Cstone's Multispecific Antibody Clinical Trial Application tau pom zoo nyob rau hauv Tuam Tshoj yog cia siab tias yuav dhau los ua Ib tiam tom ntej ntawm PD-(L)1 Kev Kho Mob

Thaum lub Cuaj Hlis 15, Hong Kong cov tuam txhab tshuaj tshiab tshiab Cstone Pharmaceuticals (HK: 2616) tau tshaj tawm tias nws cov tshuaj tiv thaiv ntau yam tshwj xeeb CS2006 / NM21-1480 Suav kev sim tshuaj (IND) tau pom zoo los ntawm Tuam Tshoj National Medical Products Administration (NMPA). Center pom zoo. Cov khoom no muaj peev xwm ntawm qhov zoo tshaj plaws-nyob rau hauv-chav kawm immunotherapy molecules molecule thiab cia siab tias yuav los ua ib tug cog lus rau tiam tom ntej PD-(L)1 kev kho mob nyob rau hauv lub teb ntawm qog immunotherapy. Qhov kev pom zoo no yog qhov tseem ceeb tshaj plaws rau Cstone' lub raj xa dej 2.0 lub tswv yim, thiab nws yog ib kauj ruam tseem ceeb rau Cstone' txoj kev tshawb fawb kho tshiab.

Nws tau nkag siab tias CS2006 / NM21-1480 muaj cov qauv tsim tshwj xeeb thiab yog monovalent trispecific antibody uas ib txhij tsom rau PD-L1, 4-1BB thiab tib neeg cov ntshav albumin (HSA). Nws tuaj yeem ua rau lub cev tiv thaiv kab mob costimulatory receptor 4-1BB thiab ua kom cov kab mob qog noj ntshav T hlwb tsuas yog thaum nws khi rau cov qog cell nto ligand PD-L1, yog li nws yuav zam tsis txhob siv 4-1BB agonist antibodies yav dhau los Pom lub siab toxicity. .

Piv nrog rau lwm cov PD-L1 / 4-1BB bispecific neeg sib tw cov tshuaj tiv thaiv, nws cov qauv monovalent tshwj xeeb tsim thiab ultra-siab affinity rau PD-L1 yuav ua rau kom muaj peev xwm ntawm ob qhov teebmeem ntawm PD-L1 thiab 4-1BB hauv cov qog. , Cov nyhuv curative yog dav thiab ntev-ntev thaum tsis txhob muaj kab mob toxicity. Tsis tas li ntawd, los ntawm kev sib txuas HSA, nws ib nrab-lub neej tuaj yeem ua kom ntev, muab cov neeg mob yooj yim dua rau kev siv ntau zaus. Yog li, CS2006/NM21-1480 yuav tsum muaj txiaj ntsig zoo tiv thaiv ntau hom qog nqaij hlav nrog PD-L1 qhia, thiab tuaj yeem kov yeej thawj thiab theem nrab tiv thaiv PD-1 / PD-L1 cov tshuaj tiv thaiv.

Vim yog cov yam ntxwv no, CS2006/NM21-1480, raws li qhov muaj peev xwm zoo tshaj plaws hauv chav kawm kho mob, tuaj yeem siv rau hauv kev kho ib tus neeg sawv cev lossis ua ke nrog ntau yam kev kho mob, thiab xav tias yuav dhau los ua ib qho kev cog lus rau tiam tom ntej PD-(L) nyob rau hauv daim teb ntawm qog immunotherapy. 1 Txoj kev kho mob. Qhov kev sim tshuaj ntsuam xyuas yuav tsum tau ua los soj ntsuam kev nyab xeeb, cov yam ntxwv ntawm cov tshuaj pharmacokinetic thiab kev tiv thaiv qog nqaij hlav ntawm CS2006 / NM21-1480 hauv Suav cov neeg mob uas muaj ntau hom qog nqaij hlav.

Dr. Xie Yizhao, Tus Thawj Saib Xyuas Kev Tshawb Fawb ntawm Cstone Pharmaceuticals, tau hais tias CS2006/NM21-1480' daim ntawv thov kev kho mob hauv Suav teb tau pom zoo los ntawm NMPA thiab kev sim tshuaj yuav pib sai sai. Qhov no yog lub sijhawm tseem ceeb hauv Cstone' lub raj xa dej 2.0 lub tswv yim. Nws tau pom zoo kom nkag mus rau thawj qhov kev sim tib neeg hauv Tebchaws Meskas thaum lub Tsib Hlis, thiab kev tshawb fawb tseem tab tom ua." Cstone Pharmaceuticals tsom rau lub ntiaj teb' thawj thiab zoo tshaj plaws-hauv-chav kawm cov khoom lag luam hauv cov kev kho mob tshwm sim hauv thaj chaw oncology. Nyob rau hauv lub neej yav tom ntej, peb yuav ceev nrooj kev txhim kho ntawm ntau yam khoom pipelines nrog rau CS2006 / NM21-1480, thiab pab cov neeg mob nyob rau hauv Tuam Tshoj thiab thoob ntiaj teb. Nqa ntau txoj kev kho mob tshiab."

Nws tau tshaj tawm tias CS2006/NM21-1480 tau tsim thiab tsim los ntawm Numab Therapeutics, tus khub ntawm CStone Pharmaceuticals, thiab tau txais kev pom zoo nkag mus rau thawj tib neeg sim hauv Tebchaws Meskas thaum lub Plaub Hlis 2020. Kev tshawb fawb tam sim no tab tom ua. Raws li daim ntawv cog lus kev koom tes ntawm ob tog, Cstone Pharmaceuticals yuav muab nyiaj txiag rau kev tshawb fawb thiab kev loj hlob ntawm CS2006/NM21-1480 kom txog rau thaum ua tiav ntawm thawj theem Ib lub chaw kuaj mob. Nyob rau tib lub sijhawm CStone Pharmaceuticals yuav ua haujlwm hauv Suav teb loj (xws li Tuam Tshoj Mainland, Hong Kong, Macau thiab Taiwan), Kaus Lim Qab Teb thiab Singapore muaj txoj cai tsim kho thiab kev lag luam. Numab khaws txhua txoj cai rau cov neeg sib tw tshuaj yeeb hauv lwm lub ntiaj teb.

Nyob rau hauv cov nqe lus ntawm pipeline 2.0, Cstone Pharmaceuticals yog tam sim no ntxiv dag zog rau nws endogenous innovation muaj peev xwm los ntawm nws unremitting kev rau siab nyob rau hauv kev tshawb fawb thiab kev loj hlob, thiab tsim ib tug txawv txoj kev tshuaj pipeline nrog ntiaj teb no txoj cai thiab kev txaus siab. Tam sim no, muaj 15 cov khoom lag luam, ntawm 8 yog kev tshawb fawb ywj pheej thiab kev tsim kho, thiab 7 tau qhia los yog sib koom ua ke tsim, npog me me molecules, monoclonal antibodies, polyclonal antibodies thiab ADCs thiab lwm yam subdivisions.