A ranar 21 ga Mayu, 2025, InnoCare Pharma ta sanar da cewa Hukumar Kayayyakin Lafiya ta Kasa ta China (NMPA) ta amince da Minjuvi® (tafasitamab), wani maganin rigakafi na Fc da aka gyara wanda ke nufin monoclonal antibody, tare da lenalidomide, sannan kuma maganin Minjuvi monotherapy, don maganin manya marasa lafiya da suka sake komawa ko suka sake komawa baya, wadanda ba su cancanci dashen ƙwayoyin halitta na autologous ba (ASCT). Wannan shine maganin rigakafi na farko na CD19 da aka amince da shi don maganin sake dawowa ko kuma wanda ya sake komawa baya a China.
Game da Tafasitamab
Tafasitamab wani nau'in antibody ne da aka gyara ta hanyar Fc wanda ke nufin monoclonal antibody. Tafasitamab ya haɗa da wani yanki na Fc wanda aka ƙera, wanda ke daidaita aikin ƙwayoyin B ta hanyar apoptosis da tsarin tasirin garkuwar jiki, gami da Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) da Antibody-Dependent Cellular Phagocytosis (ADCP).
MorphoSys da Incyte sun shiga cikin: (a) a watan Janairun 2020, yarjejeniyar haɗin gwiwa da lasisi don haɓaka da kuma tallata tafasitamab a duk duniya; da kuma (b) a watan Fabrairun 2024, yarjejeniya inda Incyte ta sami haƙƙin keɓancewa na haɓakawa da tallata tafasitamab a duk duniya.
A watan Agusta na shekarar 2021, Incyte ta shiga yarjejeniyar haɗin gwiwa da lasisi tare da InnoCare don haɓaka da kuma tallata tafasitamab na musamman a fannin ilimin jini da ciwon daji a Babban Birnin China.
A Amurka, Monjuvi (tafasitamab-cxix) ta sami amincewar gaggawa daga Hukumar Abinci da Magunguna ta Amurka tare da lenalidomide don maganin manya marasa lafiya da suka sake komawa ko suka sake komawa DLBCL wanda ba a ƙayyade shi ba, gami da DLBCL da ke tasowa daga ƙarancin lymphoma, kuma waɗanda ba su cancanci dashen ƙwayoyin halitta na autologous ba (ASCT). A Turai, Minjuvi (tafasitamab) ya sami izinin tallatawa na sharaɗi daga Hukumar Magunguna ta Turai tare da lenalidomide, sannan sai Minjuvi monotherapy, don maganin manya marasa lafiya da suka sake komawa ko suka sake komawa manyan ƙwayoyin halitta na B (DLBCL) waɗanda ba su cancanci dashen ƙwayoyin halitta na autologous ba (ASCT).
A halin yanzu, har yanzu akwai gwaje-gwaje da yawa na asibiti na sabbin fasahohin yaƙi da cutar kansa a China waɗanda ke neman marasa lafiya. Tuntuɓi kan sabbin magunguna da fasahohi, zaku iya tuntuɓar Sashen Ƙasa da Ƙasa na Asibitin Oncology na Yankin Kudu na Beijing.
Lambar Waya: 4008803716
Email：myimmnet@163.com
Lokacin Saƙo: Mayu-27-2025