Abriil 25, 2025, InnoCare Pharma waxay ku dhawaaqday in daawada cusub ee jiilka cusub ee pan-TRK ee zurletrectinib (ICP-723) ay siisay dib u eegis mudnaan leh Xarunta Qiimaynta Daawada (CDE) ee Maamulka Badeecadaha Caafimaadka Qaranka ee Shiinaha (NMPA), oo aqbashay Codsiga Daawada Cusub (NDA) ee zurletrectinib si loogu daaweeyo bukaanada qaba burooyinka adag ee horumarsan ee dhawaan ku jira isku-dhafka hidde-sidaha NTRK. Dib u eegista mudnaanta leh waa mid ka mid ah siyaasadaha muhiimka ah ee ay soo bandhigtay CDE si loo dedejiyo oggolaanshaha daawada.
Tijaabada diiwaangelinta ee bukaanada qaba burooyinka adag ee isku-dhafka NTRK, zurletrectinib waxay muujisay waxtar aad u wanaagsan oo leh astaamo badbaado oo wanaagsan.
Dr. Jasmine Cui, oo ah aasaasaha, guddoomiyaha iyo madaxa shirkadda InnoCare, ayaa tiri, "Aad ayaan ugu faraxsanahay in zurletrectinib la siiyay dib u eegis mudnaan leh. Zurletrectinib wuxuu muujiyay waxtar aad u wanaagsan iyo muuqaal badbaado oo wanaagsan. Waxaan rajeyneynaa inay siin doonto fursado daaweyn oo wanaagsan bukaanada u qalma ee qaba burooyinka adag goor hore."
Zurletrectinib waa daawo ka hortagta pan-TRK oo ay samaysay InnoCare. Joornaalka Ingiriiska ee Kansarka, oo qayb ka ah joornaalka sayniska ee ugu horreeya Nature, ayaa daabacay warqad cinwaankeedu ahaa "Zurletrectinib waa daawo ka hortagta TRK ee jiilka soo socda oo leh dhaqdhaqaaq xooggan oo gudaha maskaxda ah oo ka dhan ah burooyinka isku-dhafka NTRK oo leh iska caabin bartilmaameed ah oo ku wajahan wakiilada jiilka koowaad".
Wargeysku wuxuu tilmaamay in zurletrectinib uu muujiyay awood xooggan oo ka dhan ah kinases-ka TRKA, TRKB, iyo TRKC WT, iyo sidoo kale isbeddellada iska caabbinta ee la helay TRKA G595R iyo TRKA G667C. Zurletrectinib wuxuu ka firfircoonaa jiilka koowaad ee FDA ay ansixisay ama si caafimaad ahaan loo tijaabiyay (larotrectinib) iyo jiilka xiga (selitrectinib iyo repotrectinib) TRK inhibitors oo ka dhan ah inta badan isbeddellada iska caabbinta ee TRK inhibitors. Sidoo kale, zurletrectinib (1 mg/kg BID) wuxuu joojiyay koritaanka burooyinka ee moodooyinka xenograft ee laga soo qaatay unugyada isku-dhafka NTRK ee leh qiyaas 30 jeer ka hooseeya marka la barbar dhigo selitrectinib.
Warqaddu waxay si dheeraad ah u muujisay in, daraasad lagu sameeyay habdhiska dhexe ee neerfaha (CNS) oo lagu sameeyay jiirka SD, zurletrectinib wuxuu muujiyay awood uu ku dhex geli karo caqabadda dhiigga-maskaxda, isagoo si wax ku ool ah u gaaraya maskaxda marka loo eego selitrectinib iyo repotrectinib. Galmada maskaxda ee kordhay ee Zurletrectinib ayaa sidoo kale loo tarjumay firfircooni ka hortagga burooyinka oo la hagaajiyay. Qaabka glioma xenograft ee jiirka orthotopic-ga oo wata isbeddelka iska caabbinta TRKA G598R/G670A, zurletrectinib (15 mg/kg) ayaa si weyn u wanaajiyey badbaadada jiirarka qaba gliomas-ka orthotopic NTRK ee isku-dhafka ah, TRK-mutant gliomas (badbaadada dhexdhexaadka ah = 41.5, 66.5, iyo 104 maalmood oo loogu talagalay seletrectinib, repotrectinib, iyo zurletrectinib siday u kala horreeyaan; P < 0.05), oo muujinaya waxtar sare marka loo eego repotrectinib (15 mg/kg) iyo seletrectinib (30 mg/kg) (P=0.0384 iyo 0.0022, siday u kala horreeyaan), oo leh astaamo badbaado oo aad u fiican.
Hidde-sidayaasha isku-dhafka NTRK waxay ku dhacaan noocyo kala duwan oo burooyinka dadka waaweyn iyo carruurta ah. Burooyinka qaar ee naadirka ah, sida kansarka qanjidhada candhuufta, kansarka naasaha ee qarsoon, iyo fibrosarcoma-da carruurta, dhacdooyinka isku-dhafka hidda-wadaha NTRK waxay ka badan yihiin 90%. Waxaa lagu qiyaasaa in ay jiraan qiyaastii 6,500 oo kiis oo cusub oo ah burooyinka isku-dhafka NTRK ee isku-dhafka ah ee wanaagsan sannad kasta laga helo Shiinaha. Waxaa jira baahiyo caafimaad oo muhiim ah oo aan la dabooli karin oo ka jira aaggan sababtoo ah la'aanta ikhtiyaarrada daaweynta ee waxtarka leh.
Waqtigan xaadirka ah, waxaa weli jira tijaabooyin caafimaad oo badan oo ku saabsan teknoolojiyada cusub ee ka hortagga kansarka ee Shiinaha oo raadinaya bukaanno. La-tashi ku saabsan daawooyinka cusub iyo teknoolojiyada, waxaad la xiriiri kartaa Waaxda Caalamiga ah ee Isbitaalka Oncology ee Gobolka Koonfureed ee Beijing.
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Waqtiga boostada: Maajo-07-2025