Ikimenyetso cya kane cya Ameile cyemewe mu bucuruzi, kigamije ubuvuzi bwunganira kanseri y'ibihaha idafata uturemangingo duto nyuma yo kubagwa.

Ku ya 9 Gicurasi 2025, Hansoh Pharmaceutical yatangaje ko ikimenyetso gishya cya Ameile (ibinini bya almonertinib mesylate) cyemejwe ku isoko. Iki kimenyetso gishya ni icyo kuvura abarwayi bakuru barwaye kanseri y'ibihaha itari nto (NSCLC) bafite ibibyimba bifite receptor y'izamuka ry'izuba (EGFR) exon 19 deletion cyangwa exon 21 (L858R), kandi bakaba baraciwe kanseri. Ameile ubu ifite ibimenyetso bine byemewe mu Bushinwa, ikomeje ku mwanya wa mbere mu bakinnyi bateye imbere mu gihugu ba EGFR-TKIs.

Uku kwemezwa gushingiye ahanini ku bushakashatsi bwa ARTS (HS-10296-302), igerageza ry’ubuvuzi ryakozwe mu buryo butunguranye, butareba impande zombi, rigenzurwa, kandi rikorerwa mu byiciro byinshi. Ibisubizo by’ubushakashatsi byatanzwe nk’incamake mu nama ngarukamwaka y’Ishyirahamwe ry’Abanyamerika rishinzwe ubushakashatsi ku ndwara ya kanseri (AACR) yo mu 2025.

Amakuru yavuye mu bushakashatsi bwa ARTS bwatanzwe mu nama ngarukamwaka ya AACR yo mu 2025 yemeje ko ku barwayi bakuwe burundu mu cyiciro cya II–IIIB EGFR-mutant NSCLC, ubuvuzi bwunganira Ameile—igihe bukenewe—bushobora kongera cyane ubuzima buzira indwara (DFS). Igipimo cya DFS cy’imyaka 2 cyageze kuri 90.2%, hamwe na HR ya 0.17, kandi umutekano muri rusange wari ushoboka. Ikigaragara ni uko ubushakashatsi bwagaragaje abarwayi b’Abashinwa gusa, bugaragaza imikorere myiza n’umutekano wa EGFR-TKI yateye imbere mu gihugu mu baturage b’Abashinwa.

Ku bijyanye na Ameile

Nk’umuti wa mbere w’umwimerere wa EGFR-TKI mu Bushinwa wo mu gisekuru cya gatatu, Ameile (Aumolertinib Mesilate Tablets) ifite uburyo bwiza bwo kugabanya ubukana bw’amaraso n’ubudahangarwa, bigatuma ibasha kwinjira neza mu ruzitiro rw’amaraso n’ubwonko hamwe n’ingaruka nke z’ingaruka mbi. Kuri ubu, Ameile yemerewe ibimenyetso bine: kuvura abarwayi bafite NSCLC yateye imbere cyangwa yateye imbere bafite T790M mutation, bamaze gutera imbere nyuma cyangwa nyuma yo kuvurwa na EGFR-TKI; kuvura abarwayi bakuru bafite NSCLC yateye imbere cyangwa yateye imbere bafite ibibyimba bifite EGFR exon 19 deletions cyangwa exon 21 (L858R) substitute mutation positive; kuvura abarwayi bafite kanseri y’ibihaha idakira (Stage III) non-small cell pulmonary cancer ("NSCLC") indwara yabo itaratera imbere nyuma ya platinum based chemoradiotherapy ifite ibibyimba bifite epidermal growth factor receptor ("EGFR") exon 19 deletions cyangwa exon 21 (L858R) substitute mutations; kuvura abarwayi bakuru barwaye kanseri y'ibihaha itari nto (NSCLC) bafite ibibyimba bifite receptor y'ingufu zo gukura mu mubiri (EGFR) exon 19 deletion cyangwa exon 21 (L858R), kandi bakaba baraciwe ikibyimba.

Kugeza ubu, haracyari igeragezwa ryinshi ry’ikoranabuhanga rishya rirwanya kanseri mu Bushinwa rishaka abarwayi. Inama ku miti mishya n’ikoranabuhanga, ushobora kuvugana n’Ishami Mpuzamahanga ry’Ibitaro bya Oncology bya Beijing mu Karere k’Amajyepfo.

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