A ranar 26 ga Yuni, 2025, CARsgen ta sanar da cewa Hukumar Kayayyakin Lafiya ta Kasa (NMPA) ta kasar Sin ta amince da Amfani da Sabbin Magunguna (NDA) don maganin satriccabtagene autoleucel ("satri-cel", CT041) (wani samfurin CAR T-cell mai cin gashin kansa wanda ke adawa da furotin Claudin18.2) don maganin adenocarcinoma na ciki/gastroesophageal (G/GEJA) mai ci gaba da Claudin18.2 a cikin marasa lafiya da suka kasa cin nasara a kalla layuka biyu na magani a baya. Gabatarwar NDA ta dogara ne akan sakamakon gwajin asibiti na Phase II mai lakabin budewa, mai cibiya da yawa, wanda aka gudanar a kasar Sin (CT041-ST-01, NCT04581473). An gabatar da bayanan a cikin The Lancet da kuma taron shekara-shekara na American Society of Clinical Oncology (ASCO) na shekarar 2025.
Game da Satri-cel
Satri-cel wani samfurin ƙwayoyin T na CAR ne da ke da ikon yin tsayayya da furotin Claudin18.2 wanda ke da yuwuwar zama na farko a duniya. Satri-cel yana mai da hankali kan maganin ciwon daji na Claudin18.2 mai kyau tare da mayar da hankali kan G/GEJA da ciwon daji na pancreas (PC). Gwaje-gwajen da masu bincike suka fara sun haɗa da gwaje-gwajen da masu bincike suka fara (CT041-CG4006, NCT03874897), gwajin asibiti na Phase II mai tabbatarwa don ci gaban G/GEJA a China (CT041-ST-01, NCT04581473), gwajin rajista na Phase Ib don maganin PC mai taimako a China (CT041-ST-05, NCT05911217), gwajin da mai bincike ya fara yi don satri-cel da za a yi amfani da shi azaman maganin haɗaka bayan maganin adjuvant ga marasa lafiya da aka cire G/GEJA (CT041-CG4010, NCT06857786), da gwajin asibiti na Phase 1b/2 don ci gaban ciwon daji na ciki ko pancreas a Arewacin Amurka (CT041-ST-02, NCT04404595).
Cibiyar Nazarin Magunguna (CDE) ta ƙasar Sin ta ba wa Satri-cel Bita Mai Muhimmanci don maganin Claudin18.2-positive G/GEJA ga marasa lafiya waɗanda suka gaza aƙalla layukan magani biyu a watan Mayu na 2025. An ba wa Satri-cel Naɗi Mai Kyau daga CDE na NMPA na ƙasar Sin don maganin Claudin18.2-positive G/GEJA ga marasa lafiya waɗanda suka gaza aƙalla layukan magani biyu a baya a watan Mayu na 2025. An ba wa Satri-cel Naɗi Mai Kyau daga CDE na NMPA na ƙasar Sin don maganin Claudin18.2-positive G/GEJA ga marasa lafiya waɗanda suka gaza aƙalla layukan magani biyu a baya a watan Maris na 2025. Hukumar Kula da Lafiya ta Amurka (FDA) ta ba wa Satri-cel Naɗi Mai Kyau na Regenerative Medicine Advanced Therapy don maganin G/GEJA mai ci gaba tare da ciwon daji na Claudin18.2 a watan Janairu na 2022. Satri-cel ya sami naɗin Orphan Drug daga Hukumar Kula da Lafiya ta Amurka (FDA) don maganin G/GEJA a watan Satumba na 2020.
A halin yanzu, har yanzu akwai gwaje-gwaje da yawa na asibiti na sabbin fasahohin yaƙi da cutar kansa a China waɗanda ke neman marasa lafiya. Tuntuɓi kan sabbin magunguna da fasahohi, zaku iya tuntuɓar Sashen Ƙasa da Ƙasa na Asibitin Oncology na Yankin Kudu na Beijing.
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Qi, Changsong et al. Claudin-18 isoform 2-specific CAR T-cell therapy (satri-cel) idan aka kwatanta da maganin da likita ya zaɓa don ciwon daji na ciki ko na esophagus da aka yi wa magani a baya (CT041-ST-01): gwaji na mataki na 2 wanda aka tsara bazuwar, wanda aka buɗe. The Lancet, Juzu'i na 0, Issue 0
Lokacin Saƙo: Yuni-26-2025