Rongchang Bio-Titacept ua tiav theem kev kho mob hauv tsev ntawm IgA nephropathy

Thaum Lub Yim Hli 10th, Rongchang Biotech (09995.HK) tshaj tawm tias nws lub ntiaj teb tus kheej' thawj qhov kev kho mob thib ob ntawm kev kho mob lupus erythematosus biologic tshuaj tshiab tatacept (RC18) rau kev kho IgA nephropathy hauv tsev theem II kev sim tshuaj Kev kawm mus txog qhov kawg thiab tau txais txiaj ntsig zoo.

Tag nrho ntawm 44 tus neeg mob tau raug xaiv rau txoj kev tshawb fawb no. Kev tshuaj xyuas ua ntej pom tias qib protein ntau ntawm cov neeg mob hauv pawg kho mob tytacept tau qis dua li ntawm cov hauv paus, thiab qhov sib txawv yog qhov tseem ceeb ntawm kev sib piv piv rau cov pab pawg placebo. Ib qho ntxiv, ob peb lwm cov ntsiab lus kawg txuas ntxiv qhia qhov sib txawv tseem ceeb ntawm pab pawg kho mob thiab pab pawg tswj hwm cov placebo. Cov ntaub ntawv kho mob uas muaj feem yuav raug tshaj tawm hauv cov rooj sib tham thoob ntiaj teb lossis cov ntawv xov xwm. Rongchang Bioplan yuav ua kev tshawb fawb ntxiv hauv Suav teb thiab Tebchaws Meskas.

IgA Nephropathy (IgA Nephropathy, IgAN) yog glomerulonephritis tshwm sim los ntawm kev tiv thaiv kab mob, uas tshwm sim li hematuria, proteinuria, thiab ua rau lub raum tsis ua haujlwm. Thaum kawg cov neeg mob yuav ua rau lub raum tsis ua haujlwm lossis mob raum kawg, thiab txog li 50% ntawm cov neeg mob yuav xav tau kev lim ntshav lossis hloov pauv lub raum. Raws li Frost& Sullivan, cov neeg mob nrog IgA nephropathy hauv ntiaj teb tau nce los ntawm 8.8 lab xyoo 2015 txog 9.3 lab xyoo 2020 (suav nrog 2.2 lab hauv Suav). Nws tau kwv yees tias tag nrho cov neeg mob IgA nephropathy hauv ntiaj teb yuav nce mus txog 9.7 lab nyob rau xyoo 2025 (suav nrog 2.3 lab hauv Suav) thiab 10.2 lab xyoo 2030 (suav nrog 2.4 lab hauv Suav).

Txog rau tam sim no, tsis muaj kev kho mob tshwj xeeb lossis tshuaj lom neeg pom zoo rau kev kho IgA nephropathy hauv ntiaj teb. Cov txheej txheem kho mob yog renin-angiotensin-aldosterone system blockers thiab tiv thaiv kab mob tiv thaiv kab mob, suav nrog corticosteroids, tab sis lawv feem ntau suav nrog tshuaj lom hnyav thiab phiv, thiab muaj qhov chaw kho mob loj xav tau tshuaj tshiab. Tam sim no, Tuam Tshoj tsuas muaj thawj qhov tshuaj lom neeg tshiab hu ua Tatacept hauv theem tshawb fawb soj ntsuam, thiab theem III kev sim tshuaj kho mob tab tom yuav pib. Nws tau tshaj tawm tias cov tshuaj' IgA nephropathy indications tau pom zoo los ntawm Asmeskas Cov Khoom Noj thiab Tshuaj (FDA), thiab nws raug zam los ntawm theem I kev sim tshuaj kho mob hauv Tebchaws Meskas thiab ncaj qha ua theem II chaw kho mob kev sim siab.

Raws li lub ntiaj teb thawj zaug thiab thawj zaug hauv chav kawm BLyS/APRIL ob lub hom phiaj fusion protein tsim cov tshuaj tshiab, Tatacept qhov tshwj xeeb ob lub hom phiaj kev siv tshuab thiab bioinformatics-txhim kho cov qauv tsim ua rau nws muaj kev ua haujlwm ntau dua thiab hauv cov txheej txheem Nws muaj cov qauv siab dua qub hauv kev tsim khoom. Nyob rau tib lub sijhawm, nws cov tib neeg cov amino acid ua ntu zus tuaj yeem txo qis qhov muaj peev xwm tiv thaiv kab mob, yog li txo qis kev phiv ntawm cov tshuaj, thiab txhim kho kev nyab xeeb thiab ua haujlwm tau zoo ntawm kev kho. Thaum Lub Peb Hlis 9, 2021, Taltazep tau pom zoo los ntawm National Food and Drug Administration, cim tias kuv lub tebchaws tau ua tus coj hauv ntiaj teb hauv kev tsim cov tshuaj tshiab rau kev kho mob ntawm cov kab mob lupus erythematosus thiab ua tiav qhov kev kov yeej loj. Ntxiv rau cov kab mob lupus erythematosus, cov tshuaj muaj peev xwm siv tau ntau yam ntawm lwm yam kev qhia autoimmune nrog cov kev xav tau kho mob loj. Nws kho IgA nephropathy, Sjogren's syndrome, optic neuromyelitis, ntau yam sclerosis thiab myasthenia gravis, thiab lwm yam. Cov theem hauv tsev Ⅱ/Ⅲ kev kuaj mob ntawm cov cim qhia tau pib ua tiav, thiab cov cim qhia txog yuav pib thoob ntiaj teb ntau lub chaw kho mob tshawb fawb .