Te Whakatairanga Tono Taauau Hou mo te Hepatitis B

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He tata ki te 1.59 miriona nga turoro mate pukupuku B (CHB) mau tonu i te US Ascletis Pharma Inc. i whakapuaki i tenei ra i te whakaaetanga tono Investigational New Drug (IND) e te US Food and Drug Administration (FDA) me te timatatanga o te whakawhanaketanga ao o ASC22 (Envafolimab) , he antibody PD-L1 i raro i te kiri mo te rongoa mahi mo te mate kakā B (CHB).

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Ko te pepa rangahau o tata nei [1], i tapaina ko "Te Hunga o te Mate Mate Hepatitis B i te United States" i whakaputaina i te marama o Hune 2020, i whakaatu i te nuinga o te whakapae mo te mate mate hepatitis B mau tonu (HBV) i te US o te 1.59 miriona nga turoro (awheawhe. 1.25–2.49 miriona). Ko te Whakahaere Hauora o te Ao (WHO) me te US Department of Health and Human Services (DHHS) kua whakatakoto mahere mo te whakakore i te mate ate ate.

Ko te ako ASC22 Phase IIb (ClinicalTrials.gov Identifier: NCT04465890) he whakamatautau haumanu matapōkere, kotahi-matapo, placebo-whakahaere, maha-pokapū whakamatautau haumanu i Haina e aromatawai ana i te kaha me te haumaru o nga turoro 149 CHB mo te maimoatanga 24-wiki o te 1 mg / kg, 2.5 mg/kg ASC22 ranei, ka hoatu ki te placebo kotahi ia rua wiki (Q2W) me nga NA. Ko nga hua mo te wa poto, i whakaaetia mo te whakaaturanga a-waha i te Late Breaking Session i Te Hui Ate ® 2021 e te American Association for the Study of Liver Diseases (AASLD) i whakaatu i nga turoro me te taumata antigen mata hepatitis B (HBsAg) ≤ 500 IU. /mL, tata ki te 19% (3/16) o nga turoro i roto i te roopu maimoatanga i whiwhi mate HBsAg me te kore kaupapa i tutuki i te mate HBsAg i roto i te roopu placebo me te kore e hoki mai i muri i te horopeta whakamutunga o te ASC22, e tohu ana i te rongoa HBV.

Ko nga rangahau haumanu Wāhanga IIa me IIb o ASC22 mo te rongoa mahi HBV i tohua mo te whakauru ki roto i te "He pai rawa atu o te Hui Ate Huihuinga" i te tau 2021 e te komiti arotake AASLD. He honore motuhake taua whakaurunga me te tohu i te taumata teitei e whakaaro ana te komiti arotake AASLD ki te rangahau a Ascletis mo te rongoa mahi CHB.

I kii a Ascletis kua whiwhi raihana motuhake mai i te 8 o Whiringa-a-rangi, 2021 mai i Suzhou Alphamab ki te whakawhanake me te hokohoko ASC22 mo nga mate huaketo katoa tae atu ki te Hepatitis B. Ko nga pukapuka a Ascletis e hoko ana i te ao mo te ASC22 o nga mate huaketo katoa.

Ko te ASC22 te tino whakamaarama haumanu mo te atamira haumanu i te ao mo te rongoa mahi a CHB, ara te mate HBsAg, na te aukati i te ara PD-1/PD-L1.

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Ko te Kaiwhakahaere Matua mo eTurboNew ko Linda Hohnholz. Kei roto ia i te eTN HQ i Honolulu, Hawaii.

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