Gwero lachidziwitso chamakampani: State Food and Drug Administration, tengshengbo pharmaceutical, Tsinghua University
Chitsogozo: Chidziwitso choyamba cha China chodziphunzira chokha cha COVID-19 chothandizira kuphatikiza ma antibody.
Madzulo a pa Disembala 8, 2021, tsamba lovomerezeka la State Administration of Drug Administration lidalengeza kuti kugwiritsa ntchito anti-anti-anti-anti-anti-covid-19 kuphatikiza BRII-196 ndi BRII-198 kudalembetsedwa ndi State Administration of Drug Administration.Uwu ndi mwayi woyamba ku China wodziphunzitsa nokha mankhwala a COVID-19 osasokoneza antibody kuphatikiza mankhwala.
Malinga ndi zofunikira za lamulo la kayendetsedwe ka mankhwala, Boma la Food and Drug Administration lidzachita kafukufuku wadzidzidzi ndi kuvomereza malinga ndi ndondomeko yapadera yovomerezeka ya mankhwala, ndikuvomereza kuphatikiza kwa mankhwala awiri omwe ali pamwambawa ochizira anthu akuluakulu komanso akuluakulu. ndi achinyamata (azaka 12 mpaka 17, olemera kuposa 40kg) omwe ali ndi matenda a New Coronavirus (COVID-19) omwe ali pachiwopsezo chachikulu (kuphatikiza kugonekedwa m'chipatala kapena imfa).Mwa iwo, achinyamata (wazaka 12-17, kulemera kwa ≥ 40kg) okhala ndi ziwonetsero amaloledwa kuvomerezedwa.
BRII-196/BRII-198 kuphatikiza mankhwala motsogozedwa ndi Pulofesa Zhang Linqi, mkulu wa likulu la kafukufuku wathunthu wa Edzi ndi malo ofufuza zaumoyo padziko lonse ndi matenda opatsirana ku Tsinghua University School of Medicine ndi Tsinghua University.Mankhwala a Tengsheng adalimbikitsidwa mogwirizana ndi University of Tsinghua ndi chipatala chachitatu cha anthu ku Shenzhen.Mankhwalawa adatsimikizira kuti ndi othandiza kwambiri polimbana ndi COVID-19 pogwiritsa ntchito kafukufuku wosasinthika, wosawona kawiri, woyendetsedwa ndi placebo.Pakadali pano, chivomerezochi ndi munthu woyamba kudzipanga R & D ku China ndipo watsimikizira kuti ndi mankhwala othandiza othana ndi COVID-19 kudzera mu kafukufuku wosasinthika, wosawona kawiri, woyendetsedwa ndi placebo.
Pulofesa Zhang Linqi adati: "Kuvomerezedwa kwa mankhwala ophatikizika a ambacizumab / romistimub kwabweretsa mankhwala atsopano ku China.Kuphatikizika kumeneku kwawonetsa chitetezo ndi chitetezo chabwino kwambiri pamayesero amayiko osiyanasiyana.Ndi mankhwala okhawo padziko lonse lapansi omwe adawunika momwe chithandizo chamankhwala cha anthu omwe ali ndi matenda osiyanasiyana ndikupeza zambiri.Thandizo lophatikiza ma antibody ili ndilobwino kwambiri kwa ine China yapereka chithandizo chapadziko lonse lapansi cha COVID-19.Anasonyeza mokwanira kudzikundikira kwambiri ndi nkhokwe luso la University Tsinghua m'munda wolimbana ndi matenda opatsirana, ndi luso ndi luso kuitana kubwera, kumenyana, kumenyana ndi kumenyana.Yathandiza kwambiri pantchito yoletsa ndi kuwongolera miliri ku China komanso padziko lonse lapansi.Ndife olemekezeka kwambiri kukhala pamaziko a chipatala chachitatu cha anthu a Shenzhen ndi mankhwala a Tengsheng Bo.Kugwirizana kwapamwamba mu kafukufuku wachipatala ndi kusintha kwapangitsa kuti izi zitheke.Mu sitepe yotsatira, tipitiriza kuphunzira ntchito yodzitetezera ya monoclonal antibody kuphatikiza mankhwala m'magulu omwe ali pachiopsezo chachikulu komanso omwe ali ndi chitetezo chamthupi.”
