Bioglutide ntsiav tshuajyog ib qho GLP qhov ncauj-1 receptor agonist, uas muaj cov txheej txheem ua tiav hauv qhov ncauj nqus cov tshuaj peptide thiab ua kom yooj yim tswj hwm hauv cov ntsiav tshuaj daim ntawv. Kev siv cov txheej txheem tshwj xeeb npaj ua ke nrog kev nqus- txhim kho cov khoom xyaw, nws tiv thaiv cov khoom xyaw tshuaj nquag los ntawm kev zom cov kua qaub hauv plab thiab ua kom pom tseeb hauv cov hnyuv, ntsuas kev kho mob nrog kev yooj yim ntawm kev tswj hwm. Lub ntsiab tseem ceeb ntawm cov ntsiav tshuaj yog Bioglutide, uas ua rau txo qis cov piam thaj hauv cov ntshav los ntawm kev ua kom lub cev muaj zog ntawm endogenous GLP-1, txo qhov kev pheej hmoo ntawm hypoglycemia. Nws kuj inhibits hepatic qabzib ntau lawm thiab qeeb plab hnyuv plab los pab tswj qhov hnyav. Cov ntsiav tshuaj yog rationally formulated nyob rau hauv specifications, tso cai rau gradual dosage hloov raws li cov neeg mob cov ntshav qabzib tswj raws li txoj cai.
Peb Cov Khoom Muag Khoom
Bioglutide NA-931 COA
Anti-Kev Laus: Kev Kho Mob Ntxiv thiab Kev Laus Ncua
Kev laus yog cov txheej txheem physiological ntawm tib neeg lub cev, tab sis ntev - lub sij hawm metabolic ntshawv siab, mob o, oxidative kev nyuaj siab, tsis noj qab nyob zoo tus cwj pwm thiab lwm yam yuav ua rau kom lub aging txheej txheem, tshwm sim raws li cov tawv nqaij tsis zoo, txo lub cev tsis muaj zog, lub cev tsis ua hauj lwm, lub hlwb qaug zog, qaug zog thiab lwm yam tsos mob. Qhov no tsis tsuas yog cuam tshuam rau sab nrauv tab sis kuj ua rau muaj kev pheej hmoo ntawm ntau yam kab mob. Nyob rau hauv xyoo tas los no, kev tiv thaiv kev laus - kev cuam tshuam kev laus tau txuas ntxiv los ntawm "kev saib xyuas tawv nqaij" mus rau "kev kho mob hauv lub cev", nrog rau lub hom phiaj tseem ceeb ntawm kev ncua kev laus, txhim kho kev laus- cov tsos mob ntsig txog thiab nce kev noj qab haus huv, es tsis yog nrhiav "kev ncua sij hawm ntev".
Core positioning ntawmBioglutide ntsiav tshuajhauv kev tiv thaiv- daim ntawv thov kev laus yog "adjuvant conditioning and me intervention". Nws tsis yog ib qho mob siab rau "tshuaj tiv thaiv-kev laus", tab sis tso siab rau nws cov txiaj ntsig ntawm kev tswj hwm cov metabolism hauv lub cev, inhibiting o thiab tiv thaiv cell ua haujlwm kom tsis txhob ncua kev laus thiab txhim kho kev laus -cov tsos mob, ua rau nws tshwj xeeb tshaj yog rau cov neeg uas muaj kev laus zuj zus xws li nruab nrab- hnub nyoog thiab cov neeg laus thiab cov neeg mob ntshav qab zib hom 2. Piv nrog rau ntau yam los tiv thaiv- cov khoom noj qab haus huv, cov ntsiav tshuaj muaj kev txhawb nqa tshuaj thiab cov ntaub ntawv pov thawj, nrog kev nyab xeeb dua, thiab tuaj yeem ua haujlwm nrog kev tswj hwm kev noj qab haus huv txhua hnub (kev noj haus thiab kev tawm dag zog) kom ua tiav kev tiv thaiv kev laus dua -. Piv nrog rau cov tshuaj tiv thaiv kev laus, cov ntsiav tshuaj tsis tas yuav tsum tau txhaj tshuaj, ua kom lub qhov ncauj yooj yim thiab muaj kev cuam tshuam me me, ua rau lawv tsim nyog rau lub sijhawm ntev - txias txias yam tsis muaj kev pheej hmoo ntawm kev noj qab haus huv los ntawm kev cuam tshuam ntau dhau.
