ADC Sac-TMT nke Kelun-Biotech natara ọkwa ọgwụgwọ ọhụrụ na China.

Na June 11, Kelun-Biotech kwupụtara na ha emepụtara ọgwụ TROP2 ADC sac-TMT (佳泰莱) nke aka ha, yana ọgwụ mgbochi monoclonal PD-L1 monoclonal tagitanlimab (科泰莱"), enyerela aha Breakthrough Therapy (BTD) site na Center for Drug Evaluation (CDE) nke National Medical Products Administration (NMPA) nke China maka ọgwụgwọ mbụ nke ndị ọrịa nwere kansa akpa ume nke na-abụghị obere mkpụrụ ndụ ihe nketa (NSCLC) nke na-enweghị mgbanwe mkpụrụ ndụ ihe nketa.

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Sac-TMT, ihe bụ isi nke ụlọ ọrụ ahụ, bụ TROP2 ADC ọhụrụ nke mmadụ nke ụlọ ọrụ ahụ nwere ikike ikike ọgụgụ isi, na-elekwasị anya na etuto siri ike dị elu dịka NSCLC, kansa ara (BC), kansa afọ (GC), etuto ụmụ nwanyị, na ndị ọzọ. E mepụtara Sac-TMT site na njikọ ọhụrụ iji jikọta ibu ibu ahụ, ihe mgbochi topoisomerase I nke belotecan-derivative nwere oke ọgwụ-na-antibody (DAR) nke 7.4. Sac-TMT na-amata TROP2 kpọmkwem n'elu mkpụrụ ndụ tumor site na recombinant anti-TROP2 humanized monoclonal antibodies, nke mkpụrụ ndụ tumor na-etinye ma na-ewepụta KL610023 n'ime sel. KL610023, dị ka ihe mgbochi topoisomerase I, na-akpata mmebi DNA na mkpụrụ ndụ tumor, nke na-eduga na njide okirikiri sel na apoptosis. Na mgbakwunye, ọ na-ewepụtakwa KL610023 na gburugburu ebe obibi tumor. Ebe ọ bụ na KL610023 nwere ike ịbanye n'ime akpụkpọ ahụ, ọ nwere ike ime ka mmetụta nke onye na-ahụ ya n'anya, ma ọ bụ n'ikwu ya n'ụzọ ọzọ, gbuo mkpụrụ ndụ kansa ndị dị nso.

Nkọwa Ọgwụgwọ a dabere na arụmọrụ na nchekwa sitere na otu ndị na-abụghị squamous nke ọmụmụ Phase II OptiTROP-Lung01.

E gosipụtara nsonaazụ nke ọmụmụ OptiTROP-Lung01 Phase II, na-enyocha sac-TMT yana KL-A167 (ọgwụ mgbochi PD-L1 monoclonal antibody) dị ka ọgwụgwọ mbụ maka ndị ọrịa NSCLC nwere mkpụrụ ndụ ihe nketa na-adịghị mma, na Nzukọ Ọmụmụ Ihe Ọmụmụ CSCO nke afọ 2024.

Nchọpụta ndị a gosiri: Maka ndị otu 1A, nleba anya etiti bụ ọnwa 14.0, yana ọnụego nzaghachi ebumnuche (ORR) nke 48.6% (18/37, ikpe abụọ na-echere nkwenye), ọnụego njikwa ọrịa (DCR) nke 94.6%, ndụ na-enweghị ọganihu (PFS) nke ọnwa 15.4 (95% CI: 6.7, NE), na ọnụego PFS nke ọnwa 6 nke 69.2%; maka ndị otu 1B, nleba anya etiti bụ ọnwa 6.9, yana ORR nke 77.6% (45/58, ikpe 5 na-echere nkwenye), DCR nke 100.0%, PFS nke etiti erubeghị, na ọnụego PFS nke ọnwa 6 nke 84.6%.

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: Jun-12-2025