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Tianjin CanSino Files Seeking China's 3rd Covid-19 Vaccine Approval
Published on: 2021-02-26
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​Two more homegrown COVID-19 vaccines are being reviewed by China's top drug regulator to obtain conditional market approval, the drugmakers announced on Wednesday.
 

CanSino Biologics, a company based in Tianjin municipality, said it had filed for conditional authorization to the National Medical Products Administration on Sunday for its one-shot vaccine, jointly developed with a research team under the Academy of Military Sciences.
 

With a single injection, the candidate has an efficacy rate of 65.28 percent at preventing all symptomatic cases and a rate of 90.07 percent at preventing severe infections 28 days after inoculation, the company said in a statement released on Wednesday.
 

The data is based on interim results from Phase-3 clinical trials enrolling more than 4,000 participants in Pakistan, Mexico, Russia, Chile and Argentina, according to the statement.
 

On the same day, the Wuhan Institute of Biological Products, administered by State-owned Sinopharm, said it also applied for conditional market approval to the top drug regulator on Sunday.
 

Interim results from late-stage human trials show its inactivated vaccine has an overall efficacy rate of 72.51 percent, according to the company. Full inoculation with this vaccine requires two doses.
 

China has so far granted conditional approval to two vaccines, one manufactured by Sinopharm's Beijing Institute of Biological Products and the other from Beijing-based Sinovac Biotech.
 

康希诺重组新冠病毒疫苗附条件上市申请获受理

2月24日午间,康希诺发布公告,其重组新冠病毒疫苗(5型腺病毒载体)附条件上市申请获国家药监局受理。截至目前,我国已批准2款新冠疫苗附条件上市,应急批准5条技术线路共16个疫苗品种开展临床试验,有6个疫苗品种已开展Ⅲ期临床试验。
 

重组新型冠状病毒疫苗(5型腺病毒载体)(商品名为“克威莎”)由康希诺与军事科学院军事医学研究院生物工程研究所共同开发,采用基因工程方法构建,以复制缺陷型人5型腺病毒为载体,可表达新冠病毒S抗原,拟用于预防新冠病毒感染引起的疾病。该疫苗已在巴基斯坦、墨西哥、俄罗斯、智利及阿根廷5个国家开展全球多中心Ⅲ期临床研究,完成4万余受试者的接种及期中数据分析。
 

克威莎的Ⅲ期临床试验期中分析数据结果显示,在单针接种疫苗28天后,疫苗对所有症状的总体保护效力为65.28%;在单针接种疫苗14天后,疫苗对所有症状总体保护效力为68.83%。疫苗对重症的保护效力,单针接种疫苗28天后为90.07%;单针接种疫苗14天后为95.47%。保护效力数据结果达到世界卫生组织相关技术标准及国家药监局印发的《新型冠状病毒预防用疫苗临床评价指导原则(试行)》中相关标准要求。
 

截至目前,我国已有两款新冠疫苗附条件上市,分别为2020年12月30日获批的国药集团中国生物的新冠病毒灭活疫苗、2021年2月5日获批的北京科兴中维的新冠病毒灭活疫苗。根据我国相关法律规定,对于应对重大突发公共卫生事件急需的疫苗,国家药监部门可以附条件批准注册申请,同时督促企业继续按计划完成Ⅲ期临床试验及其他上市后研究。除灭活疫苗外,我国正在同步推进的其他技术线路包括重组蛋白疫苗、腺病毒载体疫苗、减毒流感病毒载体疫苗和核酸疫苗。

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