Na June 26, 2025, CARsgen kwupụtara na National Medical Products Administration (NMPA) nke China anabatala Ngwa Ọgwụ Ọhụrụ (NDA) maka satriccabtagene autoleucel ("satri-cel", CT041) (onye na-achọ ngwaahịa CAR T-cell autologous megide protein Claudin18.2) maka ọgwụgwọ nke adenocarcinoma gastric/gastroesophageal junction (G/GEJA) dị elu nke Claudin18.2 na ndị ọrịa dara ma ọ dịkarịa ala usoro ọgwụgwọ abụọ gara aga. Ntinye NDA dabere na nsonaazụ nke nnwale ahụike nke akara mepere emepe, multicenter, randomized controlled confirmatory Phase II clinical trial (CT041-ST-01, NCT04581473) emere na China. E gosipụtara data ahụ na The Lancet na na Nzukọ Kwa Afọ nke American Society of Clinical Oncology (ASCO) nke 2025.
Banyere Satri-cel
Satri-cel bụ ọgwụ CAR T-cell nke na-achọ ọgwụgwọ megide protein Claudin18.2 nke nwere ike ịbụ nke mbụ n'ụwa niile. Satri-cel na-elekwasị anya na ọgwụgwọ nke etuto siri ike Claudin18.2 nke nwere isi ihe na-elekwasị anya na G/GEJA na kansa pancreas (PC). Nnwale ndị a malitere gụnyere nnwale ndị onye nyocha malitere (CT041-CG4006, NCT03874897), nnwale ahụike nke Phase II maka G/GEJA dị elu na China (CT041-ST-01, NCT04581473), nnwale ndebanye aha Phase Ib maka ọgwụgwọ PC adjuvant na China (CT041-ST-05, NCT05911217), nnwale nke onye nyocha malitere maka satri-cel ka ejiri mee ihe dị ka ọgwụgwọ njikọta mgbe ọgwụgwọ adjuvant gasịrị na ndị ọrịa nwere G/GEJA ewepụrụ (CT041-CG4010, NCT06857786), na nnwale ahụike nke Phase 1b/2 maka adenocarcinoma afọ dị elu ma ọ bụ pancreas na North America (CT041-ST-02, NCT04404595).
E nyere Satri-cel Nyocha Mbụ site n'aka Center for Drug Evaluation (CDE) nke NMPA nke China maka ọgwụgwọ nke Claudin18.2-positive advanced G/GEJA na ndị ọrịa dara ma ọ dịkarịa ala usoro ọgwụgwọ abụọ gara aga na Mee 2025. E nyere Satri-cel Nhọpụta Breakthrough Therapy site na CDE nke NMPA nke China maka ọgwụgwọ nke Claudin18.2-positive advanced G/GEJA na ndị ọrịa dara ma ọ dịkarịa ala usoro ọgwụgwọ abụọ gara aga na Machị 2025. E nyere Satri-cel nhọpụta Regenerative Medicine Advanced Therapy site na US FDA maka ọgwụgwọ nke G/GEJA advanced nwere etuto Claudin18.2-positive na Jenụwarị 2022. Satri-cel natara nhọpụta Orphan Drug site na US FDA maka ọgwụgwọ G/GEJA na Septemba 2020.
Ugbu a, enwere ọtụtụ nnwale ahụike nke teknụzụ ọhụrụ na-egbochi kansa na China na-achọ ndị ọrịa. Maka ndụmọdụ gbasara ọgwụ na teknụzụ ọhụrụ, ị nwere ike ịkpọtụrụ Ngalaba Mba Nile nke Ụlọ Ọgwụ Oncology nke Beijing South Region.
Nọmba ekwentị: 4008803716
Ozi ịntanetị:myimmnet@163.com
Qi, Changsong na ndị ọzọ. Ọgwụgwọ mkpụrụ ndụ CAR T nke Claudin-18 nke nwere usoro abụọ (satri-cel) na ọgwụgwọ nke onye dọkịta họọrọ maka kansa afọ ma ọ bụ eriri afọ nke a na-agwọbu (CT041-ST-01): nnwale nke usoro nke abụọ, nke a na-emegheghị emeghe. Lancet, Mpịakọta 0, Mbipụta 0
Oge ozi: Juun-26-2025