Ubusabe bwa Ameile bwo kwamamaza bwemejwe kugira ngo buhabwe ikimenyetso cya gatatu

Ku ya 10 Werurwe 2025, Hansoh Pharma yatangaje ko imiti mishya ya gatatu (“NDA”) y’umuti mushya wa Ameile (阿美乐®) (Aumolertinib Mesilate Tablets) yemewe n’Ikigo cy’Igihugu gishinzwe Ibikoresho by’Ubuvuzi mu Bushinwa (“NMPA”) mu kuvura abarwayi bafite kanseri y’ibihaha idasanzwe, idakira (Stage III) itari ntoya (“NSCLC”) indwara yabo itaratera imbere nyuma yo kuvura kanseri ishingiye kuri platine ifite kanseri ifite receptor y’izamuka ry’izuba (“EGFR”) exon 19 deletions cyangwa exon 21 (L858R) substitute mutations. Iki ni cyo kimenyetso cya gatatu cyemewe kuri Ameile kuva yatangira gukoreshwa mu myaka itanu ishize. Kubera iyo mpamvu, Ameile yabaye EGFR-TKI yonyine y’igisekuru cya gatatu yemewe mu gihugu kugira ngo ivurwe neza ku barwayi bafite NSCLC y’icyiciro cya gatatu idakira nyuma yo kuvura kanseri.

Kwemeza kwashingiye ahanini ku bushakashatsi bwa POLESTAR (HS-10296-304), igerageza ry’ubuvuzi ryakozwe mu buryo bwa "multicenter", ryakozwe mu buryo butaziguye, budafite aho buhuriye n’amaso, rigenzurwa na placebo, rigamije gusuzuma ingaruka za Ameile nk'ubuvuzi bwo kubungabunga mu cyiciro cya gatatu cya NSCLC nyuma yo kuvurwa hakoreshejwe imiti ikoreshwa mu maraso. Ubushakashatsi bwa POLESTAR bwayobowe n'umuhanga mu by'amashuri Professor Yu Jinming wo mu bitaro bya Shandong Cancer Hospital nk'umushakashatsi mukuru. Ibisubizo byatoranyijwe ku rutonde rw'Inama Mpuzamahanga ku Kanseri y'Ibihaha (WCLC) yo mu 2024, byatanzwe mu nama ya Perezida w'inama.

Ibisubizo by’ubushakashatsi byagaragaje ko Ameile yagabanyije ibyago byo kwiyongera kw’indwara ku kigero kirenga 80% kandi ko ikigereranyo cyo kubaho nta guhindagurika kw’indwara (mPFS) ku barwayi bavuwe na Ameile cyari amezi 30.4 ugereranije n’amezi 3.8 gusa ku bavuwe na placebo. Byongeye kandi, inyungu ya Ameile kuruta placebo kuri PFS yari ihoraho mu matsinda yose yagenwe mbere, bigaragaza inyungu yuzuye. Byongeye kandi, igipimo cy’ingaruka zifatika (ORR) mu itsinda ryavuwe na Ameile ryasuzumwe na BICR cyageze kuri 57%, aho igihe cyo hagati cyo gusubiza (DoR) cyageze ku mezi 16.59 naho ikigereranyo cyo hagati cyo kubaho (OS) kitaragera. Umubare w’ibisebe bya CNS n’ibisebe bya metastases byari bike. Uburyo bwo kwihanganira no gucunga Ameile muri rusange ku barwayi nyuma yo kuvura hakoreshejwe imiti byari byiza. Ku bijyanye n’ingaruka mbi (AEs), umubare w’ibihaha bya ≥3 byari 0, naho umubare w’ibihaha bya pneumonia na byo byari 0.

Ku bijyanye na Hansoh Pharma

Hansoh Pharma ni ikigo gikomeye cy’imiti mu Bushinwa gishingiye ku guhanga udushya. Yiyemeje kuvura indwara zikomeye mu bijyanye na kanseri, indwara zandura, indwara za CNS, indwara za metabolike, ndetse n’indwara zifata ubudahangarwa bw’umubiri, kandi yiyemeje kunoza ubuzima bw’abantu binyuze mu guhanga udushya duhoraho. Kugeza ubu, Hansoh Pharma yatangije imiti 7 mishya yo gukora ubucuruzi butandukanye. Hansoh Pharma imaze imyaka myinshi iri mu masosiyete 100 ya mbere ku isi acuruza imiti ndetse n’inganda 3 nziza mu Bushinwa mu bijyanye n’ubushakashatsi n’iterambere ry’imiti, kandi ni ikigo gikomeye cy’igihugu gikoresha ikoranabuhanga rihanitse kandi kikaba n’ikigo cy’igihugu cyerekana udushya mu ikoranabuhanga. Hansoh Pharma yashyizwe ku isoko ry’imigabane rya Hong Kong muri Kamena 2019 (kode y’imigabane: 03692.HK). Kugira ngo umenye byinshi, sura www.hspharm.com.

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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Amareferensi

1.https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d

2.https://cn.hspharm.com/