Umthombo wesimemezelo sebhizinisi: I-State Food and Drug Administration, tengshengbo pharmaceutical, Tsinghua University
Umhlahlandlela: Indawo yokuqala yobuhlakani yaseShayina ezifundisele i-COVID-19 yokwelapha inhlanganisela yamasosha omzimba.
Ngobusuku bangomhla ziyisi-8 kuZibandlela 2021, iwebhusayithi esemthethweni Yokuphathwa Kwezwe Lokulawulwa Kwezidakamizwa yamemezela ukuthi ukusetshenziswa kwe-COVID-19 antibody ehlanganiswe ne-BRII-196 kanye ne-BRII-198 kubhaliswe Ukuphathwa Kwezwe Lokulawulwa Kwezidakamizwa.Yindawo yokuqala yobuhlakani yaseShayina ezifundisele i-COVID-19 eyenza inhlanganisela yama-antibody ingasebenzi.
Ngokwezinhlinzeko ezifanele zomthetho wokuphathwa kwezidakamizwa, Umbuso Wokudla kanye nokuphathwa kwezidakamizwa uzoqhuba ukubuyekezwa okuphuthumayo kanye nokugunyazwa ngokwezinqubo ezikhethekile zokugunyazwa kwezidakamizwa, futhi ugunyaze inhlanganisela yale mithi emibili engenhla yokwelapha ukukhanya kanye nabantu abadala abavamile. kanye nentsha (eneminyaka eyi-12 kuye kweyi-17 ubudala, enesisindo esingaphezu kuka-40kg) ene-New Coronavirus infection (COVID-19) enezici eziyingozi kakhulu (okuhlanganisa ukulaliswa esibhedlela noma ukufa).Phakathi kwabo, intsha (iminyaka engu-12-17 ubudala, isisindo ≥ 40kg) enezinkomba ingaphansi kokuvunyelwa okunemibandela.
Ukwelashwa okuhlanganisiwe kwe-BRII-196/BRII-198 bekuholwa nguSolwazi Zhang Linqi, umqondisi wesikhungo socwaningo olunzulu ngengculazi kanye nesikhungo socwaningo lwezempilo kanye nezifo ezithathelwanayo emhlabeni wonke saseTsinghua University School of Medicine kanye neNyuvesi yaseTsinghua.I-Tengsheng pharmaceutical yathuthukiswa ngokubambisana neNyuvesi yaseTsinghua kanye nesibhedlela sabantu sesithathu sase-Shenzhen.Ukwelashwa kubonakale kusebenzayo kwezidakamizwa ze-anti-COVID-19 ngocwaningo olulawulwa ngokungahleliwe, olungaboni kabili, olulawulwa yi-placebo.Ngaleso sikhathi, ukugunyazwa kuphawula i-R & D yokuqala yokuzithuthukisa e-China futhi ibonise imishanguzo ethile ye-anti-COVID-19 ngocwaningo olulawulwa ngokungahleliwe, olungaboni kabili, olulawulwa yi-placebo.
USolwazi Zhang Linqi uthe: “Ukuvunywa kwe-mbacizumab/romistimub combination therapy kulethe umuthi omusha wokuqala wokwelapha e-China.Lokhu kwelashwa okuhlangene kubonise ukuphepha nokuvikelwa okuhle kakhulu ovivinyweni lwamazwe ngamazwe lwezindawo eziningi.Iwukuphela kwesidakamizwa emhlabeni esiye senza ukuhlolwa komthelela wokwelapha wabantu abangenwe izinhlobo ezihlukahlukene futhi bathola idatha ehamba phambili.Lokhu kwelashwa okuhlanganisa amasosha omzimba kungilungele kakhulu I-China inikeze ukwelashwa okusezingeni lomhlaba kwe-COVID-19.Ibonise ngokugcwele ukuqoqwa okujulile kanye nezinqolobane zobuchwepheshe zeNyuvesi yaseTsinghua emkhakheni wokulwa nezifo ezithathelwanayo, kanye nekhono nekhono lokuyibiza ukuthi ize, ukulwa, ukulwa nokulwa.Ibe negalelo elibalulekile emsebenzini wokuvimbela nokulawula ubhubhane e-China ngisho nasemhlabeni.Sihlonipheke kakhulu ngokuba ngesisekelo seSibhedlela sabantu sesithathu saseShenzhen kanye neTengsheng Bo imithi.Ukubambisana kwekhwalithi ephezulu ocwaningweni lwezokwelapha nolwezinguquko kwenze le mpumelelo eyingqophamlando.Esinyathelweni esilandelayo, sizoqhubeka nokutadisha indima yokuvimbela yokwelapha okuhlangene kwe-monoclonal antibody emaqenjini asengozini enkulu kanye namasosha omzimba.”
