CDE yeChina Yapa Kusarudzwa kweBreakthrough Therapy kuGFH375 yeKRAS G12D-Mutant NSCLC

Musi wa13 Kukadzi 2026, Center for Drug Evaluation (CDE) yeNational Medical Products Administration yeChina yakazivisa kuti mapiritsi eGFH375 akaiswa muBreakthrough Therapy Designation yekurapa varwere vane KRAS G12D-mutant non-small cell lung cancer (NSCLC) avo vakamborapwa kanenge kamwe chete kare.

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Kuputsa Mutemo weChinangwa "Chisingashandisi Mishonga"

Kuchinja kweKRAS kwaimboonekwa nevezvekurapa sechinangwa "chisingashandisi mushonga". Zvisinei, nekufambira mberi kwekutsvaga kwesainzi, dambudziko iri riri kukundwa zvishoma nezvishoma. KRAS G12D ndeimwe yemhando dzakajairika dzekuchinja kweKRAS, inowanzoonekwa mupancreatic ductal adenocarcinoma (PDAC), kenza yemapapu isiri diki (NSCLC), uye kenza yemudumbu.

Kukurudzira Ruzivo rweKliniki: GFH375 Inoratidza Simba reKurwisa Bundu

Ruzivo rwekiriniki kubva mukuyedzwa kweGFH375 muchikamu chekutanga cheKRAS G12D-mutant solid tumors, rwakaunzwa paMusangano weGore negore we2025 weAmerican Society of Clinical Oncology (ASCO), rwakapa mhedzisiro inokurudzira. Ruzivo rwacho rwakaratidza kuwanikwa kwakanaka kwemukanwa uye kushanda kweGFH375 kudzivirira bundu zvakanyanya. Kusvika pazuva rekupedzisira reruzivo, varwere makumi matanhatu nevaviri vane bundu rakasimba reKRAS G12D-mutant raive rakamborapwa vakanga vanyoreswa muchikamu chekutanga cheGFH375 monotherapy.

Mapoka eTarget Dose: Kushanda Kwakakosha Kwazvo

Pakati pevarwere makumi mana nevapfumbamwe vaitora mishonga ye400mg kana 600mg pazuva, ruzivo rwekushanda kwayo rwaishamisa zvikuru:

  Chiyero Chemhinduro Yechinangwa Chose (ORR): Muvarwere 43 vakaongororwa, ORR yakasvika 42%, uye Chiyero Chekudzora Zvirwere (DCR) chakakwira kusvika 91%.

   Varwere vePancreatic Ductal Adenocarcinoma (PDAC): Pakati pevarwere vePDAC makumi maviri nevatatu vanoongororwa, ORR yaive 52%, uye DCR yakasvika 100%.

   Varwere veKenza yeMapapu Isiri Yemasero Madiki (NSCLC): Pakati pevarwere gumi nevaviri veNSCLC vanoongororwa, ORR yaive 42%, uye DCR yaive 83%.

Mapoka Ese Emushonga: Basa Rakakura Uye Rinokosha

Muvarwere makumi mashanu nevaviri vakapedza kuongororwa kamwe chete mushure mekurapwa kwegomarara, ORR pamapoka ese edosi yaive 38%, neDCR ye90%. Zvinonyanya kukosha kuti varwere makumi matatu nevasere vakaderera mumaronda avo avakange vakananga, uye varwere makumi maviri vakawana mhinduro shoma. Ruzivo urwu rwekutanga runoratidza kuti GFH375 inoratidza kushanda kwakakosha kwekudzivirira gomarara muvarwere vane magomarara akasimba akadai sePDAC neNSCLC, kusanganisira avo vakafambira mberi mushure mekurapwa kwakawanda.

Kutarisana nekufambira mberi kwekurapa kwakadai, kusarudza nzvimbo yekurapa inokwanisa kupa nzira dzekurapa dzepamusoro uye mabasa akazara kwakakosha. Dhipatimendi reInternational kuBeijing South Region Oncology Hospital rakatsaurira kupa masevhisi ekurapa ekurapa kenza epamusoro kuvarwere vemuno nevekunze kwenyika. Tinoramba tichiziva nezvekuvandudzwa kwazvino muongororo yekurapa kenza yepasi rose uye takazvipira kuunza mishonga yekurapa yakaita seGFH375 kuvarwere vanoda rubatsiro nekukurumidza sezvinobvira.

Zvakanakira zvedu zvinosanganisira:

Mhinduro Dzekurapa Dzakasiyana-siyana: Tinoenderana nezvinodiwa pasi rose, tichitarisa uye tichiunza nzira dzekurapa dzepamusoro dzinosanganisira GFH375, tichipa mikana yekurapa kune varwere vane KRAS G12D mutations.

Chikwata Chenyanzvi Dzine Nyanzvi Dzakawanda: Tinobatanidza nyanzvi dzepamusoro dzekurapa kenza dzemuno dzinoshanda pamwe chete mukupa mazano ekurapa akasiyana-siyana kuti dzigadzire hurongwa hwakakwana uye hwakananga hwekurapa murwere wese.

Mitemo Yebasa Renyika Dzese: Kubva pakubvunzana, kuronga nguva yekusangana, mabasa ekushandura kusvika pakurapwa kwese, tinopa kutaurirana kwakanaka uye sevhisi yekuteerera, tichivimbisa ruzivo rwekurapa rwakasununguka uye rune chivimbo kune varwere vekune dzimwe nyika nemhuri dzavo.

Rutsigiro Rwakazara rweVarwere: Tinovavarira kuita zvakanaka kwete chete mukurapa asiwo tinotarisa pakugara zvakanaka kwepfungwa dzevarwere uye hupenyu hwavo, tichivapa rutsigiro nerubatsiro.

Taura Nesu Iye Zvino Kuti Uongorore Tariro Itsva Yekurapwa

Kana iwe kana nhengo yemhuri yako yakawanikwa ine KRAS G12D-mutant non-small cell lung cancer kana mamwe mabundu akaomarara uye isina mhinduro yakakwana kune dzimwe nzira dzekurapa dziripo, ndapota taura neInternational Department kuBeijing South Region Oncology Hospital. Chikwata chedu chehunyanzvi chichakupa ruzivo rwezvekurapa rwazvino uye mazano ekuongorora chirwere chako uye kurapwa kwacho.

Ndapota taurai nesu nenzira dzinotevera:

Nhare: 400-880-3716

WeChat: 17801183037

Email: 100085_010@163.com 或 myimmnet@163.com

Musarega daro kana zvipingamupinyi zvemutauro zvichiva zvipingamupinyi pakutsvaga kwenyu kurapwa kwepamusoro. Dhipatimendi reInternational Department kuBeijing South Region Oncology Hospital riripo kuti rikubatsirei mukurwisa kenza.


Nguva yekutumira: Kukadzi-25-2026