A ranar 10 ga Maris, 2025, Hansoh Pharma ta sanar da amincewa da amfani da sabbin magunguna na uku ("NDA") na sabuwar maganin Ameile (阿美乐®) (Aumolertinib Mesilate Allunan) na ƙungiyar daga Hukumar Kayayyakin Lafiya ta Ƙasa ta China ("NMPA") don maganin marasa lafiya da suka kamu da cutar kansar huhu ta huhu ta zamani, wadda ba ta da ƙarfi (Mataki na III) ("NSCLC") waɗanda cutar ba ta ci gaba ba bayan maganin chemoradio na platinum wanda ciwace-ciwacen ke da mai karɓar ci gaban epidermal ("EGFR") exon 19 ko maye gurbin exon 21 (L858R). Wannan shine alama ta uku da aka amince da ita ga Ameile tun lokacin da aka ƙaddamar da ita a kasuwanci shekaru biyar da suka gabata. Sakamakon haka, Ameile ta zama kawai EGFR-TKI ta ƙarni na uku da aka haɓaka a cikin gida wanda aka amince da shi don maganin kulawa ga marasa lafiya da ba za a iya cirewa ba bayan maganin chemoradiotherapy.
An amince da wannan amincewa ne bisa ga binciken POLESTAR (HS-10296-304), wani gwaji na asibiti mai tsari, wanda aka yi shi da bazuwar, wanda ba a iya cirewa ba, wanda aka sarrafa shi a cikin jini, wanda aka gudanar a mataki na uku na asibiti don tantance tasirin Ameile a matsayin maganin kulawa a matakin III na NSCLC bayan maganin chemotherapy. Farfesa Yu Jinming, Farfesa daga Asibitin Ciwon Daji na Shandong ne ya jagoranci binciken POLESTAR a matsayin babban mai bincike. An zaɓi sakamakon don jerin "Late Breaking Abstract (LBA)" na taron duniya kan cutar kansar huhu (WCLC) na 2024 kuma an gabatar da shi a taron shugaban ƙasa na taron.
Sakamakon binciken ya nuna cewa Ameile ya rage haɗarin ci gaban cututtuka da fiye da kashi 80% kuma matsakaicin rayuwa ba tare da ci gaba ba (mPFS) ga marasa lafiya da aka yi wa magani da Ameile ya kasance watanni 30.4 idan aka kwatanta da watanni 3.8 kawai ga waɗanda ke karɓar placebo. Bugu da ƙari, fa'idar Ameile fiye da placebo ga PFS ta kasance iri ɗaya a cikin dukkan ƙananan ƙungiyoyi da aka riga aka ayyana, wanda ke nuna cikakken bayanin fa'ida. Bugu da ƙari, ƙimar amsawar manufa (ORR) a cikin rukunin maganin Ameile da BICR ta kimanta ya kai kashi 57%, tare da matsakaicin tsawon lokacin amsawa (DoR) ya kai watanni 16.59 kuma matsakaicin rayuwa gaba ɗaya (OS) ba a kai ga cimma shi ba tukuna. Yawan raunukan CNS da metastases masu nisa sun yi ƙasa. Juriyar Ameile da iyawar sarrafawa gabaɗaya a cikin marasa lafiya bayan chemotherapy sun yi kyau. Dangane da abubuwan da suka faru marasa kyau (AEs), yawan kamuwa da cutar pneumonia ta radiation ≥3 shine 0, kuma yawan kamuwa da cutar pneumonia ta interstitial ita ma 0.
Game da Hansoh Pharma
Hansoh Pharma babban kamfani ne na magunguna a Greater China wanda ke da ƙwarewa a fannin kirkire-kirkire. Tana da himma wajen magance manyan cututtuka a fannoni kamar ciwon daji, cututtukan da suka shafi cututtuka, cututtukan CNS, cututtukan da suka shafi metabolism, da kuma cututtukan da ke shafar garkuwar jiki, kuma ta himmatu wajen inganta lafiyar ɗan adam ta hanyar ci gaba da kirkire-kirkire. Zuwa yanzu, Hansoh Pharma ta ƙaddamar da magunguna 7 masu ƙirƙira don ƙirƙirar fayil ɗin kasuwanci daban-daban. An sanya Hansoh Pharma a cikin manyan kamfanonin magunguna 100 na duniya da manyan kamfanonin masana'antu 3 mafi kyau a China dangane da bututun bincike da haɓaka magunguna tsawon shekaru da yawa, kuma babbar kamfani ce ta ƙasa mai fasaha da kuma kamfanin nuna fasahar zamani na ƙasa. An saka Hansoh Pharma a cikin Kasuwar Hannun Jari ta Hong Kong a watan Yunin 2019 (lambar hannun jari: 03692.HK). Don ƙarin bayani, da fatan za a ziyarci www.hspharm.com.
A halin yanzu, har yanzu akwai gwaje-gwaje da yawa na asibiti na sabbin fasahohin yaƙi da cutar kansa a China waɗanda ke neman marasa lafiya. Tuntuɓi kan sabbin magunguna da fasahohi, zaku iya tuntuɓar Sashen Ƙasa da Ƙasa na Asibitin Oncology na Yankin Kudu na Beijing.
Lambar Waya: 4008803716
Email：myimmnet@163.com
Nassoshi
1.https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d
2.https://cn.hspharm.com/
Lokacin Saƙo: Maris-14-2025