I-NDA Ukwamukelwa kwe-Satri-cel yi-NMPA yase-China

NgoJuni 26, 2025, i-CARsgen imemezela ukuthi i-National Medical Products Administration (NMPA) yaseShayina yamukele i-New Drug Application (NDA) ye-satricabtagene autoleucel (“satri-cel”, CT041) (umkhiqizo we-CAR T-cell omelene ne-protein Claudin18.2) wokwelapha i-Claudin18.2-positive advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJA) ezigulini ezihlulekile okungenani imigqa emibili yokwelashwa kwangaphambilini. Ukuhanjiswa kwe-NDA kusekelwe kakhulu emiphumeleni yesivivinyo sezokwelapha esiqinisekisiwe seSigaba II esivulekile, esinezikhungo eziningi, esingahleliwe (CT041-ST-01, NCT04581473) esenziwa eShayina. Idatha yethulwe ku-The Lancet kanye noMhlangano Wonyaka we-American Society of Clinical Oncology (ASCO) ka-2025.

Mayelana ne-Satri-cel

I-Satri-cel iwumkhiqizo we-CAR T-cell ozimele ophikisana neprotheyini i-Claudin18.2 engaba ngowokuqala emhlabeni jikelele. I-Satri-cel ihlose ukwelashwa kwezimila eziqinile ze-Claudin18.2, igxile kakhulu ku-G/GEJA kanye nomdlavuza we-pancreatic (PC). Izivivinyo eziqalisiwe zifaka phakathi izivivinyo eziqalwe ngumcwaningi (CT041-CG4006, NCT03874897), isivivinyo somtholampilo seSigaba II esiqinisekisayo se-G/GEJA ethuthukisiwe eShayina (CT041-ST-01, NCT04581473), isivivinyo sokubhalisa seSigaba Ib sokwelashwa kwe-PC adjuvant eShayina (CT041-ST-05, NCT05911217), isivivinyo esiqalwe ngumcwaningi se-satri-cel esingasetshenziswa njengokwelashwa kokuhlanganiswa ngemva kokwelashwa kwe-adjuvant ezigulini ezine-G/GEJA ekhishwe (CT041-CG4010, NCT06857786), kanye nesivivinyo somtholampilo seSigaba 1b/2 se-adenocarcinoma yesisu noma ye-pancreatic ethuthukisiwe eNyakatho Melika (CT041-ST-02, NCT04404595).

I-Satri-cel inikezwe i-Priority Review yi-Center for Drug Evaluation (CDE) ye-NMPA yaseShayina yokwelapha i-Claudin18.2-positive advanced G/GEJA ezigulini ezihlulekile okungenani emigqeni emibili yokwelashwa ngoMeyi 2025. I-Satri-cel inikezwe i-Breakthrough Therapy Designation yi-CDE ye-NMPA yaseShayina yokwelapha i-Claudin18.2-positive advanced G/GEJA ezigulini ezihlulekile okungenani emigqeni emibili yokwelashwa kwangaphambilini ngoMashi 2025. I-Satri-cel inikezwe i-Regenerative Medicine Advanced Therapy yi-US FDA yokwelapha i-G/GEJA ethuthukisiwe enezimila ze-Claudin18.2-positive ngoJanuwari 2022. I-Satri-cel ithole i-Orphan Drug evela kwi-US FDA yokwelapha i-G/GEJA ngoSepthemba 2020.

Njengamanje, kusenezivivinyo eziningi zemitholampilo zobuchwepheshe obusha bokulwa nomdlavuza eShayina ezifuna iziguli. Ukubonisana ngemithi emisha kanye nobuchwepheshe, ungaxhumana noMnyango Wezizwe Ngezizwe Wesibhedlela iBeijing South Region Oncology.

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I-imeyili：myimmnet@163.com

UQi, uChangsong nabanye. Ukwelashwa kwe-CAR T-cell oku-isoform 2-specific (satri-cel) ngokuqhathaniswa nokwelashwa okukhethwa udokotela komdlavuza wesisu noma we-gastro-oesophageal junction oselashwe ngaphambilini (CT041-ST-01): ukuhlolwa okungahleliwe, okuvulekile, kwesigaba sesi-2. I-Lancet, uMqulu 0, Udaba 0