“ʻOliʻoli mākou e hoʻokō i kēia mea nui. He hōʻike kēia hoʻokō i kā mākou kūpaʻa kūpaʻa i ka hoʻolalelale ʻana i nā mea hou i nā maʻi infectious, a me ko mākou hiki ke hoʻokō i nā pono kūpono ʻole o ka honua me ka wikiwiki, ka ʻepekema ʻepekema a me nā hopena kupaianaha, "wahi a Rogers Luo, Pelekikena a Luna Nui, Greater China o Brii Bio. "Ma ke ʻano he hui biotech multi-national hoʻomaka i hui pū ʻia ma Kina a me US, ke hana nei mākou e holomua i ke komo ʻana i kēia lapaʻau no kahi ākea o nā maʻi maʻi COVID-19 ma Kina, ʻoiai ke hoʻonui nei i kāna hoʻoikaika ʻana e kūlike i ka pono ʻO nā koho lapaʻau COVID-19 e hakakā i ka maʻi maʻi. "
Hoʻokumu ʻia ka ʻae ʻana o NMPA i nā hopena hopena maikaʻi a me nā hopena manawa mai ka NIH-sponsored ACTIV-2 Phase 3 hoʻokolohua lapaʻau me 847 i hoʻopaʻa ʻia ma waho. Ua hōʻike ʻia nā hopena hope loa he 80% (78% i nā hopena interim) ka hōʻemi ʻana o ka hale maʻi a me ka make me ka liʻiliʻi o nā make ma o 28 mau lā ma ka lima lapaʻau (0) pili i ka placebo (9), a me ka hoʻomaikaʻi ʻana i ka hopena palekana ma luna o kahi placebo ma ka non- nā maʻi maʻi COVID-19 i ka hale maʻi i ka nui o ka piʻi ʻana o ka maʻi maʻi i ka maʻi koʻikoʻi. Ua ʻike ʻia ka nui o ka hopena like i nā poʻe e hoʻomaka ana i ka lāʻau lapaʻau ma mua (0-5 mau lā) a me ka hope (6-10 mau lā), ma hope o ka hoʻomaka ʻana o ka hōʻailona, e hāʻawi ana i nā hōʻike hōʻike koʻikoʻi i nā maʻi maʻi COVID-19 i lohi no ka mālama ʻana.
Ma lalo o 20 mau mahina, ua holomua ʻo Brii Bio i ka hui ʻana o ka amubarvimab/romlusevimab mai ka ʻike ʻana a hiki i ka hoʻopau ʻana i ka hoʻomohala ʻana o ka Phase 3 e alakaʻi ana i kēia ʻae wikiwiki e ka NMPA. Hōʻike kēia ʻae i ka hui kūleʻa maikaʻi loa me nā ʻepekema maikaʻi loa a me nā noiʻi lapaʻau maikaʻi loa ma Kina a a puni ka honua ma kahi misionari kaʻana like, me ka 3rd People's Hospital of Shenzhen and Tsinghua University, nāna i ʻike i kēia mau alakaʻi antibody neutralizing; ka US National Institute of Health (NIH), ka AIDS Clinical Trial Group (ACTG), nāna i kākoʻo a alakaʻi i ka hoʻokolokolo ACTIV-2.
"Ma ke ʻano he mālama mua COVID-19 ma Kina, ʻo ka hui amubarvimab / romlusevimab e hōʻike ana i nā hopena lapaʻau maikaʻi a me ka palekana maikaʻi i ka honua, nā hoʻokolohua multicenter. ʻO ia wale nō ka hui pū ʻana o ka monoclonal antibody ma ka honua holoʻokoʻa me ka hōʻoia ʻana i ka pono lapaʻau i waena o nā mea maʻi i loaʻa i nā ʻano like ʻole o ka SARS-COV-2 i ka hoʻāʻo pre-marketing pivotal, "wahi a Prof. Linqi Zhang, Luna Hoʻokele o ka Global Health and Infectious Diseases Research Center a Comprehensive AIDS. Ke Keena Noiʻi ma ke Kula Lapaʻau ʻo Tsinghua University. "ʻO ka hui pū ʻana o ka antibody i hāʻawi i ka mālama ʻana i ka honua no Kina e hakakā i ka maʻi maʻi COVID-19, e hōʻike piha ana i kā mākou ʻike waiwai, nā mālama ʻepekema-ʻenehana, a me kā mākou kuleana a me kā mākou hiki i ke kaua ʻana i nā maʻi maʻi a me ka hana nui i ka pale ʻana. a me ka hoomalu ana i ke ahulau ma Kina a me ka honua. Hauʻoli mākou i ka hui pū ʻana me ka 3rd People's Hospital of Shenzhen a me Brii Bio i ka ʻike ʻana, ka noiʻi lapaʻau, a me ka noiʻi unuhi ʻana o ka hui ʻana a me ka hopena i loaʻa i kēia milestone koʻikoʻi. E hoʻomau mākou i ka loiloi i ka hoʻohana ʻana i ka hui ʻana o ka amubarvimab / romlusevimab ma waena o ka heluna immunocompromised ma ke ʻano he ana hou o ka prophylaxis.
"Mai ka hoʻomaka ʻana o ka maʻi maʻi COVID-19, ʻo kā mākou alakaʻi alakaʻi he ala ʻepekema ʻoiai mākou e hoʻomau nei i ka hakakā ʻana i ka maʻi maʻi. Ua loaʻa i kā mākou hui noiʻi ʻelua mau antibodies neutralizing ikaika loa mai nā mea maʻi convalesced COVID-19, nāna i hoʻokumu i ke kumu paʻa no ka hoʻomohala ʻana i ka hui amubarvimab/romlusevimab e kūʻē iā COVID-19, "wahi a Lei Liu, Luna Hoʻokele o ka National Clinical Research Center for Infectious Diseases in. Shenzhen a me Kakauolelo Party o ka Halemai Kanaka 3 o Shenzhen. "ʻOliʻoli loa mākou i ka hui pū ʻana me Prof. Linqi Zhang mai ke Kulanui ʻo Tsinghua a me Brii Bio e hāʻawi i kā mākou ʻike a haʻaheo mākou i ka hāʻawi ʻana i ka mālama mua COVID-19 ma Kina i ka manawa e hoʻomau ai ka maʻi maʻi."
He aha e lawe ʻia mai kēia ʻatikala:
- “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.
