I-NMPA IFAKE I-B7-H4-TAGETED ADC HS-20089 NJENGESITHAKO ESIQONDISWE NGOKUPHUTHUMAYO SOMCANDULA WESIBILI ONGAMELANI NE-PLATINUM

Ngomhlaka-1 Meyi 2025, i-Hansoh Pharmaceutical imemezela ukuthi i-B7-H4-target antibody-drug conjugate (ADC) HS-20089 yeQembu eyazithuthukisa ngokwayo ukuze ijovwe ithole imvume yokufakwa njengoMuthi Oqokiwe Wokwelapha yi-National Medical Products Administration (NMPA) yaseShayina, kanye nesibonakaliso esiphakanyisiwe somdlavuza we-epithelial ovarian ophindaphindayo ongamelana ne-platinum, umdlavuza we-fallopian tube noma iziguli ezinomdlavuza we-peritoneal oyinhloko.

Ukuqokwa kusekelwa yimiphumela evela ocwaningweni lweSigaba I HS-20089-101 kanye nocwaningo lweSigaba II HS-20089-201. Ucwaningo lwe-HS-20089-101 luyisilingo somtholampilo seSigaba I esinezikhungo eziningi, esivulelekile sokuhlola ukuphepha, ukubekezeleleka, i-pharmacokinetics, kanye nokusebenza kahle kwe-HS-20089 yokujova ezigulini ezinezimila eziqinile ezithuthukile. Ucwaningo lwe-HS-20089-201 luyisilingo somtholampilo seSigaba II esinezikhungo eziningi, esivulelekile sokuhlola ukusebenza kahle, ukuphepha, iphrofayili ye-pharmacokinetic, kanye nokuzivikela komzimba kwe-HS-20089 emithanjeni ezigulini ezinomdlavuza wesibeletho ophindaphindayo noma osakazekile kanye nomdlavuza we-endometrial.

I-HS-20089 iyi-ADC eqondiswe ku-B7-H4 ene-topoisomerase inhibitor (TOPOi) payload eklanyelwe ukwelapha umdlavuza we-ovarian kanye nezinye izimila zabesifazane ezivivinyweni eziningi zemitholampilo eShayina, kanti isigaba socwaningo esiphezulu kakhulu yizivivinyo zemitholampilo zeSigaba III. I-B7-H4 iyi-glycoprotein ye-transmembrane immune checkpoint ebonakala kakhulu ezimilanjeni eziningi eziqinile, kufaka phakathi umdlavuza we-endometrial kanye nomdlavuza we-ovarian, kodwa ngokubonakaliswa okulinganiselwe ezicutshini ezivamile.

Njengamanje, kusenezivivinyo eziningi zemitholampilo zobuchwepheshe obusha bokulwa nomdlavuza eShayina ezifuna iziguli. Ukubonisana ngemithi emisha kanye nobuchwepheshe, ungaxhumana noMnyango Wezizwe Ngezizwe Wesibhedlela iBeijing South Region Oncology.

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