Juun 26, 2025, CARsgen waxay ku dhawaaqday in Maamulka Badeecadaha Caafimaadka Qaranka (NMPA) ee Shiinaha uu aqbalay Codsiga Daawada Cusub (NDA) ee satriccabtagene autoleucel ("satri-cel", CT041) (oo ah musharax isku-dhafan oo CAR T-cell ah oo ka dhan ah borotiinka Claudin18.2) si loogu daaweeyo adenocarcinoma-gastric/gastroesophageal junction (G/GEJA) ee Claudin18.2-positive ee bukaanada ku guuldareystay ugu yaraan laba saf oo hore oo daaweyn ah. Soo gudbinta NDA waxay inta badan ku salaysan tahay natiijooyinka tijaabada caafimaad ee xaqiijinta Wajiga II ee furan, xarun badan, oo aan kala sooc lahayn (CT041-ST-01, NCT04581473) oo lagu sameeyay Shiinaha. Xogta waxaa lagu soo bandhigay The Lancet iyo shirkii sanadlaha ahaa ee Ururka Mareykanka ee Kansarka Caafimaadka (ASCO) ee 2025.
Ku saabsan Satri-cel
Satri-cel waa shirkad iskaa wax u qabso ah oo CAR T-cell ah oo ka soo horjeeda borotiinka Claudin18.2 kaasoo leh awood uu ku noqdo heerka koowaad ee adduunka. Satri-cel wuxuu bartilmaameedsadaa daaweynta burooyinka adag ee Claudin18.2-positive iyadoo diiradda la saarayo G/GEJA iyo kansarka ganaca (PC). Tijaabooyinka la bilaabay waxaa ka mid ah tijaabooyin ay baarayaashu bilaabeen (CT041-CG4006, NCT03874897), tijaabo caafimaad oo Wajiga II ah oo xaqiijinaysa G/GEJA ee horumarsan ee Shiinaha (CT041-ST-01, NCT04581473), tijaabo diiwaangelin ah oo Wajiga Ib ah oo loogu talagalay daaweynta PC ee lagu daweeyo fayraska korona ee Shiinaha (CT041-ST-05, NCT05911217), tijaabo uu bilaabay baare oo loogu talagalay cudurka korona ee loo isticmaalo daawaynta isku-darka ka dib daaweynta dheeraadka ah ee bukaanada qaba G/GEJA ee la jaray (CT041-CG4010, NCT06857786), iyo tijaabo caafimaad oo Wajiga 1b/2 ah oo loogu talagalay cudurka kansarka caloosha ama ganaca ee horumarsan ee Waqooyiga Ameerika (CT041-ST-02, NCT04404595).
Satri-cel waxaa la siiyay Dib-u-eegis Mudnaan leh oo ay samaysay Xarunta Qiimaynta Daawada (CDE) ee NMPA ee Shiinaha si loogu daaweeyo Claudin18.2-positive G/GEJA ee horumarsan ee bukaanada ku guuldareystay ugu yaraan laba nooc oo daaweyn ah bishii Maajo 2025. Satri-cel waxaa la siiyay Magacaabista Daaweynta Degdegga ah ee CDE ee NMPA ee Shiinaha si loogu daaweeyo Claudin18.2-positive G/GEJA ee horumarsan ee bukaanada ku guuldareystay ugu yaraan laba nooc oo daaweyn ah bishii Maarso 2025. Satri-cel waxaa la siiyay Magacaabista Daaweynta Sare ee Daawada Dib-u-cusboonaysiinta ee Mareykanka FDA si loogu daaweeyo G/GEJA ee horumarsan oo leh burooyinka Claudin18.2-positive bishii Janaayo 2022. Satri-cel waxay heshay Magacaabista Daawada Agoonta ee Mareykanka FDA si loogu daaweeyo G/GEJA ee horumarsan ee leh burooyinka Claudin18.2-positive bishii Sebtembar 2020.
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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Qi, Changsong et al. Claudin-18 isoform 2-gaar ah oo CAR T-cell therapy ah (satri-cel) marka loo eego daaweynta dhakhtarka doortay ee kansarka caloosha ama caloosha ee hore loo daaweeyay (CT041-ST-01): tijaabo aan kala sooc lahayn, calaamad furan, marxaladda 2. Lancet, Mugga 0, Arrinta 0
Waqtiga boostada: Juun-26-2025