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 marasa iyali) hypercholeemia. 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-gwajen asibiti guda uku da aka yiwa rajista a cikin tsarin mulkin demokraɗiyya, Yana da kyakkyawan bayanin martaba na 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).