Ngomhlaka-22 Meyi 2025, iKelun Bio yamemezela ukuthi isicelo senkomba entsha ye-trophoblast cell surface antigen 2 (TROP2)-directed antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT, eyaziwa nangokuthi i-SKB264/MK – 2870) (®) yamukelwe yi-Center for Drug Evaluation (CDE) ye-National Medical Products Administration (NMPA) yaseShayina. Lesi sibonakaliso esisha singesokwelashwa kweziguli ezindala ezine-hormone receptor-positive (HR+) engasuswanga endaweni ethile noma ene-metastatic hormone kanye ne-human epidermal growth factor receptor 2-negative (HER2-) breast cancer (BC) ezithole ukwelashwa kwe-endocrine ngaphambilini kanye nezinye izindlela zokwelapha ezisebenza kahle endaweni ephakeme noma ene-metastatic. Lokhu kwamukelwa kwakusekelwe emiphumeleni emihle yocwaningo lweSigaba sesi-3 lwe-OptiTROP – Breast02. Lesi sicelo siyisibonisi sesine se-sac – TMT esamukelwe yi-NMPA.
I-OptiTROP – I-Breast02 iyisifundo somtholampilo seSigaba sesi-3 esingahleliwe, esivulekile, esinama-multicenter, esihlole ukusebenza kahle kanye nokuphepha kwe-sacituzumab tirumotecan monotherapy ngesilinganiso esingu-5 mg/kg njalo emavikini amabili (Q2W) uma kuqhathaniswa nokukhetha kukadokotela i-chemotherapy ezigulini ezinomdlavuza webele ongalungiseki endaweni noma osakazekile i-HR+/HER2- (immunohistochemistry [IHC] 0, IHC 1+, noma i-IHC 2+/in situ hybridization [ISH]-) ongasuswa. Ngokusekelwe ekuhlaziyweni kwesikhashana okuchazwe kusengaphambili, isiphetho sokuqala sokusebenza kahle salolu cwaningo lomtholampilo lweSigaba sesi-3 sahlangatshezwa. Uma kuqhathaniswa nokukhetha kukadokotela i-chemotherapy, i-sac – TMT monotherapy ibonise ukuthuthuka okubalulekile ngokwezibalo kanye nokubalulekile emtholampilo endaweni yokuqala yokusinda okungenazo i-progression-free (PFS) njengoba kuhlolwe yikomidi lokubuyekeza elizimele eliyi-blind (BIRC), ngengozi encishisiwe kakhulu yokuqhubeka kwesifo noma ukufa. I-Sac – TMT iphinde yabonisa ukuthambekela okuhle ekusindeni okuphelele (OS).
Ngomhlaka-16 Meyi 2024, iwebhusayithi esemthethweni ye-CDE yamemezela ukuthi isicelo sizobuyekezwa ngenqubo yokubuyekezwa kokubalulekile kanye nokuvunywa. Lokhu kuphawula isibonakaliso sesine se-sac-TMT sokudlula enkambisweni yokubuyekezwa kokubalulekile kanye nokuvunywa kwe-CDE, kanye nezinkomba ezintathu zangaphambilini ze-sat-TMT ezamukelwe ngemuva kokubuyekezwa kokubalulekile.
Mayelana ne-sac-TMT (佳泰莱®)
I-Sac-TMT, umkhiqizo oyinhloko weNkampani, iyi-TROP2 ADC entsha yomuntu lapho iNkampani inamalungelo obunikazi obuyimfihlo, ihlose izimila eziqinile ezithuthukile njengomdlavuza wamaphaphu ongewona omncane wamangqamuzana (i-NSCLC), i-BC, umdlavuza wesisu (i-GC), izimila zabesifazane, phakathi kwezinye. I-Sac-TMT yakhiwe ngesixhumi esisha sokuhlanganisa umthwalo okhokhelwayo, i-belotecan-derivative topoisomerase I inhibitor ene-drug-to-antibody-ratio (DAR) engu-7.4. I-Sac-TMT iqaphela ngqo i-TROP2 ebusweni bamaseli ezimila ngama-antibodies e-anti-TROP2 ahlanganisiwe, abese ekhishwa amaseli ezimila bese ekhipha i-KL610023 ngaphakathi kweseli. I-KL610023, njenge-topoisomerase I inhibitor, ibangela ukulimala kwe-DNA kumaseli ezimila, okuholela ekumisweni komjikelezo weseli kanye ne-apoptosis. Ngaphezu kwalokho, ikhipha ne-KL610023 endaweni encane yesimila. Njengoba i-KL610023 ingangena kalula esikhumbeni, ingenza kube nomphumela wokulinda, noma ngamanye amazwi ibulale amaseli esimila aseduze.
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.
Inombolo yocingo: 4008803716
Email：myimmnet@163.com
Isikhathi sokuthunyelwe: Meyi-27-2025