“Sinochulumanco ukuphumelela lo mgama ubalulekileyo. Le mpumelelo ibubungqina bokuzibophelela kwethu ekukhawuleziseni izinto ezintsha kwizifo ezosulelayo, kunye nokukwazi kwethu ukuzalisekisa iimfuno ezingafezekiyo zehlabathi ngesantya, ngokungqongqo kwezenzululwazi kunye neziphumo ezincomekayo, utshilo uRogers Luo, uMongameli kunye noMphathi Jikelele, i-Greater China yeBrii Bio. "Njengenkampani yokuqala ye-biotech yelizwe ehlangeneyo e-China nase-US, sisebenzela ukuqhubela phambili ukufikelela kolu nyango kuluhlu olubanzi lwezigulana ze-COVID-19 e-China, ngelixa inyusa iinzame zayo zokuhambelana nesidingo Iinketho zonyango lwe-COVID-19 ukulwa ubhubhane. ”
Imvume ye-NMPA isekwe kwiziphumo ezincumisayo zokugqibela nezexeshana ezivela kwi-ACTIV-2 iSigaba sesi-3 solingo lwezonyango oluxhaswe yi-NIH kunye nezigulane ezingalaliswayo ezibhalisiweyo ezingama-847. Iziphumo zokugqibela zibonise i-80% yezibalo ezibalulekileyo (i-78% kwiziphumo zexeshana) ukunciphisa ukulaliswa esibhedlele kunye nokufa kunye nokufa okumbalwa ngeentsuku ze-28 kwingalo yonyango (0) ngokumalunga ne-placebo (9), kunye nesiphumo sokhuseleko esiphuculweyo ngaphezu kwe-placebo kwi-non- izigulana ezilaliswe esibhedlele ngenxa ye-COVID-19 ezisemngciphekweni omkhulu wokuqhubekela phambili kwezonyango ukuya kwisifo esiqatha. Amazinga okusebenza afanayo abonwa kubathathi-nxaxheba abaqala unyango kwangoko (iintsuku ezi-0-5) kwaye emva kwexesha (iintsuku ezi-6-10), kulandela ukuqala kweempawu, ukubonelela ngobungqina bekliniki obufunekayo kwizigulana ze-COVID-19 ezifike emva kwexesha kunyango.
Ngaphantsi kweenyanga ze-20, i-Brii Bio iqhubele phambili indibaniselwano ye-amubarvimab/romlusevimab ukusuka ekufumaneni ukuya ekugqityweni kweSigaba sesi-3 sophuhliso olukhokelela kolu kwamkelwa ngokukhawuleza yi-NMPA. Le mvume imele ubuhlakani obunempumelelo kakhulu kunye nezona nzululwazi zigqwesileyo kunye nabaphandi bezonyango e-China nakwihlabathi jikelele kuthumo ekwabelwana ngalo, kuqukwa neSibhedlele saBantu sesi-3 sase-Shenzhen kunye neYunivesithi yaseTsinghua, esithe safumanisa ezi zikhokeleli ze-antibody; i-US National Institute of Health (NIH), i-AIDS Clinical Trial Group (ACTG), owaxhasa kwaye wakhokela uvavanyo lwe-ACTIV-2.
“Njengonyango lokuqala lwe-COVID-19 e-China, indibaniselwano ye-amubarvimab/romlusevimab ibonisa iziphumo ezincomekayo zeklinikhi kunye nokhuseleko olululo kulingo lwehlabathi, lwamaziko amaninzi. Kuphela kwendibaniselwano ye-antibody ye-monoclonal kwihlabathi jikelele eqinisekisiweyo yokusebenza kwekliniki phakathi kwezigulana ezosulelwe yi-SARS-COV-2 eyahlukileyo kulingo olubalulekileyo lwaphambi kokuthengisa," utshilo uNjingalwazi uLinqi Zhang, uMlawuli weZiko leHlabathi loPhando ngeMpilo kunye neZifo ezosulelayo kunye noGawulayo oluBanzi. Iziko loPhando kwiSikolo soNyango lweYunivesithi yaseTsinghua. "Indibaniselwano ye-antibody ibonelele ngonyango olukumgangatho wehlabathi eTshayina ukulwa nobhubhani we-COVID-19, obonisa ngokupheleleyo amava ethu atyebileyo, oovimba bezenzululwazi nobuchwepheshe, kunye noxanduva lwethu lokulwa nezifo ezosulelayo kunye nokwenza igalelo elibalulekileyo kuthintelo. kunye nolawulo lobhubhane eTshayina nakwihlabathi. Siyavuya ukusebenzisana neSibhedlele saBantu sesi-3 sase-Shenzhen kunye ne-Brii Bio ekufumaneni, uphando lwezonyango, kunye nophando loguqulo lonyango oludibeneyo kwaye ekugqibeleni siphumelele le nkqubela phambili ibalaseleyo. Siza kuqhubeka nokuvavanya ukusetyenziswa kwendibaniselwano ye-amubarvimab/romlusevimab phakathi kwabemi abangakhuselekanga njengomlinganiselo owongezelelweyo we-prophylaxis.
Ukusukela oko kwaqala ubhubhani we-COVID-19, umgaqo wethu osisikhokelo ibiyindlela esekwe kwisayensi njengoko siqhubeka ukulwa lo bhubhani. Iqela lethu lophando liye lafumana ngempumelelo ii-antibodies ezimbini ezisebenzayo ezinokuthi zithintele kwizigulana ze-COVID-19, ezibeke isiseko esiluqilima sokuphuhlisa indibaniselwano ye-amubarvimab/romlusevimab ngokuchasene ne-COVID-19, utshilo uLei Liu, uMlawuli weZiko leSizwe loPhando lwezonyango kwiZifo ezosulelayo e. Shenzhen kunye noNobhala weQela leSibhedlele sesithathu sabantu saseShenzhen. “Kuyasivuyisa ukusebenzisana noProf.
INTO ONOKUYITHATHA KWELI NQAKU:
- "Indibaniselwano ye-antibody ibonelele ngonyango olukumgangatho wehlabathi eTshayina ukulwa nobhubhani we-COVID-19, obonisa ngokupheleleyo amava ethu atyebileyo, oovimba bezenzululwazi nobuchwepheshe, kunye noxanduva lwethu lokulwa nezifo ezosulelayo kunye nokwenza igalelo elibalulekileyo kuthintelo. kunye nolawulo lobhubhane eTshayina nakwihlabathi.
- Iziphumo zokugqibela zibonise i-80% yezibalo ezibalulekileyo (i-78% kwiziphumo zexeshana) ukunciphisa ukulaliswa esibhedlele kunye nokufa ngokufa okumbalwa ngeentsuku ze-28 kwingalo yonyango (0) ngokumalunga ne-placebo (9), kunye nesiphumo sokhuseleko esiphuculweyo ngaphezu kwe-placebo kwindawo engeyiyo. izigulana ezilaliswe esibhedlele ze-COVID-19 ezisemngciphekweni omkhulu wokuqhubekela phambili kwezonyango ukuya kwisifo esiqatha.
- Le mvume imele ubuhlakani obunempumelelo kakhulu kunye nezona nzululwazi zibalaseleyo kunye nabaphandi bezonyango e-China nakwihlabathi jikelele kuthumo ekwabelwana ngalo, kubandakanywa neSibhedlele sesithathu saBantu sase-Shenzhen kunye neYunivesithi yaseTsinghua, ethe yafumanisa ezi zikhokeleli ze-antibody.
