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FUCASO: ʻO ka lāʻau lapaʻau BCMA CAR-T kanaka piha me ka pono a me ka palekana i kūlike ʻole

He lāʻau lapaʻau CAR-T kipi ʻo FUCASO e IASO BIO e pili ana i ka BCMA, e hāʻawi ana i ka pono a me ka palekana ʻole no ka myeloma multiple relapsed a refractory paha. Me nā helu pane kiʻekiʻe, ke kala mau loa, a me kahi ʻano palekana paʻa, hāʻawi ʻo FUCASO i ka manaʻolana hou no nā maʻi a hoʻokumu i kahi kūlana hou i ka lāʻau lapaʻau CAR-T.

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    ʻO FUCASO, i hoʻomohala ʻia e Nanjing IASO Biotechnology, he lāʻau lapaʻau CAR-T hou loa i hoʻolālā kūikawā ʻia e kuhikuhi i ka B-cell maturation antigen (BCMA). Kū kēia lāʻau lapaʻau no kona pono lapaʻau a me ka palekana like ʻole, e hāʻawi ana i kahi manaʻolana hou no nā poʻe maʻi me ka relapsed a i ʻole refractory multiple myeloma (r/rMM). Ua ʻāpono ʻia e ka National Medical Products Administration (NMPA) ma Iune 30, 2023, ua hōʻike mua ʻo FUCASO i ka holomua koʻikoʻi i nā noi lapaʻau.

    Nā Pōmaikaʻi Koʻikoʻi o FUCASO

    Nā helu pane kiʻekiʻeʻO ka helu pane holoʻokoʻa (ORR) o 98.9% a me ka helu pane piha (CR) o 82.4%, ʻoi aku ke kiʻekiʻe ma mua o nā lāʻau lapaʻau ʻē aʻe i loaʻa.

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    Kala ʻana PaʻaUa hōʻike nā maʻi i mālama ʻia me FUCASO i kahi helu Progression-Free Survival (PFS) 12-mahina o 85.5%, e hōʻike ana i ke kala ʻana no ka wā lōʻihi a me ka hoʻomaikaʻi ʻana i ke ʻano o ke ola.

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    ʻIkepili PalekanaMe ka ≥3 grade Cytokine Release Syndrome (CRS) e kū nei i ka 1% wale nō o nā maʻi a ʻaʻohe hihia i hōʻike ʻia o ka ≥3 grade Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), hāʻawi ʻo FUCASO i kahi koho lapaʻau palekana i hoʻohālikelike ʻia me nā lāʻau lapaʻau CAR-T ʻē aʻe.

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    Ka Pono o ke KumukūʻaiʻOi aku ka liʻiliʻi o ke kumukūʻai o ka mālama ʻana iā FUCASO ma mua o nā ʻano like i loaʻa ma ʻAmelika Hui Pū ʻIa, e lilo ana ia i koho kūpono no kahi ākea o nā maʻi.

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    Hōʻea HonuaUa hoʻokumu ʻo IASO BIO i kahi pūnaewele kikowaena lapaʻau piha ma Kina, hiki ke lawelawe i nā maʻi mai ka honua holoʻokoʻa me nā lawelawe i hoʻohui ʻia mai ke kūkākūkā ʻana a i ka mālama ma hope o ka mālama ʻana.

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    Holomua Lapaʻau

    Ua loaʻa i ka mea maʻi mua i mālama ʻia me FUCASO ʻelima mau makahiki o ke ola ʻole ʻana mai ka maʻi kanesa, kahi hanana kupaianaha i hoʻohālikelike ʻia me ka median Progression-Free Survival (PFS) o 2.9 mau mahina wale nō me ka mālama maʻamau. Hōʻike kēia i ka hiki o FUCASO ke hoʻololi i ke ʻano lapaʻau no ka myeloma multiple.

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