A ranar 20 ga Agusta 2025, Abbisko Therapeutics ta sanar da cewa Cibiyar Kimanta Magunguna (CDE) ta Hukumar Kayayyakin Lafiya ta Kasa ta China (NlPA) ta amince da aikace-aikacen lND na maganin hana PD-1 na Abbisko, ABSK043, tare da maganin hana Shanghai Alist Pharmaceuticals KRAS G12C, glecirasib, don maganin marasa lafiya na NscLc da ke dauke da maye gurbin KRAS G12C.
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
Shaidar WeChat: 17801183037
Email：myimmnet@163.com
Game da ABSK043
ABSK043 wani sabon abu ne, wanda ake samu a baki, kuma ƙaramin ƙwayar halitta mai hana PD-L1 wanda Abbisko Therapeutics ke mallaka gaba ɗaya. Kwayoyin ciwon daji na iya amfani da wuraren binciken garkuwar jiki kamar PD-1 da ligand PD-L1 don gujewa gano da share garkuwar jiki, ta haka ne ke hana ko iyakance martanin ƙwayoyin I, ABSK043 yana ɗaurewa da mai karɓar PD-L1 da kuma haifar da shiga cikin tantanin halitta, yana hana hulɗar PD-1/PD-L1 da kuma rage matsin lamba na kunna ƙwayoyin T da PD-L1 ke jagoranta. A cikin samfuran da suka gabata, ABSK043 ya nuna ingancin maganin ƙari wanda ya yi daidai da maganin rigakafi na PD-L1 da aka amince da shi. Duk da cewa akwai wasu ƙwayoyin rigakafi na monoconal guda biyu da aka amince da su a duk faɗin duniya, babu wani ƙwayar cuta ta PD-1/PD-L1 da aka amince da ita ta baki, amma a halin yanzu babu wani ƙwayar cuta ta PD-1/PD-L1 da aka amince da ita ta baki, ana ci gaba da binciken ABSK043 a cikin wani gwaji na asibiti na Phase l don ci gaba da ciwon daji a Ostiraliya da China.
A wani bincike na mataki na I (NCT04964375), ABSK043, wani maganin hana ƙwayoyin cuta na baki, mai ƙarfi, ƙaramin ƙwayar cuta ta PD-L1, ya nuna ingancinsa na farko.
Hanyoyi
An yi wa waɗanda suka kamu da ciwon daji mai tsanani allurar ABSK043 capsules, waɗanda suka kama daga 200 mg sau ɗaya a rana (QD) zuwa 1000 mg sau biyu a rana (BID), don tantance yanayin aminci da ingancin farko. Bugu da ƙari, an tantance alamun pharmacodynamic (PD), kamar aikin ƙwayoyin T da saman PD-L1.
Sakamako
Ya zuwa ranar ƙarshe (7 ga Yuni, 2024), an yi rijistar mutane 77 kuma an yi musu magani. Kashi 87.0% na mutane sun fuskanci mummunan sakamako na magani (TEAEs), kuma kashi 29.9% sun kasance ≥ Aji na 3. TEAEs ≥15% sun kasance anemia (22.1%). Ba a bayar da rahoton cutar neuropathy ta gefe ba. A cikin dukkan tasirin tasirin ƙungiyoyin magunguna masu aiki (600 mg BID, 800 mg BID, da 1000 mg BID), an lura da ORR na 24% (8/34) a cikin mutane 10 da ke fama da cutar kansa ta huhu (9 da aka riga aka yi wa magani da kuma 1 magani-baïve), ORR ya kasance 40% (4/10). Abin lura shi ne, 3 daga cikin 6 (50%) na EGFR sun canza kuma 1 daga cikin 2 (50%) na KRAS sun sami wani ɓangare na amsawa (PR). Duk masu amsawa uku da suka sami PD-L1 TPS ≥ 50% kuma sun ci gaba bayan aƙalla layi ɗaya na jiyya na EGFR TKI, gami da ƙarni na 3. Sauran martanin sun faru a cikin nau'ikan ciwon daji guda biyar masu gauraye: ciwon daji na ciki na MSI-H/dMMR, ciwon daji na endometrial na MSI-H/dMMR, ciwon daji na squamous cell na farji, ciwon nono (Lynch syndrome), da melanoma. Tsawon lokacin amsawa a cikin binciken shine watanni 17 (endometrial adenocarcinoma) kuma pt ɗin har yanzu yana kan magani. An lura da kunna ƙwayoyin T da raguwar da ta dogara da kashi a cikin bayyanar PD-L1 a saman bayan maganin ABSK043 a cikin dukkan ƙungiyoyin allurar BID.
Game da Glecirasib
Glecirasib (AST-24081) maganin hana KRAS G12C ne. Ana ci gaba da gwaje-gwaje da dama a China, Amurka da Turai ga marasa lafiya da ke fama da ciwon daji mai tsanani wanda ke ɗauke da maye gurbin KRAS G12C. Waɗannan sun haɗa da gwaje-gwajen maganin haɗin gwiwa tare da maganin hana SHP2 AST-24082 a cikin NSCLC da gwaje-gwajen maganin ciwon daji na pancreatic guda ɗaya. Bugu da ƙari, an ba da izinin maganin ciwon daji na pancreatic a Amurka da kuma sanya masa maganin nasara a China. A watan Mayu na 2025, ChinaNMPA ta amince da ƙaddamar da Glecirasib a kasuwa.
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
Shaidar WeChat: 17801183037
Email：myimmnet@163.com
Lokacin Saƙo: Agusta-21-2025