Kutshanje, iGenFleet Therapeuticsibhengeze ukuba i-Pharmaceutical Administration Bureau (ISAF) ye-Macau Special Administrative Region yaseTshayina ivumile i-Dupert®（fulzerasib, GFH925/IBI351）yonyango lwezigulane ezinomhlaza wemiphunga ongengowesincinci (NSCLC) oqhubekekayo one-KRAS G12C mutation ezifumene ubuncinane unyango olunye olusebenzayo.
I-Fulzerasib yayiyeyona inhibitor yokuqala ye-KRAS G12C eyaphuhliswa eTshayina eyavunywa yi-NDA yayo ngePriority Review Designation ngo-Agasti 2024 yi-NMPA.
Malunga neDupert® (fulzerasib, KRAS G12C Inhibitor)
Ifunyenwe yiGenFleet Therapeutics, i-fulzerasib (GFH925/IBI351) sisithinteli seKRAS G12C esisebenzayo ngomlomo, esinamandla esenzelwe ukujolisa ngempumelelo kwi-GTP/GDP exchange, inyathelo elibalulekileyo ekusebenzeni kwendlela, ngokuguqula intsalela ye-cysteine yeprotheyini yeKRAS G12C ngokudibeneyo nangokungenakuguquguquka. Izifundo zokukhetha i-cysteine zangaphambi kweklinikhi zibonise ukukhetha okuphezulu kwe-GFH925 kwi-G12C. Emva koko, i-GFH925 ithintela ngempumelelo indlela yesignali esezantsi ukuze ibangele i-apoptosis yeeseli zethumba kunye nokubanjwa komjikelo weseli.
IFulzerasib ikwafumene isincomo seKlasi yoku-1 kunyango lwe-KRAS G12C-mutant NSCLC kwizikhokelo ze-CSCO zika-2025, inika izigulane ukhetho olutsha lonyango olujoliswe kulo olusebenza ixesha elide kunye nokunyamezeleka okuhle.
Ngokwedatha yesigaba sesiBini sophononongo lokubhalisa phakathi kwezigulane ezine-KRAS G12C mutant NSCLC, i-fulzerasib monotherapy ifumene i-ORR ye-49.1% kunye ne-PFS ephakathi yeenyanga eziyi-9.7; izinga le-OS leenyanga ezili-12 yayiyi-54.4%, kwaye izinga le-DoR leenyanga ezili-12 yayiyi-53.7%. I-monotherapy ikwanikwe ii-Breakthrough Therapy Designations ezimbini zokunyanga i-KRAS G12C-mutant NSCLC kunye nezigulane zomhlaza we-colorectal.
Ikhokelwa yiGenFleet ngokubambisana neengcali eziphambili zomhlaza wemiphunga zaseYurophu, uphando lwe-KROCUS lwe-fulzerasib kunye ne-cetuximab lukwabonelele ngempumelelo emangalisayo kuzo zonke izigulana ze-NSCLC zodidi lokuqala kwaye ngakumbi impendulo ebalaseleyo yesifo semiphunga phakathi kwezigulana ezinesifo sobuchopho. Ukongeza, olu hlobo lonyango lubonise ukhuseleko/ukunyamezeleka okungcono kunonyango lwe-fulzerasib olulodwa kunyango lwe-NSCLC lodidi lwesibini nangaphezulu. Njengomdibaniso wokuqala we-KRAS G12C inhibitor (fulzerasib) kunye ne-anti-EGFR antibody (cetuximab) kunyango lomhlaza wemiphunga lodidi lokuqala, le ndlela intsha inamandla okuseka i-SOC yesizukulwana esilandelayo kunyango lwe-NSCLC lodidi lokuqala.
Ngokwedatha ekwisishwankathelo esisandul’ ukuphela kwintetho emfutshane yomlomo yentlanganiso yonyaka yeNgqungquthela yoMhlaza wamaLung yaseYurophu ka-2025 (ELCC), abathathi-nxaxheba abangama-45 kuvavanyo bafumene ubuncinane uvavanyo olunye emva konyango lwe-tumor ukususela nge-14 kaJanuwari ngo-2025: i-ORR ifikelele kwi-80%; i-DCR ifikelele kwi-100%; i-mPFS ibiziinyanga ezili-12.5.
Okwangoku, kusekho iimvavanyo ezininzi zeklinikhi zobuchwepheshe obutsha bokulwa nomhlaza eTshayina obufuna izigulane. Iingcebiso ngamayeza amatsha kunye nobuchwepheshe, ungaqhagamshelana neSebe leMicimbi yeZibhedlele ze-Oncology zaseBeijing South Region.
Inombolo yefowuni: 4008803716
Email：myimmnet@163.com
Ixesha leposi: Julayi-15-2025