Lokhu kugunyazwa kwakusekelwe esivivinyweni somtholampilo sesigaba sesi-3 se-activ-2 esisekelwa i-National Institutes of Health (NIH), okuhlanganisa imiphumela emihle yesikhashana neyokugcina yeziguli ezibhalisiwe ezingama-847.Imiphumela yokugcina yabonisa ukuthi ukwelapha ngenhlanganisela ye-mbavizumab/romistuzumab kunganciphisa ubungozi bokulaliswa esibhedlela kanye nokufa kweziguli ezintsha ezisengozini enkulu yokulala ngama-80% (imiphumela yesikhashana ibingama-78%) uma iqhathaniswa ne-placebo, ebibalulekile ngokwezibalo.Kusukela ekupheleni komtholampilo kwezinsuku ezingama-28, abekho abashona eqenjini lokwelapha nokufa kwabantu abayisi-9 eqenjini le-placebo, futhi ukuphepha kwalo emtholampilo kwakungcono kunalokho eqenjini le-placebo.Ngesikhathi esifanayo, kungakhathaliseki ukuthi ukwelashwa kwaqalwa esigabeni sokuqala (zingakapheli izinsuku ezingu-5 ngemva kokuqala kwezimpawu) noma esigabeni sekwephuzile (phakathi kwezinsuku ezingu-6 kuya kwezingu-10 ngemva kokuqala kwezimpawu) Kulezi zifundo, ukulaliswa esibhedlela nokufa kwakubaluleke kakhulu. encishisiwe, enikeze iwindi elide lokwelapha iziguli ezinemiqhele emisha.
Ezinyangeni ezingaphansi kwezingama-20, iNyuvesi yaseTsinghua, ngokubambisana neSibhedlela Sesithathu Sabantu saseShenzhen kanye neTekoshengbo pharmaceutical, yathuthukisa ngokushesha ukwelashwa kwenhlanganisela ye-mbacizumab/romisvir kusukela ekuhlukaniseni amasosha omzimba okuqala nokuhlolwa kwaze kwaba sekuphothulweni kwesigaba sesi-3 sokuhlolwa kwemitholampilo, futhi ekugcineni yathola uhlu lwaseChina. ukugunyazwa.Le mpumelelo yimizamo ehlanganyelwe yeShayina kanye nososayensi abasezingeni lomhlaba kanye nabacwaningi bezokwelapha Imiphumela ihlanganisa ukwesekwa kwe-ACTIV-2 International Clinical Research Institute, iNational Institute of Allergy and Infectious Diseases (NIAID) yeNational Institutes of Health (NIH). ), kanye nethimba lesivivinyo somtholampilo le-ACTIV-2 (ACTG), elihola ucwaningo lomtholampilo.
U-Liu Lei, umqondisi wesikhungo sokucwaninga ngemitholampilo yezifo ezithathelwanayo e-Shenzhen kanye noNobhala wekomidi Leqembu leSibhedlela Sesithathu Sabantu sase-Shenzhen, uthe: “Kusukela ekuqaleni kwalolu bhubhane, sazibekela umgomo wokuvimbela ubhubhane lwezobuchwepheshe.Ithimba lethu likhiphe ngempumelelo amasosha omzimba asebenza kakhulu aqeda amandla ku-serum yeziguli ezintsha ezilungisa umqhele, labeka isisekelo esiqinile sokuthuthukiswa okulandelayo kwalo muthi olwa ne-COVID-19.Sijabule kakhulu ukusebenza noSolwazi Zhang Linqi kanye nenkampani yezemithi i-Tengsheng yase-Tsinghua University ukwenza umqhele omusha wokuqala wase-China wokulwa.Izidakamizwa ezibangelwa amagciwane zinikeza ukuhlakanipha nolwazi.Sithemba ukuthi ngemizamo ehlanganyelwe yenani elikhulu labasebenzi bocwaningo nabasebenzi bezokwelapha, singayinqoba i-COVID-19 ngokushesha okukhulu.
