Thaum Lub Peb Hlis 10, 2025, Hansoh Pharma tshaj tawm daim ntawv thov tshuaj tshiab thib peb ("NDA") ntawm pawg tshuaj tshiab Ameile (阿美乐®) (Aumolertinib Mesilate Tablets) tau txais kev pom zoo los ntawm National Medical Products Administration of China ("NMPA") rau kev kho mob rau cov neeg mob uas muaj mob qog nqaij hlav hauv zos, tsis tuaj yeem phais tau (Theem III) tsis yog mob qog nqaij hlav me me ("NSCLC") uas tus kab mob tsis tau nce qib tom qab kev kho mob chemoradiotherapy raws li platinum uas cov qog nqaij hlav muaj epidermal growth factor receptor ("EGFR") exon 19 deletions lossis exon 21 (L858R) hloov pauv. Qhov no yog qhov cim qhia thib peb tau pom zoo rau Ameile txij li nws tau pib ua lag luam tsib xyoos dhau los. Yog li ntawd, Ameile tau dhau los ua tib lub tebchaws tsim EGFR-TKI tiam thib peb tau pom zoo rau kev kho mob txij nkawm rau cov neeg mob uas muaj theem III NSCLC uas tsis tuaj yeem phais tau tom qab kev kho mob chemoradiotherapy.
Qhov kev pom zoo yog raws li kev tshawb fawb POLESTAR (HS-10296-304), kev sim tshuaj randomized, ob chav dig muag, tswj placebo, ntau lub chaw theem III los ntsuas cov teebmeem ntawm Ameile ua kev kho mob txij nkawm hauv theem III NSCLC uas tsis tuaj yeem phais tom qab chemoradiotherapy. Kev tshawb fawb POLESTAR tau coj los ntawm Academician Prof. Yu Jinming los ntawm Shandong Cancer Hospital ua tus kws tshawb fawb tseem ceeb. Cov txiaj ntsig tau raug xaiv rau 2024 World Conference on Lung Cancer (WCLC) "Late Breaking Abstract (LBA)" daim ntawv teev npe thiab tau nthuav tawm ntawm President's Symposium ntawm lub rooj sib tham.
Cov txiaj ntsig ntawm kev tshawb fawb qhia tau tias Ameile txo qhov kev pheej hmoo ntawm kev mob hnyav zuj zus ntau dua 80% thiab qhov nruab nrab ntawm kev ciaj sia tsis muaj kev mob hnyav zuj zus (mPFS) rau cov neeg mob uas tau kho nrog Ameile yog 30.4 lub hlis piv rau tsuas yog 3.8 lub hlis rau cov neeg uas tau txais placebo. Tsis tas li ntawd, qhov txiaj ntsig ntawm Ameile dua li placebo rau PFS yog sib xws thoob plaws txhua pawg me me uas tau teev tseg, qhia txog cov txiaj ntsig zoo. Tsis tas li ntawd, qhov kev teb rov qab (ORR) hauv pawg kho mob Ameile uas tau ntsuas los ntawm BICR tau txog 57%, nrog rau lub sijhawm nruab nrab ntawm kev teb (DoR) txuas ntxiv mus txog 16.59 lub hlis thiab qhov nruab nrab ntawm kev ciaj sia tag nrho (OS) tseem tsis tau txog. Qhov tshwm sim ntawm CNS lesions thiab metastases deb qis dua. Qhov kev kam rau siab tag nrho thiab kev tswj hwm ntawm Ameile hauv cov neeg mob tom qab chemoradiotherapy yog qhov zoo. Hauv cov xwm txheej tsis zoo (AEs), qhov tshwm sim ntawm ≥3 qib radiation pneumonitis yog 0, thiab qhov tshwm sim ntawm interstitial pneumonia kuj yog 0.
Txog Hansoh Pharma
Hansoh Pharma yog ib lub tuam txhab tshuaj ua lag luam loj hauv Greater China uas tsav los ntawm kev tsim kho tshiab. Nws cog lus rau kev kho cov kab mob loj hauv thaj chaw ntawm oncology, tiv thaiv kev kis kab mob, kab mob CNS, kab mob metabolic, nrog rau cov kab mob autoimmune, thiab mob siab rau kev txhim kho kev noj qab haus huv tib neeg los ntawm kev tsim kho tshiab tas mus li. Txog niaj hnub no, Hansoh Pharma tau tsim 7 cov tshuaj tshiab los tsim cov khoom lag luam ntau yam. Hansoh Pharma tau raug xaiv los ntawm 100 lub tuam txhab tshuaj thoob ntiaj teb thiab 3 lub tuam txhab lag luam zoo tshaj plaws hauv Suav teb hauv kev tshawb fawb thiab kev tsim kho tshuaj tau ntau xyoo, thiab yog lub tuam txhab tseem ceeb hauv tebchaws thiab lub tuam txhab ua qauv qhia txog kev tsim kho tshiab hauv tebchaws. Hansoh Pharma tau teev npe rau ntawm Stock Exchange of Hong Kong thaum Lub Rau Hli 2019 (stock code: 03692.HK). Yog xav paub ntxiv, thov mus saib www.hsparm.com.
Tam sim no, tseem muaj ntau qhov kev sim tshuaj kho mob qog noj ntshav tshiab hauv Suav teb nrhiav cov neeg mob. Kev sab laj txog cov tshuaj tshiab thiab cov thev naus laus zis, koj tuaj yeem tiv tauj Beijing South Region Oncology Hospital International Department.
Xov Tooj: 4008803716
Email：myimmnet@163.com
Cov ntaub ntawv siv los ua piv txwv
1.https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d
2.https://cn.hspharm.com/
Lub sijhawm tshaj tawm: Lub Peb Hlis-14-2025