Ngomhlaka-21 Meyi 2025, i-InnoCare Pharma yamemezela ukuthi i-China National Medical Products Administration (NMPA) ivumile i-Minjuvi® (tafasitamab), i-antibody ye-cytolytic CD19 eyenziwe umuntu eqondisa i-monoclonal antibody, ihlanganiswe ne-lenalidomide, kulandele i-Minjuvi monotherapy, yokwelapha iziguli ezindala ezine-relapse or refractory diffuse large B-cell lymphoma (DLBCL) ezingafaneleki ukufakelwa i-autologous stem cell (ASCT). Lena yi-antibody yokuqala ye-CD19 evunyelwe ukwelashwa kwe-relapse or refractory DLBCL eShayina.
Mayelana neTafasitamab
I-Tafasitamab iyi-antibody ye-cytolytic CD19 eguqulwe yaba yi-humanized Fc eqondisa i-monoclonal. I-Tafasitamab ifaka i-Fc domain eklanywe ngendlela ethuthukisiwe, eqondisa i-B-cell lysis ngokusebenzisa i-apoptosis kanye ne-immune effect mechanism okuhlanganisa i-Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) kanye ne-Antibody-Dependent Cellular Phagocytosis (ADCP).
UMorphoSys no-Incyte bangene: (a) ngoJanuwari 2020, isivumelwano sokusebenzisana kanye neselayisensi sokuthuthukisa nokwenza i-tafasitamab ibe yintengiso emhlabeni jikelele; kanye (b) ngoFebhuwari 2024, isivumelwano lapho i-Incyte ithole khona amalungelo akhethekile okuthuthukisa nokwenza i-tafasitamab ibe yintengiso emhlabeni jikelele.
Ngo-Agasti 2021, i-Incyte yangena esivumelwaneni sokusebenzisana nelayisensi ne-InnoCare sokuthuthukiswa kanye nokuthengiswa okukhethekile kwe-tafasitamab ku-hematology kanye ne-oncology eGreater China.
E-United States, i-Monjuvi (tafasitamab-cxix) ithole imvume esheshayo yi-US Food and Drug Administration ngokuhlanganiswa ne-lenalidomide yokwelapha iziguli ezindala ezine-DLBCL ephinde yabuya noma engaphikisi kahle engachazwanga ngenye indlela, okuhlanganisa ne-DLBCL evela kwi-lymphoma yezinga eliphansi, futhi ezingafaneleki ukufakelwa i-autologous stem cell (ASCT). EYurophu, i-Minjuvi (tafasitamab) ithole imvume yokumaketha enemibandela evela kwi-European Medicines Agency ngokuhlanganiswa ne-lenalidomide, kulandelwe yi-Minjuvi monotherapy, yokwelapha iziguli ezindala ezine-relapse noma relactory diffuse large B-cell lymphoma (DLBCL) ezingafaneleki ukufakelwa i-autologous stem cell (ASCT).
Njengamanje, kusenezivivinyo eziningi zemitholampilo zobuchwepheshe obusha bokulwa nomdlavuza eShayina ezifuna iziguli. Ukubonisana ngemithi emisha kanye nobuchwepheshe, ungaxhumana noMnyango Wezizwe Ngezizwe Wesibhedlela iBeijing South Region Oncology.
Inombolo yocingo: 4008803716
Email：myimmnet@163.com
Isikhathi sokuthunyelwe: Meyi-27-2025