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Ọgwụ mgbochi COVID-19 ọhụrụ ewepụtara na China na-anata ikike mmepụta

Jiangsu Recbio Technology Co., Ltd., ụlọ ọrụ biopharmaceutical na-elekwasị anya na nyocha, mmepe na ịzụ ahịa nke ọgwụ mgbochi ọhụrụ nke nwere ike ịgwọ ọrịa ndị jupụtara na ibu dị arọ, na nso nso a mara ọkwa na ụlọ ọrụ ahụ enwetala ikikere mmepụta ọgwụ (obosara: recombinant abụọ akụkụ. Ogwu COVID-19 [CHO cell]) nke Jiangsu Medical Products Administration (JSMPA) nyere.

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Ọ na-egosi na ebe nrụpụta Recbio dị na Taizhou, mpaghara Jiangsu, China (ụlọ ọrụ Taizhou) eruola ịrụpụta ọgwụ mgbochi COVID-19 nwere akụkụ abụọ (CHO cell) (ReCOV), nke na-egosi na Recbio emeela nzọụkwụ ọzọ dị ịrịba ama n'ihu. ụlọ ọrụ ịgba ọgwụ mgbochi ọrịa nwere usoro ụlọ ọrụ dum na-ekpuchi nyocha, mmepụta na ire ahịa.         

Emebere ụlọ nrụpụta ọgbara ọhụrụ a na-agbaso ụkpụrụ Ezi Nrụpụta Ngwa (cGMP) dị ugbu a. Site na mkpokọta GFA nke karịrị 17,000 sq.m., ụlọ ọrụ Taizhou nwere ikike nrụpụta kwa afọ karịa 100 nde doses, nke enwere ike ịgbasa ngwa ngwa ruo nde 300 kwa afọ.

N'ime afọ 10 gara aga, ejirila nke nta nke nta tinye akwụkwọ adjuvants n'ụlọ ọrụ ịgba ọgwụ mgbochi ọrịa wee weta mgbanwe dị ukwuu na ụlọ ọrụ ahụ. Recbio bụ otu n'ime ụlọ ọrụ ole na ole nwere ikike mmepụta azụmahịa maka ihe enyemaka ọhụụ nke FDA kwadoro maka ojiji mmadụ. N'ihi nke ahụ, ọgwụ mgbochi ndị ụlọ ọrụ mepụtara ọ bụghị nanị na ha nwere arụmọrụ ọgbara ọhụrụ, kamakwa ọ bụghị ịdabere na ndị na-ebubata ihe enyemaka ọ bụla. N'ịbụ onye akwadoro n'ime ụlọ emepụtara ọhụrụ adjuvant BFA03 benchmarking AS03, ReCOV egosipụtala ezigbo immunogenicity, nchekwa na nnabata na usoro ọmụmụ ụlọ ọgwụ Phase I na New Zealand. N'ụzọ doro anya, titer nke mgbochi mgbochi mgbochi nke ReCOV butere erughị nke ọgwụ mgbochi mRNA nke mba ụwa butere. A na-atụ anya ReCOV itinye akwụkwọ maka EUA (ikike iji ihe mberede) n'isi mbido ọkara mbụ nke 2022.

Ihe gbasara ọgwụ mgbochi COVID-19 nke mejupụtara abụọ (ReCOV)

Na Mee 2020, Recbio, yana Jiangsu Provincial Center for Disease Control and Prevention ("Jiangsu CDC") na Taizhou Medical New & High-tech Industrial Development Mpaghara, jikọtara ọnụ mepụtara ọgwụ mgbochi COVID-19 nwere akụkụ abụọ (ReCOV). N'okpuru nduzi nke Prọfesọ Fengcai Zhu sitere na Jiangsu CDC, ndị otu R&D kwalitere ọgwụ mgbochi ahụ nke ọma site na iji injinịa protein na teknụzụ adjuvant ọhụrụ ka ReCOV nwee ntụkwasị obi na-ekwe nkwa na mgbochi siri ike megide SARS-CoV-2 na ụdị nchegbu dị ka Delta. Usoro nke uru zuru oke dị ka ihe nchebe ka mma megide ụdị dị iche iche na-apụta, mmụba dị mfe mmepụta, uru ọnụ ahịa, nnweta zuru ụwa ọnụ, nkwụsi ike nke nkwadebe dị mma, na nchekwa na njem n'ime ụlọ na-aghọ ọgwụ mgbochi COVID-19 ọhụrụ nke ọgbọ nke abụọ na-asọ mpi. .

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Onye nchịkọta akụkọ bụ Linda Hohnholz.

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