Isi mmalite ọkwa ụlọ ọrụ: Nchịkwa nri na ọgwụ steeti, tengshengbo ọgwụ, Mahadum Tsinghua
Ntuziaka: China mbụ gụrụ akwụkwọ ọgụgụ isi COVID-19 na-ewepụ ọgwụgwọ ngwakọta ọgwụ mgbochi.
N'uhuruchi nke Disemba 8, 2021, webụsaịtị gọọmentị nke nchịkwa nchịkwa steeti kwupụtara na ntinye nke mgbochi mgbochi COVID-19 yana BRII-196 na BRII-198 bụ ndị nchịkwa nchịkwa steeti debara aha.Ọ bụ ikike ọgụgụ isi nke China mbụ gụrụ onwe ya COVID-19 na-ewepụ ọgwụgwọ ngwakọta ọgwụ mgbochi.
Dị ka usoro ndị dị mkpa nke iwu nchịkwa ọgwụ si dị, nchịkwa nri na ọgwụ na steeti ga-eme nyocha na nkwenye mberede dị ka usoro nkwenye pụrụ iche nke ọgwụ si dị, ma kwadoro nchikota ọgwụ abụọ a dị n'elu maka ọgwụgwọ nke ìhè na ndị okenye nkịtị. na ndị nọ n'afọ iri na ụma (12 ruo 17 afọ, na-atụ ihe karịrị 40kg) nwere ọrịa Coronavirus ọhụrụ (COVID-19) bụ ndị nwere nnukwu ihe ize ndụ (gụnyere ụlọ ọgwụ ma ọ bụ ọnwụ).N'ime ha, ndị nọ n'afọ iri na ụma (12-17 afọ, arọ ≥ 40kg) na-egosi na-n'okpuru ọnọdụ nkwado.
BRII-196 / BRII-198 jikọtara ọgwụgwọ bụ Prọfesọ Zhang Linqi, onye isi ụlọ ọrụ maka nyocha zuru oke nke AIDS na ụlọ ọrụ nyocha ahụike zuru ụwa ọnụ na ọrịa na-efe efe nke Mahadum Mahadum Tsinghua na Mahadum Tsinghua.A kwalitere ọgwụ Tengsheng na mmekorita ya na Mahadum Tsinghua na ụlọ ọgwụ mmadụ nke atọ nke Shenzhen.Ọgwụgwọ ahụ gosipụtara ọgwụ mgbochi COVID-19 dị irè site na nyocha nke enweghị usoro, nke kpuru okpukpu abụọ, nke ejiri placebo mee ihe.Ka ọ dị ugbu a, nkwado ahụ bụ akara mbụ nke R&D mepụtara na China wee gosipụtala ọgwụ mgbochi COVID-19 dị irè site na nyocha nke enweghị usoro, nke kpuru okpukpu abụọ, nke na-achịkwa placebo.
Prọfesọ Zhang Linqi kwuru, sị: "Nkwenye nke ọgwụ ngwakọta nke ,arazumab / romistimub ebutela ọgwụgwọ okpueze ọhụrụ mbụ na China.Usoro ọgwụgwọ ngwakọta a egosila ezigbo nchekwa na nchekwa na nnwale multicenter nke mba ụwa.Ọ bụ naanị ọgwụ mgbochi mmadụ n'ụwa mere nyocha nke mmetụta ọgwụgwọ nke ndị butere ụdịdị dị iche iche wee nweta data kacha mma.Usoro ọgwụgwọ ngwakọta mgbochi mmadụ bụ ihe kacha mma maka m China enyela ọgwụgwọ ọkwa ụwa maka COVID-19.O gosipụtara n'ụzọ zuru ezu mkpokọta miri emi na teknụzụ teknụzụ nke Mahadum Tsinghua n'ọhịa nke ịlụ ọgụ megide ọrịa na-efe efe, yana ikike na ike ịkpọ ya ka ọ bịa, ịlụ ọgụ, ịlụ ọgụ na ịlụ ọgụ.O meela onyinye dị mkpa na mgbochi ọrịa na njikwa ọrịa na China na ọbụna n'ụwa.Asọpụrụ anyị nke ukwuu ịbụ na ndabere nke ụlọ ọgwụ mmadụ atọ nke Shenzhen na Tengsheng Bo.Imekọ ihe ọnụ dị elu na nyocha ụlọ ọgwụ na ngbanwe emela nke a dị ịrịba ama.N'ime usoro na-esote, anyị ga-aga n'ihu na-amụ ọrụ mgbochi nke monoclonal antibody combinter therapy n'ime nnukwu ihe egwu na otu ụkọ mgbochi ọrịa.”
