I te 10 o Poutū-te-rangi, 2025, i panuitia e Hansoh Pharma te tuatoru o ngā Tono Rongoā Hou (“NDA”) o te rongoā auaha a te Rōpū, a Ameile (阿美乐®) (Ngā Papa Aumolertinib Mesilate) kua whakaaetia e te Whakahaere Hua Hauora ā-Motu o Haina (“NMPA”) mō te maimoatanga o ngā tūroro he mate pukupuku pūkahukahu kore-pūtau iti kua whanake i te rohe, kāore e taea te tango (Wāhanga III) kāore nei i te whanake haere te mate i muri i te chemoradiotherapy e hangai ana ki te platinum, ā, kua tangohia ngā tangohanga exon 19 o te epidermal growth factor receptor (“EGFR”) me ngā whakarerekētanga whakakapinga exon 21 (L858R) o ō rātou pukupuku. Koinei te tuatoru o ngā tohu kua whakaaetia mō Ameile mai i tōna whakarewatanga arumoni i ngā tau e rima ki muri. Nō reira, kua riro a Ameile hei EGFR-TKI tuatoru o te whakatupuranga anake i whakawhanakehia i te motu kua whakaaetia mō te rongoā tiaki i roto i ngā tūroro he NSCLC wāhanga III kāore e taea te tango i muri i te chemoradiotherapy.
Ko te whakaaetanga i ahu mai i te rangahau POLESTAR (HS-10296-304), he whakamātautau haumanu matapōkere, matapo-rua, whakahaeretia e te placebo, he maha-pokapū wāhanga III hei aromatawai i ngā pānga o Ameile hei rongoā pupuri i roto i te wāhanga III NSCLC kāore e taea te tango i muri i te chemoradiotherapy. I arahina te rangahau POLESTAR e te Kairangahau Ahorangi Yu Jinming o te Hōhipera Matepukupuku Shandong hei kairangahau matua. I tīpakohia ngā hua mō te rārangi "Late Breaking Abstract (LBA)" o te Huihuinga Ao mō te Matepukupuku Pūkahukahu (WCLC) 2024, ā, i whakaaturia ki te Huihuinga a te Perehitini o te huihuinga.
I whakaatuhia e ngā hua o te rangahau i whakaitihia e Ameile te mōrearea o te whanaketanga o te mate mā te neke atu i te 80%, ā, ko te oranga kore whanaketanga toharite (mPFS) mō ngā tūroro i rongoatia ki a Ameile he 30.4 marama, ki te whakaritea ki te 3.8 marama noa iho mō te hunga i whiwhi placebo. I tua atu, he rite tonu te painga o Ameile i runga i te placebo mō te PFS puta noa i ngā rōpū iti kua tautuhia i mua, e tohu ana i te whānuitanga o ngā painga. I tua atu, ko te reiti urupare whāinga (ORR) i roto i te rōpū maimoatanga Ameile i aromatawaitia e BICR i eke ki te 57%, me te roanga toharite o te urupare (DoR) e toro atu ana ki te 16.59 marama, ā, kāore anō kia eke te oranga whānui toharite (OS). He iti ake te auau o ngā whara CNS me ngā metastases tawhiti. He pai te manawanui whānui me te whakahaere o Ameile i roto i ngā tūroro i muri i te chemoradiotherapy. Mō ngā pānga kino (AE), ko te auau o te ≥3 grade radiation pneumonitis he 0, ā, ko te auau o te interstitial pneumonia he 0 anō hoki.
Mō Hansoh Pharma
He kamupene rongoā matua a Hansoh Pharma i Haina Nui e ārahihia ana e te auahatanga. E whakapau kaha ana ki te rongoā i ngā mate nui i roto i ngā mara o te oncology, te ārai mate, ngā mate CNS, ngā mate pākia, me ngā mate pūnaha ārai mate, ā, e whakapau kaha ana ki te whakapai ake i te hauora o te tangata mā te auahatanga tonu. Tae noa ki tēnei wā, kua whakarewahia e Hansoh Pharma e 7 ngā rongoā auaha hei hanga i tētahi putea arumoni kanorau. Kua whakarārangihia a Hansoh Pharma i roto i ngā kamupene rongoā 100 o runga o te ao me ngā umanga ahumahi 3 pai rawa atu i Haina e pā ana ki te paipa R&D rongoā mō ngā tau maha, ā, he umanga hangarau-teitei matua ā-motu me te umanga whakaaturanga auaha hangarau ā-motu. I whakarārangihia a Hansoh Pharma ki te Stock Exchange o Hong Kong i te Pipiri 2019 (waehere hea: 03692.HK). Mō ētahi atu pārongo, tirohia te www.hspharm.com.
I tēnei wā, he maha tonu ngā whakamātautau haumanu o ngā hangarau hou hei ārai i te matepukupuku i Haina e rapu ana i ngā tūroro. Mēnā kei te hiahia koe ki te kōrero mō ngā rongoā me ngā hangarau hou, ka taea e koe te whakapā atu ki te Tari Ao o te Hōhipera Oncology Rohe Tonga o Beijing.
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Ngā Tohutoro
1.https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d
2.https://cn.hspharm.com/
Wā tuku: Maehe-14-2025