Hauv kev siv tswv yim, adjuvant los tiv thaiv- cov txiaj ntsig kev laus ntawm cov khoom lag luam feem ntau cuam tshuam txog plaub yam tseem ceeb, suav nrog kev txhim kho kev noj qab haus huv thiab lub xeev sab nraud, thiab ua tau raws li qhov xav tau tiag tiag ntawm cov pej xeem.
Ua ntej, txhim kho daim tawv nqaij mob thiab ncua kev laus ntawm daim tawv nqaij. Kev laus ntawm daim tawv nqaij yog qhov kev paub zoo tshaj plaws ntawm kev laus, thiab hyperglycemia, oxidative kev nyuaj siab thiab mob ntev yog qhov tseem ceeb ua rau ntawm daim tawv nqaij sagging, nce wrinkles thiab dull daim tawv nqaij. Los ntawm stably tswj cov metabolism thiab txo cov khoom ntawm qib siab glycation kawg cov khoom,Bioglutide ntsiav tshuajtxo qhov kev puas tsuaj ntawm hyperglycemia rau ntawm daim tawv nqaij; Nyob rau tib lub sij hawm, nws inhibits zus tau tej cov reactive oxygen hom nyob rau hauv lub cev, alleviates oxidative kev nyuaj siab teb, thiab tiv thaiv kev ncaj ncees thiab kev ua ntawm daim tawv nqaij hlwb. Tsis tas li ntawd, cov ntsiav tshuaj tuaj yeem txo cov theem ntawm cov kab mob inflammatory hauv lub cev, txo cov stimulation ntawm cov kab mob ntev ntawm daim tawv nqaij, yog li txhim kho daim tawv nqaij elasticity, txo cov kab zoo thiab brightening ntawm daim tawv nqaij.
Cov kev soj ntsuam soj ntsuam pom tau hais tias nyob rau hauv cov pej xeem uas tau siv cov ntsiav tshuaj rau lub sij hawm ntev, cov tsos mob xws li daim tawv nqaij sagging thiab nce wrinkles tau loj hlob tuaj tom qab 6 lub hlis sib law liag, thiab daim tawv nqaij cov ntsiab lus ntawm cov dej thiab elasticity tau zoo heev. Nws yog tshwj xeeb tshaj yog haum rau cov neeg mob uas muaj hom 2 mob ntshav qab zib mellitus nrog cov tawv nqaij laus, uas tuaj yeem txhim kho cov tawv nqaij thaum tswj cov ntshav qabzib.
Thib ob, txhim kho kev tiv thaiv kab mob thiab txo qhov kev pheej hmoo ntawm kev laus - cuam tshuam txog kab mob. Lub cev tiv thaiv kab mob ua haujlwm poob qis nrog lub hnub nyoog, ua rau muaj kev mob khaub thuas, kab mob ua pa, kab mob urinary thiab lwm yam kab mob, thiab mob ntev thiab cov kab mob metabolic ua rau lub cev tsis muaj zog ntxiv. Los ntawm kev tswj cov kab mob hauv lub cev, cov khoom lag luam txo cov qib ntawm cov kab mob xws li C-reactive protein thiab interleukins, alleviate inflammatory kab mob teb, thiab txhim kho lub cev metabolic tshuav nyiaj li cas los muab ib tug zoo nyob rau hauv ib puag ncig rau kev loj hlob thiab kev ua si ntawm lub cev tiv thaiv kab mob, yog li txhim kho lub cev tiv thaiv kab mob.
