Tatacept IgA Nephropathy Phase II Cov ntaub ntawv nthuav tawm ntawm Lub Rooj Sib Tham Txhua Xyoo Ntawm American Academy ntawm Nephrology

Thaum 10:30 teev sawv ntxov lub Kaum Ib Hlis 5, Tebchaws Asmeskas, cov ntaub ntawv ntawm Phase II kev tshawb fawb soj ntsuam ntawm Tytacept IgA nephropathy tau nthuav tawm ntawm 2021 American Society of Nephrology Lub Rooj Sib Tham Txhua Xyoo, thiab tau nthuav tawm hauv qhov kev sim tshuaj ntsuam xyuas tshiab kawg (Late-Breaking Clinical Trial) hauv daim ntawv tshaj tawm. ). Cov tshuaj lom neeg tshiab no rau kev kho cov kab mob lupus erythematosus nrog ob lub hom phiaj, nws tus kheej tsim los ntawm Rongchang Biotech, ib zaug ua rau lub ntiaj teb xav tsis thoob nrog cov lus qhia tshiab.

American Society of Nephrology (ASN) yog lub koom haum laus tshaj plaws thoob ntiaj teb sab saum toj nephrology. Nws txhua xyoo ASN Raum Lub Limtiam (ASN Lub Limtiam Lub Limtiam) yog lub ntiaj teb loj tshaj plaws thiab qib siab tshaj plaws ntawm kev kawm txog kab mob raum kev kawm ib qho. Phase II kev soj ntsuam ntawm Tetazep ntawm ASN lub rooj sib tham tau coj los ntawm Zhang Hong, Tus Thawj Coj ntawm Lub Tsev Haujlwm Saib Xyuas Kev Kho Mob Nephrology, Peking University Thawj Tsev Kho Mob, thiab pib ntsuas qhov ua tau zoo thiab kev nyab xeeb ntawm Tetazep hauv kev kho mob ntawm IgA nephropathy. Cov ntaub ntawv qhia tau hais tias tom qab 24 lub lis piam ntawm kev kho mob, cov zis theem protein ntawm cov ntsiab lus nyob rau hauv 240 mg pawg ntawm Tai Ai ho txo ​​qis piv nrog rau cov hauv paus ntsiab lus, thiab qhov nruab nrab 24-teev cov zis protein theem txo los ntawm 49% los ntawm lub hauv paus, uas yog. Cov ntaub ntawv tseem ceeb piv rau pawg placebo (p< 0.05).="" yog="" li,="" taltazep="" txo="" cov="" proteinuria="" hauv="" cov="" neeg="" mob="" uas="" muaj="" kev="" pheej="" hmoo="" siab="" iga="" nephropathy,="" tuaj="" yeem="" txo="" qhov="" kev="" pheej="" hmoo="" ntawm="" iga="" nephropathy,="" thiab="" muaj="" kev="" nyab="" xeeb="">

IgA Nephropathy (IgA Nephropathy, IgAN) yog ib qho ntawm feem ntau cov thawj glomerulonephritis, suav txog li 25% -50% ntawm thawj cov kab mob glomerular hauv kuv lub tebchaws, ntawm 25% -30% yuav ntsib hauv 20 xyoo Tsim los rau qhov kawg- Lub raum kab mob (ESRD). Raws li Frost& Sullivan' cov ntaub ntawv, nws tau kwv yees tias tag nrho cov neeg mob IgA nephropathy hauv ntiaj teb yuav ncav cuag 10.2 lab hauv 2030, thiab 2.4 lab hauv kuv lub tebchaws.

Txog tam sim no, tseem tsis tau lees paub cov phiaj xwm kev kho mob hauv tsev thiab txawv teb chaws, thiab tsis muaj kev kho tshwj xeeb lossis tshuaj lom neeg pom zoo rau kev kho mob ntawm IgA nephropathy hauv ntiaj teb. Txoj kev kho tus qauv tam sim no yog kev kho kom zoo raws li renin-angiotensin-aldosterone system blockers lossis nce cov tshuaj tiv thaiv kab mob, suav nrog corticosteroids rau kev kho mob ntxiv ntawm pab pawg muaj kev pheej hmoo siab. Txawm li cas los xij, cov kab mob pathogenic tseem tsis tau raug tshem tawm, lossis lawv feem ntau nrog cov tshuaj lom thiab cov kev mob tshwm sim. Yog li ntawd, muaj kev xav tau ceev ceev kom muaj kev nyab xeeb thiab siv tau zoo tshiab txoj kev kho mob rau IgA nephropathy hauv kev kho mob.

Tam sim no, Tuam Tshoj tsuas yog muaj cov tshuaj lom neeg tshiab hu ua Tatacept nyob rau theem kev tshawb fawb soj ntsuam, thiab theem III kev sim tshuaj yuav pib. Raws li lub ntiaj teb no' thawj zaug thiab thawj-hauv-chav kawm BLyS/APRIL dual-target fusion protein cov tshuaj tshiab, Tatacept muab cov Blys thiab APRIL, ob yam tseem ceeb uas cuam tshuam rau kev ciaj sia thiab kev ua ntawm B hlwb los tiv thaiv kev loj hlob thiab maturation ntawm B hlwb thiab secretion ntawm cov tshuaj tiv thaiv. Nws xav tias yuav dhau los ua kev xaiv tshiab rau kev kho mob ntawm IgA nephropathy, qhib lub sijhawm tshiab ntawm kev kho mob nrog cov tshuaj lom neeg. Yav dhau los, cov tshuaj' s IgA nephropathy indications tau txais kev pom zoo los ntawm US Food and Drug Administration (FDA), thiab theem II kev soj ntsuam hauv Tebchaws Meskas tab tom ua.

