I te 21 o Mei, 2025, i panuitia e InnoCare Pharma kua whakaaetia e te China National Medical Products Administration (NMPA) te Minjuvi® (tafasitamab), he paturopi monoclonal CD19 kua whakarerekētia ki te Fc, me te hono atu ki te lenalidomide, ā, muri iho ko te Minjuvi monotherapy, hei rongoā i ngā tūroro pakeke me te lymphoma nui pūtau-B kua hoki mai, kua kore rānei e tika mō te whakawhitinga pūtau take autologous (ASCT). Koinei te paturopi CD19 tuatahi kua whakaaetia mō te rongoā i te DLBCL kua hoki mai, kua kore rānei e taea te rongoā i Haina.
Mō Tafasitamab
Ko Tafasitamab he paturopi monoclonal kua whakarerekētia ki te Fc kua whakahāngaihia ki te tangata, ā, he CD19 cytolytic kua whakarerekētia ki te Fc. Kei roto i te Tafasitamab he rohe Fc kua hangaia, e whakahaere ana i te pakaru o ngā pūtau-B mā te apoptosis me te tikanga whai hua ārai mate tae atu ki te Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) me te Antibody-Dependent Cellular Phagocytosis (ADCP).
I uru atu a MorphoSys rāua ko Incyte ki: (a) i te marama o Hānuere 2020, ki tētahi whakaaetanga mahi tahi me te raihana hei whakawhanake me te hokohoko i te tafasitamab puta noa i te ao; ā, (b) i te marama o Pēpuere 2024, ki tētahi whakaaetanga i whiwhi ai a Incyte i ngā mana motuhake ki te whakawhanake me te hokohoko i te tafasitamab puta noa i te ao.
I te marama o Ākuhata 2021, i uru atu a Incyte ki tētahi whakaaetanga mahi tahi me te raihana ki a InnoCare mō te whakawhanake me te hokohoko motuhake o te tafasitamab i roto i te hematology me te oncology i Haina Nui.
I te Hononga o Amerika, i whiwhi a Monjuvi (tafasitamab-cxix) i te whakaaetanga tere mai i te US Food and Drug Administration me te hono atu ki te lenalidomide mo te maimoatanga o nga turoro pakeke me te DLBCL kua hoki mai, kua kore ranei e tohua, tae atu ki te DLBCL e puta mai ana i te lymphoma iti, me te hunga kaore e tika mo te whakawhitinga pūtau take autologous (ASCT). I Uropi, i whiwhi a Minjuvi (tafasitamab) i te Whakaaetanga Hokohoko herenga mai i te European Medicines Agency me te hono atu ki te lenalidomide, a muri iho ko te Minjuvi monotherapy, mo te maimoatanga o nga turoro pakeke me te lymphoma pūtau-B nui kua hoki mai, kua kore ranei e tika mo te whakawhitinga pūtau take autologous (ASCT).
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