NDA Whakaaetanga o Satri-cel na te NMPA o Haina

I te 26 o Hune, 2025, ka panuitia e CARsgen kua whakaaetia e te National Medical Products Administration (NMPA) o Haina te New Drug Application (NDA) mō te satricabtagene autoleucel (“satri-cel”, CT041) (he hua pūtau-T CAR autologous e ārai ana i te pūmua Claudin18.2) mō te maimoatanga o te adenocarcinoma hononga puku/gastroesophageal matatau (G/GEJA) a Claudin18.2-positive i roto i ngā tūroro kua rahua i te iti rawa e rua ngā raina rongoā o mua. Ko te tuku NDA e ahu mai ana i ngā hua o tētahi whakamātautau haumanu Wāhanga II tuwhera-tapanga, maha-pokapū, matapōkeretia whakahaeretia (CT041-ST-01, NCT04581473) i whakahaerehia i Haina. Kua whakaaturia ngā raraunga ki roto i te The Lancet me te Hui-ā-Tau a te American Society of Clinical Oncology (ASCO) 2025.

Mō Satri-cel

He hua pūtau-T CAR autologous a Satri-cel hei ārai i te pūmua Claudin18.2, ā, tera pea ko ia te tuatahi o te ao. Ko te arotahi a Satri-cel ki te rongoā i ngā pukupuku totoka Claudin18.2-pai me te arotahi matua ki te G/GEJA me te mate pukupuku repeure (PC). Ko ngā whakamātautau i tīmatahia ko ngā whakamātautau i tīmatahia e te kairangahau (CT041-CG4006, NCT03874897), he whakamātautau haumanu Wāhanga II whakaū mō te G/GEJA matatau i Haina (CT041-ST-01, NCT04581473), he whakamātautau rēhita Wāhanga Ib mō te rongoā PC adjuvant i Haina (CT041-ST-05, NCT05911217), he whakamātautau i tīmatahia e te kairangahau mō te satri-cel ka whakamahia hei maimoatanga whakakotahi i muri i te rongoā adjuvant i roto i ngā tūroro me te G/GEJA kua tangohia (CT041-CG4010, NCT06857786), me te whakamātautau haumanu Wāhanga 1b/2 mō te adenocarcinoma puku, pancreatic rānei matatau i Amerika Te Raki (CT041-ST-02, NCT04404595).

Kua whakawhiwhia a Satri-cel ki te Priority Review e te Center for Drug Evaluation (CDE) o te NMPA o Haina mō te maimoatanga o te Claudin18.2-positive advanced G/GEJA i roto i ngā tūroro kua rahua i te iti rawa e rua ngā raina whakaora o mua i te marama o Mei 2025. Kua whakawhiwhia a Satri-cel ki te Breakthrough Therapy Designation e te CDE o te NMPA o Haina mō te maimoatanga o te Claudin18.2-positive advanced G/GEJA i roto i ngā tūroro kua rahua i te iti rawa e rua ngā raina whakaora o mua i te marama o Poutū-te-rangi 2025. I whakawhiwhia a Satri-cel ki te Regenerative Medicine Advanced Therapy designation e te US FDA mō te maimoatanga o te G/GEJA matatau me ngā pukupuku Claudin18.2-positive i te marama o Hanuere 2022. I whiwhi a Satri-cel i te Orphan Drug designation mai i te US FDA mō te maimoatanga o te G/GEJA i te marama o Hepetema 2020.

I tēnei wā, he maha tonu ngā whakamātautau haumanu o ngā hangarau hou hei ārai i te matepukupuku i Haina e rapu ana i ngā tūroro. Mēnā kei te hiahia koe ki te kōrero mō ngā rongoā me ngā hangarau hou, ka taea e koe te whakapā atu ki te Tari Ao o te Hōhipera Oncology Rohe Tonga o Beijing.

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Qi, Changsong et al. Te rongoā pūtau-T CAR motuhake-2 a Claudin-18 isoform 2 (satri-cel) me te maimoatanga i whiriwhiria e te tākuta mō te mate pukupuku puku, te mate pukupuku hononga gastro-oesophageal rānei kua rongoatia i mua (CT041-ST-01): he whakamātautau matapōkere, tuwhera-tapanga, wāhanga 2. The Lancet, Pukapuka 0, Putanga 0