Pa Meyi 9, 2025, Hansoh Pharmaceutical idalengeza kuti chizindikiro chatsopano cha Ameile (mapiritsi a almonertinib mesylate) chavomerezedwa kuti chigulitsidwe. Chizindikiro chatsopanochi ndi cha chithandizo chothandizira odwala akuluakulu omwe ali ndi khansa ya m'mapapo ya non-small cell (NSCLC) omwe ali ndi zotupa zomwe zili ndi epidermal growth factor receptor (EGFR) exon 19 deletion kapena exon 21 (L858R) mutations, ndipo omwe adachitidwa opaleshoni yochotsa chotupa. Ameile tsopano ali ndi zizindikiro zinayi zovomerezeka ku China, zomwe zikusunga malo ake otsogola pakati pa EGFR-TKIs ya m'badwo wachitatu yomwe idapangidwa mdziko muno.
Kuvomerezedwa kumeneku kumachokera makamaka pa kafukufuku wa ARTS (HS-10296-302), kafukufuku wachipatala wa Gawo III wochitidwa mwachisawawa, wosayang'ana mbali zonse ziwiri, wolamulidwa, komanso wapakati pa malo ambiri. Zotsatira za kafukufukuyu zidaperekedwa ngati lipoti la pakamwa pa Msonkhano Wapachaka wa 2025 wa American Association for Cancer Research (AACR).
Deta yochokera ku kafukufuku wa ARTS yomwe idaperekedwa pa Msonkhano Wapachaka wa AACR wa 2025 idatsimikiza kuti kwa odwala omwe adachotsedwa kwathunthu mu gawo la II-IIIB EGFR-mutant NSCLC, chithandizo chowonjezera ndi Ameile—ngati chilipo—chingathandize kwambiri kupulumuka popanda matenda (DFS). Chiwopsezo cha zaka ziwiri cha DFS chinafika pa 90.2%, ndi HR ya 0.17, ndipo mbiri yonse yachitetezo inali yotheka. Chochititsa chidwi n'chakuti, kafukufukuyu adalemba odwala aku China okha, zomwe zikuwonetsa kugwira ntchito bwino komanso chitetezo chotheka cha EGFR-TKI yopangidwa mdziko muno mwa anthu aku China.
About Ameile
Monga mankhwala oyamba oyamba a EGFR-TKI ku China a m'badwo wachitatu, Ameile (Aumolertinib Mesilate Tablets) ali ndi liposolubility yabwino komanso kukhazikika, zomwe zimathandiza kuti ilowe bwino mu chotchinga cha magazi ndi ubongo ndi kuchuluka kwa zotsatira zoyipa. Pakadali pano, Ameile yavomerezedwa pa zizindikiro zinayi: chithandizo chachiwiri cha odwala omwe ali ndi NSCLC yotsogola kapena yofalikira m'deralo yokhala ndi T790M mutation, omwe apita patsogolo pa chithandizo cha EGFR-TKI kapena atapita; chithandizo choyamba cha odwala akuluakulu omwe ali ndi NSCLC yotsogola kapena yofalikira m'deralo omwe ali ndi zotupa zomwe zili ndi EGFR exon 19 deletions kapena exon 21 (L858R) substitute mutation positive; chithandizo cha odwala omwe ali ndi khansa ya m'mapapo yopanda maselo ang'onoang'ono (“NSCLC”) yomwe sinapitirire patsogolo pambuyo pa mankhwala a platinum omwe ali ndi zotupa zomwe zili ndi epidermal growth factor receptor (“EGFR”) exon 19 deletions kapena exon 21 (L858R) substitute mutations; chithandizo cha odwala omwe ali ndi khansa ya m'mapapo yopanda maselo ang'onoang'ono (“NSCLC”) yomwe sinapitirire patsogolo pambuyo pa mankhwala a platinum omwe ali ndi zotupa zomwe zili ndi epidermal growth factor receptor (“EGFR”) exon 19 deletions kapena exon 21 (L858R) substitute mutations; Chithandizo chothandizira odwala akuluakulu omwe ali ndi khansa ya m'mapapo yopanda maselo ang'onoang'ono (NSCLC) omwe ali ndi zotupa zomwe zili ndi epidermal growth factor receptor (EGFR) exon 19 deletion kapena exon 21 (L858R), komanso omwe adachitidwa opaleshoni yochotsa chotupa.
Pakadali pano, pali mayesero ambiri azachipatala a ukadaulo watsopano wothana ndi khansa ku China omwe akufuna odwala. Mukafunsira mankhwala ndi ukadaulo watsopano, mutha kulumikizana ndi Dipatimenti Yapadziko Lonse ya Chipatala cha Oncology ku Beijing South Region.
Nambala ya Foni: 4008803716
Email：myimmnet@163.com
Nthawi yotumizira: Meyi-13-2025