Maarso 10, 2025, Sichuan Kelun-Biotech waxay ku dhawaaqday in daawada antibody-drug conjugate ee shirkadda ee trophoblast cell-surface antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT, oo hore u ahayd SKB264/MK-2870) ay u ansixisay suuqgeynta Maamulka Badeecadaha Caafimaadka Qaranka (NMPA) tilmaanta labaad oo ah daaweynta bukaanada qaangaarka ah ee qaba epidermal growth factor receptor (EGFR) mutant-positive maxalli ah oo horumarsan ama metastatic non-squamous non-squamous cell sambabada (NSCLC) ka dib markii ay ku dhacday daaweynta EGFR-tyrosine kinase inhibitor (TKI) iyo kiimoterabiga ku salaysan platinum. Kani waa dawada TROP2 ADC ee ugu horreysay ee loo ansixiyey suuqgeynta kansarka sambabada adduunka oo dhan. Marka la barbardhigo heerka daryeelka hadda jira, sac-TMT waxay si weyn u ballaarinaysaa faa'iidooyinka badbaadada guud ee bukaanadan.
Ansixintu waxay ku salaysan tahay daraasad muhiim ah oo xarun badan leh, oo aan kala sooc lahayn, la xakameeyey, oo muhiim ah (OptiTROP-Lung03) oo qiimeeysa waxtarka iyo astaanta badbaadada ee daaweynta monotherapy-ga sac-TMT 5mg/kg toddobaad kasta oo kale (Q2W) oo ah duritaan xidid ah marka loo eego docetaxel si loogu daaweeyo bukaanada qaba NSCLC-ga EGFR-mutant ee maxalliga ah ama metastatic kuwaas oo ku guuldareystay ka dib markii lagu daaweeyay kiimoterabiga EGFR-TKI iyo kiimoterabiga ku salaysan platinum (oo loo isticmaalo si isdaba joog ah ama isku dhafan). Sida lagu muujiyay falanqayn ku meel gaar ah oo hore loo cayimay, daaweynta monotherapy-ga sac-TMT waxay muujisay horumar tirakoob ahaan muhiim ah oo macno leh oo ku yimid heerka jawaab celinta ujeeddada (ORR), badbaadada aan horumarka lahayn (PFS) iyo badbaadada guud (OS) marka la barbar dhigo docetaxel.
Ku saabsan sac-TMT
Sac-TMT waa TROP2 ADC cusub oo bini'aadam ah oo Shirkaddu ay leedahay xuquuq hanti-garaadeed oo gaar ah, oo bartilmaameedsanaya burooyinka adag ee horumarsan sida NSCLC, kansarka naasaha (BC), kansarka caloosha (GC), burooyinka haweenka, iyo kuwo kale. Sac-TMT waxaa lagu sameeyay isku xire cusub si uu isugu xiro culayska, oo ah daawo ka hortagta topoisomerase I ee belotecan-derivative oo leh saamiga daawada-ilaa-antibody-ratio (DAR) oo ah 7.4. Sac-TMT si gaar ah ayay u aqoonsataa TROP2 dusha sare ee unugyada burooyinka iyadoo la adeegsanayo unugyada difaaca jirka ee monoclonal-ka ee dib-u-habaynta ah, kaas oo markaa ay ku sii daayaan unugyada burooyinka oo ay sii daayaan KL610023 gudaha unugyada. KL610023, oo ah daawada topoisomerase I, waxay keentaa dhaawac DNA ah oo ku yimaada unugyada burooyinka, taas oo iyaduna horseedda xidhitaanka wareegga unugyada iyo apoptosis. Intaa waxaa dheer, waxay sidoo kale sii daaysaa KL610023 jawiga burooyinka. Maadaama KL610023 uu xuubka ku dhex milmi karo, waxay awood u siin kartaa saameynta daawada, ama si kale haddii loo dhigo waxay dishaa unugyada burooyinka ee ku xiga.
Horey, NMPA waxay ansixisay suuqgeynta sac-TMT ee Shiinaha bukaanada qaangaarka ah ee qaba kansarka naasaha ee aan la daaweyn karin ee maxalliga ah ama kansarka naasaha ee saddex-geesoodka ah (TNBC) kuwaas oo helay ugu yaraan laba daawayn oo nidaamsan oo hore (ugu yaraan mid ka mid ah oo loogu talagalay xaalad horumarsan ama mid metastatic ah) waxayna aqbashay codsi daawo oo dheeraad ah (sNDA) oo raadinaya oggolaanshaha daaweynta sac-TMT ee bukaanada qaba NSCLC-ga EGFR ee mutant kuwaas oo ku guuldareystay daaweynta EGFR-TKI ka dib.
Waqtigan xaadirka ah, waxaa weli jira tijaabooyin caafimaad oo badan oo ku saabsan teknoolojiyada cusub ee ka hortagga kansarka ee Shiinaha oo raadinaya bukaanno. La-tashi ku saabsan daawooyinka cusub iyo teknoolojiyada, waxaad la xiriiri kartaa Waaxda Caalamiga ah ee Isbitaalka Oncology ee Gobolka Koonfureed ee Beijing.
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Waqtiga boostada: Maarso-20-2025