Pa Marichi 10, 2025, Hansoh Pharma idalengeza kuti kugwiritsa ntchito mankhwala atsopano ("NDA") (mankhwala atsopano a gulu la Ameile (阿美乐®) (Aumolertinib Mesilate Tablets) kwavomerezedwa ndi National Medical Products Administration of China (“NMPA”) pochiza odwala omwe ali ndi khansa ya m'mapapo yopanda maselo ang'onoang'ono (“NSCLC”) yomwe sinapitirire pambuyo pa mankhwala a platinum omwe ali ndi zotupa zomwe zimakhala ndi epidermal growth factor receptor (“EGFR”) exon 19 deletions kapena exon 21 (L858R) m'malo mwake. Ichi ndi chizindikiro chachitatu chovomerezeka cha Ameile kuyambira pomwe idayambitsidwa zaka zisanu zapitazo. Zotsatira zake, Ameile yakhala EGFR-TKI yokhayo yopangidwa mdziko muno yomwe yavomerezedwa kuti igwiritsidwe ntchito pochiza odwala omwe ali ndi NSCLC yosachotsedwa ya gawo lachitatu pambuyo pa mankhwala a chemotherapy.
Kuvomerezedwa kumeneku kunachokera makamaka pa kafukufuku wa POLESTAR (HS-10296-304), kafukufuku wachipatala wochitidwa mwachisawawa, wosawoneka bwino, wolamulidwa ndi placebo, wochitidwa m'malo osiyanasiyana, kuti awone zotsatira za Ameile ngati chithandizo chosamalira mu gawo lachitatu la NSCLC losachiritsika pambuyo pa chithandizo cha mankhwala a chemoradiotherapy. Kafukufuku wa POLESTAR anatsogoleredwa ndi Pulofesa Yu Jinming wochokera ku Shandong Cancer Hospital monga wofufuza wamkulu. Zotsatira zake zinasankhidwa pamndandanda wa Msonkhano Wapadziko Lonse wa 2024 pa Khansa ya M'mapapo (WCLC) wa “Late Breaking Abstract (LBA)” ndipo zinaperekedwa pa Msonkhano wa Purezidenti wa msonkhanowo.
Zotsatira za kafukufukuyu zasonyeza kuti Ameile inachepetsa chiopsezo cha matenda ndi zoposa 80% ndipo moyo wapakati wopanda progression (mPFS) kwa odwala omwe adalandira Ameile unali miyezi 30.4 poyerekeza ndi miyezi 3.8 yokha kwa omwe adalandira placebo. Kuphatikiza apo, phindu la Ameile kuposa placebo la PFS linali lofanana m'magulu onse omwe adafotokozedwa kale, zomwe zikusonyeza kuti phindu lonse linalipo. Kuphatikiza apo, chiŵerengero cha yankho lolunjika (ORR) mu gulu la Ameile lomwe linayesedwa ndi BICR chinafika pa 57%, pomwe nthawi yapakati yoyankha (DoR) inafika pa miyezi 16.59 ndipo moyo wapakati wonse (OS) sunafikebe. Kuchuluka kwa zilonda za CNS ndi metastases yakutali kunali kotsika. Kulekerera konse ndi kulamulira kwa Ameile mwa odwala pambuyo pa mankhwala a chemoradiotherapy kunali kwabwino. Ponena za zochitika zoyipa (AEs), kuchuluka kwa ≥3 grade radiation pneumonitis kunali 0, ndipo kuchuluka kwa interstitial pneumonia kunalinso 0.
About Hansoh Pharma
Hansoh Pharma ndi kampani yotsogola yamankhwala ku Greater China yoyendetsedwa ndi zatsopano. Yadzipereka kuchiza matenda akuluakulu m'magawo a khansa, matenda opatsirana, matenda a CNS, matenda a kagayidwe kachakudya, komanso matenda a autoimmune, ndipo yadzipereka kukonza thanzi la anthu kudzera mu zatsopano zopitilira. Mpaka pano, Hansoh Pharma yatulutsa mankhwala 7 atsopano kuti apange mbiri yosiyanasiyana yamalonda. Hansoh Pharma yakhala m'gulu la makampani 100 apamwamba padziko lonse lapansi opanga mankhwala komanso mabizinesi atatu apamwamba kwambiri ku China pankhani ya njira yofufuzira ndi chitukuko cha mankhwala kwa zaka zingapo, ndipo ndi kampani yofunika kwambiri padziko lonse lapansi komanso kampani yowonetsa zatsopano zaukadaulo. Hansoh Pharma idalembedwa pa Stock Exchange of Hong Kong mu June 2019 (khodi yamasheya: 03692.HK). Kuti mudziwe zambiri, chonde pitani ku www.hspharm.com.
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
Zolemba
1.https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d
2.https://cn.hspharm.com/
Nthawi yotumizira: Marichi-14-2025