Ma Iune 26, 2025, hoʻolaha ʻo CARsgen ua ʻae ka National Medical Products Administration (NMPA) o Kina i ka New Drug Application (NDA) no satricabtagene autoleucel (“satri-cel”, CT041) (he moho huahana CAR T-cell autologous e kūʻē i ka protein Claudin18.2) no ka mālama ʻana i ka Claudin18.2-positive advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJA) i nā maʻi i hāʻule i ʻelua mau laina mua o ka lāʻau lapaʻau. Hoʻokumu nui ʻia ka waiho ʻana o NDA ma nā hopena o kahi hoʻokolohua lapaʻau open-label, multicenter, randomized controlled confirmatory Phase II (CT041-ST-01, NCT04581473) i mālama ʻia ma Kina. Ua hōʻike ʻia nā ʻikepili ma The Lancet a ma ka 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.
E pili ana iā Satri-cel
He moho huahana CAR T-cell autologous ʻo Satri-cel e kūʻē i ka protein Claudin18.2 nona ka hiki ke lilo i mua ma ka papa honua. Hoʻolālā ʻo Satri-cel i ka mālama ʻana i nā puʻupuʻu paʻa Claudin18.2-positive me ka nānā nui ʻana i ka G/GEJA a me ke kanesa pancreatic (PC). ʻO nā hoʻokolohua i hoʻomaka ʻia e komo pū ana me nā hoʻokolohua i hoʻomaka ʻia e ka mea noiʻi (CT041-CG4006, NCT03874897), kahi hoʻokolohua lapaʻau Phase II hōʻoia no G/GEJA holomua ma Kina (CT041-ST-01, NCT04581473), kahi hoʻokolohua hoʻopaʻa inoa Phase Ib no ka lāʻau lapaʻau adjuvant PC ma Kina (CT041-ST-05, NCT05911217), kahi hoʻokolohua i hoʻomaka ʻia e ka mea noiʻi no ka satri-cel e hoʻohana ʻia ma ke ʻano he lāʻau hoʻohui ma hope o ka lāʻau lapaʻau adjuvant i nā maʻi me ka G/GEJA i ʻoki ʻia (CT041-CG4010, NCT06857786), a me kahi hoʻokolohua lapaʻau Phase 1b/2 no ka adenocarcinoma gastric a pancreatic holomua ma ʻAmelika ʻĀkau (CT041-ST-02, NCT04404595).
Ua hāʻawi ʻia ʻo Satri-cel i ka Priority Review e ke Center for Drug Evaluation (CDE) o ka NMPA o Kina no ka mālama ʻana iā Claudin18.2-positive advanced G/GEJA i nā poʻe maʻi i hāʻule ma ka liʻiliʻi he ʻelua mau laina lapaʻau ma mua i Mei 2025. Ua hāʻawi ʻia ʻo Satri-cel i ka Breakthrough Therapy Designation e ka CDE o Kina NMPA no ka mālama ʻana iā Claudin18.2-positive advanced G/GEJA i nā poʻe maʻi i hāʻule ma ka liʻiliʻi he ʻelua mau laina lapaʻau ma mua i Malaki 2025. Ua hāʻawi ʻia ʻo Satri-cel i ka Regenerative Medicine Advanced Therapy designation e US FDA no ka mālama ʻana i ka G/GEJA holomua me nā puʻupuʻu Claudin18.2-positive i Ianuali 2022. Ua loaʻa iā Satri-cel ka Orphan Drug designation mai ka US FDA no ka mālama ʻana iā G/GEJA i Kepakemapa 2020.
I kēia manawa, nui nā hoʻokolohua lapaʻau o nā ʻenehana anti-cancer hou ma Kina e ʻimi nei i nā maʻi. I ke kūkākūkā ʻana i nā lāʻau lapaʻau a me nā ʻenehana hou, hiki iā ʻoe ke hoʻokaʻaʻike aku i ka Beijing South Region Oncology Hospital International Department.
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ʻO Qi, Changsong et al. ʻO Claudin-18 isoform 2-specific CAR T-cell therapy (satri-cel) e kū'ē i ka mālama ʻana i ke koho a ke kauka no ka maʻi ʻaʻai gastric a gastro-oesophageal junction i mālama mua ʻia (CT041-ST-01): kahi hoʻokolohua randomized, open-label, phase 2. ʻO ka Lancet, Volume 0, Issue 0
Ka manawa hoʻouna: Iune-26-2025