Tushen sanarwar kasuwanci: Gudanar da Abinci da Magunguna na Jiha, Tengshengbo Pharmaceutical, Jami'ar Tsinghua
Jagora: Ilimin ilimin kai na farko na kasar Sin COVID-19 yana kawar da maganin hadewar rigakafi.
Da yammacin ranar 8 ga Disamba, 2021, gidan yanar gizon hukuma na Hukumar Kula da Magunguna ta Jiha ya ba da sanarwar cewa aikace-aikacen rigakafin cutar COVID-19 tare da BRII-196 da BRII-198 an yi rajista ta Hukumar Kula da Magunguna ta Jiha.Ita ce farkon ilimin ilimin kai na kasar Sin COVID-19 wanda ke kawar da maganin hadewar rigakafi.
Dangane da tanade-tanaden da suka dace na dokar sarrafa magunguna, Hukumar Kula da Abinci da Magunguna ta Jiha za ta gudanar da bita na gaggawa tare da amincewa bisa ga tsarin amincewa na musamman na magunguna, tare da amincewa da haɗin magungunan biyu na sama don kula da haske da manya. da matasa ('yan shekara 12 zuwa 17, suna yin nauyi fiye da 40kg) tare da Sabuwar kamuwa da cutar Coronavirus (COVID-19) waɗanda ke da haɗari sosai (ciki har da asibiti ko mutuwa).Daga cikin su, samari (shekaru 12-17, nauyi ≥ 40kg) tare da alamu suna ƙarƙashin yarda da sharadi.
BRII-196/BRII-198 hadin gwiwar farfesa ya jagoranci farfesa Zhang Linqi, darektan cibiyar bincike mai zurfi game da cutar kanjamau da cibiyar binciken lafiya da cututtuka na duniya na makarantar likitancin jami'ar Tsinghua da jami'ar Tsinghua.An inganta magungunan Tengsheng tare da haɗin gwiwar jami'ar Tsinghua da asibitin mutane na uku na Shenzhen.Maganin ya tabbatar da ingancin magungunan COVID-19 ta hanyar bazuwar, makafi biyu, binciken sarrafa wuribo.A halin yanzu, amincewar ita ce farkon haɓakar R & D a cikin Sin kuma ta tabbatar da takamaiman magungunan COVID-19 ta hanyar bazuwar, makafi biyu, binciken sarrafa wuribo.
Farfesa Zhang Linqi ya ce: "Yin amincewa da maganin hade-zumab / romistimub ya kawo sabon maganin kambi na farko ga kasar Sin.Wannan haɗin gwiwar jiyya ya nuna kyakkyawan aminci da kariya a cikin gwaji na cibiyar sadarwa na duniya.Shine kadari ne na rigakafin magani a cikin duniya wanda ya yi binciken tasirin jiyya kuma ya kamu da bambance-bambancen.Wannan maganin hadewar rigakafi shine mafi kyau a gare ni China ta ba da magani mai daraja ta duniya don COVID-19.Ya nuna cikakken tarin tarin tarin fasaha da tarin fasaha na jami'ar Tsinghua a fannin yaki da cututtuka masu yaduwa, da iyawa da iya kiranta zuwa, fada, yaki da yaki.Ya ba da gudummawa mai mahimmanci ga aikin rigakafi da shawo kan cutar a kasar Sin da ma duniya baki daya.Muna matukar farin ciki da kasancewa bisa tushen asibitin mutane na uku na Shenzhen da Tengsheng Bo.Haɗin kai mai inganci a cikin, asibiti da bincike na canji ya sanya wannan babban nasara.A mataki na gaba, za mu ci gaba da yin nazarin rawar rigakafin rigakafin ƙwayar cuta ta monoclonal a cikin manyan haɗari da ƙungiyoyin rashin ƙarfi na rigakafi.”
Wannan amincewa ya dogara ne akan gwajin gwaji na gwaji na 3 na activ-2 wanda Cibiyar Kula da Lafiya ta Kasa (NIH) ta goyi bayan, ciki har da tabbataccen wucin gadi da sakamakon ƙarshe na 847 da suka shiga marasa lafiya.Sakamakon karshe ya nuna cewa ambavizumab / romistuzumab hade far zai iya rage hadarin asibiti da kuma mutuwar babban hadarin sabon kambi outpatients ta hanyar 80% (sakamakon wucin gadi ya kasance 78%) idan aka kwatanta da placebo, wanda ya kasance mai mahimmanci.Dangane da ƙarshen ƙarshen kwanakin 28, babu mace-mace a cikin rukunin jiyya da mutuwar 9 a cikin rukunin placebo, kuma lafiyar lafiyar ta ya fi wannan a cikin rukunin placebo.A lokaci guda, ko an fara maganin a farkon matakin (a cikin kwanaki 5 bayan bayyanar cututtuka) ko kuma a ƙarshen mataki (a cikin kwanaki 6 zuwa 10 bayan bayyanar cututtuka) Daga cikin batutuwa, asibiti da mace-mace sun kasance mahimmanci. ragewa, wanda ya ba da taga magani mai tsawo ga marasa lafiya da sabon rawanin.
