Inkomoko yo gutangaza ibigo: Ubuyobozi bwa leta bushinzwe ibiryo nibiyobyabwenge, imiti ya tengshengbo, kaminuza ya Tsinghua
Ubuyobozi: Ubushinwa bwambere bwize umutungo wubwenge COVID-19 itabuza antibody guhuza imiti.
Ku mugoroba wo ku ya 8 Ukuboza 2021, urubuga rwemewe rw’ubuyobozi bwa Leta bushinzwe ibiyobyabwenge rwatangaje ko ikoreshwa rya antibody ya COVID-19 itabogamye hamwe na BRII-196 na BRII-198 ryanditswe n’ubuyobozi bwa Leta bushinzwe ibiyobyabwenge.Nubushinwa bwambere bwize umutungo wubwenge COVID-19 itabuza antibody guhuza imiti.
Dukurikije ibiteganywa n’amategeko agenga imiyoborere y’ibiyobyabwenge, ubuyobozi bwa Leta bw’ibiribwa n’ibiyobyabwenge bugomba gukora isuzuma ryihutirwa no kubyemeza hakurikijwe uburyo bwihariye bwo kwemeza ibiyobyabwenge, kandi bwemeza guhuza imiti ibiri yavuzwe haruguru yo kuvura urumuri n’abantu bakuru basanzwe. n'ingimbi (kuva ku myaka 12 kugeza kuri 17, ipima ibiro birenga 40) hamwe na New Coronavirus yanduye (COVID-19) bafite ibyago byinshi (harimo kuba mubitaro cyangwa urupfu).Muri bo, ingimbi (imyaka 12-17, uburemere ≥ 40kg) hamwe nibimenyetso byemewe byemewe.
BRII-196 / BRII-198 ivura hamwe yari iyobowe na Porofeseri Zhang Linqi, umuyobozi w’ikigo cy’ubushakashatsi bwimbitse kuri sida n’ubuzima bw’isi yose n’ubushakashatsi bw’indwara zanduza z’ishuri ry’ubuvuzi rya Tsinghua na kaminuza ya Tsinghua.Imiti ya Tengsheng yazamuwe mu bufatanye na kaminuza ya Tsinghua hamwe n’ibitaro bya gatatu bya Shenzhen.Ubuvuzi bwagaragaje imiti igabanya ubukana bwa COVID-19 binyuze mubushakashatsi butemewe, buhumye-buhumyi, bugenzurwa na platbo.Hagati aho, iyemezwa ryerekana ubwa mbere ryakozwe na R & D mu Bushinwa kandi ryerekanye imiti igabanya ubukana bwa COVID-19 binyuze mu bushakashatsi butemewe, buhumye-buhumye, bugenzurwa na platbo.
Porofeseri Zhang Linqi yagize ati: “Kwemeza imiti ivura ambacizumab / romistimub byazanye imiti ya mbere yo kuvura ikamba mu Bushinwa.Ubu buryo bwo kuvura bwerekanye umutekano nuburinzi buhebuje mugeragezwa mpuzamahanga.Nibiyobyabwenge byonyine bya antibody kwisi byakoze isuzuma ryingaruka zo kuvura abantu banduye ubwoko butandukanye kandi babonye amakuru meza.Ubu buryo bwo kuvura antibody nibyiza kuri njye Ubushinwa bwatanze ubuvuzi bwisi yose kuri COVID-19.Yerekanye byimazeyo kwirundanyiriza hamwe nububiko bwa tekinike muri kaminuza ya Tsinghua murwego rwo kurwanya indwara zanduza, nubushobozi nubushobozi bwo guhamagara kuza, kurwana, kurwana no kurwana.Yatanze umusanzu w'ingenzi mu bikorwa byo gukumira no kurwanya icyorezo mu Bushinwa ndetse no ku isi.Twishimiye cyane kuba dushingiye kubitaro bya gatatu byabantu ba Shenzhen nubuvuzi bwa Tengsheng Bo.Ubufatanye bufite ireme muri, ivuriro n’impinduka byatumye iyi ntambwe igaragara.Mu ntambwe ikurikiraho, tuzakomeza kwiga uruhare rwo gukumira antibody ya monoclonal antibody ivura ibyago byinshi hamwe no kubura ubudahangarwa bw'umubiri.”
Iki cyemezo cyari gishingiye ku cyiciro cya 3 cy’amavuriro ya activit-2 yatewe inkunga n’ikigo cy’igihugu cyita ku buzima (NIH), harimo n’agateganyo n’ibisubizo byanyuma by’abarwayi 847 banditswe.Ibisubizo byanyuma byerekanaga ko kuvura ambavizumab / romistuzumab bishobora kugabanya ibyago byo gushyirwa mubitaro no gupfa by’abarwayi bashya bafite ibyago byinshi (ibisubizo by'agateganyo byari 78%) ugereranije na placebo, byari bifite imibare ikomeye.Kuva aho ivuriro rirangirira iminsi 28, nta bantu bapfiriye mu itsinda ry’abavuzi ndetse n’abantu 9 bapfiriye mu itsinda rya placebo, kandi umutekano w’amavuriro wari mwiza kuruta uwo mu itsinda rya placebo.Muri icyo gihe, niba kuvura byatangiye hakiri kare (mugihe cyiminsi 5 nyuma yo gutangira ibimenyetso) cyangwa mugihe cyanyuma (muminsi 6 kugeza 10 nyuma yibimenyetso bitangiye) Mubisomo, ibitaro nimpfu byari bigaragara yagabanutse, itanga idirishya rirerire kubarwayi bafite amakamba mashya.
