Kwakabva chiziviso chebhizinesi: State Chikafu uye kutonga kwezvinodhaka, tengshengbo mishonga, Tsinghua University
Nhungamiro: China yekutanga kuzvidzidzisa yehungwaru pfuma COVID-19 neutralizing antibody musanganiswa kurapa.
Manheru aZvita 8, 2021, webhusaiti yepamutemo yeHurumende Administration yekutonga kwezvinodhaka yakazivisa kuti kushandiswa kweCCIDID-19 neutralization antibody yakasanganiswa neBRII-196 uye BRII-198 yakanyoreswa neHurumende Administration yekutonga zvinodhaka.Ndiyo yekutanga yeChina kuzvidzidzisa yehungwaru pfuma COVID-19 neutralizing antibody musanganiswa kurapa.
Zvinoenderana nezvinodiwa nemutemo wekutonga zvinodhaka, iyo State Chikafu uye manejimendi ezvinodhaka ichaita ongororo yekukurumidzira uye kubvumidzwa zvinoenderana nemaitiro ekubvumidzwa kwemishonga, uye kubvumidza kusanganiswa kwemishonga miviri iri pamusoro pakurapa chiedza uye vanhuwo zvavo vakuru. uye vechidiki (vane makore gumi nemaviri kusvika gumi nemanomwe ekuberekwa, vanorema kupfuura 40kg) vane New Coronavirus utachiona (COVID-19) vane njodzi huru (kusanganisira kuchipatara kana kufa).Pakati pavo, vachiri kuyaruka (12-17 makore, uremu ≥ 40kg) vane zviratidzo vari pasi pemvumo yemamiriro ezvinhu.
BRII-196/BRII-198 kurapa kwakasanganiswa kwakatungamirwa naProfessor Zhang Linqi, director wenzvimbo yekuongorora kwakadzama kweAIDS uye hutano hwepasi rose uye chirwere chinotapukira cheTsinghua University Chikoro chemishonga neTsinghua University.Tengsheng mishonga yakasimudzirwa mukubatana neTsinghua University uye yechitatu vanhu Hospital yeShenzhen.Kurapwa kwacho kwakaratidza kushanda kwemishonga yekurwisa COVID-19 kuburikidza neongororo yakanyatsorongeka, yakapetwa kaviri, inodzorwa ne placebo.Zvichakadaro, mvumo yacho inotaridza yekutanga kuzvigadzira R & D muChina uye yakaratidza kuti inoshanda anti COVID-19 chaiyo mishonga kuburikidza neyakaomesesa, yakapetwa-mapofu, placebo-inodzorwa kudzidza.
Muzvinafundo Zhang Linqi vakati: "Kutenderwa kwembacizumab / romistimub musanganiswa kurapa kwaunza mushonga mutsva wekutanga kurapwa kuChina.Iyi musanganiswa therapy yakaratidza kuchengetedzwa kwakanaka uye kudzivirira muyedzo yepasirese multicenter.Ndiwo chete mushonga weantibody pasi rose uyo wakaita ongororo yekurapa kwevanhu vakatapukirwa nemhando dzakasiyana uye vakawana data rakanakisa.Iyi antibody musanganiswa therapy ndiyo yakandinakira China yakapa pasi rose kurapwa kweCOVID-19.Yakaratidza zvizere kuunganidza kwakadzika uye matura ehunyanzvi eTsinghua University mumunda wekurwisa zvirwere zvinotapukira, uye kugona uye kugona kuidaidza kuti iuye, kurwisa, kurwisa uye kurwisa.Yakapa zvakakosha basa rekudzivirira uye kudzora denda muChina uye kunyangwe pasirese.Isu tinokudzwa zvikuru kuva pahwaro hwechipatara chechitatu chevanhu cheShenzhen uye Tengsheng Bo mushonga.Kushandirapamwe kwemhando yepamusoro mu, kukiriniki neshanduko yekutsvaga kwaita iyi budiriro yakakosha.Muchinhanho chinotevera, isu ticharamba tichidzidza basa rekudzivirira remonoclonal antibody musanganiswa werapi mumapoka ane njodzi uye anoshaya immune.”
Mvumo iyi yakabva pachikamu chechitatu chekuedza kwekliniki ye activ-2 inotsigirwa neNational Institutes of Health (NIH), kusanganisira mhedzisiro yakanaka yenguva pfupi uye yekupedzisira yevarwere 847 vakanyoresa.Mhedzisiro yekupedzisira yakaratidza kuti ambavizumab / romistuzumab musanganiswa therapy inogona kuderedza njodzi yekuiswa muchipatara uye kufa kwevarwere vane njodzi nyowani ne80% (yenguva pfupi mhedzisiro yaive 78%) zvichienzaniswa ne placebo, iyo yaive yakakosha.Nezvekumagumo kwekiriniki kwemazuva makumi maviri nemasere, pakanga pasina kufa muboka rekurapa uye 9 vakafa muboka re placebo, uye kuchengetedzwa kwayo kwekiriniki kwaive nani pane iyo muboka re placebo.Panguva imwecheteyo, kana kurapwa kwakatangwa mukutanga (mukati memazuva e5 mushure mekutanga kwezviratidzo) kana munguva yekupedzisira (mukati me6 kusvika ku10 mazuva mushure mekutanga kwezviratidzo) Pakati pezvidzidzo, kuchipatara uye kufa kwaive kwakanyanya. yakaderedzwa, iyo yakapa hwindo rekurapa refu kune varwere vane korona itsva.