Nkwenye a dabere na usoro 3 ụlọ ọgwụ nke activ-2 nke National Institutes of Health (NIH) kwadoro, gụnyere oge dị mma na nsonaazụ ikpeazụ nke ndị ọrịa 847 debanyere aha.Nsonaazụ ikpeazụ gosiri na ọgwụgwọ ngwakọta nke ambavizumab / romistuzumab nwere ike ibelata ohere nke ụlọ ọgwụ na ọnwụ nke ndị ọrịa ọhụrụ okpueze nwere nnukwu ihe ize ndụ site na 80% (nsonaazụ nwa oge bụ 78%) ma e jiri ya tụnyere placebo, bụ nke dị ịrịba ama.N'ihe gbasara njedebe ụlọ ọgwụ nke ụbọchị 28, ọ dịghị ọnwụ n'ime otu ọgwụgwọ na ọnwụ 9 n'ime otu placebo, na nchekwa ahụike ya dị mma karịa nke ahụ na placebo.N'otu oge ahụ, ma a malitere ọgwụgwọ na mmalite (n'ime ụbọchị 5 mgbe mmalite nke mgbaàmà) ma ọ bụ na njedebe (n'ime ụbọchị 6 ruo 10 mgbe mmalite nke mgbaàmà ahụ) N'ime isiokwu ndị ahụ, ụlọ ọgwụ na ọnwụ dị oke mkpa. belatara, nke nyere windo ọgwụgwọ ogologo oge maka ndị ọrịa nwere okpueze ọhụrụ.
N'ihe na-erughị ọnwa 20, Mahadum Tsinghua, na nkwado nke Shenzhen Third People's Hospital na Tengshengbo Pharmaceutical Pharmaceutical, kwalitere ngwa ngwa usoro ọgwụgwọ ọrịazumab / romisvir site na nkwụsị nkewa na nyocha nke mbụ ruo na njedebe nke usoro 3 nke mba ụwa, ma mesịa nweta ndepụta nke China. nkwado.Mmezu a bụ njikọ aka nke China na ndị ọkà mmụta sayensị na-ahụ maka ụwa na ndị nyocha ụlọ ọgwụ Nsonaazụ gụnyere nkwado nke ACTIV-2 International Clinical Research Institute, National Institute of allergies na ọrịa na-efe efe (NIAID) nke National Institutes of Health (NIH). ), na otu ACTIV-2 Clinical trial team (ACTG), nke na-eduga nyocha ụlọ ọgwụ.
Liu Lei, onye isi ụlọ ọrụ nyocha ụlọ ọgwụ maka ọrịa na-efe efe na Shenzhen na odeakwụkwọ nke kọmitii Party nke ụlọ ọgwụ mmadụ nke atọ nke Shenzhen, kwuru, sị: “Site na mmalite nke ọrịa a, anyị setịpụrụ ebumnuche mgbochi ọrịa teknụzụ.Ndị otu anyị rụpụtara nke ọma ụzọ mgbochi mgbochi mgbochi na-arụsi ọrụ ike na serum nke ndị ọrịa na-emezi okpueze ọhụrụ, na-atọgbọ ntọala siri ike maka mmepe nke ọgwụ COVID-19 na-esote.Obi dị anyị ụtọ nke ukwuu iso Prọfesọ Zhang Linqi na ụlọ ọrụ ọgwụ Tengsheng nke Mahadum Tsinghua rụkọọ ọrụ iji mee okpueze mgbochi mbụ nke China.Ọgwụ nje na-enye aka amamihe na ahụmahụ.Anyị na-atụ anya na site na njikọta ọnụ ọgụgụ buru ibu nke ndị ọrụ nyocha na ndị ọrụ ahụike, anyị nwere ike imeri COVID-19 ozugbo enwere ike.
