Munguva pfupi yadarika, Chinese State Food and Drug Administration (SFDA) yakagamuchira zviri pamutemo kushandiswa kwekushambadzira kwechiracimab (PCSK-9 Monoclonal antibody iyo inogadzirwa neINNOVENT BIOLOGICS,INC), INC yekurapa kwekutanga hypercholesterolemia (kusanganisira heterozygous mhuri hypercholesterolemia uye isiri yemhuri. hypercholesterolemia) uye yakasanganiswa dyslipidemia.Iyi ndiyo yekutanga-yakagadzirwa PCSK-9 inhibitor kunyorera kushambadzira muChina.
Tafolecimab innovative biologic drug yakazvimiririra yakagadzirwa neINNOVENT BIOLOGICS, INC. IgG2 yemunhu monoclonal antibody inosunga zvakananga PCSK-9 kuti iwedzere LDLR mazinga nekuderedza PCSK-9-mediated endocytosis, nokudaro kuwedzera LDL-C kubviswa uye kuderedza mazinga eLDL-C.
Mumakore achangopfuura, kuwanda kwe dyslipidemia kwakawedzera zvakanyanya muChina.Kuwanda kweiyo dyslipidemia uye hypercholesterolemia muvakuru yakakwira se40.4% uye 26.3% zvichiteerana.Sekureva kwe2020 mushumo weCardiovascular Health uye Zvirwere muChina, kurapwa uye kudzora mwero wedyslipidemia muvakuru vachiri padanho rakaderera, uye mwero wekuteerera weLDL-C wevarwere vedyslipidemia haunyatso kugutsa.
Pakutanga, ma statins ndiwo ainyanya kurapa hypercholesterolemia muChina, asi varwere vazhinji vachiri kutadza kuzadzisa chinangwa chekurapa chekudzikisa LDL-C mushure mekurapwa.Iko kushambadzira kwePCSK-9 kwakaunza kushanda kuri nani kune varwere.
Kuendeswa kwechiracimab kubva kuINNOVENT BIOLOGICS, INC kwakavakirwa pamibairo yezviyedzo zvitatu zvekiriniki zvakanyoreswa mudanho redemocracy, Iyo ine yakanaka yakanaka yekuchengetedza mbiri, yakafanana nekuchengetedza maitiro ezvigadzirwa zvinotengeswa, uye yakawana nguva refu (masvondo matanhatu ega ega) zvehutungamiri.Mhedzisiro yeCREDIT-2 yekudzidza yakagamuchirwa neMusangano Wepagore wa2022 weAmerican College of Cardiology (ACC) sechinhu chisinganzwisisike uye chakaburitswa online.
Kana chikumbiro ichi chikabvumidzwa, chinotyora magumo ePCSK-9, China ichava nyika yechina kuve nePCSK-9 mushure meUnited States (Amgen), France (Sanofi) neSwitzerland (Novartis).
Nguva yekutumira: Jul-04-2022