Ngomhla we-19 kuJuni, iZiko loVavanyo lwaMayeza (i-CDE) le-National Medical Products Administration (i-NMPA) libhengeze ukuba i-IBI343 ye-Innovent Biologics icetyisiwe ukuba ifakwe kwinkqubo yokuchonga unyango oluphumelelayo, olujoliswe kunyango lomhlaza wepancreatic ophucukileyo okanye osasazekileyo one-CLDN18.2 kwaye ufumene ubuncinane unyango oluphindwe kabini ngaphambili.
I-IBI343 yi-recombinant humanized anti-CLDN18.2 antibody-drug conjugate (ADC). Xa ibotshelelwe kwiiseli ze-tumor eziveza i-CLDN18.2, ingena kwi-ADC internalization exhomekeke kwi-CLDN18.2 kwaye ikhuphe umthwalo we-cytotoxic, okhokelela kumonakalo we-DNA kwaye ekugqibeleni ibangele i-apoptosis yeseli ye-tumor.
Ngomhla wesi-9 kweyoMnga ngo-2024, idatha yamva nje evela kuvavanyo lweklinikhi lweSigaba soku-1 (NCT05458219) lwe-IBI343 kwi-advanced pancreatic ductal adenocarcinoma (PDAC) yaboniswa kwiNtlanganiso yoNyaka ye-European Society for Medical Oncology Asia (ESMO Asia).
Izigulane ezingama-43 ezine-CLDN18.2-positive advanced PDAC zanyangwa nge-IBI343. Iziphumo zibonise izinga lokuphendula elijolise kuko konke (ORR) elingama-32.6%, izinga lokuphendula elijolise kuko konke eliqinisekisiweyo (cORR) elingama-23.3%, kunye nezinga lokulawula isifo eliqinisekisiweyo (cDCR) elingama-81.4%. Ubude bexesha eliphakathi lokuphendula (mDoR) yayiziinyanga ezi-7.0, kunye nezinga le-DoR leenyanga ezi-6 elingama-63%, kunye nokusinda okungapheliyo kokuqhubela phambili (PFS) yayiziinyanga ezi-5.3.
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.
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Ixesha leposi: Juni-19-2025