death.

 

Incorporated in 2009, CanSinoBIO commits to research, production and commercialization of innovative vaccines for global public health security including China. It possesses four integrated platform technologies including adenovirus-based vectors, conjugation, protein design and recombination and formulation. As of today, CanSinoBIO has a pipeline of 15 innovative vaccines covering 12 diseases, including a globally innovative Ebola virus vaccine approved for marketing in 2017. CanSinoBIO is a listed company on the Main Board of HKEx (6185.HK).

 

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