Mu gihe kitarenze amezi 20, kaminuza ya Tsinghua, ku bufatanye n’ibitaro bya gatatu by’abaturage ba Shenzhen hamwe n’imiti ya tengshengbo, byateje imbere ubuvuzi bwa ambacizumab / romisvir kuva bitandukanya antibody no kwipimisha kugeza kurangiza icyiciro mpuzamahanga cya 3 cy’amavuriro, hanyuma amaherezo ibona Ubushinwa. kwemerwa.Ibi byagezweho ni imbaraga zihuriweho n’Ubushinwa n’abashakashatsi bo ku rwego rw’isi n’abashakashatsi ku mavuriro Ibisubizo birimo inkunga y’ikigo mpuzamahanga gishinzwe ubushakashatsi ku mavuriro ACTIV-2, Ikigo cy’igihugu gishinzwe allergie n’indwara zanduza (NIAID) cy’ikigo cy’igihugu cy’ubuzima (NIH) ), hamwe nitsinda rya ACTIV-2 ryipimisha (ACTG), riyobora ubushakashatsi mubuvuzi.
Liu Lei, umuyobozi w'ikigo cy’ubushakashatsi ku mavuriro y’indwara zanduza i Shenzhen akaba n’umunyamabanga wa komite y’ishyaka ry’ibitaro bya gatatu by’abaturage ba Shenzhen, yagize ati: “Kuva icyorezo cyatangira, twihaye intego yo gukumira icyorezo cy’ikoranabuhanga.Itsinda ryacu ryakuyemo antibodiyite zikora cyane muri serumu y’abarwayi bashya basubiza mu buzima busanzwe ikamba, rishyiraho urufatiro rukomeye rw’iterambere ry’imiti irwanya COVID-19.Tunejejwe cyane no gukorana na Porofeseri Zhang Linqi na Tengsheng uruganda rukora imiti muri kaminuza ya Tsinghua kugira ngo Ubushinwa bukore ikamba rya mbere rirwanya ikamba.Ibiyobyabwenge bya virusi bitanga ubwenge nuburambe.Turizera ko hamwe nimbaraga zihuriweho numubare munini w'abakozi bashinzwe ubushakashatsi n'abakozi b'ubuvuzi, dushobora gutsinda COVID-19 vuba bishoboka.
Luo Yongqing, Perezida akaba n'umuyobozi mukuru wa Greater China, yagize ati: “Twishimiye kugera kuri iyi ntambwe ikomeye kandi turimo gukora ibishoboka byose kugira ngo iyi miti ivura abarwayi bashya bambaye ikamba.Ibi byagezweho byerekana ko twiyemeje byimazeyo kwihutisha udushya twisi yose mubijyanye nindwara zanduza no kuzuza ibikenerwa mubuvuzi bidakenewe neza, siyanse, ikomeye kandi nziza.Nka sosiyete mpuzamahanga ikorera mubushinwa no muri Reta zunzubumwe za Amerika Biotech Corp, Nishimiye ko Tengsheng Bo yageze ku biyobyabwenge, kandi ntitwashyira ingufu mu gufasha Ubushinwa guhangana na COVID-19 bikenewe mu buhanga, no guhaza ibikenerwa na ba nyampinga bacu bashya. .
Ibyerekeye ambacizumab / romistuzumab
(mbere brii-196 / brii-198)
Antibody ya monoclonal antibody na monoclonal antibody yo mucyumba ni antibody irwanya ubwoko bushya bwa syndrome ikaze yubuhumekero 2 (SARS-CoV-2) yakuwe mubitaro bya gatatu byabantu ba Shenzhen na kaminuza ya Tsinghua mugihe cyo gusubiza mu buzima busanzwe New Coronavirus. umusonga (COVID-19).Monoclonal itabuza antibodi, cyane cyane tekinoroji ya bioengineering, ikoreshwa mukugabanya ibyago bya antibody yunganiwe biterwa no kongera plasma igice cyubuzima kugirango ibone ingaruka zirambye zo kuvura.
Mu Kwakira 2021, imiti ya tengshengbo yarangije gusaba uruhushya rwo gukoresha byihutirwa (EUA) rwa ambacizumab / romistuzumab ivura imiti ivura ikigo gishinzwe ibiryo n'ibiyobyabwenge muri Amerika (FDA).
