Ngwa ọgwụ ọhụrụ nyocha maka ịba ọcha n'anya B

A Jide Free Ntọhapụ 2 | eTurboNews | eTN

Enwere ihe dị ka nde 1.59 ndị ọrịa ịba ọcha n'anya B (CHB) na-adịghị ala ala na US Ascletis Pharma Inc. mara ọkwa taa nkwado ngwa nyocha Ọhụrụ Drug (IND) nke US Food and Drug Administration (FDA) na mmalite nke mmepe zuru ụwa ọnụ nke ASC22 (Envafolimab) , nke mbụ na klaasị, nke subcutaneously na-enye ọgwụ mgbochi PD-L1 maka ọgwụgwọ arụ ọrụ nke ịba ọcha n'anya B (CHB).

Akwụkwọ nyocha na nso nso a[1], akpọrọ “Mbawanye nke Ọrịa ịba ọcha n'anya B na-adịghị ala ala na United States” nke e bipụtara na June 2020, gosipụtara ọnụ ọgụgụ zuru oke maka ọrịa ịba ọcha n'anya B (HBV) na US nke ndị ọrịa nde 1.59 1.25-2.49 nde). Ma Healthtù Ahụ Ike (wa (WHO) na Ngalaba Ahụike na Ọrụ Ndị Ọrụ US (DHHS) akọwapụtala atụmatụ mkpochapụ ịba ọcha n'anya.

Ọmụmụ ASC22 Phase IIb (ClinicalTrials.gov Identifier: NCT04465890) bụ ihe a na-ahaziri ahazi, otu-ìsì, ebe a na-achịkwa ebebo, nnwale ụlọ ọgwụ ọtụtụ etiti na China nke na-enyocha ịdị mma na nchekwa nke ndị ọrịa 149 CHB maka ọgwụgwọ izu 24 nke 1 mg / n'arọ ma ọ bụ 2.5 mg/kg ASC22 ma ọ bụ placebo dakọtara na-enye otu ugboro kwa izu abụọ (Q2W) yana njikọ NA. Nsonaazụ nwa oge, nke anabatara maka ngosipụta ọnụ na Oge nkwụsịtụ na Imeju Meeting® 2021 nke American Association for Study of Liver Diseases (AASLD) gosipụtara na ndị ọrịa nwere ọkwa antigen ịba ọcha n'anya B (HBsAg) ≤ 500 IU. / ml, ihe dịka 19% (3/16) nke ndị ọrịa nọ n'ime otu ọgwụgwọ ahụ nwetara mfu HBsAg na enweghị isiokwu enwetara mfu HBsAg n'ime otu placebo na enweghị nlọghachi mgbe usoro ikpeazụ nke ASC22 gasịrị, na-egosi ọgwụgwọ ọrụ HBV.

Usoro IIa na IIb ọmụmụ ụlọ ọgwụ nke ASC22 maka ọgwụgwọ ọrụ HBV ka ahọpụtara maka isonye na "Kachasị mma nke nchịkọta imeju imeju" na 2021 site na kọmitii nyocha AASLD. Nsonye dị otú ahụ bụ nsọpụrụ pụrụ iche ma na-egosi ọkwa dị elu nke kọmitii nyocha AASLD na-eleba anya n'ihe nyocha Ascletis na ọgwụgwọ ọrụ CHB.

Ascletis kwupụtara na ya enwetala akwụkwọ ikike zuru ụwa ọnụ na nke pụrụiche dị ka nke 8 November, 2021 site na Suzhou Alphamab iji zụlite na ịzụ ahịa ASC22 maka ọrịa nje niile gụnyere ịba ọcha n'anya B. Akwụkwọ Ascletis na-ere n'ụwa nile maka ASC22 nke ọrịa nje niile.

ASC22 bụ ọkwa immunotherapy kachasị elu n'ụwa maka ọgwụgwọ ọrụ CHB, ntụgharị HBsAg, site na igbochi ụzọ PD-1/PD-L1.

IHE Ị GA-Ewepụ na edemede a:

  • Nsonaazụ nwa oge, nke anabatara maka ngosipụta ọnụ na Oge nkwụsịtụ na Imeju Meeting® 2021 nke American Association for Study of Liver Diseases (AASLD) gosipụtara na ndị ọrịa nwere ọkwa antigen ịba ọcha n'anya B (HBsAg) ≤ 500 IU. / ml, ihe dị ka 19% (3/16) nke ndị ọrịa nọ n'ime otu ọgwụgwọ ahụ nwetara mfu HBsAg na enweghị isiokwu enwetara mfu HBsAg n'ime otu placebo na enweghị nlọghachi mgbe usoro ọgwụgwọ ikpeazụ nke ASC22 gasịrị, na-egosi ọgwụgwọ ọrụ HBV.
  • NCT04465890) bụ nke a na-ahaziri ahazi, onye kpuru ìsì, nke a na-achịkwa placebo, nnwale ụlọ ọgwụ ọtụtụ etiti na China nke na-enyocha ịdị mma na nchekwa nke ndị ọrịa 149 CHB maka ọgwụgwọ izu 24 nke 1 mg / kg ma ọ bụ 2.
  • Ascletis kwuputara na ọ nwetala ikike zuru ụwa ọnụ na nke pụrụiche dị ka nke 8 Nọvemba, 2021 site na Suzhou Alphamab ịzụlite na ịzụ ahịa ASC22 maka ọrịa nje niile gụnyere ịba ọcha n'anya B.

<

Banyere chepụtara

Linda Hohnholz

Onye nchịkọta akụkọ maka eTurboNews dabere na eTN HQ.

Idenye aha
Gwa nke
guest
1 Comment
Kacha ọhụrụ
Kasị Ochie
Inline nzaghachi
Lee echiche niile
1
0
Ga-ahụ n'anya gị echiche, biko okwu.x
Kekọrịta ka...