Ngomhla wama-26 kuJuni, ngo-2025, i-CARsgen ibhengeza ukuba i-National Medical Products Administration (NMPA) yaseTshayina iyamkele iSicelo seMithi emiTsha (NDA) se-satricabtagene autoleucel (“satri-cel”, CT041) (imveliso ye-autologous CAR T-cell echasene neproteni ye-Claudin18.2) yokunyanga i-Claudin18.2-positive advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJA) kwizigulana eziye zasilela ubuncinane kwimigca emibini yonyango yangaphambili. Ukungeniswa kwe-NDA kusekelwe ikakhulu kwiziphumo zovavanyo lweklinikhi oluqinisekisiweyo lweSigaba sesiBini oluvulekileyo, oluneziko ezininzi, nolulawulwa ngokungacwangciswanga (CT041-ST-01, NCT04581473) olwenziwe eTshayina. Idatha iboniswe kwi-The Lancet nakwiNtlanganiso yoNyaka ye-2025 ye-American Society of Clinical Oncology (ASCO).
Malunga neSatri-cel
I-Satri-cel yimveliso ye-CAR T-cell ephuma kwi-autologous ngokuchasene neproteni yeClaudin18.2 enokuba yeyona iphambili kwihlabathi liphela. I-Satri-cel ijolise kunyango lwee-Claudin18.2-positive solid tumors, ijolise kakhulu kwi-G/GEJA kunye nomhlaza we-pancreatic (PC). Izilingo eziqalisiweyo ziquka izilingo eziqalwe ngumphengululi (CT041-CG4006, NCT03874897), uvavanyo lweklinikhi lweSigaba sesiBini oluqinisekisayo lwe-G/GEJA ephucukileyo eTshayina (CT041-ST-01, NCT04581473), uvavanyo lokubhalisa lweSigaba se-Ib lonyango lwe-PC adjuvant eTshayina (CT041-ST-05, NCT05911217), uvavanyo oluqalisiweyo ngumphengululi lwe-satri-cel oluza kusetyenziswa njengonyango lokuqinisa emva konyango lwe-adjuvant kwizigulana ezine-G/GEJA esusiweyo (CT041-CG4010, NCT06857786), kunye novavanyo lweklinikhi lweSigaba se-1b/2 lwe-advanced gastric okanye pancreatic adenocarcinoma eMntla Melika (CT041-ST-02, NCT04404595).
I-Satri-cel inikwe i-Priority Review yi-Center for Drug Evaluation (CDE) ye-NMPA yaseTshayina yokunyanga i-Claudin18.2-positive advanced G/GEJA kwizigulana eziye zasilela ubuncinane kwimigca emibini yonyango yangaphambili ngoMeyi 2025. I-Satri-cel inikwe i-Breakthrough Therapy Designation yi-CDE ye-NMPA yaseTshayina yokunyanga i-Claudin18.2-positive advanced G/GEJA kwizigulana eziye zasilela ubuncinane kwimigca emibini yonyango yangaphambili ngoMatshi 2025. I-Satri-cel inikwe i-Regenerative Medicine Advanced Therapy yi-US FDA yokunyanga i-G/GEJA ephucukileyo ene-Claudin18.2-positive tumors ngoJanuwari 2022. I-Satri-cel ifumene i-Orphan Drug evela kwi-US FDA yokunyanga i-G/GEJA ngoSeptemba 2020.
Okwangoku, kusekho iimvavanyo ezininzi zeklinikhi zobuchwepheshe obutsha bokulwa nomhlaza eTshayina obufuna izigulane. Iingcebiso ngamayeza amatsha kunye nobuchwepheshe, ungaqhagamshelana neSebe leMicimbi yeZibhedlele ze-Oncology zaseBeijing South Region.
Inombolo yefowuni: 4008803716
I-imeyile：myimmnet@163.com
UQi, uChangsong nabanye. Unyango lwe-CAR T-cell oluyi-isoform 2 (satri-cel) ngokuchasene nonyango olukhethwe ngugqirha kumhlaza wesisu okanye umhlaza we-gastro-oesophageal junction oye wanyangwa ngaphambili (CT041-ST-01): uvavanyo lwesigaba sesi-2 olucwangcisiweyo, oluvulekileyo. I-Lancet, uMqulu 0, Ingxaki 0
Ixesha leposi: Juni-26-2025