Kua whakaaetia a Finotonlimab mō te whakamahi i te mate pukupuku pūtau squamous o te upoko me te kaki

I te 8 o Pēpuere, 2025, i whakaaetia e te National Medical Products Administration (NMPA) o Haina te finotonlimab a Sinocelltech Group Ltd, he paturopi monoclonal (mAb) mate-whakarite 1 (PD-1), hei whakamahi tahi me te chemotherapy e ahu mai ana i te platinum hei maimoatanga tuatahi mō te mate pukupuku squamous pūtau e hokihoki mai ana me/ranei e horapa ana o te mahunga me te kaki.

Ko te Finotonlimab he paturopi monoclonal momo IgG4 kua whakahōuhia ki te tangata, he mana pupuri hinengaro katoa tōna. Hei rongoā hou kua patenttia, he ahurei tōna hanganga ngota, ā, he painga tikanga hoki. Ka herea e Finotonlimab ki te PD-1 me te kaha nui, ka ārai i te ara PD-1/PD-L1, ka whakaora me te whakarei ake i te mahi patu ārai mate o ngā pūtau-T, ā, nā reira ka ārai i te tipu o te pukupuku.

HeI arotakehia e te whakamātautau matapōkere, matapo-rua wāhanga 3 te whai huatanga me te haumaru o te finotonlimab (SCT-I10A), he paturopi monoclonal mate pūtau 1 (PD-1) kua whakaritea, i honoa ki te cisplatin me te 5-fluorouracil (C5F) mō te maimoatanga raina tuatahi o te R/M HNSCC. I tohua matapōkeretia ngā tūroro whai mana (n = 370) 2:1 ki te whiwhi finotonlimab me te C5F (n = 247) placebo me te C5F rānei (n = 123). Ko te mutunga tuatahi ko te oranga whānui (OS). I roto i te rōpū finotonlimab me te C5F, ko te OS he 14.1 marama (95% wā whakawhirinaki (CI) 11.1–16.4), ki te whakarite ki te 10.5 marama (95% CI 8.1–11.8) i roto i te rōpū placebo me te C5F. Ko te ōwehenga mōrearea he 0.73 (95% CI 0.57–0.95, P = 0.0165), e tutuki ana i ngā paearu hiranga kua tautuhia mō te pito tuatahi. I whakaatuhia e Finotonlimab me te C5F te hiranga OS nui ki te whakataurite ki te C5F anake me te kōtaha haumaru e whakaaetia ana me te R/M HNSCC, e tautoko ana i tōna whakamahinga hei kōwhiringa maimoatanga raina-tuatahi mō te R/M HNSCC. Mā ēnei hua ka whakamanahia te whai huatanga me te haumaru o te whakakotahitanga o te finotonlimab me te C5F i roto i ngā tūroro Āhia me te R/M HNSCC.

I tēnei wā, he maha tonu ngā whakamātautau haumanu o ngā hangarau hou hei ārai i te matepukupuku i Haina e rapu ana i ngā tūroro. Mēnā kei te hiahia koe ki te kōrero mō ngā rongoā me ngā hangarau hou, ka taea e koe te whakapā atu ki te Tari Ao o te Hōhipera Oncology Rohe Tonga o Beijing.

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Ngā Tohutoro

1.国家药品监督管理局 (nmpa.gov.cn)

2.Finotonlimab me te chemotherapy i roto i te mate pukupuku o te upoko me te kaki e hokihoki ana, e horapa ana rānei: he whakamātautau matapōkere wāhanga 3 | Rongoā Taiao