Mumwedzi isingasviki makumi maviri, Tsinghua University, yakabatana neShenzhen Third People's Hospital uye tengshengbo mishonga, yakakurumidza kusimudzira ambacizumab / romisvir musanganiswa therapy kubva pakuparadzana kwekutanga kupatsanurwa kweantibody uye kuongororwa kusvika pakupedzwa kwechikamu chetatu chekiriniki, uye pakupedzisira akawana runyorwa rweChina. mvumo.Kubudirira uku ndiko kuedza kwakabatana kweChina uye masayendisiti epasi rose uye vaongorori vekiriniki Mhedzisiro yacho inosanganisira kutsigirwa kweACTIV-2 International Clinical Research Institute, National Institute of allergy uye zvirwere zvinotapukira (NIAID) yeNational Institutes of Health (NIH). ), uye ACTIV-2 kliniki yekuedza timu (ACTG), iyo inotungamirira tsvakurudzo yekiriniki.
Liu Lei, director wekiriniki yekutsvagisa zvirwere zvinotapukira muShenzhen uye Secretary of the Party committee of the third people's Hospital of Shenzhen, akati: “Kubva pakatanga denda, takaisa chinangwa chekudzivirira denda rehunyanzvi.Chikwata chedu chakabudirira kuburitsa maviri eanoshanda akasimba ekudzivirira masoja ekudzivirira chirwere kubva muserum yevarwere vanogadzirisa korona, vachiisa hwaro hwakasimba hwekuvandudzwa kweiyi anti-COVID-19 mushonga.Isu tinofara zvikuru kushanda naProfessor Zhang Linqi uye Tengsheng kambani yemishonga yeTsinghua University kugadzira China yekutanga nyowani anti korona.Mishonga yemavhairasi inopa huchenjeri uye ruzivo.Tinovimba kuti nekuedza kwakabatana kwehuwandu hukuru hwevashandi vekutsvagisa nevashandi vekurapa, tinogona kukunda COVID-19 nekukasira.
Luo Yongqing, Mutungamiriri uye maneja mukuru weGreater China, akati: "Tinofara kuwana chiitiko chakakosha ichi uye tiri kushanda nesimba kusimudzira kuwaniswa kwekurapa kwemusanganiswa uyu kuvarwere vatsva vekuChina.Kubudirira uku kunoratidza kuti takanga takazvipira kukurumidza kusimudzira hunyanzvi hwepasi rose mumunda wezvirwere zvinotapukira uye kuzadza zvishuwo zvekurapa zvisingaite nemhedzisiro, yesainzi, yakaoma uye yakanakisa mhedzisiro.Sekambani yepasi rose inoshanda muChina neUnited States Biotech Corp, ndinodada nekubudirira kwezvinodhaka kwaTengsheng Bo, uye isu tinoshingirira kubatsira China kubata nezvinodiwa neCOVID-19 nesainzi, uye kusangana nezvinodiwa zvekiriniki zvevakwikwidzi vedu vatsva. .
About ambacizumab / romistuzumab
(kare brii-196 / brii-198)
Iyo monoclonal antibody kune monoclonal antibody uye mumakamuriway monoclonal antibody isiri yemakwikwi nyowani-yakaoma acute respiratory syndrome virus 2 (SARS-CoV-2) yakawanikwa kubva kuchipatara chechitatu chevanhu cheShenzhen neTsinghua University munguva yekuvandudzwa kweNew Coronavirus. mabayo (COVID-19).Monoclonal neutralizing antibodies, kunyanya bioengineering tekinoroji, anoshandiswa kudzikisa njodzi yekuwedzera masoja ekudzivirira anotsamira uye kurebesa hafu yehupenyu hweplasma kuti uwane mamwe mhedzisiro yekurapa.
Muna Gumiguru 2021, tengshengbo Pharmaceutical yapedza chikumbiro chemvumo yekushandiswa kwekukurumidzira (EUA) yembacizumab / romistuzumab musanganiswa kurapa kuUS Food and Drug Administration (FDA).
Pamusoro pezvo, tengshengbo arikushingairira kusimudzira chikumbiro chekunyoreswa kwembacizumab / romisizumab musanganiswa kurapa mune mamwe misika yakakura uye ichiri kusimukira pasirese, kutanga nekuona kuwanikwa kwemusika munyika dzakaita miedzo yekiriniki uye nyika dzine mukaha wakakura mukuwana kurapwa kwakasimba. .Tengshengbo achaitawo imwe tsvagiridzo muChina kuti aongorore ambacizumab/ Prophylactic uye immunopotentiating mhedzisiro yeakasanganiswa kurapa ne romisvir mAb mune immunosuppressed huwandu.