A cikin kasa da watanni 20, jami'ar Tsinghua, tare da hadin gwiwar asibitin mutane na Shenzhen na uku da na Tengshengbo, sun inganta aikin hada magunguna da sauri da sauri, daga aikin kawar da kwayar cutar ta hanyar kawar da kwayar cutar daga farkon matakin kawar da kwayar cutar, har zuwa kammala gwajin asibiti na kasa da kasa kashi 3, kuma a karshe an samu jerin sunayen kasar Sin. yarda.Wannan nasarar ita ce yunƙurin haɗin gwiwa na kasar Sin da ƙwararrun masana kimiyya na duniya da masu bincike na asibiti Sakamakon ya haɗa da goyon bayan Cibiyar Nazarin Lafiya ta Duniya ta ACTIV-2, Cibiyar Nazarin Allergy da cututtuka (NIAID) na Cibiyar Kiwon Lafiya ta Kasa (NIH) ), da kuma ACTIV-2 ƙungiyar gwaji na asibiti (ACTG), wanda ke jagorantar bincike na asibiti.
Liu Lei, darektan cibiyar bincike kan cututtuka masu yaduwa a Shenzhen kuma sakataren kwamitin jam'iyyar na asibitin mutane na uku na Shenzhen, ya ce: "Tun daga farkon barkewar cutar, mun tsara manufar rigakafin cutar ta fasaha.Teamungiyarmu ta yi nasarar fitar da wasu nau'ikan rigakafi guda biyu masu aiki sosai daga maganin sabbin majinyatan gyaran kambi, suna aza harsashi mai ƙarfi don haɓakar wannan maganin na COVID-19 na gaba.Mun yi farin cikin yin aiki tare da Farfesa Zhang Linqi da kamfanin harhada magunguna na Tengsheng na jami'ar Tsinghua don yin sabon kambi na farko na kasar Sin.Magungunan ƙwayoyin cuta suna ba da gudummawar hikima da gogewa.Muna fatan cewa tare da ƙoƙarin haɗin gwiwa na ɗimbin ma'aikatan bincike da ma'aikatan kiwon lafiya, za mu iya kayar da COVID-19 da wuri-wuri.
Luo Yongqing, shugaban kuma babban manajan babban jami'in kasar Sin, ya ce: "Mun yi matukar farin ciki da cimma wannan muhimmin mataki, kuma muna aiki tukuru don sa kaimi ga samun damar yin amfani da wannan maganin hadin gwiwa ga sabbin majinyatan kambi na kasar Sin.Wannan nasarar ta tabbatar da cewa mun dage sosai don haɓaka sabbin abubuwa a duniya a fagen cututtukan da ke yaduwa da kuma cike buƙatun likita waɗanda ba a biya su ba tare da ingantaccen, kimiyya, tabbataccen sakamako.A matsayina na kamfani na kasa da kasa da ke aiki a kasar Sin da Amurka Biotech Corp, ina alfahari da nasarar da Tengsheng Bo ya samu, kuma ba za mu yi kasa a gwiwa ba wajen taimakawa kasar Sin wajen tinkarar hadadden bukatu na COVID-19 a kimiyyance, da biyan bukatun asibiti na sabbin zakarunmu. .
Game da tazumab / romistuzumab
(a da brii-196 / brii-198)
Maganin rigakafi na monoclonal zuwa maganin rigakafi na monoclonal da ɗakin dakuna monoclonal antibody wani sabon nau'in sabon nau'in cutar sankara ne mai tsanani na numfashi 2 (SARS-CoV-2) wanda aka samu daga Asibitin mutane na uku na Shenzhen da Jami'ar Tsinghua a cikin lokacin gyara sabon Coronavirus. ciwon huhu (COVID-19).Monoclonal neutralizing ƙwayoyin cuta, musamman fasahar bioengineering, ana amfani da su don rage haɗarin haɓakar abin da ya dace na rigakafi da kuma tsawaita rabin rayuwar plasma don samun ƙarin tasirin warkewa na dindindin.
A cikin Oktoba 2021, Tengshengbo Pharmaceutical ya kammala aikace-aikacen izinin amfani da gaggawa (EUA) na aikin hadezumab / romistuzumab ga Hukumar Abinci da Magunguna ta Amurka (FDA).
Bugu da kari, Tengshengbo tana ci gaba da inganta aikace-aikacen yin rajistar bayyanarzumab / romisizumab hade far a cikin sauran manyan kasuwanni masu tasowa a duniya, da farko tabbatar da samun kasuwa a cikin kasashen da suka gudanar da gwaje-gwaje na asibiti da kuma kasashen da ke da babban gibi wajen samun ingantaccen magani. .Har ila yau, Tengshengbo za ta ci gaba da gudanar da bincike a kasar Sin don kimanta tasirin cutarzumab/Prophylactic da na rigakafi da ke tattare da hadewar jiyya tare da romisvir mAb a cikin yawan mutanen da ba su da maganin rigakafi.
