Ke kumu o ka hoʻolaha ʻoihana: State Food and drug administration, tengshengbo pharmaceutical, Tsinghua University
Alakaʻi: ʻO ka waiwai naʻauao mua o Kina i hoʻonaʻauao mua ʻia COVID-19 neutralizing antibody combination therapy.
I ke ahiahi o Dekemaba 8, 2021, ua hoʻolaha ka pūnaewele mana o ka State Administration of drug administration i ka noi ʻana o COVID-19 neutralization antibody i hui pū ʻia me BRII-196 a me BRII-198 i hoʻopaʻa inoa ʻia e ka State Administration of drug administration.ʻO ia ka waiwai naʻauao mua o Kina i hoʻonaʻauao mua ʻia ʻo COVID-19 neutralizing antibody combination therapy.
E like me nā ʻōlelo kūpono o ke kānāwai hoʻokele lāʻau lapaʻau, e hoʻokō ka State Food a me ka hoʻokele lāʻau lapaʻau i ka loiloi pilikia a me ka ʻae ʻia e like me nā kaʻina hana apono kūikawā o nā lāʻau lapaʻau, a ʻae i ka hui ʻana o nā lāʻau lapaʻau ʻelua i luna no ka mālama ʻana i ka māmā a me nā pākeke maʻamau. a me nā ʻōpio (12 a 17 mau makahiki, ʻoi aku ke kaumaha ma mua o 40kg) me ka maʻi maʻi Coronavirus Hou (COVID-19) he mau mea pilikia loa (me ka hoʻokipa a i ʻole ka make).I waena o lākou, ʻo nā ʻōpio (12-17 mau makahiki, ke kaumaha ≥ 40kg) me nā hōʻailona e pili ana i ka ʻae ʻia.
ʻO ka BRII-196/BRII-198 hui pū ʻia ka lāʻau lapaʻau i alakaʻi ʻia e Polofesa Zhang Linqi, ka luna o ke kikowaena no ka noiʻi piha ʻana o ka AIDS a me ke olakino olakino a me ka maʻi maʻi maʻi maʻi maʻi maʻi o Tsinghua University School of Medicine a me Tsinghua University.Ua hoʻolaha ʻia ka lāʻau lapaʻau ʻo Tengsheng ma ka hui pū ʻana me ke Kulanui ʻo Tsinghua a me ke kolu o ka Halemai o ka poʻe o Shenzhen.Ua hōʻoia ka mālama ʻana i nā lāʻau lapaʻau anti COVID-19 ma o kahi noiʻi hoʻopaʻa ʻia, pālua-makapō, placebo-controlled study.Eia nō naʻe, ua hōʻailona ka ʻae i ka R&D mua i kūkulu ʻia ma Kina a ua hōʻoia i ka maikaʻi o nā lāʻau lapaʻau anti COVID-19 ma o kahi noiʻi paʻa paʻa, pālua-makapō, placebo-controlled study.
Ua ʻōlelo ʻo Polofesa Zhang Linqi: "ʻO ka ʻae ʻana o ka ambacizumab / romistambub hui ʻana i ka lāʻau lapaʻau mua i lawe mai i ka lāʻau lapaʻau mua i Kina.Ua hōʻike kēia hui ʻana i ka palekana a me ka palekana i ka hoʻokolokolo multicenter honua.ʻO ia wale nō ka lāʻau antibody ma ka honua i hoʻokō i ka loiloi o ka hopena o ka mālama ʻana i nā poʻe i loaʻa i nā ʻano ʻano like ʻole a loaʻa ka ʻikepili maikaʻi loa.ʻO kēia antibody combin therapy ka mea maikaʻi loa iaʻu ua hāʻawi ʻo Kina i kahi mālama papa honua no COVID-19.Ua hōʻike piha i ka hōʻiliʻili hohonu a me ka mālama ʻenehana o ke Kulanui ʻo Tsinghua ma ke kahua o ka hakakā ʻana i nā maʻi infectious, a me ka hiki a me ka hiki ke kāhea iā ia e hele mai, e kaua, e kaua a kaua.Ua hāʻawi nui ʻia i ka hana pale a me ka mālama ʻana i ka maʻi maʻi ma Kina a me ka honua.Hoʻohanohano nui ʻia mākou ma ke kumu o ke kolu o ka Halemai o Shenzhen a me Tengsheng Bo lāʻau.ʻO ka launa pū ʻana o ke kūlana kiʻekiʻe i loko o ka noiʻi lapaʻau a me ka hoʻololi ʻana i hoʻokō i kēia pae ʻāina.I ka pae aʻe, e hoʻomau mākou i ke aʻo ʻana i ka hana pale o ka monoclonal antibody combined therapy i nā pūʻulu kiʻekiʻe a me ka pale ʻole.”
