Mayu 2023: Chimeric antigen receptor (CAR) T-cell far wani sabon ci gaba ne a fagen maganin cutar kansa. Nasu T-cell na majiyyaci ana gyaggyarawa ta kwayoyin halitta yayin aikin masana'anta don bayyana mai karɓa na roba wanda ke ɗaure zuwa antigen ƙari. Ana sawa jikin mai haƙuri da ƙwayoyin CAR T waɗanda aka girma don amfanin asibiti kuma suna shirye don yaƙar ƙwayoyin cutar kansa. Ko da yake ana ɗaukar maganin CAR T-cell a matsayin babban ci gaba a cikin rigakafin cutar kansa, ba tare da lahani ba.
Chimeric antigen receptor T-cell (CAR T-cell) far wani abu ne mai rushewa a cikin maganin cututtukan jini. Magungunan CAR T-cell guda shida a halin yanzu an amince da su daga Hukumar Abinci da Magunguna ta Amurka (FDA) (axicabtagene ciloleucel, brexucabtagene autoleucel, idecabtagene vicleucel, lisocabtagene maraleucel, tisagenlecleucel, da ciltacabtagene autoleucel), amma ɗaya ne (tisa-cel) miƙa a Koriya. A cikin wannan binciken, muna magana ne game da matsaloli da cikas da CAR T-cell magani yanzu ke fuskanta a Koriya, kamar matsaloli tare da samun damar haƙuri, farashi, da kuma biyan kuɗi.
A cikin 2021, yawancin kasuwancin Koriya sun yi tsalle cikin haɓakar hanyoyin CAR-T. Masu binciken masana'antu sun yi iƙirarin cewa kamfanonin biopharmaceutical na gida sun yi farin ciki tare da amincewar gida na Novartis' CAR-T far (abincin: tisagenlecleucel).
Ta hanyar gabatar da masu karɓar antigen na chimeric a cikin ƙwayoyin T na rigakafi, maganin CAR-T nau'in maganin tantanin halitta ne wanda ke kaiwa ga ƙwayoyin cutar kansa. Wani lokaci ana kiransa da "maganin maganin ciwon daji na mu'ujiza" saboda yawan martaninsa na ban mamaki.
Ƙirƙirar sa aiki ne mai wahala wanda ya haɗa da tara ƙwayoyin T na majiyyaci a asibiti da kuma noma su a cikin wurin da ke bin kyawawan ayyukan masana'antu (GMP).
CAR T-Cell samarwa da tsarin gudanarwa
Tisa-cel, samfurin CAR T-cell guda ɗaya mai lasisin kasuwanci a Koriya, ingantaccen salon salula ne mai sarrafa kansa wanda ke buƙatar ayyukan leukapheresis kafin gudummawar T-cell daga majiyyaci. Ƙirƙirar waɗannan sel daga baya an ba da amana ga masana'antun masana'antu masu lasisi (a cikin sauran sassan duniya). Ana aika samfuran da aka gama zuwa asibitoci don jiko na haƙuri bin masana'anta da ingantaccen dubawa [2]. Marasa lafiya suna fuskantar babban cikas saboda dabarar gudanarwa da ƙwarewar samar da ƙwayoyin CAR T-cell. Iyakantaccen ramukan samarwa na iya hana aiwatar da matakai masu nasara tunda samarwa ya dogara da ƙarfin aiki na masana'antun, yayin da katsewar sarkar samar da kayayyaki wani lokaci ke haifar da jinkirin da ba a zata ba.
Rashin ingantattun wuraren jiyya na CAR T-cell har yanzu wani muhimmin batu ne tare da samun damar haƙuri. Jiyya T-Sel ta riga ta cinye albarkatu da yawa saboda yana kira don ƙwararrun ƙwararrun masana da ingantattun more rayuwa [3]. Akwai buƙatar sashin kulawa mai zurfi, wurin aikin leukapheresis, isassun ma'ajin tantanin halitta, rukunin da aka tsara na asibiti tare da ƙayyadaddun ka'idoji don saka idanu da sarrafa marasa lafiya da ke fama da matsananciyar matsaloli, da rukunin asibiti tare da ingantaccen tsarin aiki. Likitocin jini, ƙwararrun ƙwararrun likitancin kulawa, likitocin neurologists, da ƙwararrun ma'aikatan aikin jinya ana buƙata koyaushe dangane da ma'aikatan lafiya. Ma'aikatar Abinci da Tsaro ta Koriya ta Koriya dole ne ta kimanta duk cibiyoyin da ke shirin ba da maganin CAR T-cell daidai da "aiki kan aminci da tallafi don ingantaccen magani na farfadowa da samfuran halittu masu ci gaba" da "takardar aiwatar da dokar a kan. aminci da goyan baya ga ci-gaban magungunan sake haɓakawa da samfuran ilimin halitta na ci gaba” [4]. Sakamakon haka, Seoul gida ne na zahiri ga yawancin wuraren jiyya na CAR T-cell na Koriya, yana ƙara ƙarin hani da aka riga aka yi.