Chivomerezochi chinachokera ku gawo lachitatu la mayesero achipatala a activ-2 othandizidwa ndi National Institutes of Health (NIH), kuphatikizapo zotsatira zabwino zapakati ndi zomaliza za odwala 847 omwe adalembetsa.Zotsatira zomaliza zidawonetsa kuti mankhwala ophatikizira a ambavizumab / romistuzumab atha kuchepetsa chiwopsezo chogonekedwa m'chipatala ndi kufa kwa odwala omwe ali pachiwopsezo chachikulu ndi 80% (zotsatira zanthawi yayitali zinali 78%) poyerekeza ndi placebo, zomwe zinali zofunika kwambiri.Pofika kumapeto kwachipatala kwa masiku 28, panalibe omwalira m'gulu lachipatala ndi 9 omwe adamwalira m'gulu la placebo, ndipo chitetezo chake chachipatala chinali chabwinoko kuposa cha gulu la placebo.Panthawi imodzimodziyo, ngati chithandizocho chinayambika kumayambiriro (pasanathe masiku 5 chiyambireni zizindikiro) kapena kumapeto kwa siteji (pakati pa 6 mpaka masiku 10 chiyambireni zizindikiro) Mwa maphunzirowa, kugonekedwa m'chipatala ndi kumwalira kunali kwakukulu. kuchepetsedwa, zomwe zinapereka zenera lalitali la chithandizo kwa odwala omwe ali ndi korona watsopano.
Pasanathe miyezi 20, Tsinghua University, mogwirizana ndi chipatala cha Shenzhen Third People's Hospital ndi tengshengbo pharmaceutical, idalimbikitsa chithandizo chophatikiza cha ambacizumab / romisvir kuyambira pakupatukana koyambirira kwa antibody ndikuwunika mpaka kumapeto kwa mayeso azachipatala apadziko lonse lapansi 3, ndipo pamapeto pake adapeza mndandanda waku China. kuvomereza.Kupambana kumeneku ndi kuyesayesa kogwirizana kwa China ndi asayansi apamwamba padziko lonse lapansi komanso ofufuza azachipatala Zotsatira zake zikuphatikiza thandizo la ACTIV-2 International Clinical Research Institute, National Institute of Allergy and Infectious Diseases (NIAID) ya National Institutes of Health (NIH). ), ndi gulu la ACTIV-2 (ACTG), lomwe limatsogolera kafukufuku wachipatala.
Liu Lei, mkulu wa malo ofufuza za matenda opatsirana ku Shenzhen komanso Mlembi wa komiti ya Party ya chipatala chachitatu cha anthu ku Shenzhen, anati: "Kuyambira pa mliriwu, tidakhala ndi cholinga choletsa miliri yaukadaulo.Gulu lathu lidatulutsa bwino ma antibodies awiri omwe amagwira ntchito kwambiri mu seramu ya odwala atsopano okonzanso korona, ndikuyika maziko olimba pakukulitsa kotsatira kwa mankhwalawa a anti COVID-19.Ndife okondwa kugwira ntchito limodzi ndi Pulofesa Zhang Linqi ndi kampani yopanga mankhwala ya Tengsheng ya ku yunivesite ya Tsinghua kuti apange korona woyamba ku China.Mankhwala obwera chifukwa cha mavairasi amapereka nzeru komanso chidziwitso.Tikukhulupirira kuti mogwirizana ndi kuchuluka kwa ogwira ntchito ofufuza ndi ogwira ntchito zachipatala, titha kugonjetsa COVID-19 posachedwa.
