Akụkọ

N'oge na-adịbeghị anya, nchịkwa nri na ọgwụ ọjọọ nke China State (SFDA) nabatara ngwa ahịa nke tafolecimab (PCSK-9 Monoclonal antibody nke INNOVENT BIOLOGICS, INC) mere maka ọgwụgwọ hypercholesterolemia nke mbụ (gụnyere heterozygous familial hypercholesterolemia na ndị na-abụghị ezinụlọ). hypercholesterolemia) na dyslipidemia agwakọta. Nke a bụ PCSK-9 inhibitor nke mbụ rụpụtara onwe ya iji tinye akwụkwọ maka ire ahịa na China.

Tafolecimab bụ ọgwụ ọhụrụ emepụtara n'onwe ya site na INNOVENT BIOLOGICS, INC. IgG2 mmadụ monoclonal antibody na-ejikọta PCSK-9 kpọmkwem iji mụbaa ọkwa LDLR site na ibelata endocytosis mediated PCSK-9, si otú ahụ na-abawanye mkpochapụ LDL-C na ibelata ọkwa LDL-C.

N'afọ ndị na-adịbeghị anya, mgbasa nke dyslipidemia abawanyela nke ukwuu na China. Ọnụnọ nke dyslipidemia na hypercholesterolemia na ndị okenye ruru 40.4% na 26.3% n'otu n'otu. Dabere na akụkọ 2020 na ahụike na ọrịa obi na China, ọgwụgwọ na njikwa nke dyslipidemia na ndị okenye ka nọ n'ọkwa dị ala, yana ọnụego nnabata LDL-C nke ndị ọrịa dyslipidemia na-enwechaghị afọ ojuju.

Na mbụ, statins bụ ọgwụgwọ bụ isi maka hypercholesterolemia na China, mana ọtụtụ ndị ọrịa ka na-emezughị ebumnuche ọgwụgwọ nke mbelata LDL-C mgbe ọgwụgwọ gasịrị. Ahịa nke PCSK-9 ewetala ndị ọrịa arụmọrụ ka mma.

Nrubeisi nke tafolecimab sitere na INNOVENT BIOLOGICS, INC dabere na nsonaazụ nke nnwale ụlọ ọgwụ atọ debara aha na ọkwa onye kwuo uche ya, Ọ nwere profaịlụ nchekwa zuru oke, dị ka njirimara nchekwa nke ngwaahịa ahịa, wee nweta ogologo oge (izu ọ bụla 6) nke nchịkwa. Nsonaazụ nke ọmụmụ CREDIT-2 nabatara Nzukọ Kwa Afọ nke 2022 nke American College of Cardiology (ACC) dị ka ihe nkịtị ma bipụta ya n'ịntanetị.

Ọ bụrụ na akwadoro ngwa ahụ, ọ ga-agbaji nkwụsị nke PCSK-9 na-enweghị isi, China ga-abụ obodo nke anọ nwere PCSK-9 mgbe United States (Amgen), France (Sanofi) na Switzerland (Novartis).