Kune "delta" muChina COVID-19, Tengsheng Bo, iyo yakakonzerwa neiyo mutant strain, yakapa vanhu vangangosvika mazana matatu emamiriyoni evanhu kubva kuGuangdong Province, Yunnan Province, Jiangsu Province, Hunan Province, Henan Province, Fujian. Province, Ningxia autonomous region, Gansu Province, the Inner Mongolia Autonomous Region, Heilongjiang Province, Qinghai Province, China Province neprovince muna Chikumi 2021. , vangangosvika mazana mapfumbamwe varwere vakarapwa, inova ndiyo nhamba huru yevarwere vane masoja ekudzivirira chirwere mune imwechete. nyika.Nhamba huru yevashandi vehutano vakawana ruzivo uye chivimbo mukushandisa iyi musanganiswa kurapa uye vakaita mipiro mikuru mukurwisa denda.
Nezve activ-2 yekuedza chikamu 3
Mvumo yekushambadzira ye ambacizumab / romistuzumab musanganiswa therapy neChina Drug Administration (nmpa) yakavakirwa pamuyedzo we activ-2 (nct04518410) inotsigirwa neNational Institutes of Health (NIH) Yenguva uye yekupedzisira yechikamu chechitatu. Mhedzisiro yekupedzisira yakaratidza kuti kana zvichienzaniswa ne placebo, iyi musanganiswa kurapa yakaderedza iyo inoumbwa yekupedzisira yekuchipatara uye kufa kweCOVID-19 varwere vari panjodzi huru yekufambira mberi kwekiriniki ne80%, iyo yaive yakakosha.Kubva pamazuva makumi maviri nemasere ekupedzisira kwekiriniki, pakanga pasina vakafa muboka rekurapa uye 9 vakafa muboka re placebo.Hapana njodzi itsva dzekuchengetedza dzakaonekwa.
Mhedzisiro yenguva pfupi yakaburitswa muna Gumiguru 4, 2021 yakaratidza kuti ambacizumab / romisizumab musanganiswa therapy yakaderedza magumo ekupedzisira ekurapwa uye kufa kwevarwere veCovid-19 vari panjodzi huru yekufambira mberi kwekiriniki ne78% zvichienzaniswa ne placebo, iyo yaive yakakosha (isina kugadziriswa, imwe-sided test p value <0.00001) 2% (4/196) yezvidzidzo zvakagamuchira ambacizumab / romisizumab musanganiswa therapy mukati memazuva mashanu mushure mekunge chiratidzo chatanga kuenda kuchipatara kana kufa, zvichienzaniswa ne11% (21/197) mu placebo. boka.Saizvozvo, 2% (5 / 222) yezvidzidzo zvakagamuchira ambacizumab / romisizumab musanganiswa therapy 6 kusvika 10 mazuva mushure mekutanga kwechiratidzo Muyero wekufambira mberi kuenda kuchipatara kana kufa kwaive 11% (24 / 222) muboka re placebo.Ongororo iyi yakaratidzawo kuti pakange pasina kufa muboka rekurapa mukati memazuva makumi maviri nemasere, nepo paine vasere vafa muboka re placebo.Mune ambacizumab / romistumab musanganiswa wekurapa boka, zviitiko zvakashata (AE) zvegiredhi 3 kana pamusoro zvaive zvishoma pane izvo zviri muboka re placebo, vaive 3.8% (16/418) uye 13.4% (56/419), zvichiteerana, kwete. Zviitiko zvakakomba zvine chekuita nezvinodhaka (SAE) kana kuti infusion reactions zvakaonekwa.
Chidzidzo ichi chakaitwa munzvimbo dzinoverengeka dzekuyedza kiriniki pasi rose, kusanganisira United States, Brazil, South Africa, Mexico, Argentina nePhilippines.Chidzidzo ichi chaisanganisira varwere vakanyoresa munguva yepasi rose yekukurumidza kubuda kwemasars-cov-2 akasiyana kubva muna Ndira kusvika Chikunguru 2021. Sechikamu cheongororo iyi, data rekiriniki rekushanda kwembavizumab / romisizumab musanganiswa therapy richabvawo parudzi rwemhando dzakasiyana dzehutachiona. Evaluation.Ikozvino in vitro chimeric virus test data inoratidza kuti musanganiswa kurapa ambacizumab / romistumab inochengetedza kuita kushoma pakatarisana nemhando huru dzesars-cov-2 dzinonetsa, kusanganisira 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) uye b.1.621 (“Miao”, mu).Kuedzwa kweb.1.1.529 (Omicron) musiyano urikuenderera mberi.
Nguva yekutumira: Zvita-10-2021