Musi wa10 Kurume, 2025, Hansoh Pharma yakazivisa kuti mushonga mutsva wechitatu ("NDA") weboka reAmeile (阿美乐®) (Aumolertinib Mesilate Tablets) wakabvumidzwa neNational Medical Products Administration of China ("NMPA") wekurapa varwere vane kenza yemapapu isingabvisike (Stage III) isiri diki yemasero madiki ("NSCLC") vane chirwere chisina kufambira mberi mushure mekurapa kwe platinum-based chemoradiotherapy ine mabundu ane epidermal growth factor receptor ("EGFR") exon 19 deletions kana exon 21 (L858R) substitute mutations. Ichi ndicho chiratidzo chechitatu chakabvumidzwa kuna Ameile kubva payakatanga kutengeswa makore mashanu apfuura. Nekuda kweizvozvo, Ameile yave yega EGFR-TKI yakagadzirwa munyika ino yakatenderwa kurapwa kwekuchengetedza varwere vane NSCLC yedanho rechitatu risingabvisike mushure mekurapa kwechemotherapy.
Kubvumidzwa kwacho kwakavakirwa zvakanyanya paongororo yePOLESTAR (HS-10296-304), bvunzo yekiriniki yechikamu chechitatu chechikamu chechitatu chekuongorora mhedzisiro yaAmeile sekurapa kwekuchengetedza muchikamu chechitatu cheNSCLC mushure mekurapa nechemotherapy. Chidzidzo chePOLESTAR chakatungamirwa naProf. Yu Jinming weShandong Cancer Hospital semuongorori mukuru. Mhedzisiro yacho yakasarudzwa pa2024 World Conference on Lung Cancer (WCLC) “Late Breaking Abstract (LBA)” uye yakapihwa paSymposium yeMutungamiriri wemusangano.
Zvakabuda muongororo iyi zvakaratidza kuti Ameile yakaderedza njodzi yekufambira mberi kwechirwere neinopfuura 80% uye avhareji yekurarama pasina progression (mPFS) yevarwere vakarapwa neAmeile yaive mwedzi 30.4 zvichienzaniswa nemwedzi 3.8 chete kune avo vakagamuchira placebo. Pamusoro pezvo, kubatsirwa kweAmeile pane placebo yePFS kwaive kwakafanana mumapoka ese akatsanangurwa, zvichiratidza huwandu hwekubatsira kwakazara. Uyezve, chiyero chekupindura chakanangana (ORR) muboka rekurapwa reAmeile rakaongororwa neBICR chakasvika 57%, nepakati penguva yekupindura (DoR) ichisvika kumwedzi 16.59 uye avhareji yekurarama kwese (OS) isati yasvika. Kuwanda kwezvironda zveCNS uye metastases dziri kure kwaive kwakaderera. Kushivirira uye kugona kubata kweAmeile muvarwere mushure mekurapa nechemotherapy kwaive kwakanaka. Panyaya yezviitiko zvakaipa (AEs), kuwanda kwe≥3 grade radiation pneumonitis kwaive 0, uye kuwanda kweinterstitial pneumonia kwaivewo 0.
NezveHansoh Pharma
Hansoh Pharma ikambani inotungamira mumishonga muGreater China inotungamirirwa nehunyanzvi hutsva. Yakazvipira kurapa zvirwere zvikuru munzvimbo dzekenza, kudzivirira hutachiona, zvirwere zveCNS, zvirwere zvemetabolic, pamwe nezvirwere zve autoimmune, uye yakazvipira kuvandudza hutano hwevanhu kuburikidza nehunyanzvi hutsva hunoramba huripo. Kusvika pari zvino, Hansoh Pharma yakatanga mishonga minomwe mitsva yekugadzira portfolio yekutengeserana yakasiyana-siyana. Hansoh Pharma yave iri pakati pemakambani epamusoro zana epasi rose emishonga uye mabhizinesi matatu epamusoro eindasitiri muChina maererano nepipeline yeR&D yemishonga kwemakore akati wandei, uye ibhizinesi guru repamusoro-soro renyika uye bhizinesi renyika rinoratidza hunyanzvi hutsva. Hansoh Pharma yakanyorwa paStock Exchange yeHong Kong muna Chikumi 2019 (kodhi yemasheya: 03692.HK). Kuti uwane rumwe ruzivo, ndapota shanyira www.hspharm.com.
Parizvino, kuchine miedzo yakawanda yekiriniki yehunyanzvi hutsva hwekurwisa gomarara muChina huri kutsvaga varwere. Kana muchida kubvunzana nezvemishonga mitsva netekinoroji, munogona kubata Dhipatimendi reBeijing South Region Oncology Hospital International.
Nhamba yefoni: 4008803716
Email：myimmnet@163.com
Mareferensi
1.https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d
2.https://cn.hspharm.com/
Nguva yekutumira: Kurume-14-2025