Isicelo Esisha Sokuphenya Kwezidakamizwa Ze-Hepatitis B Engamahlalakhona

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Kuneziguli ezilinganiselwa ezigidini eziyi-1.59 zesifo sokusha kwesibindi kohlobo B (CHB) e-US i-Ascletis Pharma Inc. ememezele namuhla ukugunyazwa kwesicelo se-Investigational New Drug (IND) yi-US Food and Drug Administration (FDA) kanye nokuqalwa kokuthuthukiswa komhlaba wonke kwe-ASC22 (Envafolimab) , i-antibody ye-PD-L1 yesigaba sokuqala, elawulwa ngaphansi kwesikhumba ukuze zelaphe ukusebenza kwe-hepatitis B (CHB) engapheli.

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Iphepha locwaningo lakamuva[1], elinesihloko esithi "Ukusabalala Kokutheleleka Ngegciwane Le-Hepatitis B Okungapheli e-United States" elanyatheliswa ngoJuni 2020, libonise ukusabalala okulinganiselwe kokutheleleka ngegciwane le-hepatitis B (HBV) elingamahlalakhona e-US ezigulini eziyizigidi eziyi-1.59 (ububanzi 1.25–2.49 million). Kokubili i-World Health Organization (WHO) kanye noMnyango Wezempilo Nezinsizakalo Zabantu wase-US (DHHS) baveze izinhlelo ezisemthethweni zokuqeda ukusha kwesibindi.

Ucwaningo lwe-ASC22 Phase IIb (ClinicalTrials.gov Identifier: NCT04465890) luyisivivinyo somtholampilo esingahleliwe, esingaboni okukodwa, esilawulwa yi-placebo, esimaphakathi amaningi e-China esihlola ukusebenza kahle nokuphepha kweziguli eziyi-149 CHB ekwelashweni kwamaviki angama-24 kwe-1 mg/ kg noma 2.5 mg/kg ASC22 noma i-placebo efanayo enikezwa kanye emavikini amabili (Q2W) kuhlanganiswe nama-NA. Imiphumela yesikhashana, eyamukelwe ukuze yethulwe ngomlomo ku-Late Breaking Session ku-The Liver Meeting® 2021 yi-American Association for the Study of Liver Diseases (AASLD) ibonise ukuthi ezigulini ezinezinga lokuqala le-hepatitis B surface antigen (HBsAg) ≤ 500 IU /mL, cishe u-19% (3/16) weziguli eziseqenjini lokwelapha zithole ukulahlekelwa kwe-HBsAg ngokuqhathaniswa nokulahlekelwa kwe-HBsAg okuzuziwe eqenjini le-placebo futhi akukho ukuphindaphinda ngemva kokudoswa kokugcina kwe-ASC22, okubonisa ukwelashwa okusebenzayo kwe-HBV.

Izifundo zomtholampilo zeSigaba IIa kanye ne-IIb ze-ASC22 zokwelashwa okusebenzayo kwe-HBV zikhethelwe ukufakwa “Esifinyezweni Somhlangano Wesibindi Esingcono Kakhulu” ngo-2021 yikomiti lokubuyekeza i-AASLD. Ukufakwa okunjalo kuwudumo olulodwa futhi kukhombisa izinga eliphezulu ikomidi elibuyekeza i-AASLD elibheka ngalo ucwaningo luka-Ascletis ekwelapheni okusebenzayo kwe-CHB.

I-Ascletis imemezele ukuthi ithole ilayisense yomhlaba wonke nekhethekile kusukela ngomhla ziyisi-8 kuLwezi, 2021 kwaSuzhou Alphamab ukuze ithuthukise futhi ihwebe nge-ASC22 yazo zonke izifo ezibangelwa amagciwane okuhlanganisa i-Hepatitis B. Amabhuku e-Ascletis athengiswa emhlabeni wonke nge-ASC22 yazo zonke izifo ezibangelwa amagciwane.

I-ASC22 iyisigaba somtholampilo esithuthuke kakhulu sokwelashwa kwamasosha omzimba emhlabeni wonke sokwelapha okusebenzayo kwe-CHB, okungukuthi ukulahleka kwe-HBsAg, ngokuvimba indlela ye-PD-1/PD-L1.

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