Cov ntaub ntawv kho mob qhia tau tias qhov tshwm sim ntawm tus mob khaub thuas, kis kab mob thiab lwm yam kab mob hauv nruab nrab- cov neeg laus thiab cov neeg laus uas tau noj cov ntsiav tshuaj rau lub sijhawm ntev tau txo qis los ntawm 30% -40% piv nrog rau pawg tswj hwm, thiab kev rov qab sai tom qab kis tau sai dua, txo cov kev pheej hmoo ntawm kev noj qab haus huv los ntawm kev laus - cuam tshuam txog kev kis kab mob. Nws yog qhov tshwj xeeb tshaj yog haum rau lub sijhawm ntev - lub sijhawm txias ntawm cov neeg laus thiab cov neeg laus uas muaj kev tiv thaiv qis.
Thib peb, ncua lub cev tsis ua haujlwm thiab pab tswj kev noj qab haus huv. Lub hauv paus ntawm kev laus yog qhov txo qis ntawm cov kab mob hauv nruab nrog cev, tshwj xeeb tshaj yog rau cov kab mob tseem ceeb xws li cov islets, cov hlab ntsha thiab lub plawv, thiab tus nqi ntawm cov khoom hauv nruab nrog cev poob qis yog nrawm nrawm rau cov neeg mob ntshav qab zib hom 2. Los ntawm kev tiv thaiv kev ua haujlwm ntawm tes, txhim kho cov metabolism thiab txo qhov mob, nws tuaj yeem cuam tshuam kev laus ntawm cov kabmob xws li cov islets thiab cov hlab ntsha. Piv txwv li, cov ntsiav tshuaj tuaj yeem tiv thaiv kev ua haujlwm ntawm pancreatic islet hlwb, txo qis kev ua haujlwm ntawm cov islet, pab tswj lub cev cov ntshav qabzib tswj muaj peev xwm thiab txo cov tshuaj dependence. Nyob rau tib lub sijhawm, nws tuaj yeem txhim kho vascular endothelial muaj nuj nqi, txo cov hlab ntsha thiab lwm yam teeb meem tshwm sim los ntawm vascular laus, thiab pab tswj kev mob plawv.
Rau kev noj qab haus huv nruab nrab- cov neeg laus thiab cov neeg laus, ntev- kev tswj hwm ntawm cov ntsiav tshuaj tuaj yeem tswj hwm lub cev ua haujlwm thiab ncua kev laus; rau cov neeg mob uas muaj ntshav qab zib hom 2, nws tuaj yeem txo qhov tshwm sim ntawm kev laus- cuam tshuam txog lub cev muaj teeb meem thaum tswj ntshav qabzib, ua tiav ob lub hom phiaj ntawm "cov ntshav qabzib tswj + tiv thaiv- laus", uas kuj yog ib qho tseem ceeb ntawm cov ntsiav tshuaj piv nrog cov tshuaj hypoglycemic.
Plaub, txhim kho kev puas siab puas ntsws thiab txo kev laus -txog cov tsos mob tsis xis nyob. Nruab nrab- cov neeg laus thiab cov neeg laus thiab cov neeg mob uas muaj ntshav qab zib hom 2 feem ntau ntsib kev laus- cov tsos mob xws li qaug zog, qaug zog thiab pw tsaug zog tsis zoo, uas cuam tshuam nrog cov kab mob metabolic thiab tsis muaj zog ntawm tes.Bioglutide ntsiav tshuajtuaj yeem txhim kho kev ua haujlwm ntawm lub cev lub zog metabolism, txhim kho cov cellular qabzib thiab siv, thiab muab lub zog txaus rau cov ntaub so ntswg thiab cov kabmob, yog li txo cov tsos mob xws li qaug zog thiab kev puas siab puas ntsws, txhim kho kev pw tsaug zog zoo thiab pab cov neeg mob tswj lub hlwb zoo.
