“Tinofara kuwana chiitiko chakakosha ichi. Zvakaitwa izvi chiratidzo chekuzvipira kwedu kwakasimba mukusimudzira hunyanzvi muzvirwere zvinotapuriranwa, uye kugona kwedu kuzadzisa zvido zvepasi rose zvisingaite nekukurumidza, kusimba kwesainzi uye nemhedzisiro inoshamisa, "akadaro Rogers Luo, Mutungamiriri uye General Manager, Greater China weBrii Bio. "Sekambani yekutanga yenyika dzakawanda dzebiotech yakabatana muChina neUS, tiri kushanda kuti tifambise mukana wekurapwa uku kwevarwere vakasiyana-siyana veCCIDID-19 muChina, tichiwedzerawo kuedza kwayo kuenderana nezvinodiwa COVID-19 nzira dzekurapa kurwisa denda."
Mvumo yeNMPA inobva pamigumisiro yakanaka yekupedzisira uye yenguva pfupi kubva kuNIH-sponsored ACTIV-2 Phase 3 kliniki yekuedza ne847 vakanyoresa kunze. Mhedzisiro yekupedzisira yakaratidza huwandu hwakakosha 80% (78% mumhedzisiro yenguva pfupi) kuderedzwa kwekuiswa muchipatara uye kufa nerufu rushoma kuburikidza nemazuva makumi maviri nemasere muruwoko rwekurapa (28) maererano ne placebo (0), uye yakagadziridzwa kuchengetedzwa kwemhedzisiro pane placebo mune isiri- muchipatara varwere veCCIDID-9 vari panjodzi huru yekufambira mberi kwekiriniki kusvika kuchirwere chakakomba. Mwero wekuita wakafanana wakaonekwa muvatori vechikamu kutanga kurapwa (mazuva 19-0) uye kunonoka (mazuva matanhatu-5), zvichitevera kutanga kwechiratidzo, ichipa humbowo hwekiriniki hunodiwa muvarwere veCOVID-6 vakanonoka kurapwa.
Mumwedzi isingasviki makumi maviri, Brii Bio akafambisira mberi amubarvimab/romlusevimab musanganiswa kubva pakuwanikwa kusvika pakupera kweChikamu chechitatu budiriro inotungamira kune iyi kukurumidza kubvumidzwa neNMPA. Mvumo iyi inomiririra kudyidzana kwakabudirira zvikuru nemasaenzi epamusoro uye vaongorori vekiriniki muChina nepasirese pasi rose pachinangwa chakagovaniswa, kusanganisira 20rd People's Hospital yeShenzhen neTsinghua University, vakawana izvi zvinotungamirira masoja ekudzivirira chirwere; iyo US National Institute of Health (NIH), iyo AIDS Clinical Trial Group (ACTG), uyo akatsigira uye akatungamira muyedzo weACTIV-3.
"Sekutanga kurapwa kweCCIDID-19 muChina, musanganiswa wemubarvimab/romlusevimab unoratidza mhedzisiro yekiriniki yakanaka uye kuchengetedzeka kwakanaka mumiedzo yepasirese, yakawanda. Ndiwo chete musanganiswa wemonoclonal antibody pasi rose uye wakasimbiswa kushanda kwekiriniki pakati pevarwere vakatapukirwa neSARS-COV-2 akasiyana muyedzo yakakosha yekushambadzira, "akadaro Prof. Linqi Zhang, Director weGlobal Health and Infectious Diseases Research Center uye Comprehensive AIDS. Research Center paChikoro cheMishonga Tsinghua University. "Musanganiswa weantibody wakapa mushonga wepasi rose kuChina kurwisa denda reCCIDID-19, iro rinoratidza zvizere ruzivo rwedu, sainzi-tekinoroji yekuchengetedza, uye kuzvidavirira uye kugona kwedu mukurwisa zvirwere zvinotapukira uye kuita basa rakakosha mukudzivirira. uye kutonga kwedenda muChina nepasirese. Isu tinofara kubatana ne3rd People's Hospital yeShenzhen neBrii Bio mukuwanikwa, tsvakiridzo yekiriniki, uye tsvakiridzo yekududzira yemubatanidzwa therapy uye takazowana ichi chiitiko chakakosha. Ticharamba tichiongorora kushandiswa kwemusanganiswa we amubarvimab/romlusevimab pakati pehuwandu hwevanhu vasina kudzivirirwa seimwe chiyero cheprophylaxis.
"Kubva pakatanga denda reCCIDID-19, nhungamiro yedu yanga iri nzira yakavakirwa pasainzi isu tichiramba tichirwisa denda. Chikwata chedu chekutsvagisa chakabudirira kutora masoja maviri akasimba ekudzivirira kubva kuvarwere veCCIDID-19, iyo yakaisa hwaro hwakasimba hwekugadzira amubarvimab/romlusevimab musanganiswa kurwisa COVID-19, "akadaro Lei Liu, Director weNational Clinical Research Center yeZvirwere Zvinotapukira mu. Shenzhen uye Secretary Secretary we3rd People's Hospital yeShenzhen. "Tinofara zvikuru kubatana naProf. Linqi Zhang vekuTsinghua University naBrii Bio kuti tipe hunyanzvi hwedu uye tinodada nekupa kurapa kweChina kwekutanga kweCCIDID-19 panguva iyo denda riri kuramba richiitika."
