A ranar 16 ga Maris, 2025, Akeso ta sanar da cewa Hukumar Kayayyakin Lafiya ta Kasa (NMPA) ta amince da sabuwar na'urar hana PD-1 monoclonal antibody mai suna penpulimab, don maganin cutar kansa ta nasopharyngeal mai sake dawowa ko kuma ta hanyar hada ta da chemotherapy.
Penpulimab (PD-1 Monoclonal Antibody) a halin yanzu ita ce kawai maganin rigakafi na monoclonal PD-1 da aka bambanta wanda ke amfani da nau'in IgG1 tare da ingantaccen Fc-nulldomain, wanda zai iya inganta tasirin immunotherapy da kuma rage mummunan halayen da ke da alaƙa da garkuwar jiki. Ana amfani da shi wajen magance manyan cututtuka kamar ciwon huhu, lymphoma, ciwon nasopharyngeal, ciwon hanta, da ciwon ciki, tare da ingantaccen aminci da inganci kamar yadda aka nuna a cikin nazarin asibiti.
Wannan shine alama ta huɗu da aka amince da ita don maganin penpulimab. Baya ga alamomi guda biyu na NPC, an kuma amince da penpulimab don maganin ciwon daji na huhu na farko (NSCLC) idan aka haɗa shi da maganin chemotherapy, da kuma maganin monotherapy ga marasa lafiya da suka sake komawa ko suka sake kamuwa da cutar Hodgkin lymphoma (cHL) waɗanda a baya suka sami aƙalla layuka biyu na maganin chemotherapy na tsarin jiki. Bugu da ƙari, ana sake duba ƙarin amfani da sabon magani (sNDA) don penpulimab tare da anlotinib don maganin ciwon daji na hanta na farko (HCC) a halin yanzu.
A da, an amince da amfani da penpulimab a matsayin magani na uku ga masu fama da cutar NPC mai ci gaba. Da wannan sabon amincewa, yanzu penpulimab tana ba da cikakken kariya ga magani a duk matakai na NPC, tana ba wa marasa lafiya damar ci gaba da zaɓin maganin rigakafi daga magani na farko zuwa na uku.
A ranar 19 ga Yuni, 2024, "Siginar Transduction da Manufa" ta buga sakamakon wani bincike na mataki na biyu kan maganin cutar kansa ta nasopharyngeal da aka yi wa magani a baya tare da pembrolizumab.
Wannan gwaji na hannu ɗaya, mataki na biyu da aka gudanar a cibiyoyin kula da tsofaffi 20 a China ya yi rajistar manyan marasa lafiya da ke fama da cutar kansa ta nasopharyngeal (NPC) waɗanda suka gaza a jere biyu ko fiye na maganin chemotherapy na tsarin da aka yi a baya. Marasa lafiya sun karɓi 200-mg penpulimab ta hanyar jijiya a kowace mako 2 (makonni 4 a kowace zagaye) har sai cutar ta ci gaba ko kuma gubar da ba za a iya jurewa ba. Babban ƙarshen ƙarshen shine ƙimar amsawa ta gaskiya (ORR) ga kowane RECIST (sigar 1.1), kamar yadda kwamitin bita na rediyo mai zaman kansa ya tantance. Ƙarshen ƙarshen na biyu ya haɗa da rayuwa ba tare da ci gaba ba (PFS) da rayuwa gabaɗaya (OS). An yi rajistar marasa lafiya ɗari da talatin kuma an kimanta ingancin 125. A ranar yanke bayanai (Satumba 28, 2022), majiyyaci 1 ya sami cikakken amsawa kuma marasa lafiya 34 sun sami rabin amsawa. ORR ya kasance 28.0% (95% CI 20.3–36.7%). Amsar ta kasance mai ɗorewa, tare da 66.8% har yanzu suna cikin amsawa a watanni 9. Marasa lafiya talatin da uku (26.4%) har yanzu suna kan magani. Matsakaicin PFS da OS sun kasance watanni 3.6 (95% CI = watanni 1.9–7.3) da watanni 22.8 (95% CI = watanni 17.1 ba a kai su ba), bi da bi. Marasa lafiya goma (7.6%) sun fuskanci matakin 3 ko sama da haka na irAEs. Penpulimab yana da ayyukan hana ƙari da kuma guba mai karɓuwa a cikin marasa lafiya da suka kamu da cutar NPC da aka riga aka yi musu magani, wanda ke tallafawa ci gaban asibiti a matsayin magani na uku na cutar NPC da ta kamu da cutar.
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: Afrilu-25-2025