Ngomhla we-9 kuMeyi, ngo-2025, iHansoh Pharmaceutical yabhengeza ukuba isalathisi esitsha se-Ameile (iipilisi ze-almonertinib mesylate) sivunyiwe ukuba sithengiswe. Isibonakaliso esitsha sesonyango oluncedisayo lwezigulane ezindala ezinomhlaza wamaphaphu ongengowesincinci (i-NSCLC) ezineethumba ezine-epidermal growth factor receptor (EGFR) exon 19 deletion okanye i-exon 21 (L858R), kwaye eziye zasikwa i-tumor resection. I-Ameile ngoku inezibonakaliso ezine ezivunyiweyo eTshayina, igcina indawo yayo ephambili phakathi kwe-EGFR-TKIs yesizukulwana sesithathu esaphuhliswayo ekhaya.
Olu vunywa lusekelwe ikakhulu kuphando lwe-ARTS (HS-10296-302), uvavanyo lweklinikhi lweSigaba sesiThathu olucwangcisiweyo, olungaboni kabini, olulawulwayo, oluneendawo ezininzi. Iziphumo zophando ziboniswe njengengxelo yomlomo kwiNtlanganiso yoNyaka ye-American Association for Cancer Research (AACR) ka-2025.
Idatha evela kuphando lwe-ARTS eyavezwa kwiNtlanganiso yoNyaka ye-AACR ka-2025 iqinisekisile ukuba kwizigulane ezine-NSCLC ye-EGFR esusiweyo ngokupheleleyo kwinqanaba lesi-II–IIIB, unyango oluncedisayo nge-Ameile—xa lusebenza—lunokuphucula kakhulu ukusinda okungenasifo (i-DFS). Izinga le-DFS leminyaka emi-2 lifikelele kwi-90.2%, nge-HR ye-0.17, kwaye iprofayili yokhuseleko iyonke yayilawuleka. Okuphawulekayo kukuba, olu phononongo lubhalise kuphela izigulane zaseTshayina, nto leyo egxininisa ukusebenza kakuhle kunye neprofayili yokhuseleko olulawulekayo lwe-EGFR-TKI ephuhliswe ekhaya kubemi baseTshayina.
Malunga no-Ameile
Njenge-EGFR-TKI yokuqala yesizukulwana sesithathu eTshayina, i-Ameile (Aumolertinib Mesilate Tablets) ine-liposolubility elungileyo kunye nokuzinza, okuvumela ukuba ingene ngcono kumqobo wegazi-ubuchopho kunye nenani eliphantsi leempendulo ezimbi. Okwangoku, i-Ameile ivunyiwe kwiimpawu ezine: unyango lwesibini lwezigulane ezine-NSCLC ephucukileyo okanye eguqukileyo ene-T790M mutation, eziye zaqhubeka emva okanye emva konyango lwe-EGFR-TKI; unyango lwenqanaba lokuqala lwezigulane zabantu abadala abane-NSCLC ephucukileyo okanye eguqukileyo ene-tumor ene-EGFR exon 19 deletions okanye i-exon 21 (L858R) substitute mutation positive; unyango lwezigulane ezine-local advanced, unresectable (Stage III) non-small cell lung cancer (“NSCLC”) isifo sazo esingaqhubekekanga emva kwe-definitive platinum-based chemoradiotherapy ene-tumor ene-epidermal growth factor receptor (“EGFR”) exon 19 deletions okanye i-exon 21 (L858R) substitute mutations; unyango oluncedisayo lwezigulane zabantu abadala abanomhlaza wemiphunga ongengoweeseli ezincinci (i-NSCLC) abaneethumba ezine-epidermal growth factor receptor (EGFR) exon 19 deletion okanye i-exon 21 (L858R), kwaye abaye banqunyulwa ithumba.
Okwangoku, kusekho iimvavanyo ezininzi zeklinikhi zobuchwepheshe obutsha bokulwa nomhlaza eTshayina obufuna izigulane. Iingcebiso ngamayeza amatsha kunye nobuchwepheshe, ungaqhagamshelana neSebe leMicimbi yeZibhedlele ze-Oncology zaseBeijing South Region.
Inombolo yefowuni: 4008803716
Email：myimmnet@163.com
Ixesha leposi: Meyi-13-2025