I-Semeglutide API ye-Shenzhen JYMed yamukelwe yiqeqebana lokuqala le-NMPA yasekhaya futhi Ibhaliswe ku-US FDA (DMF No. 036009) enesimo esithi “A”.

NgoMeyi 2022, i-Shenzhen JYMed Technology Co., Ltd. (ngemuva kwalokhu ebizwa nge-JYMed peptide) yathumela isicelo sokubhaliswa kwe-semaglutide API kwa-US Food and Drug Administration (FDA) (inombolo yokubhalisa ye-DMF: 036009), Isidlulile. ukubuyekezwa kobuqotho, futhi isimo samanje sithi “A”.I-peptide ye-JYMed isibe enye yeqoqo lokuqala labakhiqizi be-semaglutide API e-China ukuze baphumelele ukubuyekezwa kwe-US FDA.

NgoFebhuwari 16, 2023, iwebhusayithi esemthethweni ye-Drug Evaluation Center ye-State Drug Administration yamemezela ukuthi i-semaglutide API [inombolo yokubhalisa: Y20230000037] ebhalisiwe futhi yamenyezelwa ngu-Hubei JXBio Co., Ltd., inkampani ephethwe yi-JYMed peptide, isitholile kwamukelwe.I-peptide ye-JYMed isibe ngomunye wabakhiqizi bezidakamizwa bokuqala abasicelo sabo sokumaketha lo mkhiqizo samukelwe e-China.

Mayelana ne-semaglutide
I-Semaglutide i-GLP-1 receptor agonist eyakhiwe nguNovo Nordisk (Novo Nordisk).Umuthi ungakhuphula i-glucose metabolism ngokugqugquzela ama-pancreas β cell ukuthi akhiphe i-insulin, futhi avimbele ukukhiqizwa kwe-glucagon kumaseli e-pancreatic α ukunciphisa ukuzila kanye noshukela wegazi wangemva kokudla.Ngaphezu kwalokho, kunciphisa ukudla ngokunciphisa isifiso sokudla nokunciphisa ukugaya esiswini, okugcina kunciphisa amafutha omzimba kanye nezinsiza ekunciphiseni isisindo.
1. Ulwazi oluyisisekelo
Ngokombono wesakhiwo, uma kuqhathaniswa ne-liraglutide, ushintsho olukhulu kakhulu lwe-semaglutide ukuthi ama-AEEA amabili engeziwe ochungechungeni oluseceleni lwe-lysine, futhi i-palmitic acid ithathelwe indawo yi-octadecanedioic acid.I-Alanine yathathelwa indawo yi-Aib, eyandisa kakhulu isigamu sempilo ye-semaglutide.

Umfanekiso Ukwakhiwa kwe-semaglutide

2. Izinkomba
I-1) I-Semaglutide inganciphisa ingozi yezenzakalo zenhliziyo ezigulini ezine-T2D.
I-2) I-Semaglutide yehlisa ushukela wegazi ngokuvuselela ukugcinwa kwe-insulin nokunciphisa ukugcinwa kwe-glucagon.Lapho ushukela uphezulu, ukukhiqizwa kwe-insulin kuyavuselelwa futhi ukukhiqizwa kwe-glucagon kuyavinjwa.
I-3) Isivivinyo somtholampilo se-Novo Nordisk PIONEER sibonise ukuthi ukuphathwa ngomlomo kwe-semaglutide 1mg, i-0.5mg kunemiphumela engcono ye-hypoglycemic kanye nokulahlekelwa kwesisindo kune-Trulicity (dulaglutide) 1.5mg, 0.75mg.
I-3) I-Oral semaglutide yikhadi lecilongo leNovo Nordisk.Ukuphatha ngomlomo kanye ngosuku kungasusa ukuphazamiseka nokuhlukunyezwa kwengqondo okubangelwa umjovo, futhi kungcono kune-liraglutide (umjovo kanye ngesonto).Imiphumela ye-hypoglycemic neyokwehlisa isisindo yezidakamizwa ezivamile njenge-empagliflozin (SGLT-2) ne-sitagliptin (DPP-4) iheha kakhulu ezigulini nakodokotela.Uma kuqhathaniswa nokwakhiwa komjovo, ukwakheka komlomo kuzothuthukisa kakhulu ukusebenziseka komtholampilo kwe-semaglutide.

3. Isifinyezo
Impela kungenxa yokusebenza kwayo okuhle kakhulu ku-hypoglycemic, ukuncipha kwesisindo, ukuphepha kanye nezinzuzo zenhliziyo ukuthi i-semaglutide ibe "inkanyezi entsha" yezinga elingavamile elinethemba elikhulu lemakethe.