Umthombo wesaziso seshishini: Ukutya kukaRhulumente kunye nolawulo lweziyobisi, tengshengbo amayeza, iYunivesithi yaseTsinghua
Isikhokelo: Ipropathi yokuqala yaseTshayina yokuzifundisa i-COVID-19 yenza unyango oludityanisiweyo lwe-antibody.
Ngorhatya lwe-8 kaDisemba 2021, iwebhusayithi esemthethweni yoLawulo lukaRhulumente lolawulo lwamachiza yabhengeza ukuba ukusetyenziswa kwe-COVID-19 yokungathathi hlangothi kwe-antibody kudityaniswe ne-BRII-196 kunye ne-BRII-198 yabhaliswa nguLawulo lukaRhulumente lolawulo lwamachiza.Yipropathi yokuqala yaseTshayina yokuzifundisa i-COVID-19 yonyango oludibanisa amajoni omzimba.
Ngokwamalungiselelo afanelekileyo omthetho wolawulo lweziyobisi, uKutya kukaRhulumente kunye nolawulo lweziyobisi kuya kuqhuba uphononongo olungxamisekileyo kunye nokwamkelwa ngokungqinelana neenkqubo zokuvunywa okukhethekileyo kwamachiza, kwaye avume indibaniselwano yala mayeza mabini angentla kunyango lokukhanya kunye nabantu abadala abaqhelekileyo. kunye nabafikisayo (abaneminyaka eli-12 ukuya kweli-17 ubudala, abanobunzima obungaphezulu kwama-40kg) abanosulelo lweNtsholongwane eNtsha yeCoronavirus (COVID-19) abakwimiba esemngciphekweni omkhulu (kubandakanya ukulaliswa esibhedlele okanye ukufa).Phakathi kwabo, ulutsha (iminyaka eyi-12-17 ubudala, ubunzima ≥ 40kg) kunye nezibonakaliso zixhomekeke kwimvume enemiqathango.
I-BRII-196 / BRII-198 unyango oludibeneyo lukhokelwa nguNjingalwazi uZhang Linqi, umlawuli weziko lophando olubanzi lwe-AIDS kunye nempilo yehlabathi kunye neziko lophando lwezifo ezosulelayo kwiYunivesithi yaseTsinghua yeSikolo seyeza kunye neYunivesithi yaseTsinghua.I-Tengsheng amayeza yakhuthazwa ngokubambisana neYunivesithi yaseTsinghua kunye nesibhedlele sabantu sesithathu saseShenzhen.Unyango lubonakalise amachiza asebenzayo e-anti-COVID-19 ngophononongo olungqongqo, olungaboni kakuhle, olulawulwa yi-placebo.Ngeli xesha, imvume iphawula i-R & D yokuqala yokuziphuhlisa e-China kwaye ibonakalise amayeza athile e-anti-COVID-19 ngokungqongqo ngokungqongqo, ukungaboni kakuhle, uphononongo olulawulwa yi-placebo.
Unjingalwazi uZhang Linqi uthe: “Ukuvunywa kwembacizumab / romistimub yonyango oludityanisiweyo kuzise iyeza lokuqala eTshayina.Olu nyango ludityanisiweyo lubonise ukhuseleko olugqwesileyo kunye nokhuseleko kulingo lwamazwe ngamazwe lwamaziko amaninzi.Lichiza kuphela le-antibody ehlabathini elenze uphononongo lwesiphumo sonyango lwabantu abosulelwe ziintlobo ezahlukeneyo kwaye bafumana eyona datha ilungileyo.Olu nyango ludityanisiweyo lwe-antibody lolona lundilungeleyo I-China ibonelele ngonyango olukumgangatho wehlabathi lwe-COVID-19.Ibonise ngokupheleleyo ukuqokelela okunzulu kunye nokugcinwa kobugcisa beYunivesithi yaseTsinghua kwintsimi yokulwa nezifo ezithathelwanayo, kunye nokukwazi ukubiza ukuba kuza, ukulwa, ukulwa nokulwa.Yenze igalelo elibalulekileyo kumsebenzi wokuthintela nokulawula ubhubhane eTshayina nakwihlabathi liphela.Siwonge kakhulu ukuba sibe kwisiseko seSibhedlele sabantu sesithathu saseShenzhen kunye neTengsheng Bo amayeza.Intsebenziswano ekumgangatho ophezulu, uphando lwezonyango kunye notshintsho lwenze le mpumelelo ibalulekileyo.Kwinqanaba elilandelayo, siya kuqhubeka nokufunda indima yokukhusela yonyango oludibeneyo lwe-monoclonal antibody kumngcipheko ophezulu kunye namaqela angenayo i-immune.”
