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Sabbin Aikace-aikacen Magunguna na Bincike don Cutar Hanta ta B

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Akwai kimanin mutane miliyan 1.59 na marasa lafiya na ciwon hanta na ciwon hanta na B (CHB) a cikin Amurka Ascletis Pharma Inc. An sanar a yau amincewar aikace-aikacen Binciken Sabuwar Drug (IND) ta Hukumar Abinci da Magunguna ta Amurka (FDA) da ƙaddamar da ci gaban duniya na ASC22 (Envafolimab) , ajin farko, da subcutaneously sarrafa PD-L1 antibody domin aikin warkar da na kullum hepatitis B (CHB).

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Takardar binciken kwanan nan [1], mai taken "Yawancin Cutar Cutar Cutar Hepatitis B a cikin Amurka" da aka buga a watan Yuni 2020, ta nuna kiyasin gabaɗayan kamuwa da kamuwa da cutar hanta ta B (HBV) a cikin Amurka na marasa lafiya miliyan 1.59 (kewayo). 1.25-2.49 miliyan). Dukkan Hukumar Lafiya ta Duniya (WHO) da Ma'aikatar Lafiya da Sabis na Jama'a ta Amurka (DHHS) sun fito da tsare-tsaren kawar da cutar hanta.

Nazarin ASC22 Phase IIb (ClinicalTrials.gov Identifier: NCT04465890) wani bazuwar, makafi guda ɗaya, mai sarrafa wuribo, gwajin asibiti da yawa a cikin Sin wanda ke kimanta inganci da amincin marasa lafiya na 149 CHB don maganin 24-mako na 1 mg / kg ko 2.5 mg/kg ASC22 ko madaidaicin placebo da ake bayarwa sau ɗaya kowane mako biyu (Q2W) tare da NAs. Sakamakon wucin gadi, wanda aka karɓa don gabatarwar baki a cikin Late Breaking Session a Hanta Meeting® 2021 ta Ƙungiyar Amirka don Nazarin Cututtukan Hanta (AASLD) ta nuna cewa a cikin marasa lafiya tare da matakin antigen na Hepatitis B (HBsAg) matakin ≤ 500 IU. / mL, kusan 19% (3/16) na marasa lafiya a cikin rukunin jiyya sun sami asarar HBsAg ba tare da wani batun da aka samu asarar HBsAg a cikin rukunin placebo ba kuma babu sake dawowa bayan kashi na ƙarshe na ASC22, yana nuna maganin aikin HBV.

Mataki na IIa da IIb nazarin asibiti na ASC22 don maganin aikin HBV an zaɓi su don haɗawa a cikin "Mafi kyawun Takaitaccen Takaitaccen Taron Hanta" a cikin 2021 ta kwamitin nazarin AASLD. Irin wannan haɗawa shine girmamawa guda ɗaya kuma yana nuna babban matakin wanda kwamitin nazarin AASLD ya kula da binciken Ascletis a cikin maganin aikin CHB.

Ascletis ya sanar da cewa ya sami lasisi na duniya da keɓaɓɓen kamar na 8 Nuwamba, 2021 daga Suzhou Alphamab don haɓakawa da kasuwanci ASC22 don duk cututtukan ƙwayar cuta ciki har da Hepatitis B. Littattafan Ascletis tallace-tallace a duniya don ASC22 na duk cututtukan hoto.

ASC22 shine mafi ci gaba na matakin rigakafi na asibiti a duniya don maganin aikin CHB, watau asarar HBsAg, ta hanyar toshe hanyar PD-1/PD-L1.

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Edita a shugaba na eTurboNew ita ce Linda Hohnholz. Ta dogara ne a HQ eTN a Honolulu, Hawaii.

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