Luo Yongqing, Onye isi ala na onye isi njikwa nke Greater China kwuru, sị: "Anyị nwere obi ụtọ iji nweta ihe dị mkpa a dị mkpa ma na-agbasi mbọ ike iji kwalite nnweta ọgwụgwọ ngwakọta a maka ndị ọrịa okpueze ọhụrụ China.Mmezu a na-egosi na anyị agbasiwo mbọ ike n'ịkwalite mmepụta ihe ọhụrụ zuru ụwa ọnụ n'ihe gbasara ọrịa na-efe efe na-ejuputa mkpa ahụike na-adịghị mma na nke ọma, sayensị, siri ike na ezigbo nsonaazụ.Dị ka ụlọ ọrụ mba dị iche iche na-arụ ọrụ na China na United States Biotech Corp, enwere m obi ụtọ maka mmezu ọgwụ Tengsheng Bo, na anyị etinyeghị mgbalị ọ bụla iji nyere China aka ịnagide mkpa COVID-19 dị mgbagwoju anya na sayensị, ma gboo mkpa ụlọ ọgwụ nke ndị mmeri ọhụrụ anyị. .
Gbasara igwezumab / romistuzumab
(nke gara aga brii-196 / brii-198)
Ihe mgbochi monoclonal na mgbochi monoclonal na ime ụlọ monoclonal mgbochi bụ ụdị na-abụghị asọmpi ọhụrụ-ụdị ajọ ọrịa iku ume 2 (SARS-CoV-2) enwetara n'ụlọ ọgwụ mmadụ nke atọ nke Shenzhen na Mahadum Tsinghua na oge mgbanwe nke New Coronavirus. oyi oyi (COVID-19).A na-eji ọgwụ mgbochi monoclonal na-ewepụ ihe mgbochi, ọkachasị teknụzụ bioengineering, iji belata ihe egwu nke nkwalite dabere na mgbochi mmadụ na ịgbatị ọkara ndụ plasma iji nweta nsonaazụ ọgwụgwọ na-adịgide adịgide.
N'ọnwa Ọktoba 2021, tengshengbo pharmaceutical emechaala ngwa maka ikike iji ihe mberede mee ihe (EUA) nke ọgwụ ngwakọta agbasazumab / romistuzumab na nchịkwa nri na ọgwụ US (FDA).
Na mgbakwunye, Tengshengbo na-arụsi ọrụ ike n'ịkwalite ngwa maka ndebanye aha ọgwụgwọ ngwakọta ọgwụ njezumab / romisizumab n'ahịa ndị ọzọ tozuru oke na nke na-apụta gburugburu ụwa, na-ebu ụzọ hụ na ịnweta ahịa na mba ndị megoro ule ụlọ ọgwụ na mba ndị nwere nnukwu oghere na ịnweta ọgwụgwọ dị mma. .Tengshengbo ga-eme n'ihu nyocha na China iji nyochaa nkọwazumab/Prophylactic na immunopotentiating mmetụta nke ngwakọta ọgwụgwọ na romisvir mAb n'ime ọnụ ọgụgụ ndị immunosuppressed.
Maka "delta" dị na China COVID-19, Tengsheng Bo, bụ nke kpatara nje mutant, nyere ihe fọrọ nke nta ka ọ bụrụ mmadụ 3000 ihe fọrọ nke nta ka ọ bụrụ nde mmadụ abụọ sitere na Guangdong Province, Yunnan Province, Jiangsu Province, Hunan Province, Henan Province, Fujian N'ógbè, Ningxia kwụụrụ onwe mpaghara, Gansu Province, Inner Mongolia Autonomous Region, Heilongjiang Province, Qinghai Province, China Province na ógbè na June 2021, ihe fọrọ nke nta ka ọ bụrụ ndị ọrịa 900 ka a na-agwọ, nke bụ ọnụ ọgụgụ kasịnụ nke ndị ọrịa nwere ọgwụ mgbochi mgbochi n'otu n'otu. obodo.Ọnụ ọgụgụ dị ukwuu nke ndị ọkachamara na-ahụ maka ahụike nwetara ahụmahụ na obi ike n'iji usoro ọgwụgwọ a na-ejikọta ọnụ ma nyere aka dị ukwuu n'ịlụso ọrịa a ọgụ.
