I-Tirzepatide ye-Jment's jymed iqeda ukugcwaliswa kwe-US-DMF

UJymed Technology Co, Ltd ujabule ukumemezela ukuthi umkhiqizo wawo, ukubhaliswa kwe-Tirzepatide, uqede ngempumelelo ukubhaliswa kwefayela le-Drug Master (DMF) nge-US FDA (DMF: 040115) futhi uthole imvume kaFDA ngo-Agasti 2, 2024.

Ukukhiqizwa kwesisindo ngekhwalithi ezinzile

Ngokusho kwabaphathi abaphezulu be-Jment Technology's Management, ukukhiqizwa ngobuningi be-Tirezepatide ye-Tirzepatide asebenzayo izithako (API) kungafinyelela amazinga amakhilogremu. Ama-batches okukhiqizwa aqinile futhi aqhubekayo, ngokuhluka okuncane phakathi kwama-batches, aqinisekise ikhwalithi engaguquki.

Imiphumela ebalulekile ku-glucose kanye ne-lipid ukuncishiswa

I-TirzePatide ingukuqala komhlaba evunyelwe kanye ne-GIP / glp-1 i-agonist ye-receptor. Njenge-agonist ebilikezelwa kabili, ingabopha ngasikhathi sinye futhi isebenze womabili i-insulinotror-encike ye-insulinotropic exhomekeke ye-insulinotropic (GIP) ne-glp-1 receptor emzimbeni womuntu. Ngaphezu kokwehlisa amazinga we-glucose, kunciphisa ukudla ukudla, isisindo somzimba, nokuqukethwe kwamafutha, kanye nokulawula ukusetshenziswa kwe-lipid. Ngaphandle kwemiphumela yayo ebalulekile ye-glucose - ukwehlisa isisindo, ukuhlaziya okuphakathi kochungechunge lwe-sypass of tudy kukhombisile ukuthi i-tirzepatide futhi ithuthukisa izinkomba ze-metabolic ezinjengomfutho wegazi, ama-bmid, i-BMI kanye ne-waist.

Ukuvunyelwa kwamazwe amaningi namathemba athembisayo

Ngokwemininingwane efanele, i-monjaro eyehliselayo kashukela yavunyelwa okokuqala yi-US FDA ngoMeyi 2022 ukuze kwethiwe abantu abadala abanesifo sikashukela sohlobo 2. Sekuthengisile ngokulandelayo ama-eu, eJapan nezinye izifunda. NgoNovemba 2023, i-FDA nayo yavunywa inkomba yokunciphisa isisindo ngaphansi kwegama lomkhiqizo we-zepbound. NgoMeyi 2024, yangena ngempumelelo emakethe yaseChina. Njengoba kunikezwe amathemba alo abanzi wesicelo kanye nemininingwane yokucwaninga eqinile, iTirzepatide isibe ngenye yezidakamizwa ezivelele kakhulu ze-peptide namuhla. Ukuthengisa kwayo kufinyelele kuma- $ 5.163 billion ngo-2023, kanti ikota yokuqala ka-2024 kuphela yabona ukuthengiswa kwama- $ 2.324 billion, kukhombisa izinga lokukhula okumangazayo.

Mayelana noJymed

I-Shenzhen jymed Technology Co, Ltd. (Laqishefethi okukhulunywa ngayo njengoba uJymed) yasungulwa ngo-2009, enakekela ocwaningweni, ekuthuthukisweni, ekukhiqizeni nasekuthengisweni kwemikhiqizo ehlobene ne-pepttide. Ngama-One Research Center kanye nezisekelo ezintathu ezinkulu zokukhiqiza, i-jymed ingenye yezisebenzi ezinkulu kakhulu zamakhemikhali enzelwe amakhemikhali we-peptide apes in China. Iqembu le-Core R & D liqhosha iminyaka engaphezu kwengu-20 yesipiliyoni embonini ye-pepttide futhi selidlule ngempumelelo ukuhlolwa kwe-FDA kabili. Uhlelo oluphelele lwe-Pepment oluphelele nolusebenzayo lwe-Peptide lwe-Weeptide lunikeza amakhasimende uhla oluphelele lwezinsizakalo, kufaka phakathi ukuthuthukiswa kwama-peptides zokwelapha, ama-peptides wezilwane, ama-antimicrobial ama-peptides, kanye nokubhalisa kanye nokusekelwa kokubhaliswa.

Imisebenzi Eyinhloko Yebhizinisi

Ukubhaliswa kwe-1.domatoristic kanye namazwe aphesheya kwama-peptide apis

Ama-ceptides angama-2.vetetic kanye nama-cosmetic

3.Custom Peptides kanye ne-CRO, CMO, OEM Services

Izidakamizwa ze-4.PDC (i-peptide-radionuclide, i-pottide-molecule-molecule encane, i-peptide-protein, i-peptide-rna)

Ngaphezu kwe-TirzePatide, uJymed uhambise imidwebo yokubhalisa nge-FDA ne-CDE ngeminye imikhiqizo eminingana ye-API, kufaka phakathi izidakamizwa ezithandwayo ze-API ezithandwayo njengamanje njenge-semaglutide ne-liraglutide. Amakhasimende esikhathi esizayo asebenzisa imikhiqizo kaJymed's azokwazi ukubheka ngqo inombolo yokubhaliswa kwe-CDE noma inombolo yefayela le-DMF lapho uhambisa izinhlelo zokubhalisa ku-FDA noma i-CDE. Lokhu kuzonciphisa kakhulu isikhathi esidingekayo sokulungiselela amadokhumenti okusebenzisa, kanye nesikhathi sokuhlola kanye nezindleko zokubuyekezwa komkhiqizo.