Hu rau:Errol Zhou (Mr.)
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Tsis ntev los no, Zymeworks tshaj tawm tias HER2 bispecific antibody tshuaj zanidatamab tau ua tiav cov txiaj ntsig zoo ib ntus hauv kev kho thawj kab ntawm HER2-expressing gastroesophageal adenocarcinoma (GEA).
Hauv qhov kev sim tshuaj no, 30 tus neeg mob tau txais zanidatamab ua ke nrog kev kho tus qauv ntawm kev kho mob, thiab 14 tus neeg mob tseem raug kho. Ntawm lawv, ntawm 22 HER2 cov tshuaj tiv thaiv zoo ntsuas cov neeg mob, qhov pom tseeb lub hom phiaj cov tshuaj tiv thaiv yog 68.2%, thiab tus kab mob tswj tau yog 90.9%. Kev kho mob ntsig txog cov xwm txheej tsis zoo yog feem ntau ua raws li cov lus qhia dhau los ntawm zanitatamab thiab / lossis cov tshuaj khomob, thiab feem ntau ntawm cov ntawv ceeb toom yog qib 1 lossis 2 qhov hnyav.
Zanidatamab yog ib hom tshuaj tiv thaiv bispecific tsom HER2 tsim los ntawm Zymeworks' Cov tswv cuab ntawm Azymetric® platform. Zanidatamab khi rau ob qhov chaw sib txawv ntawm HER2 tib lub sijhawm. Qhov kev tsim tshwj xeeb no ua rau ntau lub tswv yim ntawm kev ua, suav nrog dual HER2 teeb liab thaiv, nce cov tshuaj tiv thaiv kab mob, kev sib sau receptor thiab tshem tawm HER2 ntawm lub xov tooj ntawm tes, nrog rau cov txiaj ntsig zoo ua haujlwm.
Yav dhau los, zanidatamab tau tso cai rau kev kho mob rau kev mob qog noj ntshav los ntawm FDA, nrog rau ob qho kev xaiv ceev ceev, ib qho rau yav tas los kho lossis rov qab mob HER2-zoo biliary tract cancer, thiab lwm yam rau thawj kab gastroesophageal adenocarcinoma ua ke. nrog kev kho mob chemotherapy. Tsis tas li ntawd, zanidatamab kuj tau txais cov npe tshuaj me nyuam ntsuag rau kev kho mob qog noj ntshav biliary, mob qog noj ntshav thiab qog nqaij hlav zes qe menyuam hauv Tebchaws Meskas, thiab rau kev kho mob plab hnyuv hauv European Union. Tam sim no, zanidatamab tab tom raug tshuaj xyuas nyob rau theem 1, theem 2 thiab cov kev sim tshuaj tseem ceeb thoob ntiaj teb raws li kev kho mob zoo tshaj plaws rau cov neeg mob uas muaj HER2-expressing cancers, nrog rau cov kua tsib, gastroesophageal adenocarcinoma, mob cancer mis thiab lwm hom qog.
Zymeworks, lub tuam txhab tshawb fawb thev naus laus zis thiab kev tsim kho tom qab zanidatamab, tuaj yeem piav qhia tias yog qhov kev nce qib hauv kev tshawb fawb thiab kev loj hlob ntawm bispecific antibody. Founded hauv 2003, lub tuam txhab no yog lub chaw kho mob theem biomedical tuam txhab mob siab rau txoj kev loj hlob ntawm ib tiam tshiab ntawm multifunctional antibodies, headquartered nyob rau hauv Vancouver, Canada. Lub tuam txhab muaj kev tshawb fawb thiab kev loj hlob muaj peev xwm thiab muaj peb qhov kev siv thev naus laus zis ntxiv, ua rau lub tuam txhab tsim cov tshuaj tiv thaiv kab mob tshiab tsis tu ncua thiab tsis tu ncua. Txij li thaum nws tsim, Zymeworks tau ua tiav 8 qhov nyiaj txiag. Nyob rau lub Tsib Hlis 2017, lub tuam txhab tau teev nyob rau hauv New York Tshuag Txauv; Thaum Lub Rau Hli 2019, lub tuam txhab tau ua tiav qhov kev tshaj tawm thib ob, nce US $ 201.3 lab.
Zymeworks' thev naus laus zis platform thiab R&D peev xwm tau nyiam ntau lub tuam txhab los koom tes nrog lawv los tsim tshuaj, xws li Eli Lilly, GSK, Merck, BeiGene, thiab lwm yam.
Thaum lub Kaum Ib Hlis 2018, Zymeworks thiab BeiGene tau mus txog qhov kev koom tes zoo ntawm kev kho mob thiab kev lag luam ntawm zanidatamab thiab lwm yam tshuaj tiv thaiv kab mob bispecific, ZW49. Raws li kev pom zoo, BeiGene tau txais daim ntawv tso cai tshwj xeeb rau kev txhim kho thiab kev lag luam ntawm zanidatamab thiab ZW49 hauv Asia (tshwj tsis yog Nyiv), Australia thiab New Zealand. Zymeworks yuav tau txais cov nyiaj them poob qis ntawm US $ 40 lab, qhov tseem ceeb ntawm kev them nyiaj mus txog US $ 390 lab, thiab cov nyiaj tau txais txiaj ntsig raws li kev muag khoom yav tom ntej.
Thaum Lub Ib Hlis 13, 2020, Zymeworks tshaj tawm tias nws yuav pib qhov kev sim thib ob ntawm zanidatamab kev sib xyaw ua ke thiab tau txais kev pom zoo nrog Pfizer txhawm rau txhim kho kev tshawb fawb ua ke. Zanidatamab yuav siv ua ke nrog Pfizer' s qhov ncauj CDK 4/6 inhibitor Ibrance (palbociclib) thiab fulvestrant rau HR-positive, HER2-positive hauv zos advanced lossis metastatic cov neeg mob qog noj ntshav.