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Mutsva weCOVID-19 Vaccine Yakagadzirwa muChina Inotambira Rezinesi Rekugadzira

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Jiangsu Recbio Technology Co., Ltd., kambani yebiopharmaceutical inotarisa mukutsvagisa, kusimudzira uye kushambadzira kwemishonga yekudzivirira inogona kugadzirisa zvirwere zvakapararira nemitoro yakakura, nguva pfupi yadarika yakazivisa kuti kambani yakagamuchira Pharmaceutical Production License (chiyero: recombinant maviri-chikamu. COVID-19 vaccine [CHO cell]) yakapihwa neJiangsu Medical Products Administration (JSMPA).

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Zvinotaridza kuti nzvimbo yekugadzira yeRecbio muTaizhou, mudunhu reJiangsu, China (Taizhou nzvimbo) yave inokwanisa kugadzira mubatanidzwa wezvikamu zviviri zveCCIDID-19 vaccine [CHO cell] (ReCOV), izvo zvinoreva kuti Recbio yatora rimwe danho rakakosha kuenda kuchipatara. bhizinesi rekudzivirira neindasitiri yese cheni yakavharira tsvakiridzo, kugadzira uye kushambadzira.         

Iyo ichangobva kuvakwa yepasi-ye-art yekugadzira nzvimbo yakagadzirwa ichitevera ikozvino Yakanaka Manufacturing Maitiro (cGMP) zviyero. Iine GFA yakazara inodarika zviuru gumi nezvinomwe sq.m., nzvimbo yeTaizhou ine huwandu hwegore hwekugadzira hunopfuura mamirioni zana emadhora, ayo anogona kukurumidza kuwedzerwa kusvika kumamiriyoni mazana matatu emadhora pagore.

Mumakore gumi apfuura, zvinyorwa zvitsva zvakashandiswa zvishoma nezvishoma muindasitiri yekudzivirira uye zvakaunza shanduko dzakadzama kuindasitiri. Recbio ndeimwe yeashoma makambani ane kushambadzira kugadzirwa kweanova adjuvants ayo akatenderwa neFDA kushandiswa kwevanhu. Nekuda kweizvozvo, majekiseni akagadzirwa nekambani haana chete kuita-ye-art kuita, asi zvakare asingavimbi kune chero adjuvant mutengesi. Yakashongedzerwa ne-in-house yakagadzirwa novel adjuvant BFA10 benchmarking AS03, ReCOV yakaratidza yakanakisa immunogenicity, chengetedzo, uye kushivirira muChikamu I chekiriniki chidzidzo muNew Zealand. Zvikuru, iyo titer yekusadzikamisa masoja ekudzivirira chirwere akakonzereswa neReCOV yaive isiri shoma pane iyo yakakonzerwa neyakajairwa pasi rose mRNA vaccin. ReCOV inotarisirwa kunyorera EUA (Emergency Use Authorization) kutanga kwehafu yekutanga ya03.

Nezve Recombinant Two-Component COVID-19 Vaccine (ReCOV)

Muna Chivabvu 2020, Recbio, pamwe chete neJiangsu Provincial Center for Disease Control and Prevention (“Jiangsu CDC”) neTaizhou Medical New & High-tech Industrial Development Zone, vakabatana vakagadzira recombinant maviri-component COVID-19 vaccine (ReCOV). Nekutungamirwa naProfessor Fengcai Zhu kubva kuJiangsu CDC, timu yeR&D yakanyatso gadziridza jekiseni vachishandisa mapuroteni engineering uye matsva eadjuvant matekinoroji kuitira kuti ReCOV ive nevimbiso yekuchengeteka uye yakasimba immunogenicity kurwisa SARS-CoV-2 uye akasiyana ekunetsekana seDelta. Yakateedzana yemabhenefiti akazara senge nani kuyambuka-dziviriro kubva kune ari kusimukira akasiyana, kugadzirwa kuri nyore kukwira, mutengo wakanaka, kuwanikwa kwepasirese, kugadzikana kwakanaka kwekugadzirira, uye kuchengetedza uye chekufambisa pakupisa kwekamuri inove inokwikwidza chizvarwa chechipiri cheCCIDID-19. .

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Mupepeti mukuru ndiLinda Hohnholz.

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