Ua hoʻokumu ʻia kēia ʻae ʻia ma ka hoʻāʻo hoʻokolohua ʻo 3 o ka activ-2 i kākoʻo ʻia e ka National Institutes of Health (NIH), me nā hopena maikaʻi a me nā hopena hope loa o nā maʻi maʻi 847.Ua hōʻike nā hopena hope loa e hiki i ka ambavizumab / romistuzumab hui hui ke hōʻemi i ka pilikia o ka hale maʻi a me ka make ʻana o nā poʻe maʻi maʻi lei aliʻi kiʻekiʻe e 80% (ʻo 78% nā hopena interim i hoʻohālikelike ʻia me kahi placebo, he mea nui ka helu.E like me ka helu hope o ke kino o 28 mau lā, ʻaʻohe make ma ka hui lapaʻau a me 9 mau make ma ka hui placebo, a ʻoi aku ka maikaʻi o kona palekana ma mua o ka hui placebo.I ka manawa like, inā ua hoʻomaka ʻia ka mālama ʻana i ka wā mua (i loko o 5 mau lā ma hope o ka hoʻomaka ʻana o nā hōʻailona) a i ʻole ma ka hopena hope (i loko o 6 a 10 mau lā ma hope o ka hoʻomaka ʻana o nā hōʻailona) ʻO nā kumuhana, ʻo ka hale hoʻokipa a me ka make i ka nui. hōʻemi ʻia, ka mea i hāʻawi i kahi puka lāʻau lapaʻau lōʻihi no nā maʻi me nā lei aliʻi hou.
Ma lalo o 20 mau mahina, ʻo Tsinghua University, i ka hui pū ʻana me Shenzhen Third People's Hospital a me tengshengbo pharmaceutical, hoʻolaha wikiwiki ʻia ʻo ambacizumab / romisvir hui pū ʻana mai ka hoʻokaʻawale ʻana o ka antibody a me ka screening a hiki i ka hoʻopau ʻana o ka pae honua 3 hoʻokolohua lapaʻau, a loaʻa iā Kina ka papa inoa. ʻae ʻia.ʻO kēia hoʻokō ʻo ka hoʻoikaika pū ʻana o Kina a me nā ʻepekema papa honua a me nā mea noiʻi lapaʻau. ), a me ka hui ho'āʻo kino ACTIV-2 (ACTG), nāna e alakaʻi i ka noiʻi lāʻau lapaʻau.
Ua ʻōlelo ʻo Liu Lei, ka luna o ke kikowaena noiʻi lapaʻau no nā maʻi infectious ma Shenzhen a me ke Kakauolelo o ke komite Party o ke kolu o ka Halemai o Shenzhen: "Mai ka hoʻomaka ʻana o ka maʻi maʻi, ua hoʻonohonoho mākou i ka pahuhopu o ka pale ʻana i ka maʻi maʻi.Ua hoʻopuka maikaʻi kā mākou hui i ʻelua o nā antibodies neutralizing ikaika loa mai ka serum o nā mea maʻi hoʻoponopono lei aliʻi hou, e kau ana i kahi kumu paʻa no ka hoʻomohala ʻana o kēia lāʻau anti COVID-19.Ua hauʻoli nui mākou i ka hana pū ʻana me Professor Zhang Linqi a me Tengsheng pharmaceutical company o ke Kulanui ʻo Tsinghua e hana i ka lei aliʻi anti hou mua loa ma Kina.Hāʻawi nā lāʻau viral i ka naʻauao a me ka ʻike.Manaʻo mākou me ka hui pū ʻana o ka nui o nā limahana noiʻi a me nā limahana lapaʻau, hiki iā mākou ke lanakila iā COVID-19 i ka hiki.
