Ma Malaki 10, 2025, ua hoʻolaha ʻo Hansoh Pharma i ke kolu o ka Noi Lāʻau Hou ("NDA") o ka lāʻau lapaʻau hou a ka Hui ʻo Ameile (阿美乐®) (Aumolertinib Mesilate Tablets) i ʻāpono ʻia e ka National Medical Products Administration of China ("NMPA") no ka mālama ʻana i nā maʻi me ka maʻi kanesa māmā non-small cell holomua kūloko, hiki ʻole ke hoʻopau ʻia (Stage III) ("NSCLC") nona ka maʻi i holomua ʻole ma hope o ka chemoradiotherapy platinum-based definitive nona nā tumors i loaʻa i ka epidermal growth factor receptor ("EGFR") exon 19 deletions a i ʻole exon 21 (L858R) substitute mutations. ʻO kēia ke kolu o ka hōʻailona i ʻāpono ʻia no Ameile mai kona hoʻomaka ʻana i ke kālepa ʻana i ʻelima mau makahiki i hala. ʻO ka hopena, ua lilo ʻo Ameile i hoʻomohala ʻia ma ka home i ka hanauna ʻekolu o EGFR-TKI i ʻāpono ʻia no ka mālama ʻana i nā maʻi me ka unresectable stage III NSCLC ma hope o ka chemoradiotherapy.
Ua hoʻokumu nui ʻia ka ʻāpono ʻana ma ke aʻo ʻana ʻo POLESTAR (HS-10296-304), kahi hoʻokolohua lapaʻau randomized, double-blind, placebo controlled, multicenter phase III e loiloi i nā hopena o Ameile ma ke ʻano he mālama mālama ma ka pae III NSCLC hiki ʻole ke hoʻopau ʻia ma hope o ka chemoradiotherapy. Ua alakaʻi ʻia ke aʻo ʻana ʻo POLESTAR e Academician Prof. Yu Jinming mai ka Shandong Cancer Hospital ma ke ʻano he mea noiʻi nui. Ua koho ʻia nā hopena no ka papa inoa "Late Breaking Abstract (LBA)" o ka 2024 World Conference on Lung Cancer (WCLC) a hōʻike ʻia ma ka Symposium a ka Pelekikena o ka ʻaha kūkā.
Ua hōʻike nā hopena o ke aʻo ʻana ua hōʻemi ʻo Ameile i ka pilikia o ka holomua ʻana o ka maʻi ma mua o 80% a ʻo ka awelika o ke ola ʻole o ka holomua (mPFS) no nā maʻi i mālama ʻia me Ameile he 30.4 mau mahina i hoʻohālikelike ʻia me 3.8 mau mahina wale nō no ka poʻe e loaʻa ana i ka placebo. Eia kekahi, ua kūlike ka pōmaikaʻi o Ameile ma luna o ka placebo no PFS ma nā hui liʻiliʻi i wehewehe mua ʻia, e hōʻike ana i kahi ʻikepili pōmaikaʻi piha. Eia kekahi, ua hiki i ka helu pane pahuhopu (ORR) i ka hui mālama ʻo Ameile i loiloi ʻia e BICR i 57%, me ka lōʻihi waena o ka pane (DoR) e hoʻonui ana i 16.59 mau mahina a ʻaʻole i hiki i ka awelika holoʻokoʻa ola (OS). Ua haʻahaʻa ka nui o nā lesions CNS a me nā metastases mamao. Ua maikaʻi ka hoʻomanawanui holoʻokoʻa a me ka hoʻokele ʻana o Ameile i nā maʻi ma hope o ka chemoradiotherapy. Ma ke ʻano o nā hanana ʻino (AE), ʻo ka nui o ka radiation pneumonitis ≥3 grade he 0, a ʻo ka nui o ka pneumonia interstitial he 0 nō hoʻi.
E pili ana iā Hansoh Pharma
He ʻoihana lāʻau lapaʻau alakaʻi ʻo Hansoh Pharma ma Kina Nui i hoʻokele ʻia e ka hana hou. Ua kūpaʻa ia i ka mālama ʻana i nā maʻi nui ma nā wahi o ka oncology, anti-infections, nā maʻi CNS, nā maʻi metabolic, a me nā maʻi autoimmune, a ua hoʻolaʻa ʻia i ka hoʻomaikaʻi ʻana i ke olakino kanaka ma o ka hana hou mau. A hiki i kēia lā, ua hoʻokuʻu ʻo Hansoh Pharma i 7 mau lāʻau lapaʻau hou e hana i kahi waihona kālepa like ʻole. Ua helu ʻia ʻo Hansoh Pharma ma waena o nā ʻoihana lāʻau lapaʻau honua kiʻekiʻe 100 a me nā ʻoihana ʻoihana 3 maikaʻi loa ma Kina ma ke ʻano o ka pipeline R&D lāʻau lapaʻau no kekahi mau makahiki, a he ʻoihana ʻenehana kiʻekiʻe koʻikoʻi aupuni a he ʻoihana hōʻikeʻike hana hou ʻenehana aupuni. Ua helu ʻia ʻo Hansoh Pharma ma ka Stock Exchange o Hong Kong i Iune 2019 (code stock: 03692.HK). No ka ʻike hou aku, e kipa i ka www.hspharm.com.
I kēia manawa, nui nā hoʻokolohua lapaʻau o nā ʻenehana anti-cancer hou ma Kina e ʻimi nei i nā maʻi. I ke kūkākūkā ʻana i nā lāʻau lapaʻau a me nā ʻenehana hou, hiki iā ʻoe ke hoʻokaʻaʻike aku i ka Beijing South Region Oncology Hospital International Department.
Helu Kelepona：4008803716
Email：myimmnet@163.com
Nā Kuhikuhi
1.https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d
2.https://cn.hspharm.com/
Ka manawa hoʻouna: Malaki-14-2025