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UGonyo olutsha lwe-COVID-19 oluphuhliswe e-China luFumana iPhepha-mvume leMveliso

Ibhalwe ngu umhleli

I-Jiangsu Recbio Technology Co., Ltd., inkampani ye-biopharmaceutical egxile kuphando, uphuhliso kunye nokuthengiswa kwezitofu zokugonya ezinokuthi zijongane nezifo ezixhaphakileyo ezinomthwalo obalulekileyo, kutshanje ibhengeze ukuba inkampani ifumene iLayisensi yeMveliso yoShishino (ububanzi: icandelo eliphindwe kabini Ugonyo lwe-COVID-19 [iseli ye-CHO]) lukhutshwe nguLawulo lweeMveliso zonyango lwe-Jiangsu (JSMPA).

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Kubonisa ukuba indawo yokuvelisa i-Recbio e-Taizhou, kwiphondo laseJiangsu, e-China (indawo yase-Taizhou) ikwazile ukwenza iyeza eliphinda-phinda kabini le-COVID-19 [i-CHO cell] (ReCOV), nto leyo ethetha ukuba i-Recbio ithathe elinye inyathelo elibalulekileyo ekulweni Ishishini lokugonya elinophando loshishino olupheleleyo, imveliso kunye nentengiso.         

Indawo esanda kwakhiwa yemveliso yobugcisa yayilwa ngokulandela imigangatho yangoku ye-Good Manufacturing Practices (cGMP). Nge-GFA iyonke engaphezulu kwe-17,000 sq.m., indawo yaseTaizhou inomthamo wemveliso wonyaka ongaphezulu kweedosi zezigidi ezili-100, ezinokwandiswa ngokukhawuleza ukuya kwi-300 yezigidi zeedosi ngonyaka.

Kule minyaka ili-10 idlulileyo, izincedisi zenoveli ziye zasetyenziswa kancinci kancinci kwishishini lokugonya kwaye zisa utshintsho olukhulu kwishishini. I-Recbio yenye yeenkampani ezimbalwa ezinesakhono semveliso yorhwebo yeenoveli ze-adjuvants ezivunyiweyo yi-FDA ukuba zisetyenziswe ngabantu. Enkosi kulonto, izitofu zokugonya eziphuhliswe yinkampani azinamsebenzi waseburhulumenteni nje kuphela, kodwa zingathembeli kuye nawuphi na umboneleli othile oncedisayo. Ixhotyiswe nge-in-house ephuhliswe inoveli ye-adjuvant BFA03 benchmarking AS03, i-ReCOV ibonakalise ukugonyamela okugqwesileyo, ukhuseleko, kunye nokunyamezela kwiSigaba soku-I sophononongo lwezonyango eNew Zealand. Ngokucacileyo, i-titer ye-anti-anti-antigens ebangelwa yi-ReCOV yayingekho ngaphantsi kwaleyo ibangelwe lugonyo oluqhelekileyo lwehlabathi lwe-mRNA. I-ReCOV kulindeleke ukuba ifake isicelo se-EUA (uGunyaziso lokuSebenzisa oluNgxamisekileyo) kwangoko kwisiqingatha sokuqala sika-2022.

Malunga neNdibaniselwano yaMacandelo amabini e-COVID-19 (ReCOV)

NgoMeyi ka-2020, i-Recbio, kunye neZiko lePhondo laseJiangsu loLawulo lweSifo kunye noThintelo (“Jiangsu CDC”) kunye neTaizhou Medical New & High-tech Industrial Development Zone, ngokudibeneyo baphuhlise isitofu sokugonya esinamacandelo amabini e-COVID-19 (ReCOV). Phantsi kwesikhokelo sikaNjingalwazi uFengcai Zhu ovela kwi-Jiangsu CDC, iqela le-R&D lilenze ngokupheleleyo isitofu sokugonya lisebenzisa ubunjineli beprotheyini kunye nobuchwepheshe obutsha be-adjuvant ukuze i-ReCOV ibe nokhuseleko oluthembisayo kunye nokungakhuseleki okunamandla ngokuchasene ne-SARS-CoV-2 kunye nokwahluka kwenkxalabo efana neDelta. Uthotho lweengenelo ezibanzi ezinje ngokhuseleko olunqamlezayo ngokuchasene nokwahluka okuvelayo, ukunyuswa ngokulula kwemveliso, inzuzo yeendleko, ukufikeleleka kwihlabathi liphela, ukuzinza okuhle kwamalungiselelo, kunye nokugcinwa kunye nokuhamba kwiqondo lobushushu begumbi kuba lukhuphiswano lwesizukulwana sesibini sesitofu esitsha se-COVID-19. .

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Umhleli oyintloko nguLinda Hohnholz.

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