Thaum Lub Kaum Hli 13, 2025, Shiyao Group (1093. HK) tshaj tawm tias nws cov chaw muag khoom, Shiyao Group Baike (Shandong) Biopharmaceutical Co., Ltd., tau txais kev pom zoo los ntawm National Medical Products Administration ntawm Cov Neeg Sawv Cev ntawm Tuam Tshoj rau kev tso tshuaj tshiab ntawm Idaglutide A Txhaj. Cov khoom no yog Class 1 daim ntawv thov tshuaj tshiab rau cov khoom siv tshuaj lom neeg, thiab nws cov lus qhia tau ntev - tswj qhov hnyav hauv cov neeg laus rog rog los yog rog los ntawm kev tswj kev noj zaub mov thiab ua kom muaj zog.
1. General Specification (hauv Tshuag)
(1) API (Ntshiab hmoov)
(2) Tablet
(3) Capsule
(4) Txhaj tshuaj
(5) Ua kua dej
2.Customization:
Peb yuav sib tham tus kheej, OEM / ODM, Tsis muaj hom, rau kev tshawb nrhiav kev ruaj ntseg nkaus xwb.
Internal Code: BM-3-094
GLP-1 CAS Nr .: 87805-34-3
Lub khw tseem ceeb: Tebchaws Asmeskas, Australia, Brazil, Nyiv, Lub Tebchaws Yelemees, Indonesia, UK, New Zealand, Canada thiab lwm yam.
Chaw tsim tshuaj paus: BLOOM TECH Xi'an Hoobkas
Peb muabGLP-1 Txhaj, thov xa mus rau lub vev xaib hauv qab no kom paub meej specifications thiab cov ntaub ntawv khoom.
Khoom siv:https://www.bloomtechz.com/oem-odm/injection/glp-1-injections.html
Cov khoom no yog ib tug recombinant tib neeg glucagon zoo li peptide-1 (hGLP-1) Fc fusion protein txhaj, uas cov neeg mob yuav tsum tau siv ib zaug ib lub lim tiam. Cov khoom no tuaj yeem xaiv khi thiab qhib GLP-1 receptors, ua kom poob phaus los ntawm cov txheej txheem xws li kev noj qab haus huv thiab kev noj zaub mov kom tsawg. Nws kuj tseem tuaj yeem ua tiav cov piam thaj concentration nyob ntawm qhov txo qis ntawm cov ntshav qab zib thiab txhim kho cov hlab plawv thiab cov ntsuas metabolic.
Kev tso tawm ntawm cov tshuaj tshiab no feem ntau yog ua raws li kev sim tshuaj tseem ceeb hauv theem melon, nrog rau cov neeg koom nrog rog lossis rog rog nrog tsawg kawg ib qho teeb meem cuam tshuam. Cov txiaj ntsig kev soj ntsuam tau pom tias piv nrog cov placebo, cov khoom no tuaj yeem txo lub cev hnyav thiab lub duav qis dua, ntshav qabzib, ntshav siab, ntshav lipids thiab lwm yam ntsuas ntawm tus neeg mob, nqa cov txiaj ntsig zoo ntawm cov hlab plawv thiab cov metabolism hauv cov neeg mob.
Nyob rau tib lub sijhawm, cov khoom lag luam muaj kev nyab xeeb zoo thiab ua haujlwm ntev. Muab piv nrog cov tshuaj zoo sib xws uas twb muaj nyob rau hauv kev ua lag luam, cov khoom no muaj tsawg dua qhov tshwm sim ntawm kev mob plab hnyuv thiab qhov tshwm sim ntawm kev kho mob raug tshem tawm lossis txiav tawm vim muaj cov xwm txheej tsis zoo. Tsis tas li ntawd, koob tshuaj escalation regimen yog sai dua thiab yooj yim dua, thiab tuaj yeem ua tiav lub hom phiaj kev noj tshuaj hauv 4 lub lis piam xwb.
Tam sim no, ob theem kev sim tshuaj ntawm cov khoom no hauv cov neeg mob uas muaj ntshav qab zib hom 2 tau txhawb nqa kom ua kom cov neeg mob tau txais txiaj ntsig ntau dua los ntawm nws.
Hengrui Newco's Kailera nce $ 600 lab hauv Series B nyiaj
Thaum Lub Kaum Hli 14, 2025, Kallera Therapeutics (Hengrui Newco) tau tshaj tawm qhov ua tiav ntawm $ 100 lab Series B nyiaj puag ncig, coj los ntawm cov neeg ua lag luam tshiab Bain Capital Private Equity thiab txhawb nqa los ntawm cov tub ua lag luam tshiab thiab tam sim no. Cov nyiaj no yuav raug siv los txhawb kev txhim kho txuas ntxiv ntawm Kailera cov kev kho mob rog rog, suav nrog kev nce qib thoob ntiaj teb kev sim tshuaj ntsuam xyuas ntawm nws cov neeg sib tw tseem ceeb tshuaj KAl-9531.
Kev ua tiav ntawm Series B nyiaj txiag tsis yog tsuas yog nqa nyiaj txiag txaus rau Kallera, tab sis kuj tseem muab kev txhawb zog rau kev tshawb fawb thiab kev txhim kho hauv kev kho mob rog. Qhov nyiaj txiag no yuav pab Kailera nrawm nws txoj kev txhim kho tshuaj tshiab, nqa cov kev kho mob tshiab rau cov neeg mob rog thoob ntiaj teb.
