Ngomhla we-10 kweyoKwindla, ngo-2025, iHansoh Pharma yabhengeza ukuba iSicelo sesithathu seDrug New (“NDA”) seyeza elitsha leQela i-Ameile (阿美乐®) (Aumolertinib Mesilate Tablets) sivunyiwe yiNational Medical Products Administration of China (“NMPA”) sokunyanga izigulane ezine-in-advanced local, unresectable (Stage III) non-small cell lung cancer (“NSCLC”) ezinesifo esingahambelanga emva kwe-definitive platinum-based chemoradiotherapy ene-tumor ene-epidermal growth factor receptor (“EGFR”) exon 19 deletions okanye i-exon 21 (L858R) substitute mutations. Olu luphawu lwesithathu oluvunyiweyo kwi-Ameile ukusukela oko yasungulwa kwintengiso kwiminyaka emihlanu eyadlulayo. Ngenxa yoko, i-Ameile ibe yi-EGFR-TKI yesizukulwana sesithathu ephuhliswe ekhaya evunyiweyo kunyango lolondolozo kwizigulane ezine-NSCLC yesigaba sesithathu esingasukiyo emva kwe-chemoradiotherapy.
Imvume yayisekelwe ikakhulu kuphando lwePOLESTAR (HS-10296-304), uvavanyo lweklinikhi olucwangcisiweyo, olungaboni kabini, olulawulwa yi-placebo, oluneziko lesithathu lokuvavanya imiphumo ye-Ameile njengonyango lokugcina kwisigaba sesi-3 se-NSCLC esingenakususwa emva kwe-chemotherapy. Uphononongo lwePOLESTAR lwalukhokelwa yi-Academician Prof. Yu Jinming waseShandong Cancer Hospital njengomphandi oyintloko. Iziphumo zikhethwe kuluhlu lwe-2024 World Conference on Lung Cancer (WCLC) “Late Breaking Abstract (LBA)” kwaye zanikezelwa kwiSimposium kaMongameli wengqungquthela.
Iziphumo zophando zibonise ukuba i-Ameile inciphise umngcipheko wokuqhubela phambili kwesifo ngaphezulu kwe-80% kwaye i-median progression-free survival (mPFS) kwizigulana ezinyangwe nge-Ameile yayiyiinyanga ezingama-30.4 xa kuthelekiswa neenyanga ezi-3.8 kuphela kwabo bafumana i-placebo. Ukongeza, inzuzo ye-Ameile kune-placebo ye-PFS yayifana kuzo zonke ii-subgroups ezichazwe kwangaphambili, nto leyo ebonisa iprofayili yenzuzo epheleleyo. Ngaphezu koko, izinga lokuphendula elijolise ngqo (ORR) kwiqela lonyango lwe-Ameile elihlolwe yi-BICR lifikelele kwi-57%, kunye nexesha eliphakathi lokuphendula (DoR) lifikelela kwiinyanga ezili-16.59 kunye ne-median iyonke yokuphila (OS) ingekafikelelwa. Iziganeko zezilonda ze-CNS kunye ne-metastases ezikude zaziphantsi. Ukunyamezeleka kunye nokulawulwa kwe-Ameile kwizigulana emva kwe-chemoradiotherapy kwakukuhle. Ngokuphathelele iziganeko ezimbi (ii-AE), i-≥3 grade radiation pneumonitis yayiyi-0, kwaye i-interstitial pneumonia nayo yayiyi-0.
Malunga neHansoh Pharma
IHansoh Pharma yinkampani ephambili yamayeza eGreater China eqhutywa bubuchule bokuvelisa izinto ezintsha. Izimisele ekunyangeni izifo eziphambili kwiindawo ze-oncology, ukulwa nosulelo, izifo ze-CNS, izifo ze-metabolic, kunye nezifo zokuzikhusela komzimba, kwaye izinikele ekuphuculeni impilo yabantu ngokusebenzisa ubuchule obuqhubekayo. Ukuza kuthi ga ngoku, iHansoh Pharma iqalise amayeza amatsha asi-7 ukwenza ipotifoliyo eyahlukeneyo yorhwebo. IHansoh Pharma ibiphakathi kweenkampani zamayeza eziphambili ezili-100 zehlabathi kunye namashishini amathathu aphambili e-China ngokwemibhobho ye-R&D yamayeza kangangeminyaka eliqela, kwaye lishishini eliphambili lesizwe lobuchwepheshe obuphezulu kunye neshishini lesizwe lokubonisa ubuchule bobuchwepheshe. IHansoh Pharma idweliswe kwiStock Exchange yaseHong Kong ngoJuni ka-2019 (ikhowudi yesitokhwe: 03692.HK). Ukuze ufumane ulwazi oluthe kratya, nceda undwendwele i-www.hspharm.com.
Okwangoku, kusekho iimvavanyo ezininzi zeklinikhi zobuchwepheshe obutsha bokulwa nomhlaza eTshayina obufuna izigulane. Iingcebiso ngamayeza amatsha kunye nobuchwepheshe, ungaqhagamshelana neSebe leMicimbi yeZibhedlele ze-Oncology zaseBeijing South Region.
Inombolo yefowuni: 4008803716
Email：myimmnet@163.com
Iireferensi
1.https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d
2.https://cn.hspharm.com/
Ixesha leposi: Matshi-14-2025