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Katemera Watsopano wa COVID-19 Wopangidwa Ku China Walandila License Yopanga

Written by mkonzi

Jiangsu Recbio Technology Co., Ltd., kampani ya biopharmaceutical yomwe ikuyang'ana kwambiri kafukufuku, chitukuko ndi malonda a katemera wamakono omwe angathe kuthana ndi matenda omwe ali ndi zolemetsa zazikulu, posachedwapa adalengeza kuti kampaniyo yalandira License Yopanga Mankhwala (chiwerengero: chophatikizanso zigawo ziwiri). Katemera wa COVID-19 [CHO cell]) woperekedwa ndi Jiangsu Medical Products Administration (JSMPA).

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Zikuwonetsa kuti malo opanga a Recbio ku Taizhou, m'chigawo cha Jiangsu, China (malo a Taizhou) ali oyenerera kupanga katemera wa COVID-19 wophatikiza zigawo ziwiri [CHO cell] (ReCOV), zomwe zikusonyeza kuti Recbio yatenganso gawo lina lofunikira kuti apeze chithandizo. kampani ya katemera yokhala ndi kafukufuku wamakampani onse, kupanga ndi kutsatsa.         

Malo opangira zida zamakono omwe angomangidwa kumene adapangidwa motsatira miyezo yapano ya Good Manufacturing Practices (cGMP). Ndi GFA okwana pa 17,000 sq.m., Taizhou malo ali pachaka kupanga mphamvu oposa 100 miliyoni Mlingo, amene mwamsanga kukodzedwa kwa 300 miliyoni Mlingo pachaka.

M'zaka 10 zapitazi, ma adjuvants atsopano adagwiritsidwa ntchito pang'onopang'ono m'makampani a katemera ndipo adabweretsa kusintha kwakukulu pamakampani. Recbio ndi imodzi mwamakampani ochepa omwe ali ndi luso lopanga malonda a adjuvants atsopano omwe avomerezedwa ndi FDA kuti agwiritsidwe ntchito ndi anthu. Chifukwa chake, katemera wopangidwa ndi kampaniyo samangogwira ntchito mwaluso, komanso osadalira othandizira ena aliwonse. Yokhala ndi buku lamkati lopangidwa ndi BFA03 benchmarking AS03, ReCOV yawonetsa chitetezo chokwanira, chitetezo, komanso kulekerera mu kafukufuku wachipatala wa Phase I ku New Zealand. Makamaka, gawo la ma antibodies oyambitsidwa ndi ReCOV silinali locheperapo poyerekeza ndi katemera wa mRNA wapadziko lonse lapansi. ReCOV ikuyembekezeka kulembetsa ku EUA (Emergency Use Authorization) kumayambiriro kwa theka loyamba la 2022.

Za Katemera wa Recombinant Two-Component COVID-19 Vaccine (ReCOV)

Mu Meyi 2020, Recbio, limodzi ndi Jiangsu Provincial Center for Disease Control and Prevention (“Jiangsu CDC”) ndi Taizhou Medical New & High-tech Industrial Development Zone, mogwirizana adapanga katemera wa zigawo ziwiri za COVID-19 (ReCOV). Motsogozedwa ndi Pulofesa Fengcai Zhu wochokera ku Jiangsu CDC, gulu la R&D lidakwaniritsa bwino katemerayu pogwiritsa ntchito uinjiniya wa mapuloteni ndi matekinoloje atsopano a adjuvant kotero kuti ReCOV ikhale ndi chitetezo chodalirika komanso chitetezo champhamvu motsutsana ndi SARS-CoV-2 ndi mitundu yosiyanasiyana monga Delta. Ubwino wochulukirapo monga chitetezo chokwanira kumitundu yomwe ikubwera, kupanga kosavuta kupanga, phindu lamtengo wapatali, kupezeka kwapadziko lonse lapansi, kukhazikika kwakukonzekera bwino, kusungirako komanso kuyenda ndi kutentha kwachipinda kumakhala katemera wopikisana kwambiri wam'badwo wachiwiri wa COVID-19. .

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mkonzi

Mkonzi wamkulu ndi Linda Hohnholz.

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