Ua ʻōlelo ʻo Luo Yongqing, ka Pelekikena a me ka luna nui o Greater China: "Ua hauʻoli mākou i ka hoʻokō ʻana i kēia mea koʻikoʻi koʻikoʻi a ke hana ikaika nei mākou e hoʻoikaika i ka hiki ʻana o kēia lāʻau hoʻohui no nā poʻe maʻi lei hou Kina.Hōʻike kēia hoʻokō i ko mākou kūpaʻa paʻa i ka hoʻolalelale ʻana i ka hana hou honua ma ke kahua o nā maʻi infectious a me ka hoʻopiha ʻana i nā pono lapaʻau kūpono ʻole me nā hopena maikaʻi, ʻepekema, koʻikoʻi a maikaʻi loa.Ma ke ʻano he hui multinational e hana ana ma Kina a me ʻAmelika Hui Pū ʻIa Biotech Corp, haʻaheo wau i ka hoʻokō ʻana o ka lāʻau lapaʻau ʻo Tengsheng Bo, a ʻaʻole mākou e hoʻāʻo e kōkua iā Kina e hoʻokō i ka paʻakikī COVID-19 pono i ka ʻepekema, a hoʻokō i nā pono lapaʻau o kā mākou mau poʻokela hou. .
E pili ana i ambacizumab / romistuzumab
(brii-196 / brii-198 ma mua)
ʻO ka antibody monoclonal i ka monoclonal antibody a me ka lumi lumi monoclonal antibody he ʻano hoʻokūkū hou ʻole ʻo ia ka maʻi maʻi maʻi hanu acute respiratory syndrome 2 (SARS-CoV-2) i loaʻa mai ke kolu o ka Halemai o Shenzhen a me Tsinghua University i ka manawa hoʻoponopono o New Coronavirus. pneumonia (COVID-19).Hoʻohana ʻia nā antibodies monoclonal neutralizing, ʻoi aku ka ʻenehana bioengineering, e hōʻemi i ka hopena o ka antibody mediated dependent enhancement a hoʻolōʻihi i ka hapalua o ke ola o ka plasma no ka loaʻa ʻana o nā hopena therapeutic mau loa.
I ʻOkakopa 2021, ua hoʻopau ka lāʻau lapaʻau tengshengbo i ka noi no ka ʻae ʻana i ka hoʻohana pilikia (EUA) o ambacizumab / romistuzumab hui pū ʻana i ka US Food and Drug Administration (FDA).
Eia kekahi, ke hoʻoikaika ikaika nei ʻo Tengshengbo i ka noi no ka hoʻopaʻa inoa ʻana o ambacizumab / romisizumab hui pū ʻana i nā mākeke ʻē aʻe a e kū mai ana a puni ka honua, e hōʻoia mua ana i ke komo ʻana o ka mākeke i nā ʻāina i hana i nā hoʻokolohua lapaʻau a me nā ʻāina i loaʻa kahi ākea nui i ke komo ʻana i ka mālama pono. .E hana hou ʻo Tengshengbo i ka noiʻi hou ʻana ma Kina e loiloi i ka ambacizumab/Prophylactic a me ka immunopotentiating hopena o ka hui pū ʻana me ka romisvir mAb i ka heluna immunosuppressed.
No ka "delta" ma Kina COVID-19, ʻo Tengsheng Bo, ka mea i hoʻokumu ʻia e ka mutant strain, hāʻawi i kahi kokoke i 3000 ka nui o ka poʻe ma kahi o ʻelua miliona mau kānaka mai Guangdong Province, Yunnan Province, Jiangsu Province, Hunan Province, Henan Province, Fujian ʻO ka mokuʻāina, Ningxia autonomous māhele, Gansu Province, ka Inner Mongolia Autonomous Region, Heilongjiang Province, Qinghai Province, Kina a me ka panalāʻau i Iune 2021. , kokoke i 900 mau mea maʻi i mālama ʻia, ʻo ia ka helu nui o nā mea maʻi me ka neutralizing antibodies i hoʻokahi. ʻāina.Ua loaʻa i kahi heluna nui o nā limahana mālama olakino ka ʻike a me ka hilinaʻi i ka hoʻohana ʻana i kēia ʻano lāʻau hoʻohui a hāʻawi i nā kōkua nui i ka hakakā ʻana i ka maʻi maʻi.
