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                                                      我公司新冠疫苗在烏茲別克斯坦Ⅲ期臨床試驗進展順利

                                                      發布時間2021-02-14  |  點擊率:

                                                        我公司在烏茲別克斯坦共和國開展的重組新型冠狀病毒疫苗(CHO細胞)(簡稱ZF2001疫苗)國際多中心Ⅲ期臨床試驗由烏茲別克斯坦共和國創新發展部下屬先進技術中心與烏茲別克斯坦共和國國家病毒研究所共同承擔。目前進展順利,并取得了階段性成果,已有6829人接種了第一針,1634人接種了第二針,截今為止無明顯不良反應,疫苗安全可靠。同時ZF2001疫苗的Ⅰ、Ⅱ期臨床試驗結果也表明該疫苗具有很好的安全性和免疫原性。

                                                        目前烏茲別克斯坦共和國內迫切需要新冠肺炎疫苗用于人群接種,形成群體免疫保護,控制疫情的傳播蔓延。為此,烏茲別克斯坦共和國正在積極推動我公司ZF2001疫苗的緊急使用許可(EUA)。鑒于我公司在烏茲別克斯坦共和國開展臨床試驗中所得到的友好合作與支持,雙方結下深厚友誼。我公司將優先為烏茲別克斯坦共和國提供緊急使用疫苗,將烏茲別克斯坦共和國作為ZF2001疫苗在該國的共同開發國,未來在該國擁有優先合作生產、聯合商業化、新疫苗開發和科學研究的權利。我公司將與烏茲別克斯坦共和國政府共同努力,盡快推動ZF2001疫苗在烏茲別克斯坦共和國獲得緊急使用許可(EUA)或上市許可(MA),用于烏茲別克斯坦共和國的新冠肺炎疫情防控,以幫助實現烏茲別克斯坦共和國的公共衛生目標。

                                                        The International Multi-centers Phase III trials of recombinant Novel Coronavirus Vaccine(CHO Cell) (ZF2001 vaccine), sponsored by Anhui Zhifei Longcom Biopharmaceutical Co.,Ltd, are undertaken by the Center of Advance Technologies under the Ministry of Innovative Development and the Institute of Microbiology. The trials are actively ongoing in Uzbekistan, and have made initial progress, 6,829 subjects have received the first doses, and 1,634 subjects have received the second doses, so far no significant adverse events have been observed, the vaccine is safe and reliable. At the same time, results from the Phase I and Phase II clinical trials in china has demonstrated the satisfied safety profile and immunogenicity of the vaccine.

                                                        In Uzbekistan, it is now urgently called for large scale vaccinations of COVID-19 vaccines for the people, so as to achieve herd immunity of the population and control the spread of Covid-19. In this case, the Uzbekistan government is actively promoting the emergency usage authorization(EUA) of ZF2001 vaccine. In view of the contribution and efforts of the Ministry of Innovative Development of the Republic of Uzbekistan for ZF2001 vaccine development and the deep friendship both have built since the cooperation of the clinical trials, Anhui Zhifei Longcom Biopharmaceutical Co.,Ltd will give priority to the Republic of Uzbekistan for the emergency usage vaccine supply, and also the Republic of Uzbekistan will act as a co-developing country for ZF2001 in Uzbekistan, with the priority in Uzbekistan on the cooperative production, joint commercialization, new vaccine development and scientific research.

                                                        Anhui Zhifei Longcom Biopharmaceutical Co.,Ltd, together with the government of Uzbekistan, will jointly work on the approval of emergency usage authorization (EUA) and marketing authorization (MA) of ZF2001 vaccine in the Republic of Uzbekistan for the prevention and control of the COVID-19 in the country, so as to achieve the public health goals of Uzbekistan.

                                                        (With EUA and MA approval, ZF2001 vaccine will be distributed in the Republic of Uzbekistan under the name ZF-UZ-Vac2001.)