Kailera tsom mus rau kev kho mob rog rog thiab cov kab mob metabolic ntsig txog, thiab qhov nyiaj txiag no txhawb nqa nws txoj haujlwm tseem ceeb hauv kev ua haujlwm ntawm - tiam tom ntej cov tshuaj poob phaus. Yav dhau los, lub tuam txhab ua tiav $ 400 lab Series A nyiaj txiag thaum Lub Kaum Hli 2024, nrog rau cov nyiaj tau los ntawm $ 1 nphom, thiab cov tub ua lag luam suav nrog -cov koom haum paub zoo xws li Atlas Venture thiab Bain Capital Life Sciences.
KA1-9531 yog ib qho tshuaj txhaj GLP-1 / GIP dual receptor agonist, uas yog lub hom phiaj los txhim kho kev rog thiab hom 2 mob ntshav qab zib los ntawm kev tswj kev qab los noj mov thiab cov metabolism. Tom qab lub sijhawm 2 kaw lub rooj sib tham nrog FDA, Kailera npaj yuav pib nws txoj haujlwm thoob ntiaj teb theem 3 thaum kawg ntawm lub xyoo no. Qhov kev zov me nyuam yuav suav nrog ob qhov kev sim rau cov neeg rog rog lossis rog rog uas muaj lossis tsis muaj ntshav qab zib hom 2, thiab ib qho kev sim ntxiv rau cov neeg laus uas muaj BM ntawm 35 lossis siab dua.
Qhov ncauj GLP-1RA orforglipron tau pom tias muaj kev tswj hwm glycemic zoo tshaj hauv ob qhov kev kawm tiav Phase 3
Thaum Lub Kaum Hli 15, 2025, Eli Lilly thiab Tuam Txhab tau tshaj tawm cov txiaj ntsig zoo tshaj plaws ntawm ob theem 3 kev sim tshuaj, ACHIEVE-2 thiab ACHIEVE-5. ACHIEVE-2 yog lub taub hau thib ob rau lub taub hau tswj kev kawm hauv cov kev tshawb fawb no, uas tau soj ntsuam qhov ua tau zoo ntawm orforglipron piv rau SGLT-2 inhibitor dagelin hauv kev kho mob ntawm hom 2 mob ntshav qab zib cov neeg laus uas tsis zoo glycemic tswj los ntawm ob txoj kev. ACHIEVE-5 tau ntsuas qhov ua tau zoo ntawm orforglipron piv rau cov placebo hauv hom 2 mob ntshav qab zib cov neeg laus uas muaj kev tswj tsis zoo glycemic tom qab kev kho mob insulin glargine (nrog lossis tsis muaj DMD thiab / lossis SGLT-2 inhibitors).
Ntawm 40th lub lim tiam ntawm ob txoj kev tshawb fawb, raws li lub hom phiaj ntawm kev kwv yees kev ua tau zoo thiab lub hom phiaj ntawm kev kwv yees txoj kev kho mob, orforglipron (3mg, 12mg, 36mg) tau mus txog qhov tseem ceeb thiab tag nrho cov ntsiab lus tseem ceeb thib ob, ua tiav qhov tseem ceeb A1C txo, thiab txo qhov hnyav thiab txhim kho ntau yam kab mob plawv. Cov txiaj ntsig ntawm ob txoj kev tshawb fawb tau zoo ib yam nrog kev tshawb fawb yav dhau los ntawm kev mob ntshav qab zib hom 2.
Hauv ob qho tib si kev tshawb fawb, tag nrho kev nyab xeeb, kev zam, thiab kev cuam tshuam kev kho mob ntawm orforglipron tau ua raws li cov kev tshawb fawb yav dhau los. Cov xwm txheej tsis zoo tshaj plaws yog kev cuam tshuam ntawm plab hnyuv, feem ntau me me mus rau nruab nrab. Tsis pom daim siab kev nyab xeeb
Orforglipron yog ib qho me me molecule (tsis yog peptide) glucagon zoo li peptide-1 receptor agonist (GLP-1 RA) uas tam sim no nyob rau hauv txoj kev loj hlob thiab tswj qhov ncauj ib hnub ib zaug. Cov tshuaj no tuaj yeem noj txhua lub sijhawm ntawm hnub tsis muaj kev txwv rau kev noj zaub mov thiab dej kom tsawg.
Cov tshuaj no tau tshawb pom los ntawm Chugai Pharmaceutical Co., Ltd. thiab tau tso cai rau kev txhim kho los ntawm Eli Lilly hauv 2018. Zhongwai Pharmaceutical thiab Eli Lilly koom ua ke luam tawm cov ntaub ntawv tshuaj kho mob rau cov tshuaj no. Tam sim no, Lilly tab tom ua cov kev tshawb fawb theem 3 ntawm orforglipron rau kev kho mob ntshav qab zib hom 2, thiab kev tswj qhov hnyav rau cov neeg laus rog rog lossis rog rog tsawg kawg yog ib qho teeb meem hnyav. Tsis tas li ntawd, Lilly tseem tab tom kawm txog lub peev xwm ntawm orforglipron raws li kev kho mob rau obstructive pw tsaug zog apnea, kub siab, thiab osteoarthritis mob rau cov neeg laus rog.
