• intloko_ibhena_01

Semaglutide

Inkcazelo emfutshane:

I-Semaglutide yi-agonist ye-GLP-1 ye-receptor agonist esetyenziselwa unyango lwe-2 yeswekile kunye nokulawulwa kwesisindo esingapheliyo. I-API yethu ephezulu ye-Semaglutide API iveliswa ngokusebenzisa i-chemical synthesis, ikhululekile kwiiprotheni zeeseli ze-host kunye neentsalela ze-DNA, iqinisekisa i-biosafety egqwesileyo kunye nomgangatho ongaguqukiyo. Ukuthobela izikhokelo ze-FDA, imveliso yethu ihlangabezana nemida engqongqo yokungacoceki kwaye ixhasa imveliso enkulu.


Iinkcukacha zeMveliso

Iithegi zeMveliso

Semaglutide API

I-Semaglutide yi-synthetic ye-glucagon-efana ne-peptide-1 (GLP-1) ye-receptor agonist yokwenziwa, ephuhliswe kunyango lwe-2 yesifo sikashukela kunye nokukhuluphala. Ukuguqulwa ngokwesakhiwo ukuxhathisa ukuthotywa kwe-enzymatic kunye nokuphucula i-half-life, i-Semaglutide ivumela ukulungelelaniswa kwe-dosing kanye ngeveki, ukuphucula kakhulu ukuthotyelwa kwesigulane.

YethuSemaglutide APIiveliswa ngenkqubo yokwenziwa ngokupheleleyo, isusa imingcipheko eyayanyaniswa neenkqubo zokuchaza ngokwebhayoloji, ezifana neprotein yeseli ye-host okanye ungcoliseko lwe-DNA. Yonke inkqubo yokwenziwa kwemveliso iye yaphuhliswa kwaye yaqinisekiswa kwisikali sekhilogram, ihlangabezana neemfuno ezingqongqo zomgangatho ezichazwe kwi-FDA's 2021 isikhokelo malunga nokungeniswa kwe-ANDA kumachiza e-peptide okwenziwa acocekileyo.

Indlela yokwenza

I-Semaglutide ilinganisa i-GLP-1 yomntu, i-hormone ye-incretin edlala indima ebalulekileyo kwi-glucose metabolism. Isebenza ngeendlela ezininzi ze-synergistic:

  • Ivuselela ukukhutshwa kwe-insulinngendlela exhomekeke kwi-glucose

  • Inciphisa ukukhutshwa kweglucagon, ukunciphisa i-hepatic glucose output

  • Ilibazisa ukukhupha isisu, ekhokelela ekuphuculeni ulawulo lwe-glycemic postprandial

  • Yehlisa umdla wokutya kunye nokuthatha amandla, ukuxhasa ukulahleka kwesisindo

Iziphumo zoNyango

Izifundo ezininzi zeklinikhi (umzekelo, i-SUSTAIN kunye ne-STEP izilingo) zibonise ukuba i-Semaglutide:

  • Ukunciphisa ngokuphawulekayo i-HbA1c kunye nokuzila ukutya kwe-plasma ye-glucose amanqanaba kwizigulane ze-2 zeswekile

  • Ikhuthaza ukwehla okukhulu kunye nokugcinwa kobunzima kubantu abatyebe kakhulu okanye abatyebe kakhulu

  • Inciphisa iimpawu zengozi ye-cardiovascular risk markers ezifana noxinzelelo lwegazi kunye nokuvuvukala

Ngeprofayili ekhuselekileyo yokhuseleko kunye neenzuzo ezibanzi ze-metabolic, i-Semaglutide iye yaba yinto yokuqala ye-GLP-1 RA kwisifo seswekile kunye nonyango oluchasene nokutyeba. Inguqulo yethu ye-API igcina ukuthembeka okuphezulu kwesakhiwo kunye namanqanaba aphantsi okungcola (≤0.1% ukungcola okungaziwayo yi-HPLC), ukuqinisekisa ukuhambelana okugqwesileyo kwe-pharmacological.


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