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FUCASO: Kev Kho Mob BCMA CAR-T Uas Hloov Pauv Tag Nrho Rau Tib Neeg Nrog Kev Ua Haujlwm Zoo Thiab Kev Nyab Xeeb Tsis Sib Xws

FUCASO yog ib txoj kev kho mob CAR-T uas tsom mus rau BCMA los ntawm IASO BIO, muab kev ua haujlwm zoo tshaj plaws thiab kev nyab xeeb rau cov mob multiple myeloma uas rov qab los lossis tsis kho tau. Nrog rau cov lus teb siab, kev zam txim ntev, thiab cov ntaub ntawv kev nyab xeeb zoo, FUCASO muab kev cia siab tshiab rau cov neeg mob thiab teeb tsa tus qauv tshiab hauv kev kho mob CAR-T.

    cov ntsiab lus ntawm cov khoom

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    FUCASO, tsim los ntawm Nanjing IASO Biotechnology, yog ib txoj kev kho mob CAR-T tshiab uas tsim tshwj xeeb los tsom rau B-cell maturation antigen (BCMA). Txoj kev kho mob no sawv tawm rau nws qhov kev ua haujlwm zoo thiab kev nyab xeeb tsis muaj qhov sib piv, muab kev cia siab tshiab rau cov neeg mob uas rov qab mob lossis tsis kho tau ntau yam mob myeloma (r/rMM). Tau txais kev pom zoo los ntawm National Medical Products Administration (NMPA) thaum Lub Rau Hli 30, 2023, FUCASO twb tau ua pov thawj tias muaj kev vam meej hauv kev siv kho mob.

    Cov txiaj ntsig tseem ceeb ntawm FUCASO

    Cov Lus Teb SiabFUCASO muaj qhov ntsuas tag nrho (ORR) ntawm 98.9% thiab qhov ntsuas tag nrho (CR) ntawm 82.4%, siab dua li lwm yam kev kho mob muaj.

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    Kev zam txim ntevCov neeg mob uas tau kho nrog FUCASO tau pom tias muaj 12 lub hlis uas tsis muaj kev vam meej (PFS) ntawm 85.5%, qhia tias kev zam txim mus sij hawm ntev thiab lub neej zoo dua.

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    Cov Ntaub Ntawv Kev Nyab XeebTsuas yog 1% ntawm cov neeg mob uas muaj Cytokine Release Syndrome (CRS) theem ≥3 xwb thiab tsis muaj cov neeg mob uas muaj Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) theem ≥3, FUCASO muaj kev kho mob zoo dua piv rau lwm yam kev kho mob CAR-T.

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    Kev Siv Nyiaj ZooKev kho mob FUCASO pheej yig dua li cov kev kho mob zoo sib xws uas muaj nyob hauv Tebchaws Meskas, ua rau nws yog ib qho kev xaiv zoo rau ntau tus neeg mob.

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    Kev ncav cuag thoob ntiaj tebIASO BIO tau tsim kom muaj ib lub chaw kho mob thoob plaws hauv Suav teb, uas muaj peev xwm pab cov neeg mob thoob plaws ntiaj teb nrog cov kev pabcuam sib xyaw ua ke los ntawm kev sab laj mus rau kev saib xyuas tom qab kho mob.

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    Kev vam meej hauv kev kho mob

    Tus neeg mob thawj zaug uas tau kho nrog FUCASO tau ua tiav tsib xyoos ntawm kev ciaj sia tsis muaj mob qog noj ntshav, uas yog ib qho tseem ceeb heev piv rau qhov nruab nrab ntawm Kev Ciaj Sia Tsis Muaj Kev Loj Hlob (PFS) uas tsuas yog 2.9 lub hlis nrog kev saib xyuas tus qauv. Qhov no qhia txog FUCASO lub peev xwm los hloov pauv qhov kev kho mob rau ntau yam myeloma.

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