Babban farashi & CAR T-Cell samar da magani a Koriya
Yawan tsadar magungunan da kamfanonin harhada magunguna na kasa da kasa suka kirkira ya sa majinyata na Koriya ke da wahala su samu damar yin amfani da su. Sakamakon haka, kasuwancin Koriya sun ƙirƙira kuma sun keɓance magungunan CAR-T a ƙoƙarin magance waɗannan batutuwa. Kasuwanci da yawa sun fara haɓaka hanyoyin kwantar da hankali na CAR-T ko kuma sun bayyana niyyar yin hakan, gami da Curocell, Abclon, GC Cell, Ticaros, Helixmith, Toolgen, Cllengene, Eutilex, da Vaxcell Bio.
A matsayin kamfanin Koriya na farko da ya fara gwajin gwaji na asibiti na CAR-T a Koriya, Curocell ya sami izini daga Ma'aikatar Abinci da Tsaro ta Drug a watan Fabrairu don gwajin gwaji na 1 na CRC01, ɗan takarar CAR-T.
Kamfanin ya yi amfani da fasaharsa ta musamman da aka sani da "cin nasara kan hana rigakafi" don haɓaka CRC01, CD19 CAR-T far wanda ke hana maganganun masu karɓar maganin rigakafi, PD-1 da TIGIT.
Bayan daukar majinyata da ke da babban lymphoma na B-cell wanda ya sake dawowa ko kuma ya koma baya bayan zagaye biyu ko fiye na chemotherapy, kamfanin a halin yanzu yana gudanar da gwajin a Cibiyar Kiwon Lafiya ta Samsung. Kamfanin Curocell, wanda ya fara jiyya a watan Afrilu, kwanan nan ya haifar da tsammanin ta hanyar fitar da binciken farko na bayanan rukunin sa na 1 mafi ƙanƙanta.
At101 ɗan takarar CD19 CAR-T ne, kuma Abclon sun ƙaddamar da sabon aikin neman magani don gwajin lokaci na 1 a watan Yuni. Marasa lafiya tare da sake dawowa ko juriya B-cell wanda ba Hodgkin's lymphoma su ne yawan jama'a na kamfanin.
Har yanzu dai mahukunta ba su ba kamfanin damar tafiya ba, ko da yake. GC Cell na da niyyar haɓaka maganin CAR-T a cikin Amurka, ba kamar Curocell da Abclon ba.
Ta hanyar Novacel, yana da niyyar aiwatar da gwaji na asibiti don takamaiman maganin CAR-T na mesothelin. Bugu da ƙari, kamfanin yana so ya magance m ciwon daji.
Manyan asibitocin jami'o'i sun fara binciken hanyoyin kwantar da hankali na CAR-T kuma suna shirye don kafa abubuwan more rayuwa masu alaƙa, don haka sha'awar hanyoyin CAR-T ba ta iyakance ga kasuwanci ba.
Cibiyar kula da kwayar halitta ta CAR-T ta farko a cikin al'umma da aka yi muhawara a watan Afrilu a Cibiyar Kiwon Lafiya ta Samsung. Asibitin Seoul St. Mary's da Eutilex sun sanya hannu a MOU a watan Satumba don yin aiki tare don haɓaka maganin CAR-T.
Bugu da ƙari, a farkon wannan watan Ma'aikatar Abinci da Kare Magunguna da Ma'aikatar Lafiya da Jin Daɗi sun ba wa asibitin Jami'ar Seoul albarka don gwajin asibiti na maganin CAR-T ga marasa lafiya na yara masu fama da cutar sankarar lymphoblastic mai muni.
