Dhawaan, GenFleet TherapeuticsXafiiska Maamulka Daawada (ISAF) ee Gobolka Maamulka Gaarka ah ee Macau ee Shiinaha ayaa ku dhawaaqay in Dupert®(fulzerasib, GFH925/IBI351) uu u ansixiyay daaweynta bukaanada qaba kansarka sambabka ee unugyada yaryar (NSCLC) ee qaba isbeddelka KRAS G12C kuwaas oo helay ugu yaraan hal daaweyn nidaamsan.
Fulzerasib waxay ahayd daawada KRAS G12C ee ugu horreysay ee laga sameeyay Shiinaha taasoo NDA ay ansixisay iyadoo la raacayo Magacaabista Dib-u-eegista Mudnaanta bishii Agoosto 2024 iyadoo la raacayo Magacaabista Dib-u-eegista Mudnaanta.
Ku saabsan Dupert® (fulzerasib, KRAS G12C Inhibitor)
Iyada oo ay ogaatay GenFleet Therapeutics, fulzerasib (GFH925/IBI351) waa daawo cusub, afka ka shaqeysa, awood leh oo KRAS G12C ah oo loogu talagalay in si wax ku ool ah loogu bartilmaameedsado is-weydaarsiga GTP/GDP, oo ah tallaabo muhiim ah oo ku saabsan kicinta marinnada, iyadoo wax laga beddelayo haraaga cysteine-ka ee borotiinka KRAS G12C si isku mid ah oo aan dib loo celin karin. Daraasadaha xulashada cysteine-ka ee kahor kiliinikada ayaa muujiyay xulasho sare oo GFH925 ah oo u jeeda G12C. Dabadeed, GFH925 si wax ku ool ah ayuu u joojiyaa marinnada calaamadaha ee hoose si uu u kiciyo apoptosis-ka unugyada burooyinka iyo joojinta wareegga unugyada.
Fulzerasib waxay sidoo kale kasbatay talada Heerka 1aad ee daawaynta KRAS G12C-mutant NSCLC ee tilmaamaha CSCO ee 2025, iyadoo bukaanada siinaysa ikhtiyaar cusub oo daaweyn bartilmaameedsan oo leh waxtar waara iyo dulqaad wanaagsan.
Sida laga soo xigtay xogta wejiga II ee daraasadda diiwaangelinta ee bukaannada qaba KRAS G12C mutant NSCLC, daaweynta fulzerasib monotherapy waxay gaartay ORR oo ah 49.1% iyo PFS dhexdhexaad ah oo ah 9.7 bilood; heerka OS-ga 12-ka bilood ah wuxuu ahaa 54.4%, heerka DoR-ka 12-ka bilood ahna wuxuu ahaa 53.7%. Daaweynta monotherapy-ga waxaa sidoo kale la siiyay laba Magacaab oo loogu talagalay daaweynta bukaannada kansarka mindhicirka iyo KRAS G12C ee horumarsan.
Daraasadda KROCUS ee fulzerasib oo ay hoggaaminayso GenFleet oo ay weheliyaan khubarada ugu sarreeya ee kansarka sambabka ee Yurub, oo ay weheliso cetuximab ayaa sidoo kale waxtar cajiib ah u leh dhammaan bukaannada NSCLC ee safka hore iyo gaar ahaan jawaab celinta burooyinka ee bukaannada qaba kansarka maskaxda. Intaa waxaa dheer, daawadani waxay muujisay badbaado/dulqaad wanaagsan marka loo eego daaweynta fulzerasib ee safka labaad iyo ka sarreeya daaweynta NSCLC. Iyada oo ah isku-darka hormuudka ah ee daawada KRAS G12C ee ka hortagga (fulzerasib) iyo antibody-ka ka hortagga EGFR (cetuximab) ee daaweynta kansarka sambabka ee safka hore, habkan cusub wuxuu leeyahay awoodda lagu aasaasayo SOC-ga jiilka xiga ee daaweynta NSCLC ee safka hore.
Sida laga soo xigtay xogta ku jirta qoraal kooban oo goor dambe soo baxay oo ku saabsan bandhigga yar ee afka ah ee shirkii sanadlaha ahaa ee Shirka Kansarka Sambabka ee Yurub (ELCC) ee 2025, 45 ka mid ah ka qaybgalayaasha tijaabada ah ayaa helay ugu yaraan hal qiimeyn burooyinka daaweynta ka dib laga bilaabo Janaayo 14 sanadkii 2025: ORR waxay gaartay 80%; DCR waxay gaartay 100%; mPFS waxay ahayd 12.5 bilood.
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.
Lambarka Taleefanka: 4008803716
Email:myimmnet@163.com
Waqtiga boostada: Luulyo-15-2025
