Apr 10, 2026 Tso lus

Prisys Biotech Txhawb IND Kev Pom Zoo Ntawm UX-GIP001 Los ntawm FDA Thiab CDE|NHP CNS Delivery Platform

 
Tsis ntev los no, iPSC- muab cov khoom siv kho mob ntawm tes UX-GIP001 Txhaj, nws tus kheej tsim los ntawm UniXell Biotechnology, tau txais kev pom zoo los ntawm US Food and Drug Administration thiab Center for Drug Evaluation nyob rau hauv National Medical Products Administration (NMPA) ntawm Tuam Tshoj. Qhov kev zov me nyuam yuav tsum nkag mus rau kev tshawb fawb soj ntsuam nyob rau yav tom ntej.

 

Lub ntsiab lus tseem ceeb no yog ib kauj ruam tseem ceeb rau pem hauv ntej hauv kev kho mob txhais lus ntawm kev kho mob ntawm tes rau kev puas siab puas ntsws thiab qhia txog tus nqi ntawm kev sib koom tes ntawm ntau tus neeg muaj feem cuam tshuam hauv kev txhim kho cov kev kho tshiab rau lub tsev kho mob.

 

Advancing Mechanism-Driven Approaches for Epilepsy Treatment

 

Epilepsyyog ib qho nyuaj thiab nthuav dav hauv nruab nrab paj hlwb (CNS/Neurology) kev tsis sib haum xeeb, nrog rau feem ntau ntawm cov neeg mob uas qhia cov lus teb tsawg rau cov kev kho mob uas twb muaj lawm. Raws li qhov tshwm sim, tseem muaj qhov tseeb tsis tau txais kev kho mob.

 

Nyob rau hauv xyoo tas los no, kev kho mob ntawm tes-raws li txoj hauv kev tau tshwm sim los ua ib lub tswv yim zoo hauv daim teb no. UX-GIP001 yog tsim los ntawm induced pluripotent stem cell (iPSC) platform, qhov twg tib neeg pluripotent qia hlwb sib txawv hauv vitro rau hauv neural progenitor hlwb nrog cov yam ntxwv ua haujlwm. Txoj hauv kev no yog tsim los hloov kho cov kab mob tsis zoo ntawm lub paj hlwb cuam tshuam nrog kev qaug dab peg, muab cov txheej txheem - tsav txoj hauv kev rau kev kho mob.

 

Thaum qhov kev nce qib ntawm txoj haujlwm no,Prisys Biotechpab txhawb rau theem tsis muaj kev kho mob los ntawm kev txhawb nqa kev tshawb fawb intracerebral, leveraging nws cov kev paub nyob rau hauv non-tib neeg primate (NHP) qauv thiab CNS- phiaj tswj technologies.

 

Prisys Biotech Supports IND Approval of UX-GIP001 by FDA and CDE NHP CNS Delivery Platform

 

Prisys Biotech's Non-Human Primate (NHP) Kev Tshawb Fawb Muaj Peev Xwm

 

Comprehensive NHP Kab Mob Model Portfolio

Tsis yog -tib neeg primates (NHPs) sib koom siab zoo sib xws nrog tib neeg hauv caj ces, lub cev, thiab lub cev tiv thaiv kab mob, ua rau lawv muaj feem cuam tshuam rauKev txhais lus-Kev tshawb fawb-Center. Prisys Biotech tau tsim ntau dua 40 tus qauv kab mob nrog rau kev soj ntsuam zoo, suav nrog:

 

 

Core Technology Platforms rau Kev Tshawb Fawb Kev Txhais Lus

Txhawm rau txuas qhov sib txawv ntawm cov kev tshawb fawb preclinical thiab kev siv tshuaj kho mob, Prisys Biotech tau tsim cov txheej txheem ntawm cov tswv cuab uas muaj txiaj ntsig zoo txhais lus.

 

iMRI-Guided Intracerebral Delivery Platform hauv NHPs

Prisys tau tsim lub sijhawm tiag tiag -,MRI-Kev Qhia Qhia Tshuaj Rau CNS Kev Tshawb Fawbhauv NHPs. Txhawb nqa los ntawm ClearPoint® neuro-navigation system, lub platform no tso cai rau submillimeter trajectory npaj thiab meej lub hom phiaj ntawm lub paj hlwb.

 

Hauv qhov kev tshawb fawb no,Convection -Kev xa khoom zoo (CED) Technologytau thov, tso cai tsis tu ncua tsawg- tus nqi, zoo- siab infusion los tsim ib qho chaw convective hauv lub hlwb. Qhov no ua rau muaj kev faib tawm volumetric ntawm kev kho mob, txhim kho ob qho tib si kev pab them nqi thiab homogeneity ntawm lub hom phiaj.

