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FUCASO: Ọgwụgwọ BCMA CAR-T nke zuru oke nke mmadụ nwere arụmọrụ na nchekwa na-enweghị atụ

FUCASO bụ ọgwụgwọ CAR-T nke BCMA na-elekwasị anya na ya site n'aka IASO BIO, na-enye arụmọrụ na nchekwa na-enweghị atụ maka ọrịa myeloma ndị na-alọghachi azụ ma ọ bụ ndị na-adịghị ike. Site na ọnụego nzaghachi dị elu, mgbaghara na-adịgide adịgide, na profaịlụ nchekwa siri ike, FUCASO na-enye olileanya ọhụrụ maka ndị ọrịa ma na-esetịpụ ọkọlọtọ ọhụrụ na ọgwụgwọ CAR-T.

    nkọwa ngwaahịa

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    FUCASO, nke Nanjing IASO Biotechnology mepụtara, bụ ọgwụgwọ CAR-T dị egwu nke e mere kpọmkwem iji lekwasị anya na antigen B-cell maturation (BCMA). Ọgwụgwọ a pụtara ìhè maka arụmọrụ ahụike na nchekwa ya na-enweghị atụ, na-enye olileanya ọhụrụ maka ndị ọrịa nwere myeloma multiple myeloma (r/rMM) na-alaghachi azụ ma ọ bụ na-adịghị ike. FUCASO nke National Medical Products Administration (NMPA) kwadoro na June 30, 2023, FUCASO egosila nnukwu ihe ịga nke ọma na ngwa ahụike.

    Uru dị mkpa nke FUCASO

    Ọnụego Nzaghachi Dị Elu: FUCASO nwere Oke Nzaghachi zuru oke (ORR) nke 98.9% na ọnụego Nzaghachi zuru oke (CR) nke 82.4%, nke dị elu nke ukwuu karịa ọgwụgwọ ndị ọzọ dị.

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    Nkwụghachi Na-adịgide AdịgideNdị ọrịa ejiri FUCASO gwọọ egosila na ha nwere ike nweta ndụ ha site na ọganihu ruo na-enweghị ọganihu (PFS) ruo ọnwa iri na abụọ, nke gosiri na ha ga-enwe mgbaghara ogologo oge ma nwee ndụ ka mma.

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    Profaịlụ Nchekwa: Ebe ọ bụ na ọrịa Cytokine Release Syndrome (CRS) nke ≥3 na-eme naanị 1% nke ndị ọrịa na enweghị akụkọ gbasara ọrịa Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) nke ≥3, FUCASO na-enye nhọrọ ọgwụgwọ dị nchebe karịa ma e jiri ya tụnyere ọgwụgwọ CAR-T ndị ọzọ.

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    Ịrụ ọrụ ọnụ ahịaỌgwụgwọ FUCASO dị ọnụ ala karịa ọgwụgwọ ndị yiri ya dị na United States, nke na-eme ka ọ bụrụ nhọrọ bara uru maka ọtụtụ ndị ọrịa.

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    Nnweta zuru ụwa ọnụ: IASO BIO eguzobela netwọk ebe ọgwụgwọ zuru oke na China, nke nwere ike ijere ndị ọrịa sitere gburugburu ụwa ozi site na ndụmọdụ ruo na nlekọta mgbe ọgwụgwọ gasịrị.

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    Ihe Ịga nke Ọma n'Ọgwụgwọ

    Onye ọrịa mbụ ejiri FUCASO gwọọ enwetala ndụ afọ ise nke enweghị kansa, ihe dị ịrịba ama ma e jiri ya tụnyere nkezi Progression-Free Survival (PFS) nke naanị ọnwa 2.9 site na nlekọta nkịtị. Nke a na-egosipụta ike FUCASO nwere ịgbanwe ọdịdị ọgwụgwọ maka ọtụtụ myeloma.

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