Amakuru

Vuba aha, Ikigo cy’Ubushinwa gishinzwe ibiryo n’ibiyobyabwenge (SFDA) cyakiriye ku mugaragaro ikoreshwa ry’isoko rya tafolecimab (PCSK-9 Monoclonal antibody ikorwa na INNOVENT BIOLOGICS, INC), INC mu kuvura hypercholesterolemia y'ibanze (harimo na heterozygous familial hypercholesterolemia na non-familialial) hypercholesterolemia) hamwe na dyslipidemiya ivanze.Nibintu byambere byakozwe na PCSK-9 inhibitor isaba kwamamaza mubushinwa.

Tafolecimab numuti wibinyabuzima udasanzwe wigenga wigenga wakozwe na INNOVENT BIOLOGICS, INC.

Mu myaka yashize, ubwiyongere bwa dyslipidemiya bwiyongereye cyane mu Bushinwa.Indwara ya dyslipidemiya na hypercholesterolemia ku bantu bakuru iri hejuru ya 40.4% na 26.3%.Raporo ya 2020 ivuga ku buzima bw’indwara zifata umutima n’indwara mu Bushinwa, igipimo cyo kuvura no kugenzura indwara ya dyslipidemiya ku bantu bakuru kiracyari ku rwego rwo hasi, kandi igipimo cya LDL-C cy’abarwayi ba dyslipidemiya nticyashimishije.

Mbere, statin niwo muti wingenzi wavura hypercholesterolemia mu Bushinwa, ariko abarwayi benshi ntibashoboye kugera ku ntego yo kuvura LDL-C nyuma yo kuvurwa.Kwamamaza PCSK-9 byazanye umusaruro mwiza kubarwayi.

Gutanga tafolecimab ivuye muri BIOLOGIQUE ZIDASANZWE, INC ishingiye ku byavuye mu manza eshatu z’amavuriro zanditswe mu cyiciro cya demokarasi, Ifite imiterere myiza y’umutekano muri rusange, isa n’ibiranga umutekano w’ibicuruzwa byacurujwe, kandi imaze kugera ku ntera ndende (buri byumweru 6) y'ubuyobozi.Ibyavuye mu bushakashatsi bwa CREDIT-2 byemejwe n’inama ngarukamwaka ya 2022 y’ishuri rikuru ry’umutima w’Abanyamerika (ACC) nk'ibisobanuro kandi bitangazwa kuri interineti.

Niba gusaba byemewe, bizaca intege PCSK-9, Ubushinwa buzaba igihugu cya kane gifite PCSK-9 nyuma y’Amerika (Amgen), Ubufaransa (Sanofi) n'Ubusuwisi (Novartis).