Na Ọgọst 28, Center for Drug Evaluation (CDE) nke National Medical Products Administration (NMPA) kwupụtara na a na-atụ aro ka BL-B01D1 maka ịgba ọgwụ n'ime usoro nyocha mbụ. A na-eme ya maka ndị ọrịa nwere kansa nasopharyngeal na-emegharị ugboro ugboro ma ọ bụ ndị a gwọrọla na mbụ site na iji ọgwụ mgbochi monoclonal PD-1/PD-L1 ma ghara inweta ọgwụgwọ chemotherapy ma ọ dịkarịa ala ụzọ abụọ (nwere opekata mpe otu ahịrị nwere platinum).
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.
Nọmba ekwentị: 4008803716
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iza-bren bụ ADC nke mbụ n'ime klas nke mejupụtara antibody EGFR x HER3 bispecific nke ejikọtara na topo-I inhibitor payload ọhụrụ (Ed-04) site na njikọ a na-apụghị ịgbagha agbagha nke dabere na tetrapeptide. Usoro abụọ nke Iza-bren nke ime ihe na-egbochi EGFR na HER3 akara na mkpụrụ ndụ kansa, na-ebelata mmụba na akara ndụ. Na mgbakwunye, mgbe antibody na-abanye n'ime ahụ, a na-ahapụ ibu ọgwụgwọ iza-bren na-akpata nrụgide genotoxic nke na-eduga na ọnwụ mkpụrụ ndụ kansa.
E gosipụtara nsonaazụ nke BL-B01D1 n'ime ndị ọrịa nwere kansa akpa ume nke na-abụghị obere mkpụrụ ndụ (NSCLC) nke nwere mgbanwe mkpụrụ ndụ ihe nketa (GA) n'èzí mgbanwe EGFR nkịtị na Nzukọ Kwa Afọ nke American Society of Clinical Oncology (ASCO) nke 2025.
Ụzọ: Akụkụ nke Phase Ib nke ọmụmụ ihe a gụnyere ndị otu mgbasa, nke ọ bụla akọwapụtara site na GA akọwapụtara, gụnyere ntinye EGFR exon 20, mgbanwe EGFR na-abụghị nke oge ochie, mgbanwe na HER2, ALK, ROS1, BRAF (V600E na ndị ọzọ), KRAS (G12C na ndị ọzọ), SMARCA4, MET (Exon 14), RET, na NTRK. Ndị nwere GA ndị a gara n'ihu na ọgwụgwọ ebumnuche ọkọlọtọ (ọ bụrụ na ọ dị) na enweghị ihe karịrị otu usoro chemotherapy mbụ edenyere aha. E nyere iza-bren na 2.5 mg/kg D1D8 Q3W.
Nsonaazụ: Ruo Disemba 5, 2024, e debara aha 73 NSCLC nwere GA edepụtara. 5% ka nọ na ọgwụgwọ, mana ewepụrụ ha na nyocha ahụ n'ihi na ezughị ezu maka nyocha post-baseline mbụ (lee tebụl dị n'okpuru). N'ime 7% nwere ntinye EGFR exon 20, 85.7% (6 n'ime 7) nwetara cPR. N'ime 8% nwere mgbanwe KRAS G12C, 3 cPR na 1 PR na-echere nkwenye. A ga-egosi irè maka obere ndị otu. Ndị TRAE hematologic kachasị (ọkwa niile) bụ anaemia (87.7%), leukopenia (74.0%), thrombocytopenia (74.0%), na neutropenia (72.6%); Ndị TRAE kachasị na-anaghị agba ọbara bụ asthenia (42.5%), ọgbụgbọ (41.1%), stomatitis (37.0%), afọ ọsịsa (32.9%), na alopecia (31.5%). E nwere ike ijikwa TRAE nke ọkwa nke atọ na karịa, nke bụkarị ihe gbasara ọbara, site na iji usoro nkwado ọkọlọtọ gụnyere mbelata dose, dịka TRAE gosiri, nke butere ọnụego nkwụsị nke 2.7%. Naanị otu ikpe nke G2 ILD ka a hụrụ. Nke a pụtara ìhè bụ na a kọghị ọnwụ metụtara iza-bren. Ahụghị ihe mgbaàmà nchekwa ọhụrụ.
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.
Nọmba ekwentị: 4008803716
WeChat ID: 17801183037
Email：myimmnet@163.com
Oge ozi: Sep-05-2025