Don "delta" na kasar Sin COVID-19, Tengsheng Bo, wanda ya haifar da nau'in mutant, ya ba da gudummawar kusan mutane kusan 3000 na kusan mutane miliyan biyu daga lardin Guangdong na lardin Yunnan na lardin Jiangsu na lardin Hunan na lardin Henan da Fujian. Lardi, Ningxia mai cin gashin kansa, lardin Gansu, yankin Mongoliya ta ciki, lardin Heilongjiang, lardin Qinghai, lardin kasar Sin da lardin a cikin watan Yuni na shekarar 2021, an yi wa marasa lafiya kusan 900 magani, wanda shi ne mafi yawan marasa lafiya da ke dauke da kwayar cutar garkuwar jiki guda daya. kasa.Yawancin kwararrun likitocin kiwon lafiya sun sami gogewa da kwarin gwiwa wajen yin amfani da wannan hanyar haɗin gwiwa kuma sun ba da gudummawa sosai don yaƙar cutar.
Game da activ-2 gwaji mataki 3
Amincewa da tallan tallazumab / romistuzumab hade far da Hukumar Kula da Magunguna ta kasar Sin (nmpa) ta dogara ne kan gwajin activ-2 (nct04518410) wanda Cibiyar Kula da Lafiya ta Kasa (NIH) ta goyan bayan sakamakon wucin gadi da na karshe na lokaci na 3. Sakamakon karshe ya nuna cewa. idan aka kwatanta da placebo, wannan haɗin maganin ya rage haɗakar ƙarshen ƙarshen asibiti da mutuwar marasa lafiya na covid-19 a babban haɗarin ci gaban asibiti da 80%, wanda ke da mahimmanci a kididdiga.Tun daga ranar ƙarshen ƙarshen asibiti na kwanaki 28, babu mace-mace a cikin rukunin jiyya da mutuwar 9 a cikin rukunin placebo.Ba a sami sabon haɗarin aminci ba.
Sakamako na wucin gadi da aka buga a ranar 4 ga Oktoba, 2021 ya nuna cewa bayyanarzumab / romisizumab hade far ya rage hadadden ƙarshen asibiti da mutuwar masu cutar covid-19 a cikin haɗarin ci gaba na asibiti da kashi 78% idan aka kwatanta da placebo, wanda ke da mahimmancin ƙididdiga (ba a daidaita shi ba, gwajin gefe ɗaya p darajar <0.00001) 2% (4 / 196) na batutuwan da suka karɓi aikin hadezumab / romisizumab a cikin kwanaki 5 bayan bayyanar alamar ta ci gaba zuwa asibiti ko mutuwa, idan aka kwatanta da 11% (21 / 197) a cikin placebo rukuni.Hakazalika, 2% (5/222) na batutuwan da suka sami maganin hadewar bayyanarzumab / romisizumab 6 zuwa kwanaki 10 bayan bayyanar alamun bayyanar Yawan ci gaba zuwa asibiti ko mutuwa shine 11% (24/222) a cikin rukunin placebo.Binciken ya kuma nuna cewa babu mace-mace a cikin rukunin masu magani a cikin kwanaki 28, yayin da akwai mutuwar 8 a cikin rukunin placebo.A cikin ƙungiyar taurarozumab / romistumab haɗin gwiwa, abubuwan da suka faru (AE) na aji 3 ko sama sun kasance ƙasa da waɗanda ke cikin rukunin placebo, waɗanda suka kasance 3.8% (16/418) da 13.4% (56/419), bi da bi, babu An lura da halayen haɗari masu haɗari (SAE) ko halayen jiko.
An gudanar da binciken a wasu cibiyoyin gwaji na asibiti a duniya, ciki har da Amurka, Brazil, Afirka ta Kudu, Mexico, Argentina da Philippines.Binciken ya haɗa da marasa lafiya da suka yi rajista a cikin saurin fitowar duniya na sars-cov-2 bambance-bambancen daga Janairu zuwa Yuli 2021. A matsayin wani ɓangare na wannan binciken, bayanan ingancin asibiti na ambavizumab / romisizumab hade far kuma za a dogara ne akan nau'in bambance-bambancen hoto. Kimantawa.Bayanan gwajin ƙwayoyin cuta na in vitro chimeric na yanzu sun nuna cewa haɗin maganin bayyanarzumab / romistumab yana kula da ayyukan neutralizing da manyan bambance-bambancen sars-cov-2 na babban damuwa, gami da 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) da b.1.621 ("Miao", mu).Gwaji don bambance-bambancen b.1.1.529 (Omicron) yana kan ci gaba a halin yanzu.
Lokacin aikawa: Dec-10-2021