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Tianjin based CanSino's recombinant COVID-19 vaccine approved as special military drug
Published on: 2020-06-30
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SINO 01Chinese biopharmaceutical firm CanSino Biologics Inc announced on Monday that a recombinant novel coronavirus vaccine (Ad5-nCoV) the company developed with a military research team has received special one-year military drug approval.

The approval for the military use of Ad5-nCoV was granted by the Health Bureau of the Logistics Support Department of the Central Military Commission on June 25, for one year. Ad5-nCoV is currently limited to military use and cannot be expanded to a broader vaccination range without the approval of the Logistics Support Department, the statement said.

Ad5-nCoV is being jointly developed by CanSino and a team led by military infectious disease expert Chen Wei from the Institute of Biotechnology under the Academy of Military Medical Sciences.

SINO 02The vaccine was approved for clinical trials in March. Phase one and two clinical trials for Ad5-nCoV have been conducted in China, with phase two trials were unveiled on June 11, 2020, according to CanSino. Data from the clinical trials showed a good safety profile and high levels of humoral and cellular immune responses. The overall clinical results indicate Ad5-nCoV has the potential to prevent diseases caused by SARS-CoV-2. According to regulations of the Chinese People's Liberation Army (PLA) covering drugs, special military drugs are those that the military uses to prevent and treat war injuries and diseases in special military environments.

Such drugs are limited to military use. Local medical institutes have to obtain the approval of local provincial-level governments and the military logistics support department to use such drugs, according to the regulations.

天津康希诺生物:重组新冠疫苗获军队特需药品批件

6月29日早间,康希诺生物股份公司公告披露,重组新型冠状病毒疫苗(腺病毒载体)获得军队特需药品批件。

公告称,公司与军事科学院军事医学研究院生物工程研究所联合开发的重组新型冠状病毒疫苗(腺病毒载体)(Ad5-nCoV),已于2020年6月25日获得中央军委后勤保障部卫生局颁发的军队特需药品批件,有效期一年。

Ad5-nCoV的I期及II期临床试验已在中国开展,并于2020年6月11日完成II期临床试验。康希诺生物称,临床试验数据证实其具有良好的安全性,及较高的体液免疫及细胞免疫应答水平。总体试验结果表明,Ad5-nCoV具有预防由SARS-CoV-2引起的疾病的潜力。

公告提到,根据《中国人民解放军实施〈中华人民共和国药品管理法〉办法》有关规定,Ad5-nCoV现阶段仅限军队内部使用,未经军委后保部批准,不得扩大接种范围。

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