Ngomhlaka-9 Meyi 2025, i-Hansoh Pharmaceutical yamemezela ukuthi inkomba entsha ye-Ameile (amaphilisi e-almonertinib mesylate) ivunyelwe ukumaketha. Inkomba entsha ingeyokwelashwa kweziguli ezindala ezinomdlavuza wamaphaphu ongewona omncane (i-NSCLC) ezinamathumba ane-epidermal growth factor receptor (EGFR) exon 19 deletion noma i-exon 21 (L858R), futhi eziye zasikwa umdlavuza. I-Ameile manje inezinkomba ezine ezivunyiwe eShayina, igcina isikhundla sayo esiphambili phakathi kwe-EGFR-TKIs yesizukulwane sesithathu ethuthukiswe ekhaya.
Lokhu kuvunyelwa kusekelwe kakhulu ocwaningweni lwe-ARTS (HS-10296-302), isivivinyo somtholampilo seSigaba III esingahleliwe, esingaboni kabili, esilawulwayo, esinama-centre amaningi. Imiphumela yocwaningo yethulwe njengombiko womlomo eMhlanganweni Waminyaka Yonke we-American Association for Cancer Research (AACR) ka-2025.
Idatha evela ocwaningweni lwe-ARTS eyethulwe eMhlanganweni Waminyaka Yonke we-AACR ka-2025 iqinisekisile ukuthi ezigulini ezine-EGFR-mutant NSCLC ekhishwe ngokuphelele esigabeni sesi-II–IIIB, ukwelashwa okungeziwe nge-Ameile—uma kusebenza—kungathuthukisa kakhulu ukusinda okungenazifo (i-DFS). Izinga le-DFS leminyaka emi-2 lifinyelele ku-90.2%, nge-HR engu-0.17, futhi iphrofayili yokuphepha iyonke yayingalawuleka. Okuphawulekayo ukuthi lolu cwaningo lubhalise iziguli zaseShayina kuphela, okugqamisa ukusebenza kahle okukhulu kanye nephrofayili yokuphepha elawuleka ye-EGFR-TKI ethuthukiswe ngaphakathi ezweni kubantu baseShayina.
Mayelana no-Ameile
Njenge-EGFR-TKI yokuqala yesizukulwane sesithathu eShayina, i-Ameile (Amaphilisi e-Aumolertinib Mesilate) ine-liposolubility enhle kanye nokuqina, okuvumela ukuthi ingene kangcono emgoqweni wegazi nobuchopho ngesilinganiso esincane semiphumela emibi. Njengamanje, i-Ameile ivunyelwe izinkomba ezine: ukwelashwa komugqa wesibili kweziguli ezine-NSCLC ethuthukisiwe noma esakazekile endaweni ene-T790M mutation, eziye zathuthuka ekwelashweni kwe-EGFR-TKI noma ngemva kwayo; ukwelashwa komugqa wokuqala kweziguli ezindala ezine-NSCLC ethuthukisiwe noma esakazekile endaweni ene-tumor ene-EGFR exon 19 deletions noma i-exon 21 (L858R) substitute mutation positive; ukwelashwa kweziguli ezine-local advanced, unresectable (Stage III) non-small cell lung cancer (“NSCLC”) isifo sazo esingakathuthuki ngemuva kwe-definitive based chemoradiotherapy ene-epidermal growth factor receptor (“EGFR”) exon 19 deletions noma i-exon 21 (L858R) substitute mutations; ukwelashwa okungeziwe kweziguli ezindala ezinomdlavuza wamaphaphu ongewona omncane (i-NSCLC) ezinezimila ezine-epidermal growth factor receptor (EGFR) exon 19 deletion noma i-exon 21 (L858R), futhi eziye zasikwa isimila.
Njengamanje, kusenezivivinyo eziningi zemitholampilo zobuchwepheshe obusha bokulwa nomdlavuza eShayina ezifuna iziguli. Ukubonisana ngemithi emisha kanye nobuchwepheshe, ungaxhumana noMnyango Wezizwe Ngezizwe Wesibhedlela iBeijing South Region Oncology.
Inombolo yocingo: 4008803716
Email：myimmnet@163.com
Isikhathi sokuthunyelwe: Meyi-13-2025