Hauv daim ntawv thov kev kho mob, cov neeg feem coob uas tau siv cov ntsiav tshuaj ntev ntev tau tshaj tawm tias tom qab 3 lub hlis ntawm kev tswj hwm, kev qaug zog tau txo qis, lub zog ntau dua, lub sijhawm pw tsaug zog thiab zoo tau zoo dua qub, thiab kev nkag siab ntawm kev noj qab haus huv - nyob thiab tus kheej - kev saib xyuas muaj peev xwm hauv lub neej niaj hnub tau txhim kho. Cov nyhuv no ntxiv txhim kho daim ntawv thov tus nqi ntawm cov ntsiav tshuaj hauv kev tiv thaiv- kev laus.
1999-2005
Hauv xyoo 1990, GLP-1 receptor agonists tau los ua qhov kev tshawb fawb hotspot hauv kev kho mob ntshav qab zib. Txawm li cas los xij, kev tshawb fawb thoob ntiaj teb thiab kev loj hlob ntawm cov tshuaj no yog monopolized los ntawm cov tuam txhab tshuaj txawv teb chaws, thiab feem ntau yog tib neeg cov tshuaj nrog kev hloov kho cov qauv, nrog rau cov kev pheej hmoo xws li immunogenicity. Xyoo 1999, R & D pab pawg tsawg dua 10 tus kws tshawb fawb coj los ntawm cov xibfwb Wu Dengxi thiab Sun Yukun ntawm Huayi Biotech (tus thawj coj ntawm Shanghai RemeGen Biopharmaceuticals) tau teeb tsa lub hom phiaj ntawm kev tsim cov tib neeg GLP-1 cov tshuaj tshiab, aiming kom tsis txhob muaj kev tiv thaiv kab mob ntawm cov tshuaj hloov kho hauv Suav teb.
R&D thaum ntxov ntsib ntau yam teeb meem: tsis muaj qhov kev ntsuam xyuas paub tab rau kev ua tau zoo hypoglycemic hauv Suav teb, thiab tsis muaj kev paub dhau los hauv lub sijhawm ntev -kev ruaj ntseg ntawm cov tshuaj aqueous ntawm cov tshuaj protein. Pab neeg ntawm nws tus kheej tsim tus qauv tsiaj hyperglycemic, tshuaj xyuas ntau tshaj 800 cov qauv kev npaj, thiab tshuaj xyuas ntau dua 10,000 tus qauv, maj mam kov yeej cov kev sib tw tseem ceeb xws li kev sib xyaw, kev ua kom huv thiab tsim kev ruaj ntseg ntawm tib neeg GLP-1. Hauv xyoo 2002, kev tsim cov molecular synthesis thiab kev kuaj xyuas ua ntej ntawm Bioglutide tau ua tiav, thiab nws cov piam thaj concentration-dependent hypoglycemic mechanism tau qhia meej, tso lub hauv paus rau kev tshawb fawb tom ntej.
2006-2016
Pib txij xyoo 2006, nws nkag mus rau theem ntawm kev tshawb fawb txog kev kho mob. Pab neeg no tau ua cov tshuaj pharmacodynamic, pharmacokinetic thiab kev soj ntsuam kev nyab xeeb, lees paub tias nws homology nrog tib neeg natural GLP-1 tuaj yeem txo qhov kev pheej hmoo ntawm kev tiv thaiv kab mob, thiab noj zaub mov ntawd- lub sijhawm tswj hwm tuaj yeem ua raws li lub cev GLP-1 tso tawm, ua rau muaj kev cuam tshuam me me ntawm cov metabolism hauv kev sib npaug thaum txo cov ntshav qabzib. Hauv xyoo 2009, daim ntawv thov kev kho mob rau kev txhaj tshuaj Bioglutide tau pom zoo los ntawm National Medical Products Administration (NMPA), pib qhov kev sim tshuaj Phase I-III.
Kev sim tshuaj Phaj I tau tsom mus rau kev nyab xeeb thiab kev zam, uas qhia tau tias cov kev phiv tshwm sim feem ntau yog mob plab hnyuv me, tsis muaj mob hnyav lossis tsis muaj zog tiv thaiv kab mob - cuam tshuam txog cov xwm txheej phem.
