Ngomhla we-13 kweyoMdumba ngo-2026, iZiko loVavanyo lwaMayeza (i-CDE) le-National Medical Products Administration yaseTshayina libhengeze ukuba iipilisi ze-GFH375 zibandakanyiwe kwi-Breakthrough Therapy Designation yokunyanga izigulana ezine-KRAS G12D-mutant non-small cell lung cancer (NSCLC) ezifumene ubuncinane unyango olunye lwangaphambili.
Ukuphula iKhowudi yeNjongo "engasebenzisi ziyobisi"
Utshintsho lwe-KRAS lwalukhe lwabonwa luluntu lwezonyango njengenjongo "engenakusetyenziswa". Nangona kunjalo, ngokuqhubeka kophando lwesayensi, olu celomngeni luyasoyiswa kancinci kancinci. I-KRAS G12D yenye yezona ntlobo zixhaphakileyo zotshintsho lwe-KRAS, ebonwa rhoqo kwi-pancreatic ductal adenocarcinoma (PDAC), umhlaza wamaphaphu ongengoweeseli ezincinci (NSCLC), kunye nomhlaza we-colorectal.
Ukukhuthaza Idatha Yeklinikhi: I-GFH375 Ibonisa Umsebenzi Onamandla Wokulwa Neethumba
Idatha yeklinikhi evela kuvavanyo lweSigaba soku-1 se-GFH375 kwizigulane ezinee-KRAS G12D-mutant solid tumors eziphambili, ezivezwe kwiNtlanganiso yoNyaka ye-2025 ye-American Society of Clinical Oncology (ASCO), inike iziphumo ezikhuthazayo. Idatha ibonise ukufumaneka kakuhle komlomo kunye nomsebenzi wokuthintela i-tumor okhethiweyo kakhulu we-GFH375. Ukusukela ngomhla wokugqibela wedatha, izigulane ezingama-62 ezinee-KRAS G12D-mutant solid tumors eziphambili ezazinyangwe ngaphambili zazibhaliswe kuvavanyo lweSigaba soku-1 lwe-GFH375 monotherapy.
Amaqela eeDosi ezijoliswe kuzo: Ukusebenza okuphawulekayo ngokukodwa
Phakathi kwezigulane ezingama-49 ezifumana iidosi zomlomo zemihla ngemihla ze-400mg okanye i-600mg, idatha yokusebenza yayimangalisa kakhulu:
Izinga lokuphendula kwiNjongo iyonke (ORR): Kwizigulane ezingama-43 ezivavanyiweyo, i-ORR ifikelele kwi-42%, kwaye izinga loLawulo lweZifo (DCR) laliphezulu ukuya kwi-91%.
Izigulane zePancreatic Ductal Adenocarcinoma (PDAC): Phakathi kwezigulane zePDAC ezingama-23 ezivavanyiweyo, i-ORR yayiyi-52%, kwaye i-DCR ifikelele kwi-100%.
Izigulane zomhlaza wamaphaphu ezingezizo ezincinci (i-NSCLC): Phakathi kwezigulane ezili-12 ze-NSCLC ezivavanyiweyo, i-ORR yayiyi-42%, kwaye i-DCR yayiyi-83%.
Onke Amaqela Eedosi: Umsebenzi Obanzi Nobalulekileyo
Kwizigulane ezingama-52 ezigqibe ubuncinane uvavanyo olunye lwe-tumor emva konyango, i-ORR kuzo zonke iidosi yayingama-38%, kunye ne-DCR engama-90%. Okuphawulekayo kukuba, izigulane ezingama-38 zifumana ukwehla kwizilonda zazo ekujoliswe kuzo, kwaye izigulane ezingama-20 zafumana impendulo engaphelelanga. Olu lwazi lokuqala lubonisa ukuba i-GFH375 ibonisa umsebenzi obalulekileyo wokuthintela i-tumor kwizigulane ezine-tumor eqinileyo efana ne-PDAC kunye ne-NSCLC, kuquka abo baye baqhubeka emva kweendlela ezininzi zonyango.
Ukujongana nolu tshintsho lwezonyango oluphambili, ukukhetha iziko lezonyango elikwaziyo ukubonelela ngeendlela zonyango eziphambili kunye neenkonzo ezipheleleyo kubalulekile. ISebe leMicimbi yeHlabathi kwiSibhedlele se-Oncology saseBeijing South Region lizinikele ekuboneleleni ngeenkonzo zokuxilonga umhlaza kunye nonyango oluphambili kwizigulane zasekhaya nezangaphandle. Sihlala sinolwazi ngezinto zamva nje kuphando lwe-oncology lwamazwe ngamazwe kwaye sizimisele ukuzisa unyango oluphambili olufana ne-GFH375 kwizigulane eziludingayo ngokukhawuleza.
Iingenelo zethu ziquka:
Izisombululo Zonyango Ezisemgangathweni: Sihambisana nemigangatho yamazwe ngamazwe, sigxile kwaye sazisa iindlela zonyango eziphambili kuquka i-GFH375, sinika amathuba onyango anokusetyenziswa kwizigulana ezine-KRAS G12D mutations.
Iqela leeNgcali eziNxibelelana neMicimbi eMininzi: Sidibanisa iingcali eziphambili ze-oncology zasekhaya ezisebenzisana kwiingcebiso ezinxibelelana neMicimbi eMininzi ukuze kuphuhliswe izicwangciso zonyango ezilungiselelwe umntu ngamnye nezichanekileyo.
Imigangatho yeNkonzo yaMazwe ngaMazwe: Ukususela kwingcebiso, ucwangciso lweentlanganiso, iinkonzo zokuguqulela ukuya kuyo yonke inkqubo yonyango, sinikezela ngonxibelelwano olungenamthungo kunye nenkonzo yokukhathalela, siqinisekisa amava ezonyango akhululekileyo naqinisekisayo kwizigulana zamazwe ngamazwe kunye neentsapho zazo.
Inkxaso Epheleleyo Yezigulane: Sizama ukugqwesa kungekuphela nje kunyango kodwa sigxila kwimpilo-ntle yengqondo yezigulane kunye nomgangatho wobomi, sibonelela ngenkxaso kunye nokhathalelo.
Qhagamshelana Nathi Ngoku Ukuze Uhlole Ithemba Elitsha Lonyango
Ukuba wena okanye ilungu losapho nifunyaniswe ninomhlaza wemiphunga ongengoweseli encinci we-KRAS G12D-mutant okanye ezinye iithumba eziqinileyo kwaye nibe nempendulo engonelanga kwiindlela zonyango ezikhoyo, nceda unxibelelane neSebe leHlabathi kwiSibhedlele se-Oncology saseBeijing South Region. Iqela lethu leengcali liza kukunika ulwazi lwamva nje lwezonyango kunye neengcebiso zokuxilongwa ezenzelwe wena kunye nonyango.
Nceda uqhagamshelane nathi ngale ndlela ilandelayo:
Ifowuni: 400-880-3716
I-WeChat: 17801183037
Email: 100085_010@163.com 或 myimmnet@163.com
Musa ukuvumela umgama okanye imiqobo yolwimi ibe yimiqobo ekufuneni kwakho unyango oluphambili. ISebe leMicimbi yeHlabathi kwiSibhedlele se-Oncology saseBeijing South Region lilapha ukuze lime nawe ekulweni nomhlaza.
Ixesha leposi: Februwari-25-2026