Antengene xa Selinexor cov npe tshuaj tshiab rau hauv Kaus Lim Qab Teb

Thaum Lub Ib Hlis 4, Antengene tau tshaj tawm tias nws tau xa daim ntawv thov rau chaw tu menyuam yaus tshiab cov tshuaj (NDA) rau selinexor ua ke nrog cov tshuaj dexamethasone tsawg rau Kauslim Ministry of Food thiab Drug Safety (MFDS) rau kev kho mob thiab rov ua ntau yam mob myeloma (rrMM) ) Thiab ib leeg-tus neeg sawv cev kev kho mob ntawm kev rov qab thiab rov ua dua lub cev loj B-cell lymphoma (rrDLBCL) uas tau txais tsawg kawg 2 kab kev kho mob yav dhau los.

Selinexor tau tso cai me nyuam ntsuag chaw nyob hauv Kaus Lim Qab Teb hauv Lub Kaum Hli 2020 thiab tau pom zoo los ntawm Asmeskas FDA rau lub Kaum Ob Hlis 18 ntawm tib lub xyoo rau ntau cov neeg mob myeloma uas tau txais kev kho mob tsawg kawg yog thawj zaug.

Kev xa tawm NDA yog los ntawm cov ntaub ntawv zoo ntawm ob qho tseem ceeb STORM thiab SADAL cov kev tshawb fawb. Ob txoj kev tshawb fawb tau pom tias selinexor muaj cov kab mob tseem ceeb thiab kev paub tseeb txog kev nyab xeeb. Ntawm lawv, STORM yog qhov qhib, ib txhais tes Phase 2b qhov kev tshawb fawb soj ntsuam los soj ntsuam selinexor ua ke nrog cov koob tshuaj dexamethasone tsawg dua hauv kev kho mob rrMM cov neeg mob uas tau txais tsawg kawg yog ob qho tshuaj tiv thaiv kab mob, ob lub tshuaj tiv thaiv kab mob ntshav thiab CD38 Plaub-txoj kev kho nrog rau cov tshuaj monoclonal Cov. SADAL yog qhib theem 2b kev kawm tshawb fawb los ntsuas kev kho mob selinexor monotherapy rau cov neeg mob rrDLBCL (suav nrog kev hloov los ntawm follicular lymphoma) uas yav tas los tau txais kev kho mob thib ob.

Selinexor yog thawj thiab tsuas yog qhov ncauj xaiv nuclear export inhibitor (SINE) ntawm nws yam thiab thawj cov tshuaj pom zoo los ntawm FDA rau kev kho mob ntawm ntau myeloma thiab diffuse loj B-cell lymphoma. Thaum Lub Kaum Ob Hlis 2020, National Comprehensive Cancer Network (NCCN) suav nrog peb qhov sib xyaw ua ke ntawm selinexor hauv kev kho mob thiab rov ua ntau yam myeloma rau hauv kev kho mob cov lus qhia, suav nrog SVd (selinexor, bortezomib, thiab dexamethasone), SPd (selinexor, pomalidomide, thiab dexamethasone) )). dexamethasone) thiab SDd (selinexor, daratumumab thiab dexamethasone) cov haujlwm. Antengene tau xa daim ntawv thov cov npe tshuaj tshiab rau selinexor rau kev kho mob ntawm cov neeg mob nrog rrMM thiab rrDLBCL rau Lub Chaw Haujlwm Saib Xyuas Kev Noj Qab Haus Huv ntawm Singapore (HSA) thiab Chaw Tswj Xyuas Khoom Siv Tshuaj (Medical Medicals Administration of Australia)

Mei Jianming, Founder, Chairman thiab CEO ntawm Antengene, tau hais tias: "Qhov kev tshwm sim ntawm hematoma yuav nce ntxiv nrog lub hnub nyoog. Rau cov neeg mob hematoma xws li rrMM thiab rrDLBCL, ntau lub tsev kho mob tseem tuaj yeem tsis muaj kev kho mob txaus. Kev Npaj. Kuv zoo siab heev uas pom selinexor xa cov ntawv thov rau kev lag luam hauv ntau thiab ntau dua Asia-Pacific cheeb tsam xws li Kaus Lim Qab Teb. Peb ntseeg hais tias selinexor, ib qho tshuaj noj hauv qhov ncauj, muaj peev xwm nthuav dav thiab txhim kho cov kev kho mob uas twb muaj lawm rau hematoma, uas yog kev hem thawj thiab maj rau lub neej. Nws yog qhov tseem ceeb rau cov neeg mob xav tau kev pab."