A Luo Yongqing, Purezidenti komanso manejala wamkulu wa Greater China, adati: "Ndife okondwa kukwaniritsa gawo lofunikali ndipo tikugwira ntchito molimbika kulimbikitsa kupezeka kwa chithandizo chamankhwala ichi kwa odwala atsopano aku China.Kupambana kumeneku kumatsimikizira kuti takhala odzipereka kwambiri kupititsa patsogolo luso lapadziko lonse lapansi pa nkhani ya matenda opatsirana ndikukwaniritsa zosowa zachipatala zomwe sizinakwaniritsidwe ndi zotsatira zabwino, zasayansi, zokhwima komanso zabwino kwambiri.Monga kampani yamayiko osiyanasiyana yomwe ikugwira ntchito ku China ndi United States Biotech Corp, ndikunyadira kuti Tengsheng Bo wachita bwino pamankhwala osokoneza bongo, ndipo sitichita khama kuthandiza China kuthana ndi zovuta za COVID-19 mwasayansi, ndikukwaniritsa zosowa zachipatala za akatswiri athu atsopano. .
About ambacizumab / romistuzumab
(m'mbuyomu brii-196 / brii-198)
The monoclonal antibody to monoclonal antibody and the roomway monoclonal antibody ndi kachilombo koyambitsa matenda a 2 (SARS-CoV-2) omwe amapezeka ku chipatala chachitatu cha anthu ku Shenzhen ndi Tsinghua University panthawi yokonzanso New Coronavirus. chibayo (COVID-19).Ma antibodies a monoclonal neutralizing, makamaka ukadaulo wa bioengineering, amagwiritsidwa ntchito kuchepetsa chiwopsezo cha kudalira kwa antibody ndikutalikitsa theka la moyo wa plasma kuti alandire chithandizo chokhalitsa.
Mu Okutobala 2021, tengshengbo pharmaceutical adamaliza ntchito yovomerezeka yogwiritsa ntchito mwadzidzidzi (EUA) ya ambacizumab / romistuzumab kuphatikiza mankhwala ku US Food and Drug Administration (FDA).
Kuphatikiza apo, tengshengbo akulimbikitsa kulembetsa kulembetsa kwa ambacizumab / romisizumab m'misika ina yokhwima komanso yomwe ikubwera padziko lonse lapansi, choyamba kuwonetsetsa kuti msika ukupezeka m'maiko omwe adayesa mayeso azachipatala komanso mayiko omwe ali ndi kusiyana kwakukulu pakulandila chithandizo choyenera. .Tengshengbo adzachitanso kafukufuku wina ku China kuti awunike ambacizumab/Prophylactic ndi immunopotentiating zotsatira za kuphatikiza mankhwala ndi romisvir mAb mu immunosuppressed anthu.
Kwa "delta" ku China COVID-19, Tengsheng Bo, yomwe idachitika chifukwa cha zovuta zosinthika, idapereka anthu pafupifupi 3000 anthu pafupifupi mamiliyoni awiri ochokera m'chigawo cha Guangdong, Chigawo cha Yunnan, Chigawo cha Jiangsu, Chigawo cha Hunan, Chigawo cha Henan, Fujian. Province, Ningxia autonomous region, Gansu Province, Inner Mongolia Autonomous Region, Heilongjiang Province, Qinghai Province, China Province ndi chigawo mu June 2021. , pafupifupi 900 odwala anathandizidwa, amene ndi chiwerengero chachikulu cha odwala ndi neutralizing ma antibodies mu umodzi. dziko.Ambiri ogwira ntchito zachipatala adapeza chidziwitso ndi chidaliro pakugwiritsa ntchito mankhwalawa osakaniza ndipo adathandizira kwambiri polimbana ndi mliriwu.
