Kutshanje, uLawulo loKutya kunye neziyobisi lwaseTshayina (SFDA) lwamkele ngokusesikweni isicelo sentengiso ye-chiracimab (PCSK-9 Monoclonal antibody eyenziwa yi-INNOVENT BIOLOGICS,INC), INC kunyango lwe-hypercholesterolemia ephambili (kubandakanya i-heterozygous family hypercholesterolemia kunye ne-non-familial hypercholesterolemia). hypercholesterolemia) kunye nedyslipidemia edibeneyo. Le yi-PCSK-9 inhibitor yokuqala eyenziwe ngokwayo ukufaka isicelo sokuthengisa e-China.
I-Tafolecimab iyeza elihlaziyiweyo le-biologic eliphuhliswe ngokuzimeleyo yi-INNOVENT BIOLOGICS, INC. I-IgG2 i-antibody ye-monoclonal yomntu ibophelela ngokukodwa i-PCSK-9 ukunyusa amanqanaba e-LDLR ngokunciphisa i-PCSK-9-mediated endocytosis, ngaloo ndlela inyusa ukupheliswa kwe-LDL-C kunye nokunciphisa amanqanaba e-LDL-C.
Kwiminyaka yakutshanje, ukuxhaphaka kwe-dyslipidemia kuye kwanda kakhulu e-China. Ukuxhaphaka kwe-dyslipidemia kunye ne-hypercholesterolemia kubantu abadala kuphezulu njenge-40.4% kunye ne-26.3% ngokulandelanayo. Ngokutsho kwengxelo ye-2020 yeMpilo ye-Cardiovascular and Diseases e-China, unyango kunye nesantya sokulawula i-dyslipidemia kubantu abadala basesezinga eliphantsi, kwaye izinga lokuthotyelwa kwe-LDL-C yezigulane ze-dyslipidemia azinelisekanga.
Ngaphambili, i-statins yayilolona nyango luphambili lwe-hypercholesterolemia e-China, kodwa izigulana ezininzi ziye zasilela ukufikelela usukelo lonyango lokunciphisa i-LDL-C emva konyango. Ukuthengiswa kwe-PCSK-9 kuzise ukusebenza kakuhle kwizigulane.
Ukungeniswa kwevenkilecimab evela kwi-INNOVENT BIOLOGICS, INC isekelwe kwiziphumo zolingo lwezonyango ezithathu ezibhaliswe kwisigaba sedemokhrasi, Ineprofayili yokhuseleko jikelele elungileyo, efana neempawu zokhuseleko lweemveliso ezithengisiweyo, kwaye iphumelele ixesha elide (rhoqo kwiiveki ezi-6) yolawulo. Iziphumo zophando lwe-CREDIT-2 zamkelwa yiNtlanganiso yoNyaka ka-2022 ye-American College of Cardiology (ACC) njenge-abstract kwaye ipapashwe kwi-intanethi.
Ukuba isicelo sivunyiwe, siya kuphula i-deadlock ye-PCSK-9, i-China iya kuba lilizwe lesine ukuba libe ne-PCSK-9 emva kwe-United States (i-Amgen), iFransi (i-Sanofi) kunye ne-Switzerland (i-Novartis).
Ixesha lokuposa: Jul-04-2022