A ranar 21 ga Maris, 2025, Immunofoco ta sanar da cewa Cibiyar Kimanta Magunguna (CDE) a ƙarƙashin Hukumar Kula da Kayayyakin Lafiya ta Ƙasa (NMPA) a China ta ba da izinin amfani da maganin EpCAM mai ta'azzara ƙwayoyin cuta na CAR-T, IMC001, don aikace-aikacenta na biyu na Investigational New Drug (IND), tare da lambar karɓa CXSL2400901. Wannan aikace-aikacen IND an yi shi ne don magance ciwon daji na EpCAM mai tauri. A da, IMC001 ta sami amincewar IND a China da Amurka a watan Fabrairun 2024 don maganin ciwon daji na EpCAM mai ta'azzara ƙwayoyin cuta.
Kwayar halittar mannewar ƙwayoyin epithelial (EpCAM) tana da matuƙar bayyana a kan ƙwayoyin ciwon da aka samo daga epithelial, ciki har da ciwon makogwaro, ciwon hanji, ciwon daji na pancreas, ciwon daji na ovarian, ciwon huhu, ciwon daji na ciki, da ciwon nono. Sabanin haka, bayyanarsa ba ta da yawa a cikin kyallen jiki na yau da kullun. Duk da ƙalubale kamar sarkakiyar yanayin ƙwayoyin cuta da bambancin manufa, IMC001 ta nuna aminci mai kyau da inganci na farko a cikin gwaje-gwajen asibiti na baya-bayan nan don ciwon daji na ciki, saboda zaɓin manufa ta musamman da ƙirar kirkire-kirkire. Wannan ƙarin nuni yana da nufin ƙara bincika yuwuwar asibiti.
A cikin gabatarwar fosta a taron ASCO da CSCO na 2024, bayanan binciken asibiti na IIT na IMC001 sun nuna cewa daga cikin marasa lafiya 10 da aka kimanta da cutar kansar ciki ta ci gaba, ƙimar kula da cutar ta kasance 90%, tare da majiyyaci ɗaya a cikin rukunin ƙananan allurai 33.3% da biyu a cikin rukunin matsakaicin allurai 40% sun sami amsawar wani ɓangare (PR). Matsakaicin rayuwa gabaɗaya (OS) a cikin rukunin matsakaicin allurai ya wuce makonni 55. Wani majiyyaci a cikin rukunin matsakaicin allurai ya sami tabbacin PR kafin Mako na 24, wanda ya haifar da tiyatar gastrectomy mai ƙarfi a Mako na 27, kuma majiyyacin ya rayu fiye da watanni 22 kafin ranar ƙarshe.
Tabbatar da wannan ƙarin IND yana wakiltar muhimmin ci gaba wajen faɗaɗa binciken asibiti na IMC001 daga ciwon gastrointestinal zuwa ga manyan nau'ikan ciwon daji na epithelial, ciki har da ciwon huhu na ƙananan ƙwayoyin halitta (SCLC), ciwon nono mai tauri uku (TNBC), da sauran cututtukan daji.
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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Lokacin Saƙo: Afrilu-03-2025