U-Luo Yongqing, uMongameli kanye nemenenja jikelele ye-Greater China, uthe: “Sijabule ukuzuza lesi sinyathelo esibalulekile futhi sisebenza kanzima ukukhuthaza ukufinyeleleka kwalokhu kwelashwa okuhlangene kweziguli ezintsha zaseShayina.Le mpumelelo ifakazela ukuthi sizibophezele ngokuqinile ekusheshiseni ukuqanjwa kabusha komhlaba wonke emkhakheni wezifo ezithathelwanayo kanye nokugcwalisa izidingo zezokwelapha ezingahlangatshezwana nemiphumela ephumelelayo, yesayensi, eqinile kanye nenhle kakhulu.Njengenkampani yamazwe ngamazwe esebenza e-China nase-United States Biotech Corp, ngiyaziqhenya ngempumelelo ka-Tengsheng Bo yezidakamizwa, futhi asigodli umzamo wokusiza i-China ibhekane nezidingo eziyinkimbinkimbi ze-COVID-19 ngokwesayensi, futhi sihlangabezane nezidingo zomtholampilo zabashampeli bethu abasha. .
Mayelana ne-ambacizumab / romistuzumab
(ngaphambili i-brii-196 / brii-198)
I-monoclonal antibody eya ku-monoclonal antibody kanye ne-roomway monoclonal antibody iyigciwane elingaqhudelani elisha lohlobo olusha lwe-acute acute Respiratory Syndrome virus 2 (SARS-CoV-2) etholwe eSibhedlela sabantu sesithathu sase-Shenzhen nase-Tsinghua University ngesikhathi sokuvuselelwa kwe-New Coronavirus. inyumoniya (COVID-19).Amasosha omzimba e-Monoclonal neutralizing, ikakhulukazi ubuchwepheshe be-bioengineering, asetshenziselwa ukunciphisa ubungozi bokuthuthukiswa kokuncika kwe-antibody futhi andise ingxenye yempilo ye-plasma ukuze kutholwe imiphumela ehlala njalo yokwelapha.
Ngo-Okthoba 2021, i-tengshengbo pharmaceutical isiqedile isicelo sokugunyazwa ukusetshenziswa kwezimo eziphuthumayo (i-EUA) ye-ambacizumab / romistuzumab yokwelashwa okuhlangene kwe-US Food and Drug Administration (FDA).
Ngaphezu kwalokho, u tengshengbo ukhuthaza ngenkuthalo isicelo sokubhaliswa kwe-ambacizumab/romisizumab combination therapy kwezinye izimakethe ezivuthiwe nezisafufusa emhlabeni jikelele, okokuqala ngqa ukuqinisekisa ukutholakala kwemakethe emazweni enze izivivinyo zemitholampilo kanye namazwe anegebe elikhulu ekufinyeleleni ukwelashwa okuphumelelayo. .I-Tengshengbo izophinde yenze ucwaningo olwengeziwe e-China ukuze ihlole imiphumela ye-mbacizumab/Prophylactic kanye ne-immunopotentiating yokwelapha okuhlanganisiwe ne-romisvir mAb kubantu abangenawo amandla omzimba.
Okwe-"delta" e-China COVID-19, i-Tengsheng Bo, eyadalwa uhlobo oluguquguqukayo, inikele ngenani labantu abacishe babe yizigidi ezimbili abavela esifundazweni saseGuangdong, eSifundazweni saseYunnan, eSifundazweni saseJiangsu, eSifundazweni saseHunan, eSifundazweni saseHenan, eFujian. Isifundazwe, isifunda esizimele saseNingxia, iSifundazwe saseGansu, Isifunda Esizimele Se-Inner Mongolia, ISifundazwe saseHeilongjiang, ISifundazwe saseQinghai, Isifundazwe saseShayina kanye nesifundazwe ngoJuni 2021. , cishe iziguli ezingama-900 zelashwa, okuyisibalo esikhulu kunazo zonke seziguli ezinamasosha omzimba aqeda amandla endaweni eyodwa. izwe.Inani elikhulu lochwepheshe bezokunakekelwa kwempilo bathola ulwazi nokuzethemba ekusebenziseni le nhlanganisela yokwelapha futhi laba negalelo elikhulu ekulweni nalolu bhubhane.
