N'oge na-adịbeghị anya, GenFleet TherapeuticsKwuru na Ụlọ Ọrụ Nchịkwa Ọgwụ (ISAF) nke Mpaghara Nchịkwa Pụrụ Iche nke Macau nke China akwadola Dupert®(fulzerasib, GFH925/IBI351) maka ọgwụgwọ nke ndị ọrịa nwere kansa akpa ume dị elu nke na-abụghị obere mkpụrụ ndụ (NSCLC) nke nwere mgbanwe KRAS G12C bụ ndị natara opekata mpe otu ọgwụgwọ sistemụ.
Fulzerasib bụ ọgwụ mgbochi KRAS G12C mbụ e mepụtara na China nke NMPA kwadoro NDA ya site na Nhọpụta Priority Review na Ọgọst 2024.
Banyere Dupert® (fulzerasib, KRAS G12C Inhibitor)
GenFleet Therapeutics chọpụtara fulzerasib (GFH925/IBI351) bụ ihe mgbochi KRAS G12C ọhụrụ, nke na-arụ ọrụ n'ọnụ, nke nwere ike ime ka mgbanwe GTP/GDP dị irè, nke bụ nzọụkwụ dị mkpa n'ịkwalite ụzọ, site n'ịgbanwe ihe fọdụrụ na cysteine nke protein KRAS G12C n'ụzọ na-enweghị mgbagha na nke na-enweghị mgbagha. Ọmụmụ ihe gbasara nhọrọ cysteine preclinical gosiri nnukwu nhọrọ nke GFH925 gaa na G12C. Mgbe nke ahụ gasịrị, GFH925 na-egbochi ụzọ mgbaàmà dị n'okpuru iji kpalite apoptosis nke mkpụrụ ndụ kansa na njide okirikiri sel.
Fulzerasib enwetawokwa ndụmọdụ Klas nke 1 n'ọgwụgwọ maka KRAS G12C-mutant NSCLC na ntuziaka CSCO nke 2025, na-enye ndị ọrịa nhọrọ ọhụrụ nke ọgwụgwọ ezubere iche nke nwere arụmọrụ na-adịgide adịgide na ezigbo ndidi.
Dịka data nke usoro nke abụọ nke ọmụmụ ndebanye aha n'etiti ndị ọrịa nwere mgbanwe KRAS G12C NSCLC si kwuo, ọgwụgwọ fulzerasib monotherapy nwetara ORR nke 49.1% na nkezi PFS nke ọnwa 9.7; ọnụego OS nke ọnwa 12 bụ 54.4%, na ọnụego DoR nke ọnwa 12 bụ 53.7%. E nyekwara ọgwụgwọ ahụ otu ugboro abụọ maka ọgwụgwọ ndị nwere ọrịa kansa KRAS G12C-mutant na ndị nwere kansa eriri afọ.
N'ịbụ onye GenFleet duziri, ya na ndị ọkachamara n'ihe gbasara kansa akpa ume na Europe, nnyocha KROCUS nke fulzerasib na njikọta ya na cetuximab nyekwara ezigbo irè n'ahụ ndị ọrịa NSCLC niile nke mbụ, ọkachasị ndị ọrịa nwere kansa akpa ume nke na-agbasa n'ụbụrụ. Na mgbakwunye, usoro ọgwụgwọ ahụ gosipụtara nchekwa/nkwụsi ike ka mma karịa fulzerasib monotherapy na ọgwụgwọ nke abụọ na nke karịrị NSCLC. Dịka njikọta mbụ nke KRAS G12C inhibitor (fulzerasib) na antibody anti-EGFR (cetuximab) na ọgwụgwọ kansa akpa ume nke mbụ, ụzọ ọhụrụ a nwere ike ịmepụta SOC nke ọgbọ na-esote maka ọgwụgwọ NSCLC nke mbụ.
Dịka data dị na nchịkọta akụkọ a na-eme n'oge na obere ngosipụta ọnụ nke nzukọ kwa afọ nke European Lung Cancer Conference (ELCC) nke 2025 si kwuo, mmadụ 45 n'ime ndị sonyere na nnwale ahụ natara opekata mpe otu nyocha etuto ahụ mgbe ọgwụgwọ gasịrị dịka ọ dị na Jenụwarị 14 na 2025: ORR ruru 80%; DCR ruru 100%; mPFS dị ọnwa 12.5.
Ugbu a, enwere ọtụtụ nnwale ahụike nke teknụzụ ọhụrụ na-egbochi kansa na China na-achọ ndị ọrịa. Maka ndụmọdụ gbasara ọgwụ na teknụzụ ọhụrụ, ị nwere ike ịkpọtụrụ Ngalaba Mba Nile nke Ụlọ Ọgwụ Oncology nke Beijing South Region.
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Oge ozi: Julaị-15-2025