Muva nje, i-Chinese State Food and Drug Administration (SFDA) yamukele ngokusemthethweni isicelo sokumaketha se-chiracimab (PCSK-9 Monoclonal antibody esenziwe i-INNOVENT BIOLOGICS,INC), INC ukuze zokwelapha i-hypercholesterolemia eyinhloko (okuhlanganisa i-heterozygous family hypercholesterolemia kanye ne-non-familia). hypercholesterolemia) kanye ne-dyslipidemia exubile. Lesi isivimbeli sokuqala esizikhiqizele sona se-PCSK-9 ukufaka isicelo sokumaketha e-China.
I-Tafolecimab isidakamizwa esisha se-biologic esithuthukiswe ngokuzimela yi-INNOVENT BIOLOGICS, INC. I-IgG2 i-anti-monoclonal antibody ibophezela ngokukhethekile i-PCSK-9 ukuze ikhulise amazinga e-LDLR ngokunciphisa i-PCSK-9-mediated endocytosis, ngaleyo ndlela ikhulise ukuqedwa kwe-LDL-C futhi yehlise amazinga e-LDL-C.
Eminyakeni yamuva nje, ukwanda kwe-dyslipidemia kuye kwanda kakhulu eChina. Ukusabalala kwe-dyslipidemia kanye ne-hypercholesterolemia kubantu abadala kuphezulu ku-40.4% no-26.3% ngokulandelana. Ngokombiko wango-2020 Wezempilo Nezifo Zenhliziyo E-China, izinga lokwelashwa nokulawulwa kwe-dyslipidemia kubantu abadala lisesezingeni eliphansi, futhi izinga lokuthobela i-LDL-C leziguli ze-dyslipidemia alenelisi kangako.
Phambilini, ama-statins ayewukwelapha okuyinhloko kwe-hypercholesterolemia e-China, kodwa iziguli eziningi zisahluleka ukufinyelela umgomo wokwelashwa wokunciphisa i-LDL-C ngemva kokwelashwa. Ukumakethwa kwe-PCSK-9 kulethe ukusebenza kangcono ezigulini.
Ukuhanjiswa kwe-tangecimab okuvela ku-INNOVENT BIOLOGICS, INC kusekelwe emiphumeleni yokuhlolwa kwemitholampilo okuthathu ebhaliswe esigabeni sentando yeningi, Inephrofayili yokuphepha enhle iyonke, efana nezici zokuphepha zemikhiqizo emakethe, futhi izuze izikhawu ezinde (njalo emavikini angu-6) zokuphatha. Imiphumela yocwaningo lwe-CREDIT-2 yamukelwe Umhlangano Waminyaka Yonke wango-2022 we-American College of Cardiology (ACC) njengento engabonakali futhi eshicilelwe ku-inthanethi.
Uma isicelo sivunyiwe, sizonqamula umnqamulajuqu we-PCSK-9, i-China izoba izwe lesine ukuba ne-PCSK-9 ngemuva kwe-United States (Amgen), i-France (Sanofi) ne-Switzerland (Novartis).
Isikhathi sokuthumela: Jul-04-2022