Byongeye kandi, tengshengbo iteza imbere cyane gusaba kwandikisha ambacizumab / romisizumab ivura hamwe nandi masoko akuze kandi akizamuka kwisi yose, abanza kubona isoko ryinjira mubihugu byakorewe ibizamini byamavuriro ndetse n’ibihugu bifite icyuho kinini cyo kubona imiti neza. .Tengshengbo izakora kandi ubushakashatsi mubushinwa kugirango isuzume ingaruka za ambacizumab / Prophylactic na immunopotentiating ziterwa no kuvura hamwe na romisvir mAb mubaturage badafite ubudahangarwa.
Kuri “delta” mu Bushinwa COVID-19, Tengsheng Bo, yatewe n'imihindagurikire ya mutant, yatanze abantu bagera ku 3000 bose hamwe bagera kuri miliyoni ebyiri baturutse mu Ntara ya Guangdong, Intara ya Yunnan, Intara ya Jiangsu, Intara ya Hunan, Intara ya Henan, Fujian Intara, akarere ka Ningxia yigenga, Intara ya Gansu, Intara yigenga ya Mongoliya, Intara ya Heilongjiang, Intara ya Qinghai, Intara y’Ubushinwa n’intara muri Kamena 2021., abarwayi bagera kuri 900 baravuwe, akaba ari umubare munini w’abarwayi bafite antibodiyite muri kimwe. igihugu.Umubare munini winzobere mu by'ubuzima wungutse ubunararibonye nicyizere cyo gukoresha ubu buryo bwo kuvura no gutanga umusanzu ukomeye mukurwanya iki cyorezo.
Ibyerekeye gukora-2 ikigeragezo cya 3
Kwemeza kwamamaza kwa ambacizumab / romistuzumab ivura hamwe nubuyobozi bwubushinwa bushinzwe ibiyobyabwenge (nmpa) bishingiye kubigeragezo-2 (nct04518410) bishyigikiwe nibigo byigihugu byubuzima (NIH) by'agateganyo n'ibisubizo byanyuma by'icyiciro 3. Ibisubizo byanyuma byerekanye ko ugereranije na placebo, ubu buryo bwo kuvura bwagabanije ingingo zanyuma zo gushyirwa mubitaro no gupfa kwa covid-19 abarwayi bafite ibyago byinshi byo gutera imbere kwa 80%, ibyo bikaba byari bifite imibare ikomeye.Kugeza ku munsi wa 28 w’amavuriro arangiriraho, nta bantu bapfuye mu itsinda ry’abavuzi ndetse n’abantu 9 bapfuye mu itsinda rya placebo.Nta kibazo gishya cy’umutekano cyagaragaye.
Ibisubizo by'agateganyo byatangajwe ku ya 4 Ukwakira 2021 byerekanaga ko ubuvuzi bwa ambacizumab / romisizumab bwagabanije uburyo bwo kuvura ibitaro ndetse n’urupfu rw’abarwayi ba covid-19 bafite ibyago byinshi byo gutera imbere kwa 78% ugereranije na placebo, yari ifite imibare ikomeye (idakosowe, ikizamini cyuruhande rumwe p agaciro <0.00001) 2% (4/196) byamasomo yakiriye imiti ivura ambacizumab / romisizumab mugihe cyiminsi 5 nyuma yuko ibimenyetso bitangiye bikagera mubitaro cyangwa gupfa, ugereranije na 11% (21/197) mubibanza itsinda.Mu buryo nk'ubwo, 2% (5/222) by'amasomo yakiriye imiti ivura ambacizumab / romisizumab ivura iminsi 6 kugeza 10 nyuma yo gutangira ibimenyetso Ikigereranyo cyo gutera imbere mubitaro cyangwa urupfu cyari 11% (24/222) mumatsinda ya placebo.Isesengura ryerekanye kandi ko nta bantu bapfuye mu itsinda ry’abaganga mu minsi 28, mu gihe hapfuye abantu 8 mu itsinda rya placebo.Mu itsinda rya ambacizumab / romistumab rihuza itsinda, ibintu bibi (AE) byo mu cyiciro cya 3 cyangwa hejuru byari bike ugereranije nabari mu itsinda rya placebo, bari 3.8% (16/418) na 13.4% (56/419), oya Ibiyobyabwenge bifitanye isano nibibazo bikomeye (SAE) cyangwa reaction ya infusion byagaragaye.
Ubushakashatsi bwakorewe mu bigo byinshi by’ubuvuzi ku isi, harimo Amerika, Burezili, Afurika y'Epfo, Mexico, Arijantine na Philippines.Ubushakashatsi bwarimo abarwayi biyandikishije mugihe cyihuta cyo kugaragara kwisi ya sars-cov-2 kuva muri Mutarama kugeza muri Nyakanga 2021. Mu rwego rw’ubu bushakashatsi, imibare y’ubuvuzi bwa ambavizumab / romisizumab ivura nayo izashingira ku bwoko bwa virusi. Isuzuma.Kugeza ubu muri virusi ya vitro chimeric yerekana ko uburyo bwo kuvura ambacizumab / romistumab bukomeza ibikorwa byo kutabogama kubintu bitandukanye bya sars-cov-2 bihangayikishije cyane, harimo 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).Kwipimisha kuri b.1.1.529 (Omicron) birahinduka.
Igihe cyo kohereza: Ukuboza-10-2021