I te 22 o Mei, 2025, i panuitia e Kelun Bio kua whakaaetia te tono mō tētahi tohu hou mō tana trophoblast cell surface antigen 2 (TROP2)-directed antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT, e mōhiotia ana ko SKB264/MK – 2870) (®) e te Center for Drug Evaluation (CDE) o te National Medical Products Administration (NMPA) o Haina. Ko tēnei tohu hou he mea hei rongoā mā ngā tūroro pakeke e pāngia ana e te mate pukupuku ū (HR+) kāore e taea te tango, te mate pukupuku ū rānei kua horapa te mate pukupuku ū (HR+) me te mate pukupuku ū human epidermal growth factor receptor 2-negative (HER2-) kua whiwhi i te rongoā endocrine me ētahi atu rongoā pūnaha i roto i te horopaki kua horapa te mate pukupuku. I ahu mai tēnei whakaae i ngā hua pai o te rangahau rēhitatanga Phase 3 OptiTROP – Breast02. Ko tēnei tono te tuawhā o ngā tono tohu mō te sac – TMT i whakaaetia e te NMPA.
He rangahau haumanu matapōkere, tuwhera-tapanga, maha-pokapū, Wāhanga 3 te OptiTROP – Breast02 i arotake i te whai huatanga me te haumaru o te sacituzumab tirumotecan monotherapy i te horopeta o te 5 mg/kg ia rua wiki (Q2W) i whakaritea ki te whiringa a te tākuta mo te chemotherapy i roto i ngā tūroro he mate pukupuku ū kua horapa ā-rohe, kua horapa rānei, kāore e taea te tango HR+/HER2- (immunohistochemistry [IHC] 0, IHC 1+, IHC 2+/in situ hybridization [ISH]-) kāore e taea te tango. I runga i te tātaritanga wā poto kua tohua i mua, i tutuki te pito mutunga whai huatanga tuatahi o tēnei rangahau haumanu Wāhanga 3. I whakaritea ki te whiringa a te tākuta mo te chemotherapy, i whakaatuhia e te monotherapy sac – TMT he whakapainga nui me te whai tikanga haumanu i roto i te pito mutunga tuatahi o te oranga kore-whakahaere (PFS) i aromatawaitia e te komiti arotake motuhake matapo (BIRC), me te iti haere o te mōrearea o te whanaketanga o te mate, te mate rānei. I whakaatuhia hoki e Sac – TMT he ia pai i roto i te oranga whānui (OS).
I te 16 o Mei, 2024, i pānuitia e te paetukutuku mana o te CDE ka arotakehia te Tono mā te tukanga arotake me te whakaae matua. Koinei te tuawhā o ngā tohu sac-TMT kua paahitia e te tukanga arotake me te whakaae matua o te CDE, me ngā tohu sat-TMT e toru o mua kua whakaaetia whai muri i te arotake matua.
Mō sac-TMT (佳泰莱®)
Ko Sac-TMT, he hua matua o te Kamupene, he TROP2 ADC tangata hou kei roto i te Kamupene ngā mana pupuri hinengaro, e aro ana ki ngā pukupuku totoka matatau pērā i te mate pukupuku pūkahukahu kore-pūtau iti (NSCLC), BC, mate pukupuku puku (GC), pukupuku wahine, me ētahi atu. Kua whakawhanakehia a Sac-TMT me tētahi hononga hou hei hono i te kawenga, he aukati topoisomerase I belotecan-derivative me te ōwehenga rongoā-ki-te-antibody (DAR) o te 7.4. Ka mōhio motuhake a Sac-TMT ki a TROP2 i runga i te mata o ngā pūtau pukupuku mā roto i ngā paturopi monoclonal anti-TROP2 recombinant, ka endocytosed e ngā pūtau pukupuku ka tukuna a KL610023 ki roto i te pūtau. Ko KL610023, hei aukati topoisomerase I, ka puta te kino o te DNA ki ngā pūtau pukupuku, ka arahi ki te aukati huringa pūtau me te apoptosis. Hei tāpiri, ka tukuna hoki a KL610023 ki roto i te taiao moroiti pukupuku. I te mea he uruhanga ā-kiri te KL610023, ka taea e ia te whakahohe i tētahi pānga tūmatanui, arā, te patu i ngā pūtau pukupuku e tata ana.
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.
Tau Waea：4008803716
Email：myimmnet@163.com
Wā tuku: Mei-27-2025