E pili ana i ka hana hoʻāʻo activ-2 3
Hoʻokumu ʻia ka ʻae kūʻai aku o ambacizumab / romistuzumab hui pū ʻana e China Drug Administration (nmpa) i ka hoʻāʻo activ-2 (nct04518410) i kākoʻo ʻia e ka National Institutes of Health (NIH) Interim a me nā hopena hope o ka pae 3. Ua hōʻike nā hopena hope loa. i hoʻohālikelike ʻia me ka placebo, ua hoʻemi kēia hui ʻana i ka helu hope o ka hale maʻi a me ka make ʻana o nā maʻi maʻi covid-19 i ka nui o ka piʻi ʻana o ka maʻi e 80%, he mea nui loa ia.Ma kahi o 28 mau lā maʻi maʻi, ʻaʻohe make ma ka hui lapaʻau a me 9 mau make ma ka hui placebo.ʻAʻole i ʻike ʻia nā pōʻino palekana hou.
Ua hōʻike ʻia nā hopena interim i paʻi ʻia ma ʻOkakopa 4, 2021 ʻo ka ambacizumab / romisizumab hui pū ʻana i hōʻemi i ka helu hope o ka hale hoʻokipa a me ka make ʻana o nā maʻi maʻi covid-19 i ka nui o ka piʻi ʻana o ka maʻi e 78% i hoʻohālikelike ʻia me ka placebo, he mea nui loa (ʻaʻole i hoʻoponopono ʻia, ho'āʻo hoʻokahi ʻaoʻao p waiwai <0.00001) 2% (4 / 196) o nā mea i loaʻa i ka ambacizumab / romisizumab hui hui ʻana i loko o 5 mau lā ma hope o ka hoʻomaka ʻana o ka hōʻailona i ka hale hoʻokipa a i ʻole ka make, ke hoʻohālikelike ʻia me 11% (21/197) i ka placebo hui.Pēlā nō, 2% (5 / 222) o nā mea i loaʻa i ka ambacizumab / romisizumab hui hui 6 a 10 mau lā ma hope o ka hoʻomaka ʻana o ka hōʻailona ʻO ka piʻi ʻana o ka piʻi ʻana i ka hale maʻi a i ʻole ka make he 11% (24/222) i ka hui placebo.Ua hōʻike pū ʻia ka hōʻike ʻana ʻaʻohe make ma ka hui lapaʻau i loko o 28 mau lā, ʻoiai he 8 mau make ma ka hui placebo.I loko o ka hui ambacizumab / romistumab hui pū ʻana, ʻoi aku ka liʻiliʻi o nā hanana ʻino (AE) o ka papa 3 a i luna aʻe ma mua o nā mea i loko o ka hui placebo, ʻo ia ka 3.8% (16/418) a me 13.4% (56/419), ʻaʻole. Ua ʻike ʻia nā hopena koʻikoʻi e pili ana i ka lāʻau (SAE) a i ʻole nā hopena infusion.
Ua hana ʻia ke aʻo ʻana ma kekahi mau kikowaena hoʻokolohua lapaʻau a puni ka honua, ʻo ia hoʻi ʻo ʻAmelika Hui Pū ʻIa, Brazil, ʻApelika Hema, Mexico, Argentina a me Philippines.Hoʻokomo ʻia ka haʻawina i nā maʻi i kākau inoa ʻia i ka manawa ulu wikiwiki o ka sars-cov-2 ʻano like ʻole mai Ianuali a Iulai 2021. Ma ke ʻano o kēia noiʻi ʻana, e hoʻokumu ʻia ka ʻikepili efficacy o ambavizumab / romisizumab hui pū ʻana i ke ʻano o nā ʻano like ʻole. Loiloi.Hōʻike ka ʻikepili hoʻāʻo in vitro chimeric virus i kēia manawa e mālama ka hui ʻana o ambacizumab / romistumab i ka hana neutralizing e kūʻē i nā ʻano nui sars-cov-2 o ka hopohopo nui, me ka 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) a me b.1.621 (“Miao”, mu).Ke holomua nei ka ho'āʻo ʻana no ka ʻano like ʻole b.1.1.529 (Omicron).
Ka manawa hoʻouna: Dec-10-2021