NgoMeyi ka-2022, i-Shenzhen JYMed Technology Co., Ltd. (emva koku kuthiwa yi-JYMed peptide) ingenise isicelo sokubhaliswa kwe-semaglutide API kwi-US Food and Drug Administration (FDA) (inombolo yobhaliso ye-DMF: 036009), Idlulile. uphononongo lwemfezeko, kwaye imeko yangoku ngu "A". I-peptide ye-JYMed ibe yenye yeebhetshi zokuqala ze-semaglutide API abavelisi e-China ukudlula uphononongo lwe-FDA yase-US.
Ngomhla we-16 kaFebruwari, i-2023, iwebhusayithi esemthethweni yeZiko loVavanyo lweZiyobisi kwi-State Drug Administration yazisa ukuba i-semaglutide API [inombolo yokubhalisa: Y20230000037] ibhaliswe kwaye yabhengezwa ngu-Hubei JXBio Co., Ltd., i-subsidiary ye-JYMed peptide, ifumene yamkelwe. I-peptide ye-JYMed ibe yenye yabenzi bamachiza ekrwada bokuqala abasicelo sabo sokuthengisa le mveliso samkelwe eTshayina.
Malunga ne-semaglutide
I-Semaglutide yi-GLP-1 ye-receptor agonist eyenziwe nguNovo Nordisk (Novo Nordisk). Ichiza linokunyusa i-glucose metabolism ngokuvuselela iiseli ze-pancreatic β ukuba zikhuphe i-insulin, kwaye zithintele ukukhutshwa kweglucagon kwiiseli ze-pancreatic α ukunciphisa ukuzila kunye neswekile yegazi emva kokutya. Ukongeza, kunciphisa ukutya ngokunciphisa ukutya kunye nokunciphisa ukugaya esiswini, ekugqibeleni kunciphisa amafutha omzimba kunye nokunceda ekulahlekeni kwesisindo.
1. Ulwazi olusisiseko
Ukusuka kwimbono yesakhiwo, xa kuthelekiswa ne-liraglutide, utshintsho olukhulu lwe-semaglutide kukuba ii-AEEA ezimbini zongezwe kwikhonkco le-lysine, kwaye i-palmitic acid ithathelwe indawo yi-octadecanedioic acid. I-Alanine yatshintshwa ngu-Aib, eyandisa kakhulu i-half-life ye-semaglutide.
Umzobo Ulwakhiwo lwe-semaglutide
2. Iimpawu
I-1) I-Semaglutide inokunciphisa umngcipheko weziganeko zentliziyo kwizigulane ezine-T2D.
I-2) I-Semaglutide inciphisa iswekile yegazi ngokuvuselela i-insulin secretion kunye nokunciphisa i-glucagon secretion. Xa iswekile yegazi iphezulu, i-insulin secretion iyavuselelwa kwaye i-glucagon secretion iyanqandwa.
I-3) Ulingo lwekliniki lwe-Novo Nordisk PIONEER lubonise ukuba ulawulo lomlomo lwe-semaglutide 1mg, i-0.5mg ine-hypoglycemic engcono kunye nemiphumo yokulahlekelwa kwesisindo kune-Trulicity (dulaglutide) 1.5mg, 0.75mg.
I-3) I-semaglutide yomlomo yikhadi lexilongo leNovo Nordisk. Ukulawulwa komlomo kanye ngemini kunokuphelisa ukuphazamiseka kunye nokuthuthunjiswa ngokwasengqondweni okubangelwa inaliti, kwaye kungcono kune-liraglutide (isitofu kanye ngeveki). I-hypoglycemic kunye ne-weight-loss loss effects of the mainstream drug as , empagliflozin (SGLT-2) kunye ne-sitagliptin (DPP-4) zinomtsalane kakhulu kwizigulane kunye noogqirha. Xa kuthelekiswa nokuqulunqwa kwe-injection, ukuxutywa komlomo kuya kuphucula kakhulu ukusetyenziswa kwekliniki ye-semaglutide.
3. Isishwankathelo
Kuchanekileyo ngenxa yokusebenza kwayo okugqwesileyo kwi-hypoglycemic, ukulahleka kwesisindo, ukhuseleko kunye neenzuzo ze-cardiovascular ukuba i-semaglutide ibe yinto yezinga "lenkwenkwezi entsha" enethemba elikhulu lemarike.
Ixesha lokuposa: Feb-17-2023