Mayelana nesigaba sesi-3 sesilingo se-activ-2
Ukugunyazwa ukumaketha kokwelashwa okuhlangene kwe-mbacizumab / romistuzumab yi-China Drug Administration (nmpa) kusekelwe ocwaningweni lwe-activ-2 (nct04518410) olusekelwa yiNational Institutes of Health (NIH) Yesikhashana kanye nemiphumela yokugcina yesigaba sesi-3. Imiphumela yokugcina yabonisa ukuthi uma kuqhathaniswa ne-placebo, lokhu kwelashwa okuhlanganisiwe kwehlise isiphetho esiyinhlanganisela sokulaliswa esibhedlela kanye nokufa kweziguli ezingaphandle kwe-covid-19 ezisengozini enkulu yokuthuthuka emtholampilo ngama-80%, obekubalulekile ngokwezibalo.Kusukela ekupheleni komtholampilo kwezinsuku ezingama-28, abekho abashona eqenjini kanye nabangu-9 abashona eqenjini le-placebo.Azikho izingozi ezintsha zokuphepha ezibonwe.
Imiphumela yesikhashana eshicilelwe ngo-Okthoba 4, 2021 ibonise ukuthi ukwelashwa okuhlangene kwe-mbacizumab / romisizumab kwehlise indawo yokugcina eyinhlanganisela yokulaliswa esibhedlela kanye nokufa kweziguli ezingaphandle kwe-covid-19 ezisengozini enkulu yokuqhubekela phambili emtholampilo ngama-78% uma kuqhathaniswa ne-placebo, ebibaluleke ngokwezibalo (ayilungisiwe, ukuhlolwa kohlangothi olulodwa p value <0.00001) 2% (4 / 196) wezifundo ezithole ukwelashwa okuhlangene kwe-mbacizumab / romisizumab zingakapheli izinsuku ezi-5 ngemuva kokuvela kwezimpawu kuqhubekele esibhedlela noma ekufeni, uma kuqhathaniswa no-11% (21 / 197) ku-placebo. iqembu.Ngokufanayo, i-2% (5 / 222) yezifundo ezithole ukwelashwa okuhlangene kwe-mbacizumab / romisizumab ezinsukwini ezingu-6 kuya kweziyi-10 ngemva kokuqala kwezimpawu Izinga lokuqhubekela phambili ukuya esibhedlela noma ukufa lalingu-11% (24 / 222) eqenjini le-placebo.Ukuhlaziywa kuphinde kwakhombisa ukuthi abekho abashonile eqenjini lokwelapha zingakapheli izinsuku ezingama-28, kanti kwaba nabangu-8 abashonile eqenjini le-placebo.Eqenjini le-ambacizumab / romistumab lenhlanganisela yokwelapha, izehlakalo ezimbi (AE) zebanga lesi-3 noma ngaphezulu zazingaphansi kwalezo eziseqenjini le-placebo, ezazingu-3.8% (16/418) kanye no-13.4% (56/419), ngokulandelana, cha. Izehlakalo ezimbi kakhulu ezihlobene nezidakamizwa (i-SAE) noma ukusabela kwe-infusion kwabonwa.
Ucwaningo lwenziwa ezikhungweni zocwaningo lwezokwelapha eziningana emhlabeni jikelele, okuhlanganisa i-United States, Brazil, South Africa, Mexico, Argentina kanye nePhilippines.Ucwaningo lubandakanya iziguli ezibhalise esikhathini sokuvela ngokushesha emhlabeni jikelele kwezinhlobonhlobo ze-sars-cov-2 kusukela ngoJanuwari kuya kuJulayi 2021. Njengengxenye yalolu cwaningo, idatha yokusebenza kahle komtholampilo yokwelashwa okuhlangene kwe-mbavizumab / romisizumab izosuselwa ohlotsheni lwezinhlobonhlobo zegciwane. Ukuhlola.Idatha yamanje yokuhlolwa kwegciwane le-in vitro chimeric ibonisa ukuthi ukwelapha okuhlanganisiwe kwe-ambacizumab / romistumab kugcina umsebenzi ongathathi hlangothi ngokumelene nezinhlobonhlobo ezinkulu ze-sars-cov-2 ezikhathazayo kakhulu, okuhlanganisa i-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) kanye no-b.1.621 (“Miao”, mu).Ukuhlola okuhlukile kwe-b.1.1.529 (Omicron) kuyaqhubeka okwamanje.
Isikhathi sokuthumela: Dec-10-2021