NDA yachinayi ya Kelun-Biotech's TROP2 ADC sacituzumab tirumotecan (sac-TMT) Yovomerezedwa ndi Center for Drug Evaluation

Pa Meyi 22, 2025, Kelun Bio adalengeza kuti pempho la chizindikiro chatsopano cha trophoblast cell surface antigen 2 (TROP2)-directed antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT, yomwe imadziwikanso kuti SKB264/MK – 2870) (®) yavomerezedwa ndi Center for Drug Evaluation (CDE) ya National Medical Products Administration (NMPA) ya China. Chizindikiro chatsopanochi ndi cha odwala akuluakulu omwe ali ndi khansa ya m'mawere ya anthu osachira (HR+) komanso khansa ya m'mawere ya anthu (HER2-) (BC) yomwe idalandira kale chithandizo cha endocrine ndi njira zina zochiritsira m'malo apamwamba kapena otupa. Kuvomereza kumeneku kudachokera ku zotsatira zabwino za kafukufuku wa Gawo 3 wa OptiTROP – Breast02. Pempheroli ndi pempho lachinayi la chizindikiro cha sac – TMT lovomerezedwa ndi NMPA.

OptiTROP – Breast02 ndi kafukufuku wachipatala wa Gawo 3 wochitidwa mwachisawawa, wotseguka, wokhala ndi malo ambiri, womwe unayesa mphamvu ndi chitetezo cha sacituzumab tirumotecan monotherapy pa mlingo wa 5 mg/kg milungu iwiri iliyonse (Q2W) poyerekeza ndi chisankho cha dokotala cha chemotherapy mwa odwala omwe ali ndi khansa ya m'mawere yosachiritsika kapena yofalikira ya HR+/HER2- (immunohistochemistry [IHC] 0, IHC 1+, kapena IHC 2+/in situ hybridization [ISH]-). Kutengera kusanthula kwanthawi komwe kunanenedwa kale, gawo loyamba la effectiveness la kafukufuku wachipatala wa Gawo 3 linakwaniritsidwa. Poyerekeza ndi kusankha kwa dokotala kwa chemotherapy, sac – TMT monotherapy inawonetsa kusintha kwakukulu komanso kofunikira kuchipatala mu endpoint yoyamba ya progression-free survival (PFS) monga momwe adawunikira ndi komiti yowunikira yodziyimira payokha (BIRC), yokhala ndi chiopsezo chocheperako cha kupita patsogolo kwa matenda kapena kufa. Sac – TMT inawonetsanso njira yabwino yopulumukira (OS).

Pa Meyi 16, 2024, tsamba lovomerezeka la CDE linalengeza kuti Fomuyi iwunikidwanso kudzera mu njira yowunikira ndi kuvomereza zofunikira. Ichi ndi chizindikiro chachinayi cha sac-TMT chodutsa mu njira yowunikira ndi kuvomereza zofunikira za CDE, ndi zizindikiro zitatu zam'mbuyomu za sat-TMT zomwe zavomerezedwa pambuyo powunikira zofunikira.

Za sac-TMT (佳泰莱®)

Sac-TMT, chinthu chachikulu chomwe Kampaniyo imapanga, ndi TROP2 ADC yatsopano ya anthu yomwe Kampaniyo ili ndi ufulu wopezera zinthu zanzeru, zomwe zimayang'ana kwambiri zotupa zolimba monga khansa ya m'mapapo yopanda maselo ang'onoang'ono (NSCLC), BC, khansa ya m'mimba (GC), zotupa za m'mimba, pakati pa zina. Sac-TMT imapangidwa ndi cholumikizira chatsopano kuti igwirizane ndi katundu wolipira, choletsa topoisomerase I chochokera ku belotecan chokhala ndi chiŵerengero cha mankhwala-mpaka-antibody (DAR) cha 7.4. Sac-TMT imazindikira makamaka TROP2 pamwamba pa maselo a chotupa ndi ma antibodies a monoclonal opangidwa ndi recombinant anti-TROP2, omwe kenako amachotsedwa ndi maselo a chotupa ndikutulutsa KL610023 mkati mwa maselo. KL610023, monga choletsa topoisomerase I, imayambitsa kuwonongeka kwa DNA kwa maselo a chotupa, zomwe zimapangitsa kuti maselo asamayende bwino komanso kuti apoptosis ichitike. Kuphatikiza apo, imatulutsanso KL610023 m'malo ozungulira chotupa. Popeza KL610023 imatha kulowa mu nembanemba, imatha kuyambitsa zotsatira zowoneka ngati munthu akuyang'ana, kapena mwa kuyankhula kwina kupha maselo otupa omwe ali pafupi.

Pakadali pano, pali mayesero ambiri azachipatala a ukadaulo watsopano wothana ndi khansa ku China omwe akufuna odwala. Mukafunsira mankhwala ndi ukadaulo watsopano, mutha kulumikizana ndi Dipatimenti Yapadziko Lonse ya Chipatala cha Oncology ku Beijing South Region.

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