 

Ua ke nrog intraoperative MRI, lub kaw lus enables tiag tiag - lub sij hawm pom kev thiab pov thawj ntawm infusion qhov chaw thiab tis, txhim kho cov txheej txheem tswj thiab rov tsim dua.

 

Clinical -Qib Multimodal Imaging Platform

Prisys ua haujlwm aClinical Imagingqhov chaw coj los ntawm cov kws paub txog hluav taws xob los ntawm sab saum toj -cov tsev kho mob. Nruab nrog MRI, CT, thiab digital subtraction angiography (DSA), lub platform txhawb nqa cov txheej txheem kev ntsuas qib siab rau kev txheeb xyuas ntau ntawm kev faib tshuaj thiabPharmacokinetics (PK), nrog rau kev ntsuam xyuas tsis ncaj ntawm lub hom phiaj kev koom tes los ntawm cov duab biomarkers.

 

AI-Based Markerless 3D Behavioral Analysis System (BehaviorAtlas®)

Prisys tau tsim ib qhoAI-raws li NHP Behavior Analysis Systemrau NHPs. Lub platform no tso cai rau ntev -lub sij hawm, tsis yog- kev saib xyuas thiab kev faib tawm ntau ntawm lub cev muaj zog, gait txawv txav, thiab mob-txoj kev coj cwj pwm, muab cov ntaub ntawv ua tau zoo ntau yam rau kev tshawb fawb txog kab mob paj hlwb xws li Parkinson's disease thiab mob qauv.

 

UX-GIP001, an iPSC-derived cell therapy by UniXell Biotechnology, receives IND approvals from FDA and CDE. Prisys Biotech supports CNS delivery using NHP models and MRI-guided CED technology

 

Hais txog UniXell Biotechnology

 

UniXell Biotechnology, nrhiav tau nyob rau hauv 2021, tsom rau kev txhim kho ntawm iPSC-cov khoom siv kho mob ntawm tes, nrog rau qhov tseem ceeb ntawm cov kab mob neurological. Lub tuam txhab tau nquag nce nws cov raj xa mus rau kev txhais lus kho mob thiab tshawb nrhiav cov tswv yim kho tshiab.

 

Hais txog Prisys Biotech

 

Prisys Biotech tau mob siab rau muab cov qauv uas tsis yog- tib neeg primate (NHP) thiab cov kev pabcuam tshawb fawb txog kev txhais lus rau kev txhim kho tshuaj tshiab. Lub tuam txhab tsom rauNHP Neurosciencekev tshawb fawb thiab kev yees duab siab tshaj platforms, koom ua ke cov duab kos duab -cov thev naus laus zis coj nrog hauv vivo muaj peev xwm los txhawb qhov kev ntsuam xyuas tsis zoo ntawm cov biologics nyuaj, suav nrog kev kho ntawm tes thiab noob.

 

Hu rau Prisys Biotech

 

FAQ

Q: Dab tsi yog qhov tseem ceeb ntawm UX-GIP001 IND kev pom zoo?

A: Kev pom zoo IND rau UX-GIP001 los ntawm FDA thiab CDE yog qhov tseem ceeb tshaj plaws rau UniXell Biotechnology, tso cai rau lawv cov iPSC- tau txais kev kho mob ntawm tes rau kev mob qaug dab peg nkag mus rau kev tshawb fawb soj ntsuam hauv Asmeskas thiab Tuam Tshoj.

Q: Prisys Biotech txhawb UX-GIP001 program li cas?

A: Prisys Biotech tau txhawb nqa txoj kev loj hlob tsis muaj kev kho mob los ntawm kev muab cov kws tshaj lij hauv NHP cov qauv thiab ua MRI-cov kev tshawb fawb txog kev xa tawm intracerebral siv Convection-Enhanced Delivery (CED) kom ntseeg tau tias kev faib tshuaj meej.

Q: Dab tsi tshwj xeeb thev naus laus zis ua Prisys Biotech muab rau CNS kev tshawb fawb?

A: Prisys muab ib qho iMRI-kev taw qhia stereotactic kev xa khoom platform, CED thev naus laus zis rau kev faib khoom ntim, chaw kho mob- qib multimodal imaging center, thiab AI- tsav 3D kev ntsuas kev coj cwj pwm (BehaviorAtlas®).

 

 

 
 
 
 

Xa kev nug

Prisys Biotechnologies Co., Ltd.

Tib neeg kev noj qab haus huv zoo dua los ntawm Primate Translational Sciences.

NHP CRO rau Kev Tshawb Fawb Kev Txhais Lus, PK / PD thiab Kev xa tawm Precision

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