Za activ-2 trial phase 3
Chivomerezo cha malonda a ambacizumab / romistuzumab combination therapy ndi China Drug Administration (nmpa) chimachokera pa kuyesa kwa activ-2 (nct04518410) mothandizidwa ndi National Institutes of Health (NIH) pakanthawi kochepa komanso zotsatira zomaliza za gawo 3. Zotsatira zomaliza zidawonetsa kuti poyerekeza ndi placebo, chithandizo chophatikiza ichi chinachepetsa kutha kwa kugonekedwa m'chipatala ndi kufa kwa odwala omwe ali ndi covid-19 omwe ali pachiwopsezo chachikulu cha kudwala ndi 80%, zomwe zinali zofunika kwambiri.Pofika kumapeto kwa masiku 28, panalibe omwalira m'gulu lachipatala komanso anthu 9 omwe adamwalira m'gulu la placebo.Palibe zoopsa zachitetezo zatsopano zomwe zidawonedwa.
Zotsatira zanthawi yochepa zomwe zidasindikizidwa pa Okutobala 4, 2021 zidawonetsa kuti mankhwala ophatikizira ambacizumab / romisizumab adachepetsa kutha kwa kugonekedwa m'chipatala ndi kufa kwa odwala omwe ali pachiwopsezo cha Covid-19 omwe ali pachiwopsezo chachikulu cha chipatala ndi 78% poyerekeza ndi placebo, yomwe inali yofunika kwambiri (yosasinthidwa, mayeso a mbali imodzi p mtengo <0.00001) 2% (4 / 196) mwa anthu omwe adalandira mankhwala ophatikizira ambacizumab / romisizumab mkati mwa masiku 5 chizindikirocho chidayamba kugonekedwa m'chipatala kapena imfa, poyerekeza ndi 11% (21/197) mu placebo. gulu.Momwemonso, 2% (5 / 222) mwa anthu omwe adalandira mankhwala osakaniza a ambacizumab / romisizumab 6 mpaka 10 patatha masiku 10 chiyambireni chizindikiro Mlingo wa kupita kuchipatala kapena imfa unali 11% (24 / 222) pagulu la placebo.Kuwunikaku kudawonetsanso kuti panalibe omwalira m'gulu lachipatala mkati mwa masiku 28, pomwe panali anthu 8 omwe adamwalira m'gulu la placebo.M'gulu la ambacizumab / romistumab kuphatikiza mankhwala, zochitika zoyipa (AE) za giredi 3 kapena kupitilira apo zinali zocheperapo kuposa zomwe zili mgulu la placebo, zomwe zinali 3.8% (16/418) ndi 13.4% (56/419), motsatana, ayi. Zotsatira zoyipa zokhudzana ndi mankhwala (SAE) kapena kulowetsedwa zidawonedwa.
Kafukufukuyu adachitika m'malo angapo oyeserera azachipatala padziko lonse lapansi, kuphatikiza United States, Brazil, South Africa, Mexico, Argentina ndi Philippines.Kafukufukuyu adaphatikiza odwala omwe adalembetsa munthawi yanthawi yapadziko lonse lapansi yamitundu yosiyanasiyana ya sars-cov-2 kuyambira Januware mpaka Julayi 2021. Monga gawo la kafukufukuyu, momwe chithandizo chamankhwala chophatikizira cha ambavizumab / romisizumab chidzatengera mtundu wa ma virus osiyanasiyana. Kuwunika.Zomwe zilipo panopa zoyesa kachilombo ka chimeric virus zikuwonetsa kuti kuphatikiza kwa ambacizumab / romistumab kumapangitsa kuti pakhale zosokoneza polimbana ndi mitundu yayikulu ya sars-cov-2 yomwe ili ndi nkhawa kwambiri, kuphatikiza 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) ndi b.1.621 (“Miao”, mu).Kuyesa kwa mtundu wa b.1.1.529 (Omicron) kuli mkati.
Nthawi yotumiza: Dec-10-2021