Ngomhlaka-13 kuNhlolanja 2026, i-Center for Drug Evaluation (CDE) ye-National Medical Products Administration yaseShayina yamemezela ukuthi amaphilisi e-GFH375 afakiwe ku-Breakthrough Therapy Designation yokwelapha iziguli ezine-KRAS G12D-mutant non-small cell lung cancer (NSCLC) ezithole okungenani ukwelashwa okukodwa kwangaphambilini kwesistimu.
Ukwephula Ikhodi Yenhloso "Engadakwa"
Ukuguqulwa kwe-KRAS kwake kwabhekwa umphakathi wezokwelapha njengomgomo “ongenakusetshenziswa.” Kodwa-ke, ngokuqhubeka kocwaningo lwesayensi, le nselele iyanqotshwa kancane kancane. I-KRAS G12D ingenye yezinhlobo ezivame kakhulu zokuguqulwa kwe-KRAS, evame ukubonwa ku-pancreatic ductal adenocarcinoma (PDAC), umdlavuza wamaphaphu ongewona amaseli amancane (NSCLC), kanye nomdlavuza we-colorectal.
Ukukhuthaza Idatha Yezokwelapha: I-GFH375 Ibonisa Umsebenzi Onamandla Wokulwa Nesimila
Idatha yezokwelapha evela esivivinyweni seSigaba soku-1 se-GFH375 ezigulini ezinezimila eziqinile ze-KRAS G12D-mutant ezithuthukisiwe, eyethulwe eMhlanganweni Waminyaka Yonke we-American Society of Clinical Oncology (ASCO) ka-2025, inikeze imiphumela ekhuthazayo. Idatha ibonise ukutholakala okuhle komlomo kanye nomsebenzi wokuvimbela izimila okhethwayo kakhulu we-GFH375. Kusukela ngosuku lokugcina idatha, iziguli ezingu-62 ezinezimila eziqinile ze-KRAS G12D-mutant ezithuthukisiwe ngaphambilini zazibhaliswe esivivinyweni seSigaba soku-1 se-GFH375 monotherapy.
AmaQembu Omthamo Oqondiwe: Ukusebenza Okuphawulekayo Okuphawulekayo
Phakathi kweziguli ezingu-49 ezithola imithamo yansuku zonke ye-400mg noma i-600mg ngomlomo, idatha yokusebenza kahle yayihlaba umxhwele kakhulu:
Izinga Lokuphendula Lenhloso Ephelele (ORR): Ezigulini ezingu-43 ezihlolwayo, i-ORR ifinyelele ku-42%, kanti Izinga Lokulawula Izifo (DCR) laliphezulu lifinyelela ku-91%.
Iziguli ze-Pancreatic Ductal Adenocarcinoma (PDAC): Phakathi kweziguli ze-PDAC ezingu-23 ezihlolwayo, i-ORR yayingu-52%, kanti i-DCR yafinyelela ku-100%.
Iziguli Ezingewona Amaseli Amancane Omdlavuza Wamaphaphu (i-NSCLC): Phakathi kweziguli eziyi-12 ze-NSCLC ezihlolwayo, i-ORR yayingu-42%, kanti i-DCR yayingu-83%.
Wonke Amaqoqo Omthamo: Umsebenzi Obanzi Nobalulekile
Ezigulini ezingu-52 eziqede okungenani ukuhlolwa kwesimila ngemva kokwelashwa, i-ORR kuzo zonke izilinganiso zomthamo yayingu-38%, kanye ne-DCR engu-90%. Okuphawulekayo ukuthi iziguli ezingu-38 zithole ukwehla kwezilonda zazo eziqondiwe, kanti iziguli ezingu-20 zithole impendulo engaphelele. Le datha yokuqala ikhombisa ukuthi i-GFH375 ibonisa umsebenzi obalulekile wokuvimbela isimila ezigulini ezinezimila eziqinile njenge-PDAC kanye ne-NSCLC, kufaka phakathi labo abaye bathuthuka ngemuva kwemigqa eminingi yokwelashwa.
Ukubhekana nalezi zindlela zokwelapha ezisezingeni eliphezulu, ukukhetha isikhungo sezokwelapha esikwazi ukuhlinzeka ngezinketho zokwelapha ezithuthukisiwe kanye nezinsizakalo eziphelele kubalulekile. UMnyango Wezangaphandle eBeijing South Region Oncology Hospital uzinikele ekuhlinzekeni ngezinsizakalo zokwelapha ezisezingeni eliphezulu zokuxilongwa komdlavuza kokubili iziguli zasekhaya nezakwamanye amazwe. Sihlala sazi ngentuthuko yakamuva ocwaningweni lwamazwe ngamazwe lwe-oncology futhi sizibophezele ekuletheni izindlela zokwelapha ezisezingeni eliphezulu njenge-GFH375 ezigulini ezidinga usizo ngokushesha okukhulu.
Izinzuzo zethu zifaka:
Izixazululo Zezokwelapha Ezisezingeni Eliphezulu: Sihambisana nezindinganiso zomhlaba wonke, sigxile futhi sethula izindlela zokwelapha ezithuthukisiwe ezifaka phakathi i-GFH375, sinikeza amathuba okwelapha angaba khona ezigulini ezinezinguquko ze-KRAS G12D.
Ithimba Lochwepheshe Abahlukahlukene: Sihlanganisa ochwepheshe abaphezulu be-oncology basekhaya ababambisana ekubonisaneni okuhlukahlukene ukuze bakhe izinhlelo zokwelapha eziqondene nomuntu ngamunye futhi ezinembile.
Izindinganiso Zesevisi Yamazwe Ngamazwe: Kusukela ekubonisaneni, ukuhlela ama-aphoyintimenti, izinsizakalo zokuhumusha kuya kuyo yonke inqubo yokwelashwa, sinikeza ukuxhumana okungenazinkinga kanye nensizakalo yokunaka, siqinisekisa ulwazi lwezokwelapha olukhululekile noluqinisekisayo lweziguli zamazwe ngamazwe kanye nemindeni yazo.
Ukusekelwa Okuphelele Kweziguli: Silwela ukwenza kahle hhayi nje ekwelashweni kodwa futhi sigxila enhlalakahleni yengqondo yeziguli kanye nekhwalithi yokuphila, sinikeza ukwesekwa nokunakekelwa.
Xhumana Nathi Manje Ukuze Uhlole Ithemba Elisha Lokwelashwa
Uma wena noma ilungu lomndeni litholakale linesifo somdlavuza wamaphaphu esingenamaseli amancane i-KRAS G12D-mutant noma ezinye izimila eziqinile futhi lingazange liphendule ngokwanele ezinkethweni zokwelapha ezikhona, sicela uxhumane noMnyango Wezizwe eBeijing South Region Oncology Hospital. Ithimba lethu lochwepheshe lizokunikeza ulwazi lwakamuva lwezokwelapha kanye nokuxilongwa komuntu siqu kanye nezincomo zokwelapha.
Sicela uxhumane nathi ngezindlela ezilandelayo:
Ucingo: 400-880-3716
I-WeChat: 17801183037
Email: 100085_010@163.com 或 myimmnet@163.com
Ungavumeli ibanga noma izithiyo zolimi zibe yizithiyo ekufuneni kwakho ukwelashwa okuthuthukile. UMnyango Wezizwe Zonke eBeijing South Region Oncology Hospital ulapha ukuze ume nawe ekulweni nomdlavuza.
Isikhathi sokuthunyelwe: Feb-25-2026