Na Mee 22, 2025, Kelun Bio kwupụtara na ngwa maka ihe ngosi ọhụrụ nke antigen 2 (TROP2) nke na-eduzi antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT, nke a makwaara dị ka SKB264/MK – 2870) (®) anabatala site na Center for Drug Evaluation (CDE) nke National Medical Products Administration (NMPA) nke China. Ihe ngosi ọhụrụ a bụ maka ọgwụgwọ nke ndị ọrịa toro eto nwere ọrịa kansa ara nke na-enweghị ike iwepụ ma ọ bụ nke na-adịghị mma (HR+) na nke na-akpata ọrịa kansa ara nke na-akpata 2-negative (HER2-) nke na-akpata 2-negative (HER2-) nke na-akpata 2-negative (BC) bụ ndị natara ọgwụgwọ endocrine mbụ na ọgwụgwọ sistemu ndị ọzọ na ọnọdụ dị elu ma ọ bụ nke na-akpata 2. Nnabata a dabere na nsonaazụ dị mma nke nyocha Phase 3 OptiTROP - Breast02. Ngwa a bụ ngwa ihe ngosi nke anọ maka sac - TMT nke NMPA nabatara.
OptiTROP – Breast02 bụ ọmụmụ ihe gbasara ahụike nke usoro nke atọ, nke a na-akpọ "open-label", nke nwere ọtụtụ etiti, nke nyochachara irè na nchekwa nke sacituzumab tirumotecan monotherapy na dose nke 5 mg/kg kwa izu abụọ (Q2W) ma e jiri ya tụnyere nhọrọ nke chemotherapy nke dọkịta na ndị ọrịa nwere kansa ara HR+/HER2- nke a na-anaghị ewepụ n'ógbè ma ọ bụ nke metastatic. Dabere na nyocha oge akọwapụtara, e mezuru njedebe arụmọrụ mbụ nke ọmụmụ ihe ahụike nke usoro nke atọ a. Ma e jiri ya tụnyere nhọrọ nke chemotherapy nke dọkịta, sac-TMT monotherapy gosipụtara mmụba dị mkpa na nke bara uru na njedebe mbụ nke nlanarị na-enweghị ọganihu (PFS) dịka kọmitii nyocha onwe onye kpuru ìsì (BIRC) si chọpụta, yana obere ihe egwu nke ọganihu ọrịa ma ọ bụ ọnwụ. Sac-TMT gosikwara usoro dị mma na nlanarị zuru oke (OS).
Na Mee 16, 2024, ebe nrụọrụ weebụ gọọmentị nke CDE kwupụtara na a ga-enyocha ngwa ahụ site na usoro nyocha na nkwenye mbụ. Nke a bụ ihe ngosi sac-TMT nke anọ iji gafee usoro nyocha na nkwenye mbụ nke CDE, yana ihe ngosi sat-TMT atọ gara aga akwadoro mgbe nyocha mbụ gasịrị.
Banyere sac-TMT (佳泰莱®)
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 kansa akpa ume nke na-abụghị obere sel (NSCLC), 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 sel tumor site na recombinant anti-TROP2 humanized monoclonal antibodies, nke mkpụrụ ndụ tumor na-etinye na endocytose 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.
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
Email：myimmnet@163.com
Oge ozi: Mee-27-2025