NgoMashi 10, 2025, uSichuan Kelun-Biotech wamemezela ukuthi i-trophoblast cell-surface antigen 2 (TROP2)-directed antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT, eyayiyi-SKB264/MK-2870) yeNkampani ivunyelwe ukumaketha yi-National Medical Products Administration (NMPA) njengesibonakaliso sesibili esiwukwelashwa kweziguli ezindala ezine-epidermal growth factor receptor (EGFR) mutant-positive localized advanced noma metastatic non-squamous non-small cell lung cancer (NSCLC) ngemuva kokuqhubekela phambili ekwelashweni kwe-EGFR-tyrosine kinase inhibitor (TKI) kanye ne-platinum-based chemotherapy. Lona umuthi wokuqala we-TROP2 ADC ovunyelwe ukumaketha kumdlavuza wamaphaphu emhlabeni jikelele. Uma kuqhathaniswa nezinga lokunakekelwa lamanje, i-sac-TMT yandisa kakhulu izinzuzo zokusinda zalezi ziguli.
Ukuvunyelwa kusekelwe ocwaningweni olunezikhungo eziningi, olungahleliwe, olulawulwayo, nolubalulekile (i-OptiTROP-Lung03) oluhlola ukusebenza kahle kanye nephrofayili yokuphepha kwe-sac-TMT monotherapy engu-5mg/kg njalo ngemva kwesonto (Q2W) njengomjovo womjovo ngokumelene ne-docetaxel yokwelapha iziguli ezine-NSCLC ye-EGFR-mutant ethuthukisiwe noma esakazekile eziye zehluleka ngemuva kokwelashwa nge-EGFR-TKI kanye ne-chemotherapy esekelwe eplatinum (esetshenziswa ngokulandelana noma ngokuhlanganiswa). Njengoba kuboniswe ekuhlaziyweni kwesikhashana okuchazwe kusengaphambili, i-sac-TMT monotherapy ibonise ukuthuthuka okubalulekile ngokwezibalo kanye nokubalulekile emtholampilo ku-objective response rate (ORR), progressive-free survival (PFS) kanye ne-overall survival (OS) uma kuqhathaniswa ne-docetaxel.
Mayelana ne-sac-TMT
I-Sac-TMT iyi-TROP2 ADC entsha yomuntu lapho iNkampani inamalungelo obunikazi obuyimfihlo, ihlose izimila eziqinile ezithuthukile njenge-NSCLC, umdlavuza webele (BC), umdlavuza wesisu (GC), izimila zezifo zabesifazane, phakathi kwezinye. I-Sac-TMT yakhiwe ngesixhumi esisha sokuxhumanisa 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-recombinant anti-TROP2 humanized monoclonal, abese efakwa yi-endocytos ngamaseli ezimila bese ekhipha i-KL610023 ngaphakathi kweseli. I-KL610023, njenge-topoisomerase I inhibitor, ibangela ukulimala kwe-DNA kumaseli ezimila, okuholela ekumisweni kweseli 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.
Ngaphambilini, i-NMPA ivumile ukumaketha kwe-sac-TMT eShayina kweziguli ezindala ezinomdlavuza webele osezingeni eliphezulu noma ongemuhle we-metastatic triple negative (TNBC) ezingalapheki ezithole okungenani izindlela zokwelapha ezimbili zangaphambilini (okungenani eyodwa yazo yokwelashwa okuthuthukisiwe noma ongemuhle) futhi yamukela isicelo esisha somuthi esengeziwe (sNDA) esifuna ukuvunyelwa kwe-sac-TMT monotherapy yeziguli ezine-EGFR-mutant NSCLC ezihlulekile ngemuva kokwelashwa kwe-EGFR-TKI.
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: Mashi-20-2025