Thaum Lub Peb Hlis 9 xyoo no, Taltazep tau pom zoo los ntawm National Medical Products Administration, kos npe tias kuv lub teb chaws tau ua tus thawj coj hauv ntiaj teb hauv kev tshawb fawb thiab tsim cov tshuaj tshiab rau kev kho mob ntawm cov kab mob lupus erythematosus thiab ua tiav qhov kev ua tiav loj. Ntxiv nrog rau qhov systemic lupus erythematosus, cov tshuaj muaj peev xwm siv tau ntau yam ntawm lwm cov tshuaj tiv thaiv kab mob autoimmune nrog cov kev xav tau loj heev hauv kev kho mob. 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 sim tshuaj ntsuam xyuas ntawm cov cim tau ua tiav, thiab ntau qhov qhia tau hais txog kev pib tshawb fawb thoob ntiaj teb ntau qhov chaw kho mob. . Nrog rau qhov tshwm sim ntawm kev kho mob ntawm Tetazep, nws cov txiaj ntsig kho mob hauv ntau yam kab mob autoimmune yuav raug lees paub. (Bio Valley chaw nyob)

■ Hais Txog Rongchang Bio

Rongchang Biotechnology yog lub tuam txhab tshiab biopharmaceutical nrog lub zeem muag thoob ntiaj teb, tsom mus rau kev tshawb pom, kev tsim kho thiab kev lag luam ntawm cov tshuaj tiv thaiv kab mob xws li tshuaj tiv thaiv kab mob sib txuas (ADC), tshuaj tiv thaiv kab mob fusion proteins, monoclonal antibodies thiab bispecific antibodies. autoimmune, qog, ophthalmology thiab lwm yam kab mob tau tsim ib pawg ntawm cov tshuaj lom neeg tshiab nrog cov txiaj ntsig kho mob tseem ceeb. Tam sim no, lub tuam txhab tau tsim ntau tshaj 20 tus neeg sib tw biopharmaceutical cov khoom, thiab ntau tshaj 20 qhov qhia ntawm 7 cov khoom tau raug kev sim tshuaj los yog tau nkag mus rau theem kev lag luam. Ntawm lawv, tytaxel tau pom zoo rau kev lag luam thaum Lub Peb Hlis 9, thiab nws yog lub ntiaj teb' thawj ob lub hom phiaj tshiab tshuaj rau kev kho mob ntawm cov kab mob lupus erythematosus; Thawj qhov kev qhia ntawm vedicitumumab tau pom zoo rau kev lag luam thaum Lub Rau Hli 8. Nws tsoo qhov xwm txheej ntawm tsis muaj cov tshuaj tshiab hauv tsev hauv ADC cov tshuaj thiab yog qhov tseem ceeb hauv keeb kwm kev loj hlob ntawm kuv lub teb chaws' s ywj siab tshiab tshuaj lom neeg . Thaum Lub Yim Hli 9, lub tuam txhab thiab lub tuam txhab biopharmaceutical thoob ntiaj teb nto moo Seattle Gene tau ua tiav daim ntawv tso cai thoob ntiaj teb tshwj xeeb rau kev txhim kho thiab kev lag luam ntawm vedicitumumab, thiab tau txais tag nrho txog 2.6 billion US las hauv kev them nqi qis thiab kev them nyiaj tseem ceeb, ntxiv rau kev txiav txim vedicito. Qhov muag muag hauv Seattle gene cheeb tsam muaj kev muag khoom gradient los ntawm ib tus lej siab mus rau ntau tshaj kaum feem pua, teeb tsa cov ntaub ntawv siab tshaj plaws rau Suav cov tuam txhab tshuaj hauv ib hom kev tso cai txawv teb chaws.

■ Hais txog Titacip

Tytacept (RC18, lub npe lag luam: Tyai®) yog lub ntiaj teb thawj zaug, thawj-hauv-chav kawm, recombinant B lymphocyte stimulating factor (BLyS) / proliferation-inducing compound rau txhaj tshuaj, nws tus kheej tsim los ntawm Rongchang Biotech. Lub Plaub Hlis, cov khoom lag luam fusion protein tshiab nrog ob lub hom phiaj, tuaj yeem cuam tshuam kev khi ntawm ob lub cytokines, BLyS thiab APRIL, rau saum npoo receptors ntawm B hlwb. Lub" ob-pronged mus kom ze" tiv thaiv qhov txawv txav txawv thiab kev loj hlob ntawm B hlwb, yog li kho cov kab mob autoimmune. . Thaum Lub Peb Hlis 9th, National Medical Products Administration tau pom zoo Tetazep rau kev kho mob ntawm cov kab mob lupus erythematosus. Tam sim no, Taitacept yog siv nyob rau hauv thaj tsam ntawm cov kab mob autoimmune rau ntau yam kev qhia hauv Phase II / III kev sim tshuaj.