Thaum Lub Tsib Hlis 21, 2025, InnoCare Pharma tshaj tawm tias Tuam Tshoj National Medical Products Administration (NMPA) tau pom zoo rau Minjuvi® (tafasitamab), ib qho tshuaj cytolytic CD19 uas hloov kho tib neeg los ntawm Fc, ua ke nrog lenalidomide, ua raws li Minjuvi monotherapy, rau kev kho mob rau cov neeg laus uas muaj mob rov qab los yog tsis kho tau diffuse loj B-cell lymphoma (DLBCL) uas tsis tsim nyog rau autologous stem cell transplant (ASCT). Qhov no yog thawj CD19 antibody uas tau pom zoo rau kev kho mob ntawm DLBCL uas rov qab los lossis tsis kho tau hauv Suav teb.
Txog Tafasitamab
Tafasitamab yog ib hom tshuaj Fc-modified cytolytic CD19 uas tsom mus rau monoclonal antibody. Tafasitamab muaj ib qho engineered Fc domain, uas ua rau B-cell lysis los ntawm apoptosis thiab immune effector mechanism suav nrog Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) thiab Antibody-Dependent Cellular Phagocytosis (ADCP).
MorphoSys thiab Incyte tau nkag mus rau hauv: (a) thaum Lub Ib Hlis 2020, daim ntawv cog lus koom tes thiab daim ntawv tso cai los tsim thiab ua lag luam tafasitamab thoob ntiaj teb; thiab (b) thaum Lub Ob Hlis 2024, daim ntawv cog lus uas Incyte tau txais cov cai tshwj xeeb los tsim thiab ua lag luam tafasitamab thoob ntiaj teb.
Thaum Lub Yim Hli 2021, Incyte tau nkag mus rau hauv kev koom tes thiab daim ntawv cog lus tso cai nrog InnoCare rau kev tsim kho thiab kev lag luam tshwj xeeb ntawm tafasitamab hauv kev kho mob ntshav thiab oncology hauv Greater China.
Hauv Tebchaws Meskas, Monjuvi (tafasitamab-cxix) tau txais kev pom zoo sai los ntawm US Food and Drug Administration ua ke nrog lenalidomide rau kev kho mob rau cov neeg laus uas muaj DLBCL rov qab los yog tsis kho tau uas tsis tau teev tseg, suav nrog DLBCL uas tshwm sim los ntawm cov lymphoma qib qis, thiab cov neeg uas tsis tsim nyog rau autologous stem cell transplant (ASCT). Hauv Tebchaws Europe, Minjuvi (tafasitamab) tau txais kev tso cai ua lag luam los ntawm European Medicines Agency ua ke nrog lenalidomide, ua raws li Minjuvi monotherapy, rau kev kho mob rau cov neeg laus uas muaj relapsed lossis refractory diffuse large B-cell lymphoma (DLBCL) uas tsis tsim nyog rau autologous stem cell transplant (ASCT).
Tam sim no, tseem muaj ntau qhov kev sim tshuaj kho mob qog noj ntshav tshiab hauv Suav teb nrhiav cov neeg mob. Kev sab laj txog cov tshuaj tshiab thiab cov thev naus laus zis, koj tuaj yeem tiv tauj Beijing South Region Oncology Hospital International Department.
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Lub sijhawm tshaj tawm: Tsib Hlis-27-2025