Wararka

Dhawaan, Maamulka Cuntada iyo Dawooyinka ee Dawladda Shiinaha (SFDA) waxay si rasmi ah u aqbashay arjiga suuq-geynta ee tafolecimab (PCSK-9 Monoclonal antibody taas oo ay samaysay INNOVENT BIOLOGICS, INC), INC ee daaweynta hypercholesterolemia aasaasiga ah (oo ay ku jiraan heterozygous hypercholesterolemia qoyska iyo kuwa aan qoyska ahayn). hypercholesterolemia) iyo dyslipidemia isku dhafan. Kani waa PCSK-9 inhibitor kii ugu horreeyay ee iskiis u sameeya si uu u dalbado suuqgeyn gudaha Shiinaha.

Tafolecimab waa dawo bayooloji hal abuur leh oo si madax banaan u soo saartay INNOVENT BIOLOGICS, INC. IgG2 bini'aadamka monoclonal antibody waxay si gaar ah ugu xidhaa PCSK-9 si ay u kordhiso heerarka LDLR iyada oo hoos u dhigaysa PCSK-9-dhexdhexaadinta endocytosis, taas oo kordhinaysa ciribtirka LDL-C hoosna u dhigaya heerarka LDL-C.

Sannadihii ugu dambeeyay, faafidda dyslipidemia aad ayuu ugu kordhay Shiinaha. Baahitaanka dyslipidemia iyo hypercholesterolemia ee dadka qaangaarka ah ayaa ah ilaa 40.4% iyo 26.3% siday u kala horreeyaan. Marka loo eego warbixinta 2020 ee Caafimaadka Wadnaha iyo Cudurrada Shiinaha, daawaynta iyo heerka xakamaynta dyslipidemia ee dadka waaweyn ayaa wali ku jira heer hoose, iyo heerka u hoggaansanaanta LDL-C ee bukaannada dyslipidemia xitaa waa mid aan ku qanacsanayn.

Markii hore, statins ayaa ahaa daaweynta ugu weyn ee hypercholesterolemia ee Shiinaha, laakiin bukaanno badan ayaa weli ku guuldareystay inay gaaraan bartilmaameedka daaweynta ee hoos u dhigista LDL-C daweynta ka dib. Suuqgeynta PCSK-9 ayaa bukaannada u keentay waxtar wanaagsan.

Soo gudbinta tafolecimab ee INNOVENT BIOLOGICS, INC waxay ku salaysan tahay natiijooyinka saddex tijaabo oo kiliinig ah oo ka diiwaan gashan marxalad dimuqraadi ah, Waxay leedahay muuqaal guud oo badbaado oo wanaagsan, oo la mid ah sifooyinka badbaadada ee alaabada la suuqgeyn karo, waxayna ku guulaysatay muddo dheer (6dii toddobaadba mar) ee maamulka. Natiijooyinka daraasadda CREDIT-2 waxaa aqbalay 2022 Shirka Sannadlaha ah ee Kulliyada Wadnaha ee Maraykanka (ACC) sidii aan la taaban karin oo lagu daabacay onlayn.

Haddii codsiga la oggolaado, waxay jebin doontaa xannibaadda PCSK-9, Shiinaha ayaa noqon doona waddankii afraad ee haysta PCSK-9 ka dib Maraykanka (Amgen), France (Sanofi) iyo Switzerland (Novartis).