Daim ntawv thov IND rau Oral Anticoagulant 505(b)(2) Ntawm Guangzhou Bostao tau pom zoo los ntawm FDA

Feb 01, 2023Tso lus

Thaum Lub Ib Hlis 27, 2023, Canton Pertowers 'tus kheej tsim IND daim ntawv thov rau qhov ncauj anticoagulant 505(b)(2) tshuaj tau pom zoo los ntawm United States Food and Drug Administration (FDA) rau kev sim tshuaj.

Hais txog anticoagulant qhov ncauj npaj
Kev npaj tshuaj tiv thaiv kab mob hauv qhov ncauj tau pom zoo rau lub sijhawm no yog 505 (b) (2) cov tshuaj tshiab ntawm nws tus kheej tsim los ntawm Guangzhou Positao raws li cov tshuaj tiv thaiv kab mob hnyav uas twb tau teev tseg lawm. Clinically muaj rau mob stroke, cov khoom no txo ​​cov kev pheej hmoo ntawm mob stroke thiab embolic kab mob, nrog rau hemorrhagic stroke, thiab qhov tshwm sim ntawm hemorrhage, nrog rau cov neeg tuag thiab intracranial hemorrhage, uas ua rau ib tug tseem ceeb txo nyob rau hauv kev tuag. Piv nrog rau cov khoom lag luam, cov tshuaj anticoagulant qhov ncauj npaj tsim los ntawm Bostao tuaj yeem txo qhov ntau npaum ntawm cov tshuaj, txo cov kev mob tshwm sim, thiab txhim kho kev yooj yim ntawm cov tshuaj rau cov neeg mob, uas muaj cov nqi kho mob siab thiab kev ua lag luam.

Hais txog mob stroke
Stroke (feem ntau hu ua "stroke") yog ib hom kab mob cerebrovascular mob, uas yog ib pawg ntawm cov kab mob tshwm sim los ntawm kev tawg sai sai los yog txhaws ntawm cov ntshav cerebrovascular uas tsis tuaj yeem muab rau lub hlwb thiab ua rau lub hlwb puas. Feem ntau nws tuaj yeem muab faib ua ob pawg: ischemic (cerebral infarction IS) thiab hemorrhagic (xws li cerebral hemorrhage ICH thiab subarachnoid hemorrhage SAH). Kev mob stroke tuaj yeem ua rau lub cev tuag tes tuag taw, kev hais lus tsis zoo, dysphagia, kev paub tsis meej, kev puas siab puas ntsws thiab lwm yam tsos mob, nrog rau qhov tshwm sim siab, tus nqi rov qab siab dua, kev tsis taus siab, kev tuag siab ntawm "plaub siab" yam ntxwv. Raws li 2017 Kev Tshawb Fawb Ntiaj Teb Cov Kab Mob, Kev Kho Mob thiab Kev Ruaj Ntseg (GBD), mob hlab ntsha tawg yog qhov thib ob ua rau tuag thiab thib peb ua rau muaj kev tsis taus ( ntsuas los ntawm kev xiam oob qhab-hloov lub neej xyoo [DALYs] ) thoob ntiaj teb. Lub GBD 2019 Stroke Collaboration tau luam tawm thoob ntiaj teb, cheeb tsam thiab lub teb chaws mob stroke rau 1990-2019 hauv Lancet Neurology. Cov ntaub ntawv qhia tau hais tias los ntawm 1990 txog 2019, tus naj npawb ntawm cov xwm txheej mob stroke tau nce 70 feem pua ​​​​hauv ntiaj teb thiab cov neeg mob stroke tau nce 85 feem pua. Nyob rau tib lub sijhawm, mob stroke ntsig txog kev tuag tau nce 43 feem pua ​​​​thiab mob stroke DALY s nce 32 feem pua. Ntawm qhov tod tes, qhov tshwm sim ntawm tus mob stroke tseem me me, nrog rau kev nce ntxiv hauv cov hnub nyoog tshwj xeeb mob stroke (22 feem pua ​​[21.{13}}.0]) thiab qhov tshwm sim (15 feem pua ​​[12.{17} }.0]) ntawm cov neeg muaj hnub nyoog qis dua 70 xyoo thoob ntiaj teb. Raws li cov ntaub ntawv tshaj tawm los ntawm Lub Koom Haum Saib Xyuas Kev Noj Qab Haus Huv Ntiaj Teb (WHO), thoob ntiaj teb, qhov xwm txheej mob stroke hauv cov neeg muaj hnub nyoog qis dua 35 xyoos suav txog 9.77 feem pua ​​​​ntawm tag nrho cov naj npawb. Hauv txhua 4 tus neeg laus dua 25 xyoos, 1 tus neeg yuav muaj mob stroke hauv lawv lub neej, qhia tias qhov tshwm sim ntawm tus mob stroke maj mam zuj zus.

Hais txog Guangzhou Bositao
Guangzhou Bositao yog lub tuam txhab high-tech nrog cov tshuaj tshiab tso tawm ua cov tub ntxhais. Nws yog ib qho tseem ceeb ntawm kev tshawb fawb thiab kev txhim kho kev coj ua ntawm lub tuam txhab los ua cov kev txhim kho theem nrab ntawm cov khoom uas twb muaj lawm nyob rau hauv kev ua lag luam los ntawm kev npaj tshiab technology thiab muab cov khoom lag luam nrog cov nqi kho mob ntau dua thiab cov nqi lag luam. Tam sim no, lub tuam txhab muaj ntau dua 10 cov tshuaj tshiab lossis 505 (b) (2), uas nyob rau ntau theem ntawm kev txhim kho.
Guangzhou Bospitao kuj tau tsim lub "ib-nres" kev npaj kev pabcuam platform, uas muaj peev xwm tsim ntau yam kev txhaj tshuaj thiab qhov ncauj qeeb-tswj tso tawm kev npaj, thiab tuaj yeem muab cov lag luam tshuaj hauv tsev thiab txawv teb chaws nrog ntau yam kev kho tshuaj kho mob. cov kev pab cuam, thiab tau ntse tsim thiab tshaj tawm ze li ntawm 60 ntau yam khoom rau cov neeg siv khoom hauv tsev thiab txawv teb chaws.

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