Ntiaj teb thawj cov tshuaj tua kab mob siab D: Hepcludex tau pom zoo rau kev lag luam hauv EU, thiab kev kho mob siab hom B yog nyob rau ntu II!

MYR Pharmaceuticals yog lub tuam txhab German biotechnology tsom mus rau kev txhim kho thiab ua lag luam tshuaj kho tus kab mob siab B thiab D. Tsis ntev los no, lub tuam txhab tshaj tawm tias European Commission (EC) tau tso cai rau nws cov tshuaj txhuas Hepcludex (Myrcludex B, INN npe: bulevirtide) ib txoj cai tswj hwm kev lag luam (CMA) hauv European Union.

Hepcludex yog thawj zaug European pom zoo kev kho rau tus kab mob siab D ntev (HDV) thiab muaj mob rau daim siab mob rau cov neeg laus. Cov tshuaj yog thawj chav kawm nkag tus kab mob tuaj yeem tsim los kho tus kab mob siab hom B (HBV) thiab kab mob siab D (HDV). Cov tshuaj tuaj yeem inhibit HBV nyob rau ntawm daim siab ua haujlwm. / HDV lees txais NTCP thiab tiv thaiv kev kis tus kab mob ntawm lub hlwb thiab kev kis tus kab mob hauv lub siab.

Hepcludex sawv cev rau kev kho mob siab tshaj plaws rau tus kab mob siab D. Kev pom zoo ntawm CMA, raws li cov txiaj ntsig ntawm kev tshawb fawb ob ntu II (MYR202 thiab MYR203), cov ntaub ntawv qhia tias Hepcludex txo qis viremia thiab txhim kho daim siab ua haujlwm thaum kho, thaum muaj kev tiv taus zoo thiab kev nyab xeeb. Cov.

Tam sim no, MYR Pharmaceuticals tab tom ua Kev Kawm III HDV kev soj ntsuam txog kev kho mob ntev ntev ntawm Hepcludex, thiab Phase II HDV kawm ntsuas Hepcludex ua ke nrog peginterferon. Tam sim no, Hepcludex kev kho mob ntawm tus kab mob siab hom B (HBV) kuj tseem nkag mus rau theem II.

Yav dhau los, Hepcludex tau txais Kev Tsim Tshuaj Yeeb Tshuaj Kho Mob (ODD) rau kev kho tus mob HDV tawm los ntawm European Medicines Agency (EMA) thiab Asmeskas Chaw Tswj Xyuas Khoom Noj thiab Tshuaj (FDA). Tsis tas li ntawd, Hepcludex kuj tseem tau txais cov xwm txheej tshuaj muaj feem (PRIME) tau tso cai los ntawm EMA thiab kev thim yeeb tshuaj (BTD) tso cai los ntawm FDA. Txoj haujlwm PRIME zoo ib yam li BTD qhov haujlwm, thiab ua rau kom muaj kev soj ntsuam cov tshuaj tseem ceeb hauv kev kho mob uas tsis txaus ntseeg thiab muaj txiaj ntsig zoo rau cov neeg mob kom sai li sai tau. Rau cov tshuaj kom tau ntawv pov thawj raws li PRIME lossis BTD, yuav tsum muaj cov lus pov thawj ua ntej kuaj pom tias cov tshuaj muaj cov kab mob kis tau zoo nyob rau hauv cov chaw kho mob tseem ceeb kawg piv nrog cov tshuaj kho mob uas twb muaj lawm.

Hepcludex mechanism ntawm kev nqis tes ua

Hepcludex yog Ameslikas tsim los ntawm cov kws tshawb fawb los ntawm University of Heidelberg hauv Tebchaws Yelemees thiab Fab Kis Lub Tebchaws ntawm Kev Noj Qab Haus Huv thiab Tshuaj (INSERM). Kev txhim kho cov tshuaj tau txais kev txhawb nqa los ntawm German Center for Infection Research (DZIF), lub hauv paus pib los ntawm German Tsoom Fwv Saib Xyuas Kev Kawm thiab Kev Tshawb Nrhiav (BBF).

Tus xibfwb Professor Stephan Urban, tus kws tshaj lij ntawm Hepcludex, tus xibfwb ntawm Virology ntawm Heidelberg University, thiab tus Thawj Tswm Saib Kev Tshawb Fawb ntawm txoj haujlwm tshawb fawb txuas mus ntxiv ntawm MYR Pharmaceuticals thiab Heidelberg University, qhia txog nws txoj kev txaus siab: "Niaj hnub no kev pom zoo yog rau cov neeg uas muaj kev cuam tshuam loj heev ntawm kev kis mob. Cov. Kab mob siab yog qhov ua tiav rau ib pawg neeg mob uas tsis muaj kev kho mob tshwj xeeb. Kuv zoo siab tias tom qab ntau tshaj 20 xyoo ntawm kev tshawb fawb txog kev tshawb fawb thiab kev soj ntsuam, kev kho mob hepatocyte nkag inhibitor Myrcludex B, tam sim no Hepcludex, tuaj yeem siv rau cov neeg mob, kev pom zoo ntawm cov tshuaj rau kev lag luam yuav txhim kho lawv lub neej."