I-NMPA IFAKE I-B7-H4-TARGETED ADC HS-20089 NJENGEYEZA ELIYILWAYO ELIYILWAYO LOMHLAZA WESIBINI ONGAMELIYO I-PLATINUM

Ngomhla we-1 kuMeyi, ngo-2025, iHansoh Pharmaceutical ibhengeze ukuba i-B7-H4-target antibody-drug conjugate (ADC) HS-20089 eyenzelwe yona yeQela ukuze ijojwe ifumene imvume yokuba ifakwe njenge-Breakthrough-Therapy-Designated Drug yi-National Medical Products Administration (NMPA) yaseTshayina, kunye nesalathiso esicetywayo somhlaza we-ovarian ophindaphindayo we-epithelial, umhlaza wetyhubhu ye-fallopian okanye izigulane zomhlaza we-peritoneal ovarian.

82748bdcd8677eebb33fb564e89b5e8.png

Olu phawu luxhaswa ziziphumo ezivela kuphando lweSigaba soku-1 HS-20089-101 kunye nophando lweSigaba sesi-2 HS-20089-201. Uphononongo lwe-HS-20089-101 luvavanyo lweklinikhi lweSigaba soku-1 oluneziko ezininzi, oluvulelekileyo lokuvavanya ukhuseleko, ukunyamezeleka, i-pharmacokinetics, kunye nokusebenza kakuhle kwe-HS-20089 yokujova kwizigulana ezineethumba eziqinileyo eziphucukileyo. Uphononongo lwe-HS-20089-201 luvavanyo lweklinikhi lweSigaba sesi-2 oluneziko ezininzi, oluvulelekileyo lokuvavanya ukusebenza kakuhle, ukhuseleko, iprofayili ye-pharmacokinetic, kunye nokuqina kwe-immunogenicity ye-intravenous HS-20089 kwizigulana ezinomhlaza wesibeleko ophindaphindayo okanye osasazekayo kunye nomhlaza we-endometrial.

I-HS-20089 yi-ADC ejoliswe kwi-B7-H4 ene-topoisomerase inhibitor (TOPOi) payload eyenzelwe unyango lomhlaza wesibeleko kunye nezinye izimila zesibeleko kwiimvavanyo ezininzi zeklinikhi eTshayina, apho inqanaba eliphezulu lophando liyi-Phase III clinical trials. I-B7-H4 yi-transmembrane immune checkpoint glycoprotein ebonakala kakhulu kwizimila ezininzi eziqinileyo, kubandakanya umhlaza we-endometrial kunye nomhlaza wesibeleko, kodwa inokubonakaliswa okuncinci kwizicwili eziqhelekileyo.

Okwangoku, kusekho iimvavanyo ezininzi zeklinikhi zobuchwepheshe obutsha bokulwa nomhlaza eTshayina obufuna izigulane. Iingcebiso ngamayeza amatsha kunye nobuchwepheshe, ungaqhagamshelana neSebe leMicimbi yeZibhedlele ze-Oncology zaseBeijing South Region.

Inombolo yefowuni: 4008803716

I-imeyile:myimmnet@163.com

微信图片_20241115181717


Ixesha leposi: Meyi-09-2025