Pa Meyi 21, 2025, InnoCare Pharma yalengeza kuti China National Medical Products Administration (NMPA) yavomereza Minjuvi® (tafasitamab), mankhwala a Fc-modified cytolytic CD19 omwe amalimbana ndi monoclonal antibody, kuphatikiza lenalidomide, kutsatiridwa ndi Minjuvi monotherapy, kuti athandize odwala akuluakulu omwe ali ndi relapse or refractory diffuse large B-cell lymphoma (DLBCL) omwe sali oyenerera kuikidwa autologous stem cell transplant (ASCT). Uwu ndiye mankhwala oyamba a CD19 omwe avomerezedwa kuti athandize DLBCL yobwereranso kapena yokana ku China.
About Tafasitamab
Tafasitamab ndi gulu la maselo a chitetezo cha mthupi la Fc lomwe lasinthidwa kukhala la munthu lomwe limayang'anira ma antibody a monoclonal. Tafasitamab imaphatikizapo gulu la maselo a chitetezo cha mthupi, lomwe limayendetsa maselo a B kudzera mu apoptosis ndi njira yolimbana ndi chitetezo cha mthupi kuphatikizapo Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) ndi Antibody-Dependent Cellular Phagocytosis (ADCP).
MorphoSys ndi Incyte adalowa mu: (a) mu Januwale 2020, mgwirizano wogwirizana ndi chilolezo chopanga ndikugulitsa tafasitamab padziko lonse lapansi; ndi (b) mu February 2024, mgwirizano womwe Incyte adapeza ufulu wapadera wopanga ndikugulitsa tafasitamab padziko lonse lapansi.
Mu Ogasiti 2021, Incyte adalowa mgwirizano ndi layisensi ndi InnoCare kuti apange ndikugulitsa tafasitamab mu hematology ndi oncology ku Greater China.
Ku United States, Monjuvi (tafasitamab-cxix) idavomerezedwa mwachangu ndi US Food and Drug Administration pamodzi ndi lenalidomide pochiza odwala akuluakulu omwe ali ndi DLBCL yobwereranso kapena yokana yomwe sinatchulidwe mwanjira ina, kuphatikizapo DLBCL yochokera ku lymphoma yotsika, komanso omwe sali oyenerera kuikidwa kwa autologous stem cell transplant (ASCT). Ku Europe, Minjuvi (tafasitamab) idalandira chilolezo chogulitsa kuchokera ku European Medicines Agency pamodzi ndi lenalidomide, kutsatiridwa ndi Minjuvi monotherapy, pochiza odwala akuluakulu omwe ali ndi relaxed or refractory diffuse large B-cell lymphoma (DLBCL) omwe sali oyenerera kuikidwa kwa autologous stem cell transplant (ASCT).
Pakadali pano, pali mayesero ambiri azachipatala a ukadaulo watsopano wothana ndi khansa ku China omwe akufuna odwala. Mukafunsira mankhwala ndi ukadaulo watsopano, mutha kulumikizana ndi Dipatimenti Yapadziko Lonse ya Chipatala cha Oncology ku Beijing South Region.
Nambala ya Foni: 4008803716
Email：myimmnet@163.com
Nthawi yotumizira: Meyi-27-2025