I-JYMed Technology Co., Ltd. iyajabula ukumemezela ukuthi umkhiqizo wayo, i-Tirzepatide, iqede ngempumelelo ukubhaliswa kwe-Drug Master File (DMF) ne-US FDA (Inombolo ye-DMF: 040115) futhi yathola Ukuvuma kwe-FDA ngo-Agasti 2, 2024.
Ukukhiqizwa Okuningi Ngekhwalithi Ezinzile
Ngokusho kwabaphathi abaphezulu be-JYMed Technology, ukukhiqizwa kwenqwaba ye-Tirzepatide Active Pharmaceutical Ingredient (API) kungafinyelela kumazinga ekhilogremu. Amaqoqo okukhiqiza azinzile futhi ayaqhubeka, anomehluko omncane phakathi kwamaqoqo, okuqinisekisa ikhwalithi engaguquki.
Imithelela Ebalulekile Ku-Glucose Nokwehliswa Kwe-Lipid
I-Tirzepatide iyi-agonist yokuqala emhlabeni egunyazwe kanye ngeviki ye-GIP/GLP-1. Njenge-dual receptor agonist, ingabopha kanyekanye futhi yenze kokubili i-insulinotropic polypeptide (GIP) receptor encike ku-glucose kanye ne-GLP-1 receptor emzimbeni womuntu. Ngaphezu kokunciphisa amazinga e-glucose, kunciphisa ukudla, isisindo somzimba, nokuqukethwe kwamafutha, futhi ilawula ukusetshenziswa kwe-lipid. Ngaphandle kwemiphumela yayo ebalulekile yokwehlisa i-glucose kanye nokunciphisa isisindo, ukuhlaziya kweqembu elincane okuvela ochungechungeni lwe-SURPASS kubonise ukuthi i-Tirzepatide iphinde ithuthukise izinkomba ze-metabolic ezifana nomfutho wegazi, i-blood lipids, i-BMI, nomjikelezo wokhalo.
Ukugunyazwa Kwamazwe Ahlukahlukene kanye Namathemba Athembisayo
Ngokolwazi olufanele, i-Mounjaro eyehlisa i-glucose yaqala ukugunyazwa yi-US FDA ngoMeyi 2022 ukuze belaphe abantu abadala abanesifo sikashukela sohlobo 2. Ngemuva kwalokho ithole ukugunyazwa e-EU, Japan, nakwezinye izifunda. NgoNovemba 2023, i-FDA iphinde yagunyaza inkomba yokuncipha kwesisindo ngaphansi kwegama lomkhiqizo elithi Zepbound. NgoMeyi 2024, yangena ngempumelelo emakethe yaseShayina. Uma kubhekwa amathemba ayo okusebenza okubanzi kanye nedatha yocwaningo eqinile esekelayo, i-Tirzepatide isibe yisidakamizwa se-peptide esivelele kakhulu namuhla. Ukuthengiswa kwayo kufinyelele ku-$5.163 billion ngo-2023, kanti ikota yokuqala ka-2024 iyodwa yabona ukuthengiswa kwezigidigidi ezingama-2.324 zamaRandi, okukhombisa izinga lokukhula elimangalisayo.
Mayelana ne-JYMed
I-Shenzhen JYMed Technology Co., Ltd. (ngemuva kwalokhu ebizwa ngokuthi i-JYMed) yasungulwa ngo-2009, igxile ocwaningweni, ekuthuthukisweni, ekukhiqizeni nasekuthengisweni kwama-peptide nemikhiqizo ehlobene ne-peptide. Ngesikhungo esisodwa socwaningo kanye nezisekelo zokukhiqiza ezintathu ezinkulu, i-JYMed ingomunye wabakhiqizi abakhulu bama-API e-peptide ahlanganiswe ngamakhemikhali e-China. Ithimba eliyinhloko lenkampani le-R&D liziqhayisa iminyaka engaphezu kwengu-20 yesipiliyoni embonini ye-peptide futhi seliphumelele ukuhlolwa kwe-FDA kabili. Uhlelo lwe-JYMed lwezimboni ze-peptide olubanzi futhi olusebenzayo lunikeza amakhasimende uhla olugcwele lwezinsizakalo, okuhlanganisa ukuthuthukiswa nokukhiqizwa kwama-peptide okwelapha, ama-peptide ezilwane, ama-antimicrobial peptides, nama-cosmetic peptides, kanye nokubhaliswa nokusekelwa kokulawula.
Imisebenzi Yebhizinisi Eyinhloko
1.Ukubhaliswa kwasekhaya nokwamazwe ngamazwe kwe-peptide APIs
2.Amapeptide ezilwane nezimonyo
3.Ama-peptide angokwezifiso kanye nezinsizakalo ze-CRO, CMO, OEM
Izidakamizwa ze-4.PDC (i-peptide-radionuclide, i-molecule ye-peptide-encane, i-peptide-protein, i-peptide-RNA)
Ngokungeziwe ku-Tirzepatide, i-JYMed ithumele imibhalo yokubhalisa ne-FDA kanye ne-CDE kweminye imikhiqizo embalwa ye-API, okuhlanganisa nezidakamizwa ezidumile njengamanje zekilasi le-GLP-1RA njenge-Semaglutide ne-Liraglutide. Amakhasimende azayo asebenzisa imikhiqizo ye-JYMed azokwazi ukubhekisela ngokuqondile inombolo yokubhalisa ye-CDE noma inombolo yefayela le-DMF lapho ethumela izicelo zokubhalisa ku-FDA noma ku-CDE. Lokhu kuzonciphisa kakhulu isikhathi esidingekayo sokulungiselela imibhalo yesicelo, kanye nesikhathi sokuhlola kanye nezindleko zokubuyekezwa komkhiqizo.
Xhumana nathi
I-Shenzhen JYMed Technology Co., Ltd.
Ikheli:8th & 9th Floors, Building 1, Shenzhen Biomedical Innovation IndustrialIpaki, No. 14 Jinhui Road, Kengzi Subdistrict, Pingshan District, Shenzhen
Ucingo:+86 755-26612112
Iwebhusayithi: http://www.jymedtech.com/
Isikhathi sokuthumela: Aug-12-2024