JYMed Technology Co., Ltd. iri kufara kuzivisa kuti chigadzirwa chayo, Tirzepatide, yakabudirira kupedza kunyoreswa kweDrug Master File (DMF) neUS FDA (DMF Nhamba: 040115) uye yakagamuchira Mvumo yeFDA musi waNyamavhuvhu 2, 2024.
Mass Production ine Hunhu Hwakagadzikana
Sekureva kwevakuru vakuru veJYMed Technology, kugadzirwa kwakawanda kweTirzepatide Active Pharmaceutical Ingredient (API) kunogona kusvika kilogiramu mazinga. Iwo mabheti ekugadzira akagadzikana uye anoenderera, aine mashoma musiyano pakati pemabhechi, kuve nechokwadi chakaenderana mhando.
Migumisiro Yakakosha paGlucose uye Lipid Kuderedza
Tirzepatide ndiyo yekutanga kubvumidzwa pasi rese kamwe-vhiki GIP/GLP-1 receptor agonist. Seyakaviri receptor agonist, inogona panguva imwe chete kusunga uye kumisa ese ari maviri glucose-inotsamira insulinotropic polypeptide (GIP) receptor uye GLP-1 receptor mumuviri wemunhu. Pamusoro pekudzikisa mazinga eglucose, inoderedza kudya kwekudya, uremu hwemuviri, uye mafuta emukati, uye inogadzirisa kushandiswa kwelipid. Kupfuura mhedzisiro yayo yakakosha yeglucose-kudzikisa uye huremu, diki ongororo kubva kuSURPASS yakatevedzana yezvidzidzo zvakaratidza kuti Tirzepatide inovandudza zviratidzo zvemetabolism zvakaita seBP, ropa lipids, BMI, uye chiuno chechiuno.
Mvumo dzeMarudzi Akawanda uye Tarisiro Inovimbisa
Zvinoenderana neruzivo rwakakodzera, iyo glucose-inodzikisa Mounjaro yakatanga kubvumidzwa neUS FDA muna Chivabvu 2022 kurapwa kwevakuru vane Type 2 chirwere cheshuga. Yakazogamuchira mvumo muEU, Japan, uye mamwe matunhu. MunaNovember 2023, iyo FDA yakabvumidzawo chiratidzo chekurasikirwa nehuremu pasi pezita remhando Zepbound. Muna Chivabvu 2024, yakabudirira kupinda mumusika weChinese. Tichifunga nezve tarisiro yayo yakakura yekushandisa uye yakasimba inotsigira data rekutsvagisa, Tirzepatide yave imwe yeakanyanya mukurumbira peptide mishonga nhasi. Kutengeswa kwayo kwakasvika madhora bhiriyoni mazana mashanu nemakumi matanhatu neshanu muna 2023, uye chikamu chekutanga che2024 chete chakaona kutengeswa kwemabhiriyoni mazana maviri nemakumi matatu nemakumi matatu nemana, zvichiratidza kukura kunoshamisa.
About JYMed
Shenzhen JYMed Technology Co., Ltd. (inozonzi JYMed) yakavambwa muna 2009, ichishanda mukutsvaga, kusimudzira, kugadzira, uye kutengesa kwepeptides uye zvigadzirwa zvine chekuita nepeptide. Iine imwe nzvimbo yekutsvagisa uye matatu makuru mabhesi ekugadzira, JYMed ndeimwe yevagadziri vakakura vemakemikari synthesized peptide APIs muChina. Iyo kambani yepakati R&D timu inozvirumbidza pamusoro pemakore makumi maviri echiitiko muindasitiri yepeptide uye yakabudirira kupfuura FDA ongororo kaviri. JYMed's yakazara uye inoshanda peptide maindasitiri system inopa vatengi huwandu hwakazara hwesevhisi, kusanganisira kusimudzira uye kugadzirwa kweanorapa peptides, veterinary peptides, antimicrobial peptides, uye cosmetic peptides, pamwe nekunyoresa uye kudzora tsigiro.
Main Bhizinesi Mabasa
1.Domestic uye pasi rose kunyoresa peptide APIs
2.Veterinary uye cosmetic peptides
3.Custom peptides uye CRO, CMO, OEM mabasa
4.PDC mishonga (peptide-radionuclide, peptide-diki molecule, peptide-protein, peptide-RNA)
Pamusoro peTirzepatide, JYMed yakaendesa mafirita ekunyoresa neFDA neCDE kune akati wandei zvimwe zvigadzirwa zveAPI, zvinosanganisira parizvino inozivikanwa GLP-1RA kirasi mishonga yakadai seSemaglutide neLiraglutide. Vatengi venguva yemberi vachishandisa zvigadzirwa zveJYMed vanozokwanisa kunongedzera zvakananga nhamba yeCDE yekunyoresa kana nhamba yefaira reDMF pavanotumira zvikumbiro zvekunyoresa kuFDA kana CDE. Izvi zvichaderedza zvakanyanya nguva inodiwa pakugadzirira magwaro ekunyorera, pamwe nenguva yekuongorora uye mutengo wekuongorora chigadzirwa.
Taura nesu
Shenzhen JYMed Technology Co., Ltd.
Kero:8th & 9th Floors, Building 1, Shenzhen Biomedical Innovation IndustrialPark, No. 14 Jinhui Road, Kengzi Subdistrict, Pingshan District, Shenzhen
Runhare:+86 755-26612112
Webhusaiti: http://www.jymedtech.com/
Nguva yekutumira: Aug-12-2024