Ngomhla wama-21 kuCanzibe, ngo-2025, i-InnoCare Pharma ibhengeze ukuba i-China National Medical Products Administration (NMPA) ivumile iMinjuvi® (tafasitamab), i-humanized Fc-modified cytolytic CD19 ejolise kwi-monoclonal antibody, kunye ne-lenalidomide, elandelwa yiMinjuvi monotherapy, yokunyanga izigulane zabantu abadala abane-relapse or refractory diffuse large B-cell lymphoma (DLBCL) abangafanelekanga ukufakelwa i-autologous stem cell transplant (ASCT). Le yi-antibody yokuqala ye-CD19 evunyiweyo yokunyanga i-relapse or refractory DLBCL eTshayina.
Malunga neTafasitamab
I-Tafasitamab yi-antibody ye-cytolytic CD19 eyenziwe yangumntu ejolise kwi-monoclonal antibody. I-Tafasitamab ibandakanya i-Fc domain eyakhiwe ngendlela eyiyo, elawula i-B-cell lysis ngokusebenzisa i-apoptosis kunye ne-immune effector mechanism kuquka i-Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) kunye ne-Antibody-Dependent Cellular Phagocytosis (ADCP).
UMorphoSys kunye no-Incyte bangene kwi: (a) ngoJanuwari 2020, isivumelwano sokusebenzisana kunye nelayisenisi yokuphuhlisa nokwenza i-tafasitamab ithengiswe kwihlabathi liphela; kwaye (b) ngoFebruwari 2024, isivumelwano apho i-Incyte yafumana amalungelo awodwa okuphuhlisa nokwenza i-tafasitamab ithengiswe kwihlabathi liphela.
Ngo-Agasti 2021, i-Incyte yangena kwisivumelwano sokusebenzisana nelayisenisi ne-InnoCare sokuphuhlisa kunye nokuthengiswa kwe-tafasitamab ngokukodwa kwi-hematology kunye ne-oncology eGreater China.
E-United States, iMonjuvi (tafasitamab-cxix) ifumene imvume ekhawulezileyo yi-US Food and Drug Administration ngokudibene ne-lenalidomide yokunyanga izigulane zabantu abadala abane-DLBCL ephinde yabuyela kwisimo sayo okanye engayichaziyo, kuquka ne-DLBCL evela kwi-lymphoma yezinga eliphantsi, kwaye abangafanelekiyo ukufakelwa i-autologous stem cell transplant (ASCT). EYurophu, iMinjuvi (tafasitamab) ifumene imvume yokuthengisa enemiqathango evela kwi-European Medicines Agency ngokudibeneyo ne-lenalidomide, ilandelwa yi-Minjuvi monotherapy, yokunyanga izigulane zabantu abadala abane-relaxed okanye relaxtory diffuse large B-cell lymphoma (DLBCL) abangafanelekanga ukufakelwa i-autologous stem cell transplant (ASCT).
Okwangoku, kusekho iimvavanyo ezininzi zeklinikhi zobuchwepheshe obutsha bokulwa nomhlaza eTshayina obufuna izigulane. Iingcebiso ngamayeza amatsha kunye nobuchwepheshe, ungaqhagamshelana neSebe leMicimbi yeZibhedlele ze-Oncology zaseBeijing South Region.
Inombolo yefowuni: 4008803716
Email：myimmnet@163.com
Ixesha leposi: Meyi-27-2025