A ranar 22 ga Mayu, 2025, Kelun Bio ta sanar da cewa Cibiyar Nazarin Magunguna (CDE) ta Hukumar Kayayyakin Lafiya ta Ƙasa (NMPA) ta ƙasar Sin ta amince da aikace-aikacen sabon alamar ƙwayar halittarta ta trophoblast cell surface antigen 2 (TROP2)-directed antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT, wanda kuma aka sani da SKB264/MK – 2870) (®). Wannan sabon alamar tana nufin maganin manya marasa lafiya da ba a iya cirewa ba a cikin gida ko kuma metastatic hormone receptor-positive (HR+) da kuma ɗan adam epidermal growth factor receptor 2-negative (HER2-) normal blood cancer (BC) waɗanda suka sami maganin endocrine da sauran hanyoyin magancewa a cikin yanayin ci gaba ko metastatic. Wannan karɓuwa ta dogara ne akan sakamako mai kyau na binciken Phase 3 OptiTROP - Breast02. Wannan aikace-aikacen shine aikace-aikacen nuni na huɗu don sac - TMT wanda NMPA ta amince da shi.
OptiTROP – Breast02 wani bincike ne na asibiti na Mataki na 3 wanda aka tsara bazuwar, wanda aka buɗe, wanda ke da cibiyoyi da yawa, wanda ya kimanta inganci da amincin maganin sacituzumab tirumotecan monotherapy a allurar 5 mg/kg a kowane mako biyu (Q2W) idan aka kwatanta da zaɓin likita na maganin chemotherapy a cikin marasa lafiya da ba a iya cirewa ba a cikin gida ko kuma waɗanda suka kamu da cutar kansar nono ta HR+/HER2- (immunohistochemistry [IHC] 0, IHC 1+, ko IHC 2+/in situ hybridization [ISH]-). Dangane da binciken wucin gadi da aka riga aka ƙayyade, an cimma babban tasirin wannan binciken asibiti na Mataki na 3. Idan aka kwatanta da zaɓin likita na maganin chemotherapy, maganin sac-TMT monotherapy ya nuna ci gaba mai mahimmanci da ma'ana a cikin babban ƙarshen rayuwa na rashin ci gaba (PFS) kamar yadda kwamitin bita mai zaman kansa (BIRC) ya tantance, tare da raguwar haɗarin ci gaban cuta ko mutuwa sosai. Sac-TMT kuma ya nuna kyakkyawan yanayi a cikin rayuwa gabaɗaya (OS).
A ranar 16 ga Mayu, 2024, gidan yanar gizon CDE ya sanar da cewa za a sake duba Aikace-aikacen ta hanyar tsarin bita da amincewa da fifiko. Wannan shine alama ta huɗu ta sac-TMT don shiga cikin tsarin bita da amincewa da fifiko na CDE, tare da amincewa da alamun sat-TMT guda uku a baya bayan bita na fifiko.
Game da sac-TMT (佳泰莱®)
Sac-TMT, wani muhimmin samfurin Kamfanin, wani sabon nau'in TROP2 ADC ne na ɗan adam wanda Kamfanin ke da haƙƙin mallakar fasaha, wanda ke niyya ga ciwace-ciwacen da suka ci gaba kamar ciwon huhu na ƙananan ƙwayoyin halitta (NSCLC), BC, ciwon ciki (GC), ciwon daji na mata, da sauransu. An haɓaka Sac-TMT tare da sabon mahaɗi don haɗa nauyin da ake buƙata, wani mai hana topoisomerase I na belotecan tare da rabon magani zuwa ga antibody (DAR) na 7.4. Sac-TMT musamman yana gane TROP2 a saman ƙwayoyin ciwon ta hanyar ƙwayoyin rigakafi na monoclonal masu sake haɗawa, wanda ƙwayoyin ciwon ke haifarwa kuma yana sakin KL610023 a cikin ƙwayoyin halitta. KL610023, a matsayin mai hana topoisomerase I, yana haifar da lalacewar DNA ga ƙwayoyin ciwon, wanda hakan ke haifar da kamawa da kuma apoptosis. Bugu da ƙari, yana kuma fitar da KL610023 a cikin yanayin ƙwayar ciwon. Ganin cewa KL610023 yana iya shiga cikin membrane, yana iya ba da damar tasirin gani, ko kuma a wata ma'anar yana kashe ƙwayoyin ƙari da ke kusa.
A halin yanzu, har yanzu akwai gwaje-gwaje da yawa na asibiti na sabbin fasahohin yaƙi da cutar kansa a China waɗanda ke neman marasa lafiya. Tuntuɓi kan sabbin magunguna da fasahohi, zaku iya tuntuɓar Sashen Ƙasa da Ƙasa na Asibitin Oncology na Yankin Kudu na Beijing.
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Lokacin Saƙo: Mayu-27-2025