Ib txhaj tshuaj rau ib lub lim tiam! Novo Nordisk qhov kev npaj ua ke tshiab Kyinsu tau pom zoo los ntawm European Union
Thaum Lub Kaum Ib Hlis 26, 2025, Novo Nordisk tshaj tawm tias European Commission (EC) tau pom zoo kev tso cai ua lag luam rau nws cov Kyinsu8 (ib lub lim tiam IcoSema, kev sib xyaw ntawm cov tshuaj insulin txhua lub lim tiam Ecoinsulin thiab GLP-1RA kev npaj txhua lub lim tiam Smeaglutide). Cov tshuaj no yog tsim rau cov neeg laus uas muaj hom 2 semiuria uas tau txais basal insulin lossis GLP-1 receptor agonist therapy tab sis muaj kev tswj ntshav qabzib tsis zoo. Nws yog siv los ua ib qho ntxiv rau kev noj haus thiab kev tawm dag zog, ua ke nrog cov tshuaj hypoglycemic ntawm qhov ncauj.
Kev pom zoo los ntawm European Commission yog ua raws li cov txiaj ntsig zoo ntawm Kev Sib Txuas Phaj 3a qhov kev sim tshuaj ntsuam xyuas. Tag nrho peb qhov kev sim hauv qhov haujlwm no tau ua tiav qhov tseem ceeb kawg, ua kom pom tias ib zaug hauv ib lub lis piam IcoSema zoo dua rau nws ib qho kev txo qis ntshav qabzib ( ntsuas los ntawm HbA1C kev hloov pauv), thiab tsis muaj qhov qis dua hauv kev txo cov ntshav qabzib piv rau cov zaub mov noj txhua hnub basal insulin regimen. Tsis tas li ntawd, lCoSema pom qhov poob ceeb thawj ntau dua thiab qis dua qhov tshwm sim ntawm hypoglycemia (kev kho mob tseem ceeb lossis hnyav hypoglycemia). Thoob plaws hauv Phase 3a qhov kev sim tshuaj ntsuam xyuas, ib zaug hauv ib lub lis piam, lcoSema pom tau tias muaj kev nyab xeeb thiab zoo rau cov yam ntxwv.
Qhov kev tso cai ua lag luam no siv rau tag nrho 27 lub xeev cov tswv cuab ntawm European Union, nrog rau Iceland, Norway, thiab Liechtenstein. Qhov kev pom zoo no tau txais tom qab European Medicines Agency Pawg Neeg Saib Xyuas Kev Kho Mob rau Tib Neeg Siv tau muab lub tswv yim zoo rau lub Cuaj Hli 2025.
Kyinsu @ tau ua tiav daim ntawv thov kev sau npe hauv ntau lub tebchaws thiab xav tias yuav tau txais kev txiav txim siab ntau dua los ntawm 2026
Kyinsu8 (ib zaug ib lub lim tiam lcoSema) yog kev sib xyaw ua ke ntawm basal insulin npaj txhua lub lim tiam icoinsulin thiab GLP-1RA kev npaj semaglutide txhua lub lim tiam. Qhov siab tshaj plaws txhua lub lim tiam rau ib qho kev txhaj tshuaj yog 350 koob tshuaj rau ib chav (350U icoinsulin / 1.0mg semaglutide). Hauv EU, nws tau pom zoo siv rau cov neeg laus mob ntshav qab zib hom 2 uas tau txais cov tshuaj insulin yooj yim lossis GLP-1 receptor agonist kho tab sis muaj cov ntshav qabzib tsis zoo. Raws li kev pabcuam kev noj haus thiab kev tawm dag zog, nws tau ua ke nrog cov tshuaj hypoglycemic ntawm qhov ncauj.
