“Re thabetse ho fihlela sehlohlolo sena sa bohlokoa. Katleho ena ke bopaki ba boitlamo ba rona bo tiileng ba ho potlakisa boqapi ba mafu a tšoaetsanoang, le bokhoni ba rona ba ho phethahatsa litlhoko tse sa fihlelleheng tsa lefats'e ka lebelo, matla a mahlale le liphetho tse khahlang, "ho boletse Rogers Luo, Mopresidente le Motsamaisi Kakaretso, Greater China ea Brii Bio. "Joaloka k'hamphani e qalang ea linaha tse ngata ea biotech e kopaneng China le US, re ntse re sebeletsa ho ntšetsa pele phihlello ea kalafo ena bakeng sa bakuli ba bangata ba COVID-19 naheng ea China, ha re ntse re eketsa boikitlaetso ba eona ho tsamaisana le tlhoko ea kalafo. Mekhoa ea kalafo ea COVID-19 ho loants'a seoa sena. ”
Tumello ea NMPA e ipapisitse le liphetho tse ntle tsa ho qetela le tsa nakoana ho tsoa tekong ea bongaka ea ACTIV-2 Phase 3 e tšehelitsoeng ke NIH le bakuli ba kantle ba ngolisitsoeng ba 847. Liphetho tsa ho qetela li bonts'itse palo e kholo ea 80% (78% liphethong tsa nakoana) phokotso ea ho kena sepetlele le lefu le batho ba fokolang ba shoang ka matsatsi a 28 letsohong la kalafo (0) mabapi le placebo (9), le sephetho se ntlafetseng sa polokeho ho feta placebo ho bao e seng bakuli ba sepetlele ba COVID-19 ba kotsing e kholo ea ho hatela pele ho lefu le matla. Litefiso tse ts'oanang tsa ts'ebetso li ile tsa bonoa ho barupeluoa ba qalang kalafo pele (matsatsi a 0-5) le morao (matsatsi a 6-10), kamora ho qaleha ha matšoao, ho fana ka bopaki bo hlokahalang ba kliniki ho bakuli ba COVID-19 ba neng ba liehile ho fumana kalafo.
Ka nako e ka tlase ho likhoeli tse 20, Brii Bio o ile a hatela pele ka motsoako oa amubarvimab/romlusevimab ho tloha ho sibolloa ho fihlela pheletsong ea nts'etsopele ea Mokhahlelo oa 3 e lebisang tumellong ena e potlakileng ea NMPA. Tumello ena e emetse tshebedisano e atlehileng haholo le boramahlale ba hlwahlwa ka ho fetisisa le bafuputsi ba tsa bongaka naheng ya China le lefatsheng ka bophara ka thomo e arolelaneng, ho kenyeletswa Sepetlele sa Boraro sa Batho sa Shenzhen le Yunibesithi ya Tsinghua, ba sibollotseng letoto lena la dilwantsha-mafu tse sa tsitsang; US National Institute of Health (NIH), AIDS Clinical Trial Group (ACTG), e ileng ea tšehetsa le ho etella pele teko ea ACTIV-3.
"Joaloka kalafo ea pele ea COVID-19 Chaena, motsoako oa amubarvimab/romlusevimab o bonts'a litholoana tse ntle tsa kliniki le polokeho e ntle litekong tsa lefats'e tse fapaneng. Ke eona feela motsoako oa antibody o le mong lefatšeng ka bophara o nang le ts'ebetso e netefalitsoeng ea bongaka har'a bakuli ba tšoaelitsoeng ke mefuta e fapaneng ea SARS-COV-2 tekong ea bohlokoa ea pele ho papatso, "ho boletse Prof. Linqi Zhang, Motsamaisi oa Setsi sa Lefatše sa Lipatlisiso tsa Bophelo bo Botle le Mafu a Tšoaetso le AIDS e Felletseng. Setsi sa Lipatlisiso Sekolong sa Bongaka sa Univesithi ea Tsinghua. "Motsoako oa antibody o fane ka kalafo ea maemo a lefats'e bakeng sa China ho loants'a seoa sa COVID-19, se bonts'ang ka botlalo boiphihlelo ba rona ba mahlale, matlotlo a mahlale le mahlale a theknoloji, le boikarabello ba rona le bokhoni ba rona ba ho loants'a mafu a tšoaetsanoang le ho kenya letsoho ha bohlokoa ho thibeleng. le taolo ea seoa sena Chaena le lefats'e. Re thabetse ho sebelisana 'moho le Sepetlele sa Boraro sa Batho sa Shenzhen le Brii Bio tšibollong, liphuputsong tsa bongaka, le liphuputsong tsa phetolelo ea kalafo e kopantseng 'me qetellong re fihlelle ketsahalo ena ea bohlokoahali. Re tla tsoelapele ho lekola ts'ebeliso ea motsoako oa amubarvimab/romlusevimab har'a baahi ba nang le immunocompromised e le mokhoa o mong oa prophylaxis.
"Ho tloha qalong ea seoa sa COVID-19, molao-motheo o re tataisang esale e le mokhoa o ipapisitseng le mahlale ha re ntse re tsoela pele ho loants'a seoa sena. Sehlopha sa rona sa lipatlisiso se atlehile ho fumana li-antibodies tse peli tse sebetsang tse sa sebetseng hantle ho tsoa ho bakuli ba hlaphohetsoeng ba COVID-19, e ileng ea rala motheo o tiileng oa ho theha motsoako oa amubarvimab/romlusevimab khahlano le COVID-19, "ho boletse Lei Liu, Motsamaisi oa Setsi sa Naha sa Patlisiso ea Tleliniki ea Mafu a tšoaetsanoang. Shenzhen le Mongoli oa Mokha oa Sepetlele sa 3 sa Batho sa Shenzhen. "Re thabetse ho sebetsa 'moho le Moprofesa Linqi Zhang oa Univesithi ea Tsinghua le Brii Bio ho kenya letsoho ka boitsebelo ba rona mme re motlotlo ho kenya letsoho kalafong ea pele ea China ea COVID-19 nakong eo seoa sena se ntseng se tsoela pele ho tsoela pele."
SEO U LOKELANG HO SE NKA HO SEHLOOHO ENA:
- “The antibody combination provided world-class treatment for China to fight against the COVID-19 epidemic, which fully demonstrates our rich experience, scientific-technological reserves, and our accountability and ability in fighting against infectious diseases and making an important contribution in the prevention and control of the epidemic in China and the world.
- The final results demonstrated a statistically significant 80% (78% in interim results) reduction of hospitalization and death with fewer deaths through 28 days in the treatment arm (0) relative to placebo (9), and improved safety outcome over placebo in non-hospitalized COVID-19 patients at high risk of clinical progression to severe disease.
- This approval represents the highly successful partnership with the best scientists and clinical investigators in China and around the globe on a shared mission, including the 3rd People’s Hospital of Shenzhen and Tsinghua University, who discovered these neutralizing antibody leads.
