Cell & Gene Therapy Programs

 

Thaum Lub Ib Hlis 29, 2026, SYS6055 Txhaj Tshuaj, tus kheej tsim los ntawm CSPC Pharmaceutical Group, tau txais kev sim tshuaj ntsuam xyuas pom zoo los ntawm National Medical Products Administration (NMPA) (Acceptance No.: CXSL2500947). Raws li Tuam Tshoj thawj qhov chaw kho mob tau pom zoo nyob rau hauv -vivo CAR-T kev kho mob rau relapsed / refractory aggressive B- cell lymphoma, nws rhuav tshem cov txheej txheem kev cuam tshuam ntawm cov pa ex vivo CAR-T, xa ntau dua thiab cov kev kho mob tshiab rau cov neeg mob.

 

I. Cov Kev Sib Tw Tseem Ceeb: RCL Kev Xeem Teebmeem rau Tsis yog-Canonical VSVG-Cov kab mob Lentiviruses

Qhov kev pheej hmoo tseem ceeb ntawm kev nyab xeeb ntawm -vivo CAR-T yog nyob rau hauv replication- muaj peev xwm lentivirus (RCL) kis tau tus kab mob, uas yuav ua rau tsis muaj kev tswj hwm tus kab mob hauv vivo thiab insertional mutagenesis, ua rau muaj kev txhawj xeeb txog kev nyab xeeb loj. Nws ua haujlwm raws li kev tshuaj xyuas tseem ceeb rau kev tswj xyuas los ntawm NMPA, FDA thiab lwm tus tub ceev xwm.

SYS6055 txais kev tsim cov hnab ntawv T cell- tsom rau lentivirus, txawv ntawm ib txwm muaj VSVG-enveloped lentiviral vectors xws li VSV-G thiab Cocal-G. Cov kev ntsuam xyuas RCL tsuas yog ua tau nrog VSVG- cov kab mob hauv lub hnab, nrog rau cov kev txwv suav nrog qhov tshwj xeeb tsis txaus, tsis tshua muaj siab thiab tsis ua raws li cov cai tswj hwm. Cov kev tsis txaus no ua tsis tau raws li qhov kev xav tau ntawm qhov kev sim thiab ua ib qho tseem ceeb rau kev xa mus rau IND.

 

II. HyQure Solution: Customized RCL Testing + Full -Cycle Biosafety Services

Leveraging nyob rau hauv -tshaj technological kev txawj ntse nyob rau hauv lub cell thiab noob therapy (CGT) sector, HyQure Biotech tsim ntiaj teb no - ua tus customized biosafety ntsuam xyuas cov kev daws teeb meem raws li cov kev cai ntawm CSPC's SYS6055 qhov project, kom ntseeg tau tias kev ua tau zoo thiab kev ua haujlwm tau zoo.

Customized RCL Testing to Break Technical Bottlenecks of Engineered VSVG Envelopes

Ua ke nrog CDE'sCov Lus Qhia Txog Cov Teeb Meem Feem Ntau thiab Cov Kev Xav Tau Rau Kev Hloov Pauv -Lentivirus Detection muaj peev xwmthiab FDA cov ntaub ntawv qhia, ib qho kev soj ntsuam tshwj xeeb rau cov uas tsis yog -VSVG-enveloped lentiviruses tau tsim. Qhov no txuas rau qhov sib txawv hauv tsev hauv RCL tshawb pom rau cov tsis yog -VSVG-enveloped lentiviruses thiab ua kom muaj kev nyab xeeb ntawm vector raws li cov qauv sau thoob ntiaj teb.

Tag Nrho -Cycle Biosafety Testing to Consolidate Quality Assurance for Innovative Drugs

Peb muab ib qho - nres cov kev pabcuam uas suav nrog kev txheeb xyuas lub txhab nyiaj ntawm tes, RCL tshawb pom thiab ntau- qhov sib txawv ntawm qhov sib txawv.

Nyob rau hauv nruj raws li ICH Q5A thiab Suav Pharmacopoeia cov qauv, cov khoom siv kuaj pom zoo suav nrog kev txheeb xyuas tus kheej, kev tsom xam purity thiab kev soj ntsuam tus neeg saib xyuas tau ua tiav rau Master Cell Banks (MCB) thiab Ua Haujlwm Cell Banks (WCB). Ua ke nrog NGS thev naus laus zis, tag nrho -genome characterization ntawm lentiviral vectors yog ua los lav cov qauv vector tsis zoo thiab tsis muaj qhov txawv txav, ua tiav tag nrho - txheej txheem biosafety tswj los ntawm raw khoom mus rau cov khoom kawg.

Ntiaj teb no kev ua raws cai & Kev xa khoom zoo kom nrawm thoob ntiaj teb nthuav tawm cov tshuaj tshiab

Ib qho tshwj xeeb ntsuab channel tau tsim tawm rau SYS6055 qhov project, nrog rau kev ua haujlwm zoo tshaj plaws ntawm kev ua haujlwm thiab cov pab pawg ua haujlwm laus tau xa mus. Thaum ua kom ntseeg tau cov ntaub ntawv raug thiab txhim khu kev qha, lub sijhawm ntsuas tau luv luv. Kev tswj hwm-cov ntawv ceeb toom ua raws rau kev xa tawm thoob ntiaj teb tau raug xa tawm zoo, ua kom yooj yim NMPA pom zoo sai thiab tso lub hauv paus ruaj khov rau kev sau npe txawv teb chaws tom ntej.

 

III. Kev Qhia Txog Tus Nqi: Pioneering Hauv -vivo CAR-T Kev Ntsuas los Tsav Kev Tsim Kho Tshiab

Qhov kev txhawb nqa ua tiav rau kev pom zoo ntawm CSPC SYS6055 yog qhov tseem ceeb rau HyQure Biotech hauv thaj tsam ntawm -vivo CAR-T biosafety test. Raws li ib qho ntawm thawj cov tuam txhab lag luam hauv tsev los tsim kho RCL kev sim rau hauv -vivo CAR-T, HyQure Biotech tau tsim cov txheej txheem kev qhia dav dav uas npog tshwj xeeb enveloped lentivirus kuaj, tag nrho vector characterization thiab cell bank tsim nyog. Nws tau txhawb nqa ntau tus neeg sib tw CGT nkag mus rau kev kho mob, tswj kev ua haujlwm zoo thiab muaj peev xwm ua haujlwm hauv kev lag luam.

 

Tsiv mus tom ntej, HyQure Biotech tseem yuav tsom mus rau CGT biosafety kuaj. Nrog rau kev txiav-ntev thoob ntiaj teb thev naus laus zis, kev daws teeb meem thiab kev ua haujlwm siab- cov kev pabcuam ua haujlwm tau zoo, peb yuav txhawb nqa cov tuam txhab tshuaj tshiab tshiab kom kov yeej cov teeb meem kev lag luam thiab ua kom R&D nce qib. Peb siv zog los txhawb kev tsim kev nyab xeeb thiab kev lag luam thoob ntiaj teb ntawm Suav cov tshuaj tshiab, thiab txhawb nqa qhov siab - kev loj hlob zoo ntawm Tuam Tshoj txoj kev lag luam ntawm tes thiab noob caj noob ces.