Labarai

Kwanan nan, Hukumar Kula da Abinci da Magunguna ta kasar Sin (SFDA) ta amince da aikace-aikacen tallata tafolecimab (PCSK-9 Monoclonal antibody wanda INNOVENT BIOLOGICS, INC) ke yi don maganin hypercholesterolemia na farko (ciki har da heterozygous familial hypercholesterolemia da wadanda ba na iyali ba. hypercholesterolemia) da kuma gauraye dyslipidemia. Wannan shine farkon mai hanawa PCSK-9 don neman talla a China.

Tafolecimab sabon maganin ilimin halitta ne mai zaman kansa wanda INNOVENT BIOLOGICS, INC ya kirkira. IgG2 antibody monoclonal na mutum musamman yana ɗaure PCSK-9 don haɓaka matakan LDLR ta hanyar rage PCSK-9-matsakaicin endocytosis, ta haka yana ƙara kawar da LDL-C da rage matakan LDL-C.

A cikin 'yan shekarun nan, yaduwar dyslipidemia ya karu sosai a kasar Sin. Yaduwar dyslipidemia da hypercholesterolemia a cikin manya ya kai 40.4% da 26.3% bi da bi. Dangane da rahoton shekarar 2020 kan Kiwon Lafiyar Zuciya da Cututtuka a kasar Sin, jiyya da yawan sarrafa dyslipidemia a cikin manya har yanzu suna kan matakin karanci, kuma yawan yarda da LDL-C na marasa lafiya dyslipidemia ba shi da gamsarwa.

A baya can, statins sune babban maganin hypercholesterolemia a China, amma yawancin marasa lafiya har yanzu sun kasa cimma burin jiyya na rage LDL-C bayan jiyya. Tallace-tallacen PCSK-9 ya kawo ingantaccen inganci ga marasa lafiya.

Gabatar da tafolecimab daga INNOVENT BIOLOGICS, INC ya dogara ne akan sakamakon gwaje-gwaje na asibiti guda uku da aka yi rajista a cikin tsarin mulkin demokraɗiyya, Yana da kyakkyawan bayanin martabar aminci gabaɗaya, kama da halayen aminci na samfuran kasuwa, kuma ya sami tazara mai tsawo (kowane 6 makonni) na gudanarwa. Sakamakon binciken CREDIT-2 ya karɓi ta taron shekara-shekara na 2022 na Kwalejin Ilimin Zuciya ta Amurka (ACC) a matsayin taƙaitaccen bayani kuma an buga shi akan layi.

Idan an amince da aikace-aikacen, za ta karya ma'aunin PCSK-9, China za ta zama ƙasa ta huɗu da ke da PCSK-9 bayan Amurka (Amgen), Faransa (Sanofi) da Switzerland (Novartis).