A ranar 10 ga Maris, 2025, Sichuan Kelun-Biotech ta sanar da cewa Hukumar Kayayyakin Lafiya ta Kasa (NMPA) ta amince da maganin trophoblast cell-surface antigen 2 (TROP2) wanda aka tsara don maganin antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT, wanda a da SKB264/MK-2870) don tallatawa don nuni na biyu wanda shine don maganin manya marasa lafiya da ke dauke da kwayar cutar epidermal growth factor receptor (EGFR) mutant-positive na gida ko kuma metastatic non-squamous non-squamous non-squamous non-squamous non-squamous lung cancer (NSCLC) bayan ci gaba da maganin EGFR-tyrosine kinase inhibitor (TKI) da kuma maganin chemotherapy na platinum. Wannan shine maganin TROP2 ADC na farko da aka amince da shi don tallatawa a cikin cutar kansar huhu a duniya. Idan aka kwatanta da tsarin kulawa na yanzu, sac-TMT yana ƙara yawan fa'idodin rayuwa na waɗannan marasa lafiya sosai.
Amincewar ta dogara ne akan wani bincike mai cibiya da yawa, bazuwar, mai sarrafawa, wanda aka gudanar (OptiTROP-Lung03) wanda ke kimanta inganci da amincin sac-TMT monotherapy 5mg/kg kowace mako biyu (Q2W) a matsayin allurar jijiya idan aka kwatanta da docetaxel don maganin marasa lafiya da suka kamu da cutar NSCLC mai saurin kamuwa da cutar EGFR a cikin gida ko kuma waɗanda suka kamu da cutar bayan magani da EGFR-TKI da chemotherapy bisa platinum (wanda aka yi amfani da shi a jere ko a hade). Kamar yadda aka nuna a cikin wani bincike na wucin gadi da aka riga aka ƙayyade, sac-TMT monotherapy ya nuna ci gaba mai mahimmanci da ma'ana a asibiti a cikin ƙimar amsawar da aka yarda da ita (ORR), rayuwa ba tare da ci gaba ba (PFS) da rayuwa gabaɗaya (OS) idan aka kwatanta da docetaxel.
Game da sac-TMT
Sac-TMT wani sabon magani ne na TROP2 ADC na ɗan adam wanda Kamfanin ke da haƙƙin mallakar fasaha, wanda ke nufin ciwace-ciwacen da suka ci gaba kamar NSCLC, ciwon nono (BC), ciwon ciki (GC), ciwon mata, da sauransu. An haɓaka Sac-TMT tare da sabon mahaɗi don haɗa nauyin da ake buƙata, wani maganin hana topoisomerase I na belotecan wanda aka samo asali 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 fitar da KL610023 ta 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 baya, NMPA ta amince da tallata sac-TMT a China ga manya marasa lafiya da ke fama da cutar kansar nono mai saurin yaduwa ko kuma wacce ba ta da saurin yaduwa (TNBC) waɗanda suka sami aƙalla magunguna biyu a baya (aƙalla ɗaya daga cikinsu don yanayin ci gaba ko na ci gaba) kuma sun karɓi ƙarin sabon magani (sNDA) suna neman amincewar sac-TMT monotherapy ga marasa lafiya da ke fama da cutar NSCLC mai canzawa ta EGFR waɗanda suka gaza bayan maganin EGFR-TKI.
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: Maris-20-2025