Le mvume isekelwe kwisigaba se-3 sovavanyo lwekliniki ye-activ-2 exhaswa yiNational Institutes of Health (NIH), kubandakanywa iziphumo ezilungileyo zesikhashana kunye neziphumo zokugqibela zezigulane ezibhalisiweyo ze-847.Iziphumo zokugqibela zibonise ukuba unyango oludityanisiweyo lwe-mbavizumab / romistuzumab lunokunciphisa umngcipheko wokulaliswa esibhedlele kunye nokufa kwezigulana ezingalaliswayo ezisemngciphekweni omtsha ngama-80% (iziphumo zethutyana zazingama-78%) xa kuthelekiswa ne-placebo, eyayibalulekile ngokwezibalo.Ngokubhekiselele kwinqanaba lokuphela kweklinikhi leentsuku ezingama-28, akukho kufa kwiqela lonyango kunye nokufa kwe-9 kwiqela le-placebo, kwaye ukhuseleko lwayo lwekliniki lwalungcono kunolo kwiqela le-placebo.Ngexesha elifanayo, ingaba unyango luqaliswe kwinqanaba lokuqala (ngaphakathi kweentsuku ze-5 emva kokuqala kweempawu) okanye kwinqanaba lokugqibela (ngaphakathi kwe-6 kwiintsuku ze-10 emva kokuqala kweempawu) Kwizifundo, ukulaliswa esibhedlele kunye nokufa kwakubaluleke kakhulu. yancitshiswa, eyabonelela ngefestile yonyango ende kwizigulane ezinezithsaba ezitsha.
Ngaphantsi kweenyanga ezingama-20, iDyunivesithi yaseTsinghua, ngokubambisana neSibhedlele Sesithathu Sabantu saseShenzhen kunye neTengshengbo pharmaceutical, yakhuthaza ngokukhawuleza unyango oludityanisiweyo lwembacizumab / romisvir ukusuka kulwahlulo lokuqala lwe-antibody kunye novavanyo ukuya ekugqityweni kwenqanaba lesithathu lolingo lwezonyango, kwaye ekugqibeleni lwafumana uluhlu lwaseTshayina. imvume.Le mpumelelo yimigudu edibeneyo yaseTshayina kunye nososayensi behlabathi kunye nabaphandi bezonyango Iziphumo zibandakanya inkxaso ye-ACTIV-2 International Clinical Research Institute, iNational Institute of allergy and infectious Diseases (NIAID) yamaZiko ezeMpilo eSizwe (NIH) ), kunye ne-ACTIV-2 iqela lovavanyo lweklinikhi (ACTG), olukhokelela uphando lweklinikhi.
U-Liu Lei, umlawuli weziko lophando lwezonyango kwizifo ezosulelayo e-Shenzhen kunye noNobhala wekomiti yeqela leSibhedlele sabantu sesithathu sase-Shenzhen, uthe: “Kwasekuqaleni kwalo bhubhani, sazibekela usukelo lokuthintela ubhubhani wetekhnoloji.Iqela lethu likhuphe ngempumelelo iperi ye-anti-anti-anti-anti-anti-anti-active esebenzayo kwiserum yezigulana ezintsha zokubuyisela kwisithsaba, libeka isiseko esiluqilima sophuhliso olulandelayo lweli chiza le-anti-COVID-19.Kuyasivuyisa ukusebenza noNjingalwazi uZhang Linqi kunye nenkampani yamayeza yaseTengsheng yeDyunivesithi yaseTsinghua ukwenza isithsaba sokuqala esitsha saseTshayina.Amachiza eentsholongwane anika ubulumko namava.Siyathemba ukuba ngeenzame ezidibeneyo zenani elikhulu labasebenzi bophando kunye nabasebenzi bezonyango, singayoyisa i-COVID-19 ngokukhawuleza.
