Muva nje, i-GenFleet Therapeuticskumemezela ukuthi i-Pharmaceutical Administration Bureau (ISAF) ye-Macau Special Administrative Region yaseShayina ivumile i-Dupert®（fulzerasib, GFH925/IBI351）yokwelapha iziguli ezinomdlavuza wamaphaphu ongewona omncane othuthukisiwe (i-NSCLC) one-KRAS G12C mutation ezithole okungenani ukwelashwa okukodwa kwesistimu.
I-Fulzerasib yayiyi-KRAS G12C inhibitor yokuqala eyasungulwa eShayina eyavunyelwa yi-NDA nge-Priority Review Designation ngo-Agasti 2024 yi-NMPA.
Mayelana ne-Dupert® (fulzerasib, KRAS G12C Inhibitor)
Kutholakale yi-GenFleet Therapeutics, i-fulzerasib (GFH925/IBI351) iyi-KRAS G12C inhibitor entsha, esebenza ngomlomo, enamandla eyenzelwe ukuqondisa ngempumelelo ukushintshaniswa kwe-GTP/GDP, isinyathelo esibalulekile ekusebenzeni kwendlela, ngokushintsha i-cysteine residue yeprotheyini ye-KRAS G12C ngokuhlangana nangokungaguquki. Izifundo zokukhetha i-cysteine zangaphambi kokwelashwa zibonise ukukhetha okuphezulu kwe-GFH925 ku-G12C. Ngemuva kwalokho, i-GFH925 ivimbela ngempumelelo indlela yesignali engezansi ukuze ibangele i-apoptosis yamaseli esimila kanye nokuma komjikelezo weseli.
I-Fulzerasib iphinde yathola isincomo seKlasi 1 ekwelashweni kwe-KRAS G12C-mutant NSCLC kuziqondiso ze-CSCO zango-2025, inikeza iziguli inketho entsha yokwelashwa okuqondisiwe okusebenzayo okuhlala isikhathi eside kanye nokubekezeleleka okuhle.
Ngokusho kwedatha yesigaba sesi-II socwaningo lokubhalisa phakathi kweziguli ezine-KRAS G12C mutant NSCLC, i-fulzerasib monotherapy ithole i-ORR engu-49.1% kanye ne-PFS emaphakathi yezinyanga ezingu-9.7; izinga le-OS lezinyanga ezingu-12 lalingu-54.4%, kanti izinga le-DoR lezinyanga ezingu-12 lalingu-53.7%. I-monotherapy iphinde yanikezwa izikhundla ezimbili ze-Breakthrough Therapy zokwelapha iziguli ezithuthukile ze-KRAS G12C-mutant NSCLC kanye nomdlavuza we-colorectal.
Iholwa yiGenFleet ngokubambisana nochwepheshe abaphezulu bomdlavuza wamaphaphu baseYurophu, ucwaningo lwe-KROCUS lwe-fulzerasib luhlanganiswe ne-cetuximab luphinde lwanikeza ukusebenza okumangalisayo kuzo zonke iziguli ze-NSCLC zomugqa wokuqala kanye nokusabela okumangalisayo kwesimila phakathi kweziguli ezinesifo somdlavuza ebuchosheni. Ngaphezu kwalokho, uhlelo lubonise ukuphepha/ukubekezeleleka okungcono kunokwelashwa okukodwa kwe-fulzerasib ekwelashweni kwe-NSCLC komugqa wesibili nangaphezulu. Njengenhlanganisela yokuqala ye-KRAS G12C inhibitor (fulzerasib) kanye ne-antibody ye-EGFR (cetuximab) ekwelashweni komdlavuza wamaphaphu komugqa wokuqala, le ndlela entsha inamandla okusungula i-SOC yesizukulwane esilandelayo yokwelashwa kwe-NSCLC komugqa wokuqala.
Ngokusho kwedatha emfushane emfushane esethulweni esincane somlomo somhlangano waminyaka yonke we-European Lung Cancer Conference (ELCC) ka-2025, abangu-45 babahlanganyeli besivivinyo bathole okungenani ukuhlolwa kwesimila okukodwa ngemva kokwelashwa kusukela ngoJanuwari 14 ngo-2025: i-ORR ifinyelele ku-80%; i-DCR ifinyelele ku-100%; i-mPFS yayizinyanga ezingu-12.5.
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: Julayi-15-2025