Kwanan nan, GenFleet TherapeuticsHukumar Kula da Magunguna (ISAF) ta Yankin Gudanarwa na Musamman na Macau na kasar Sin ta amince da Dupert®(fulzerasib, GFH925/IBI351) don maganin marasa lafiya da ke fama da cutar kansar huhu ta zamani (NSCLC) wacce ke dauke da maye gurbin KRAS G12C wadanda suka sami akalla magani daya na tsarin.
Fulzerasib ita ce maganin hana KRAS G12C na farko da aka samar a China wanda NMPA ta amince da shi tare da Tsarin Bitar Fifiko a watan Agusta na 2024.
Game da Dupert® (fulzerasib, KRAS G12C Inhibitor)
An gano shi ta GenFleet Therapeutics, fulzerasib (GFH925/IBI351) wani sabon maganin hana KRAS G12C ne, mai aiki da baki, wanda aka tsara don cimma nasarar musayar GTP/GDP yadda ya kamata, muhimmin mataki ne na kunna hanya, ta hanyar gyara ragowar cysteine na furotin KRAS G12C a hade kuma ba tare da juyawa ba. Nazarin zaɓin cysteine na farko ya nuna babban zaɓi na GFH925 zuwa G12C. Daga baya, GFH925 yana hana hanyar siginar da ke ƙasa don haifar da apoptosis na ƙwayoyin ƙari da kamawar zagayowar ƙwayoyin halitta.
Fulzerasib ta kuma sami shawarar Aji 1 a fannin magani ga KRAS G12C-mutant NSCLC a cikin jagororin CSCO na 2025, tana ba wa marasa lafiya sabon zaɓi na magani mai inganci mai ɗorewa da kuma juriya mai kyau.
A bisa ga bayanai na mataki na biyu na binciken rajista tsakanin marasa lafiya da ke fama da KRAS G12C mutant NSCLC, maganin fulzerasib monotherapy ya sami ORR na 49.1% da matsakaicin PFS na watanni 9.7; ƙimar OS na watanni 12 shine 54.4%, kuma ƙimar DoR na watanni 12 shine 53.7%. An kuma ba da izinin maganin na lokaci guda biyu don magance marasa lafiya da suka kamu da cutar KRAS G12C-mutant NSCLC da kuma waɗanda ke fama da cutar kansa ta hanji.
GenFleet ce ta jagoranci wannan binciken tare da haɗin gwiwar kwararru a fannin cutar kansar huhu na Turai, wanda aka yi a KROCUS, tare da haɗin gwiwar cetuximab, ya kuma ba da ingantaccen tasiri ga dukkan marasa lafiya na NSCLC na farko da kuma musamman martanin ƙari na musamman ga marasa lafiya da suka kamu da cutar kansar kwakwalwa. Bugu da ƙari, maganin ya nuna ingantaccen aminci/juriya fiye da maganin fulzerasib na biyu a cikin maganin NSCLC na biyu da sama. A matsayin haɗin farko na maganin hana KRAS G12C (fulzerasib) da maganin rigakafi na EGFR (cetuximab) a cikin maganin cutar kansar huhu na farko, wannan sabuwar hanyar tana da yuwuwar kafa SOC na gaba don maganin NSCLC na farko.
A cewar bayanai a cikin wani takaitaccen bayani da aka yi a wani ƙaramin jawabi na baki na taron shekara-shekara na Ciwon Huhu na Turai (ELCC) na 2025, mahalarta 45 na gwajin sun sami aƙalla kimanta ƙari ɗaya bayan magani kamar yadda aka yi a ranar 14 ga Janairu a 2025: ORR ya kai kashi 80%; DCR ya kai kashi 100%; mPFS ya kasance watanni 12.5.
A halin yanzu, har yanzu akwai gwaje-gwaje da yawa na asibiti na sabbin fasahohin yaƙi da cutar kansa a China waɗanda ke neman marasa lafiya. Tuntuɓi kan sabbin magunguna da fasahohi, zaku iya tuntuɓar Sashen Ƙasa da Ƙasa na Asibitin Oncology na Yankin Kudu na Beijing.
Lambar Waya: 4008803716
Email：myimmnet@163.com
Lokacin Saƙo: Yuli-15-2025