U-Luo Yongqing, uMongameli kunye nomanejala jikelele we-Greater China, uthe: “Sinochulumanco ukuphumeza lo mgama ubalulekileyo kwaye sisebenza nzima ukukhuthaza ukufikeleleka kolu nyango ludityanisiweyo kwizigulana ezitsha zaseTshayina.Le mpumelelo ingqina ukuba sizibophelele ngokuqinileyo ekukhawuleziseni ukuveliswa kwezinto ezintsha kwihlabathi jikelele kwicandelo lezifo ezosulelayo kunye nokuzalisa iimfuno zonyango ezingafezekiyo ngeziphumo ezisebenzayo, zenzululwazi, ezingqongqo kunye nezigqwesileyo.Njengenkampani yezizwe ngezizwe esebenza e-China kunye ne-United States Biotech Corp, ndiyazingca ngokuphumelela kwechiza lika-Tengsheng Bo, kwaye asigcini nzame zokunceda i-China imelane neemfuno ezintsonkothileyo ze-COVID-19 ngokwesayensi, kwaye sifezekise iimfuno zekliniki zeentshatsheli zethu ezintsha. .
Malunga nembacizumab / romistuzumab
(ngaphambili brii-196 / brii-198)
I-antibody ye-monoclonal ukuya kwi-monoclonal antibody kunye ne-monoclonal antibody ye-monoclonal luhlobo olutsha olungakhuphisaniyo olunzima lwe-acute breathing syndrome virus 2 (SARS-CoV-2) efunyenwe kwiSibhedlele sabantu sesithathu sase-Shenzhen kunye neDyunivesithi yaseTsinghua ngexesha lokubuyisela kwi-coronavirus entsha. inyumoniya (COVID-19).Ii-antibodies ze-Monoclonal neutralizing, ngakumbi itekhnoloji ye-bioengineering, isetyenziselwa ukunciphisa umngcipheko wophuculo oluxhomekeke kwi-antibody mediated kunye nokwandisa isiqingatha sobomi beplasma ukufumana iziphumo zonyango ezihlala zihleli.
Ngo-Okthobha ka-2021, i-tengshengbo pharmaceutical iye yasigqiba isicelo sogunyaziso losetyenziso olungxamisekileyo (EUA) lwe-ambacizumab / romistuzumab yonyango oludityanisiweyo kuLawulo lokuTya kunye neChiza lase-US (FDA).
Ukongeza, i-tengshengbo ikhuthaza ngenkuthalo isicelo sobhaliso lwe-ambacizumab / romisizumab unyango oludityanisiweyo kwezinye iimarike ezikhulileyo nezisakhulayo kwihlabathi liphela, okokuqala kuqinisekisa ukufikelela kwintengiso kumazwe aqhube ulingo lwezonyango kunye namazwe anesithuba esikhulu sokufikelela kunyango olusebenzayo. .I-Tengshengbo iyakuqhuba nophando olongezelelekileyo e-China ukuvavanya i-mbacizumab/Prophylactic kunye ne-immunopotentiating iziphumo zonyango oludityanisiweyo kunye ne-romisvir mAb kubantu abangakwazi ukugonyeka.
Kwi "delta" yaseTshayina COVID-19, iTengsheng Bo, eyabangelwa kukutshintsha kwenguqu, yanikela malunga ne-3000 yabantu bebonke abantu abaphantse babe zizigidi ezibini kwiPhondo laseGuangdong, kwiPhondo laseYunnan, kwiPhondo laseJiangsu, kwiPhondo laseHunan, kwiPhondo laseHenan, eFujian. Iphondo, i-Ningxia autonomous region, iPhondo laseGansu, i-Inner Mongolia Autonomous Region, iPhondo le-Heilongjiang, iPhondo laseQinghai, iPhondo lase-China kunye nephondo ngoJuni 2021. , phantse izigulane ze-900 zanyangwa, lelona nani likhulu lezigulane ezine-anti-neutralizing antibodies kwenye enye. ilizwe.Inani elikhulu labasebenzi bezempilo bafumana amava kunye nokuzithemba ekusebenziseni olu nyango oludibeneyo kwaye benza igalelo elikhulu ekulweni nobhubhane.