Phase II-III kev soj ntsuam kuaj mob hauv cov neeg mob uas muaj hom 2 mob ntshav qab zib mellitus tau tshawb pom tias nws txo HbA1c los ntawm qhov nruab nrab ntawm kwv yees li 1.5% nrog rau cov leeg qis, ua rau pom qhov sib txawv ntawm qhov zoo ntawm cov rog poob nrog kev khaws cov leeg. Hauv 2012, RemeGen Biopharmaceuticals tau xa daim ntawv thov tshuaj tshiab rau nws. Thaum kawg ntawm 2016, nws (Yishengtai) tau pom zoo, dhau los ua Tuam Tshoj thawj lub tswv yim tshiab biologic rau ntshav qab zib.
2017-2023
Txawm hais tias cov tshuaj txhaj tshuaj muaj qhov ua tau zoo, peb lub sijhawm - sijhawm - kev tswj hwm txhua hnub cuam tshuam rau tus neeg mob ua raws, ua rau pab pawg los tsim daim ntawv qhia qhov ncauj. Hauv 2017, R & D project ntawm cov ntsiav tshuaj ntawm qhov ncauj tau pib, tsom mus rau kev kov yeej cov teeb meem tseem ceeb xws li kev nqus qhov ncauj tsis zoo thiab ua rau lub plab zom mov enzyme degradation ntawm peptides. Los ntawm kev ua kom zoo tshaj plaws ntawm kev npaj thev naus laus zis, bioavailability tau txhim kho, thiab ruaj khov cov tshuaj plasma concentration tau ua tiav tom qab kev tswj hwm qhov ncauj.
Lub caij no, qhov tseem ceeb ntawm kev poob phaus ntawm nws dhau qhov hypoglycemia tau pom nyob rau hauv kev kho mob, ua rau pab neeg ua kev tshawb fawb txog kev rog rog. Thaum Lub Xya Hli 2023, Bioglutide txhaj (Feisumei) tau pom zoo rau kev rog / rog, dhau los ua Tuam Tshoj thawj thawj cov tshuaj tshiab rau kev poob phaus. Nyob rau tib lub sijhawm, cov ntsiav tshuaj ntawm qhov ncauj ua tiav cov kev tshawb fawb tseem ceeb. Raws li kev tuav pov hwm kev ua tau zoo thiab kev nyab xeeb ntawm kev txhaj tshuaj, nws ntxiv kev txhim kho cov tshuaj yooj yim, muab kev xaiv tshiab rau cov neeg mob uas muaj hom 2 mob ntshav qab zib mellitus thiab rog rog.
Lub discovery ntawmBioglutide ntsiav tshuajtau tawg lub sijhawm ntev - lub sijhawm monopoly ntawm cov tuam txhab tshuaj txawv teb chaws hauv thaj chaw ntawm GLP-1 receptor agonists. Nws tag nrho cov tib neeg tus qauv tsim muab ib tug tshiab kev taw qhia rau ntiaj teb no GLP-1 tshuaj tshawb fawb thiab kev loj hlob, thiab cov kev kawm txawj sau nyob rau hauv lub R & D txheej txheem, xws li peptide synthesis, formulation stability thiab soj ntsuam ntsuam xyuas, tau txhawb txoj kev loj hlob ntawm Tuam Tshoj txoj kev lag luam biopharmaceutical. Los ntawm cov tshuaj hypoglycemic thawj zaug mus rau ntau lub hom phiaj nrog ob qho tib si rog poob thiab cov nqaij ntshiv kev tiv thaiv cov leeg, cov txheej txheem tshawb pom ntawm nws yog kev coj ua tiag tiag ntawm Tuam Tshoj cov tshuaj tshiab los ntawm "kos" rau kev tshawb fawb ywj pheej thiab kev loj hlob.
Cim npe nrov: Tuam Tshoj bioglutide ntsiav tshuaj manufacturers, lwm tus neeg