Ihe gbasara activ-2 nnwale nkeji 3
Nkwenye ahịa ahịa nke mgbasazumab / romistuzumab ngwakọta ọgwụgwọ nke China Drug Administration (nmpa) dabeere na nyocha activ-2 (nct04518410) nke National Institutes of Health (NIH) na-akwado oge na njedebe ikpeazụ nke usoro 3. Nsonaazụ ikpeazụ gosiri na ma e jiri ya tụnyere placebo, ọgwụgwọ nchikota a belatara njedebe njedebe nke ụlọ ọgwụ yana ọnwụ nke ndị ọrịa Covid-19 n'ihe egwu dị elu nke ọganihu ụlọ ọgwụ site na 80%, bụ nke dị ịrịba ama.N'ihe dị ka ụbọchị njedebe ụlọ ọgwụ 28, ọ dịghị ọnwụ n'ime otu ọgwụgwọ yana ọnwụ 9 n'ime otu placebo.Ọnweghị ihe egwu nchekwa ọhụrụ ahụrụ.
Nsonaazụ nwa oge e bipụtara na Ọktoba 4, 2021 gosiri na ọgwụgwọ ngwakọta ọgwụzumab / romisizumab belatara njedebe njedebe nke ụlọ ọgwụ yana ọnwụ nke ndị ọrịa Covid-19 n'ihe egwu dị elu nke ịga n'ihu ụlọ ọgwụ site na 78% ma e jiri ya tụnyere placebo, bụ nke pụtara n'ụzọ ndekọ ọnụ ọgụgụ (anaghị edozi ya). Nnwale otu akụkụ p uru <0.00001) 2% (4 / 196) nke isiokwu ndị natara ọgwụgwọ ọgwụgwọ sauyezumab / romisizumab n'ime ụbọchị 5 mgbe akara mmalite malitere gaa n'ụlọ ọgwụ ma ọ bụ ọnwụ, ma e jiri ya tụnyere 11% (21 / 197) na placebo. otu.N'otu aka ahụ, 2% (5 / 222) nke isiokwu ndị natara ọgwụgwọ ngwakọta ọgwụ zumab / romisizumab 6 ruo ụbọchị 10 mgbe akara ngosi malitere, ọnụego ọganihu n'ụlọ ọgwụ ma ọ bụ ọnwụ bụ 11% (24/222) n'ime otu placebo.Nnyocha ahụ gosikwara na ọ dịghị ọnwụ n'ime otu ọgwụgwọ n'ime ụbọchị 28, ebe enwere ọnwụ 8 na otu placebo.N'ime otu satarazumab / romistumab ngwakọta ọgwụgwọ, ihe ọjọọ (AE) nke ọkwa 3 ma ọ bụ karịa erughị ndị nọ na placebo, bụ 3.8% (16/418) na 13.4% (56/419), n'otu n'otu, ọ dịghị. Ihe omume ọjọọ metụtara ọgwụ (SAE) ma ọ bụ mmeghachi omume infusion ka hụrụ.
Emere ọmụmụ ihe ahụ n'ọtụtụ ebe nnwale ụlọ ọgwụ na gburugburu ụwa, gụnyere United States, Brazil, South Africa, Mexico, Argentina na Philippines.Ọmụmụ ihe ahụ gụnyere ndị ọrịa debanyere aha na oge ntoputa ngwa ngwa zuru ụwa ọnụ nke ụdị sars-cov-2 site na Jenụwarị ruo Julaị 2021. Dị ka akụkụ nke ọmụmụ a, data nrụpụta ụlọ ọgwụ nke ambavizumab / romisizumab ngwakọta ọgwụgwọ ga-adaberekwa n'ụdị variants viral. Nlele.Ihe nyocha nje virus chimeric in vitro dị ugbu a na-egosi na nchikota ọgwụgwọ nke agbasazumab / romistumab na-ejigide ọrụ neutralizing megide isi ihe dị iche iche sars-cov-2 nke nwere nnukwu nchegbu, gụnyere b.1.1.7 (“alpha”), b.1.351 (“ beta”), P.1 (“gamma”), b.1.429 (“epsilon”), b.1.617.2 (“Delta”) , ay.4.2 (“delta +”, Deltaplus), c.37 (“ramda”, lambda) na b.1.621 (“Miao”, mu).Nnwale maka ụdị b.1.1.529 (Omicron) na-aga n'ihu ugbu a.
Oge nzipu: Dec-10-2021