Malunga ne-activ-2 yolingo lwesigaba sesi-3
Ukuvunywa kwentengiso ye-ambacizumab / romistuzumab indibaniselwano yonyango yi-China Drug Administration (nmpa) isekelwe kulingo lwe-activ-2 (nct04518410) oluxhaswa yiNational Institutes of Health (NIH) yeThutyana kunye neziphumo zokugqibela zesigaba 3. Iziphumo zokugqibela zibonise ukuba xa kuthelekiswa ne-placebo, olu nyango ludityanisiweyo lwehlise isiphelo esihlanganisiweyo sokulaliswa esibhedlele kunye nokufa kwabagulayo be-covid-19 abangaphandle kumngcipheko omkhulu wokuqhubekela phambili kwezonyango ngama-80%, nto leyo yayibalulekile ngokwezibalo.Ukusukela kwiintsuku ezingama-28 zokuphela kwendawo yonyango, akukho kufa kwiqela lonyango kunye nokusweleka kwe-9 kwiqela le-placebo.Akukho bungozi butsha bokhuseleko bujongwayo.
Iziphumo zethutyana ezipapashwe nge-4 ka-Okthobha ka-2021 zibonise ukuba unyango oludityanisiweyo lwe-mbacizumab / romisizumab lunciphise indawo edibeneyo yokulaliswa esibhedlele kunye nokufa kwabagulayo be-covid-19 abangaphandle kumngcipheko omkhulu wokuqhubekela phambili kwezonyango ngama-78% xa kuthelekiswa ne-placebo, ebibaluleke ngokwezibalo (ingalungiswa, uvavanyo olucalanye icala p ixabiso <0.00001) 2% (4 / 196) yezifundo abafumana imbacizumab / romisizumab indibaniselwano unyango phakathi kweentsuku 5 emva kokuqala kweempawu ukuqhubela phambili ukuya esibhedlele okanye ukufa, xa kuthelekiswa ne-11% (21 / 197) kwi-placebo. iqela.Ngokufanayo, i-2% (5 / 222) yezifundo ezifumene unyango lwe-mbacizumab / romisizumab oludityanisiweyo kwiintsuku ezi-6 ukuya kwezi-10 emva kokuqala kweempawu Umlinganiselo wokuqhubela phambili ukuya esibhedlele okanye ukufa kwakuyi-11% (24 / 222) kwiqela le-placebo.Uhlalutyo lukwabonise ukuba akukho kufa kwiqela lonyango phakathi kweentsuku ezingama-28, ngelixa kukho abasi-8 ababhubhileyo kwiqela le-placebo.Kwiqela le-ambacizumab / romistumab lonyango oludityanisiweyo, iziganeko ezimbi (AE) zebanga lesi-3 okanye ngaphezulu zazingaphantsi kwezo zeqela le-placebo, ezaziyi-3.8% (16/418) kunye ne-13.4% (56/419), ngokulandelanayo, hayi Iziganeko ezimbi kakhulu ezinxulumene neziyobisi (SAE) okanye iimpendulo zokungena ziye zabonwa.
Uphononongo lwenziwe kumaziko amaninzi ovavanyo lwezonyango kwihlabathi jikelele, kubandakanywa i-United States, iBrazil, uMzantsi Afrika, iMexico, iArgentina kunye nePhilippines.Uphononongo lubandakanya izigulane ezibhalise kwixesha lokuvela ngokukhawuleza kwehlabathi jikelele kokwahluka kwe-sars-cov-2 ukusuka kuJanuwari ukuya kuJulayi ka-2021. Njengenxalenye yolu phononongo, idatha yokusebenza kwezonyango ye-ambavizumab / romisizumab yonyango oludityanisiweyo nayo iya kusekelwa kuhlobo lweentlobo ezahlukeneyo zentsholongwane egazini. Uvavanyo.Idatha yangoku yovavanyo lwentsholongwane ye-in vitro chimeric ibonisa ukuba unyango oludibeneyo lwe-ambacizumab / romistumab lugcina umsebenzi wokungathathi hlangothi ngokuchasene nokwahluka okukhulu kwe-sars-cov-2 okuxhalabisa kakhulu, kubandakanywa 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) kunye b.1.621 ("Miao", mu).Uvavanyo lokwahluka kwe-b.1.1.529 (Omicron) kuyaqhubeka.
Ixesha lokuposa: Dec-10-2021