Ganli Pharmaceutical launches Tuam Tshoj thawj lub hli GLP-1RA yuag poob theem III soj ntsuam kev tshawb fawb GRADUAL-3
Thaum Lub Kaum Ib Hlis 26, 2025, Ganli Pharmaceutical Co., Ltd. (tom qab no hu ua Ganli Pharmaceutical, Tshuag code: 603087. SH) tshaj tawm tias lub tuam txhab tus kheej tsim glucagon zoo li peptide-1 receptor agonist (GLP-1 RA peptide) thiab BodRFang officially launched ib theem II soj ntsuam sim (GRADUAL-3) rau kev kho mob ntawm rog los yog hyperalgesia. Qhov no yog qhov thib peb loj-scale soj ntsuam kev tshawb fawb ntawm Bofang advertising peptide nyob rau hauv lub teb ntawm rog / rog. Txoj kev tshawb no yuav siv txoj kev npaj txhua hli ntawm kev txhaj tshuaj subcutaneous ib zaug txhua plaub lub lis piam, txhawm rau tshawb xyuas qhov muaj peev xwm ntawm kev txhaj tshuaj Bofangrupeptide hauv kev tswj thiab tswj qhov hnyav.
Cov kev taw qhia tseem ceeb ntawm CTR20254659 txoj kev tshawb fawb tau sau npe nyob rau hauv Kev Tshawb Fawb Kev Tshawb Fawb Tshuaj thiab Cov Ntaub Ntawv Tshaj Tawm Platform yog tshawb nrhiav qhov hnyav thiab kev nyab xeeb ntawm Bojige Peptide Txhaj Tshuaj tom qab 24 lub lis piam ntawm kev kho mob tas li thaum noj ib hlis ib zaug. Txoj kev tshawb no tau coj los ntawm xibfwb Ji Linong los ntawm Peking University People's Hospital, nrog rau qhov kawg ntawm qhov tseem ceeb yog qhov kev hloov pauv ntawm qhov hnyav thiab feem pua ntawm cov neeg koom nrog piv rau cov hauv paus ntsiab lus tom qab 24 lub lis piam ntawm kev kho mob.
Hais txog qhov qhia txog kev rog lossis rog dhau, Ganli Pharmaceutical yav dhau los tau pib ua ob qhov kev sim tshuaj Phase I, GRADUAL-1 thiab GRADUAL-2, rau Bofangrutide Txhaj. Nws yog ib qho tsim nyog sau cia tias hauv GRADUAL-2 txoj kev tshawb fawb, Bofanglutide txhaj tshuaj tau teeb tsa lub ntiaj teb cov ntaub ntawv. Nws yog thawj cov tshuaj GLP-1RA los ua lub taub hau mus rau lub taub hau thaum lub sijhawm tswj kev sim nrog Novoying (Smeglutide 2.4mg) ntawm Suav cov neeg laus rog / rog rog nrog lossis tsis muaj hom 2 mob ntshav qab zib mellitus. Lub hom phiaj ntawm txoj kev tshawb no yog txhawm rau txheeb xyuas thiab txheeb xyuas qhov ua tau zoo thiab kev nyab xeeb ntawm kev txhaj tshuaj Bofangrupeptide hauv cov neeg mob rog lossis rog, thiab tshawb xyuas nws cov txiaj ntsig kev txhim kho ntawm ntau yam kev ntsuas metabolic thiab kev pheej hmoo ntawm cov hlab plawv.
Txoj kev tshawb fawb soj ntsuam tshiab tau pib ua ntu zus (GRADUAL-3) yuav ua qhov kev nce qib tseem ceeb hauv cov kev tshawb fawb, ntxiv rau kev tshawb nrhiav qhov muaj peev xwm ntawm kev txhaj tshuaj Bofangrupeptide hauv kev tswj qhov hnyav thiab kev saib xyuas thaum noj ib hlis ib zaug. Pab neeg tshawb fawb vam tias yuav txhim kho cov neeg mob cov tshuaj ua raws li kev txo qis kev txhaj tshuaj ntau zaus thiab txhim kho kev kho kom yooj yim, yog li txhim kho cov teeb meem ntawm qhov hnyav rov qab thiab txo cov txiaj ntsig uas feem ntau tshwm sim hauv kev kho mob ntev ntawm GLP-1RA tshuaj.
