Ngomhla we-17 ku-Epreli, ngo-2025, iHansoh Pharmaceutical ibhengeze ukuba i-B7-H3-target antibody-drug conjugate (ADC) HS-20093 yeQela eyaziphuhlisa ngokwayo ukuze ijojwe ifumene imvume yokuba ifakwe njenge-Breakthrough-Therapy-Designated Drug yi-National Medical Products Administration (NMPA) yaseTshayina, kunye nesalathiso esicetywayo somhlaza wemiphunga we-non-squamous non-small cell (NSCLC) ophucukileyo okanye osasazekayo ngaphandle kotshintsho oluqhubekileyo, luqhubekile okanye luphinde lwavela emva kwe-chemotherapy esekelwe kwi-platinum.
I-HS-20093 yi-ADC yophando ejoliswe kwi-B7-H3 eyenziwe yi-antibody ye-anti-B7-H3 monoclonal edityaniswe ngokupheleleyo ne-topoisomerase inhibitor (TOPOi) payload kwaye yenzelwe unyango lomhlaza wemiphunga, i-sarcoma, umhlaza wentloko nentamo kunye nezinye iithumba eziqinileyo kwizilingo ezininzi zeklinikhi eTshayina, apho inqanaba eliphezulu lophando livavanyo lweklinikhi lweSigaba Ⅲ.
Olu vavanyo luxhaswa yidatha yokuqala yeklinikhi evela kuphando lwe-ARTEMIS-001. Olu luvavanyo oluqhubekayo lwesigaba sokuqala oluvulelekileyo, oluneendawo ezininzi lwezigulane ezingaphezu kwama-300 ezivavanya ukhuseleko, ukunyamezeleka, kunye nomsebenzi wokuqala wokulwa nethumba kwithumba eliqinileyo eliphambili okanye elisasazekileyo (umhlaza wemiphunga ongekho squamous non-small cell ongekho squamous ngaphandle kotshintsho oluqhubekileyo, oluqhubekeke okanye oluphinde lwenzeka emva kwe-chemotherapy esekelwe kwi-platinum), oluqhutywa yiHansoh Pharma.
Ngaphambili, i-HS-20093 ifumene imvume yokufakwa njengeyeza eliyilwe yi-NMPA njengeyeza eliPhambili loNyango ngenxa yeempawu ezimbini:
·Umhlaza Wemiphunga Weeseli Ezincinci Ezikwinqanaba Elibanzi (ES-SCLC) uye wavela emva konyango oluqhelekileyo lodidi lokuqala (i-chemotherapy yeplatinum doublet edityaniswe nonyango lwe-immuno-therapy).
·I-Osteosarcoma kwizigulana eziye zaqhubeka ubuncinane kwiindlela ezimbini zonyango zangaphambili.
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
Email：myimmnet@163.com
Ixesha leposi: Epreli-22-2025