NgoMashi 10, 2025, iHansoh Pharma yamemezela ukuthi i-New Drug Application yesithathu (“NDA”) yesidakamizwa esisha seQembu i-Ameile (阿美乐®) (Aumolertinib Mesilate Tablets) ivunyiwe yi-National Medical Products Administration of China (“NMPA”) yokwelapha iziguli ezinomdlavuza wamaphaphu ongewona omncane (“NSCLC”) othuthuke endaweni yangakini, ongasuki endaweni (“Stage III”) ongewona omncane (“NSCLC”) onesifo esingakathuthuki ngemuva kokwelashwa nge-chemoradiotherapy okusekelwe ku-platinum okunezimila ezine-epidermal growth factor receptor (“EGFR”) exon 19 deletions noma i-exon 21 (L858R) substitute mutations. Lesi yisibonakaliso sesithathu esivunyiwe nge-Ameile selokhu yasungulwa eminyakeni emihlanu edlule. Ngenxa yalokho, i-Ameile ibe yi-EGFR-TKI yesizukulwane sesithathu kuphela evunyiwe yokwelashwa kokunakekelwa kweziguli ezine-NSCLC yesigaba III engasuki ngemuva kokwelashwa nge-chemoradiotherapy.
Ukuvunyelwa kwakusekelwe kakhulu ocwaningweni lwe-POLESTAR (HS-10296-304), isivivinyo somtholampilo sesigaba sesi-3 esingahleliwe, esingaboni kabili, esilawulwa yi-placebo, esinama-centre amaningi ukuhlola imiphumela ye-Ameile njengokwelashwa kokugcina esigabeni sesi-3 se-NSCLC esingalapheki ngemuva kokwelashwa ngamakhemikhali. Ucwaningo lwe-POLESTAR lwaluholwa yi-Academician Prof. Yu Jinming waseShandong Cancer Hospital njengomphenyi oyinhloko. Imiphumela yakhethwa ohlwini lwe-2024 World Conference on Lung Cancer (WCLC) “Late Breaking Abstract (LBA)” futhi yethulwa eSikhumbuzweni sikaMongameli sengqungquthela.
Imiphumela yocwaningo ikhombisile ukuthi i-Ameile yehlise ingozi yokuqhubeka kwesifo ngaphezu kuka-80% kanti isilinganiso sokusinda esingenaso i-progression (mPFS) seziguli ezelashwe nge-Ameile sasiyizinyanga ezingu-30.4 uma kuqhathaniswa nezinyanga ezingu-3.8 kuphela kulabo abathola i-placebo. Ngaphezu kwalokho, inzuzo ye-Ameile kune-placebo ye-PFS yayifana kuwo wonke amaqembu amancane achazwe ngaphambilini, okubonisa iphrofayili yenzuzo ephelele. Ngaphezu kwalokho, izinga lokuphendula eliqondile (ORR) eqenjini lokwelashwa kwe-Ameile elihlolwe yi-BICR lifinyelele ku-57%, kanti isikhathi esimaphakathi sempendulo (DoR) sifinyelela ezinyangeni ezingu-16.59 kanti isilinganiso sokusinda okuphelele (OS) asikafinyelelwa. Isilinganiso sezilonda ze-CNS kanye ne-metastases ezikude sasiphansi. Ukubekezelelwa kanye nokuphathwa kwe-Ameile jikelele ezigulini ngemuva kokwelashwa ngamakhemikhali kwakukuhle. Ngokuphathelene nezenzakalo ezimbi (AEs), isibalo se-≥3 grade radiation pneumonitis sasingu-0, kanti isibalo se-interstitial pneumonia sasingu-0.
Mayelana neHansoh Pharma
I-Hansoh Pharma iyinkampani ehamba phambili yezokwelapha eGreater China eqhutshwa yizinto ezintsha. Izimisele ekwelapheni izifo ezinkulu ezindaweni ze-oncology, ukulwa nezifo, izifo ze-CNS, izifo ze-metabolic, kanye nezifo zokuzivikela komzimba, futhi izinikele ekuthuthukiseni impilo yabantu ngokusungula izinto ezintsha okuqhubekayo. Kuze kube manje, i-Hansoh Pharma yethule imithi emisha engu-7 yokwakha iphothifoliyo yezentengiselwano ehlukahlukene. I-Hansoh Pharma ibilokhu ibalwa phakathi kwezinkampani zemithi eziyi-100 eziphezulu emhlabeni kanye namabhizinisi amathathu aphezulu ezimboni eShayina ngokwepayipi le-R&D lezemithi iminyaka eminingana, futhi iyinkampani kazwelonke eyinhloko yobuchwepheshe obuphezulu kanye nebhizinisi likazwelonke lokubonisa ukusungula izinto ezintsha. I-Hansoh Pharma yafakwa ohlwini lwe-Stock Exchange yaseHong Kong ngoJuni 2019 (ikhodi yesitoko: 03692.HK). Ukuze uthole ulwazi olwengeziwe, sicela uvakashele ku-www.hspharm.com.
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
Izinkomba
1.https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d
2.https://cn.hspharm.com/
Isikhathi sokuthunyelwe: Mashi-14-2025