Nkhani

Posachedwa, Chinese State Food and Drug Administration (SFDA) idavomereza mwalamulo kugwiritsa ntchito malonda a dijocimab (PCSK-9 Monoclonal antibody omwe amapangidwa ndi INNOVENT BIOLOGICS,INC), INC pochiza matenda a hypercholesterolemia (kuphatikiza heterozygous family hypercholesterolemia ndi omwe si abanja). hypercholesterolemia) ndi dyslipidemia wosakanikirana. Ichi ndiye choletsa choyamba chodzipangira chokha cha PCSK-9 kuti mulembetse ntchito zotsatsa ku China.

Tafolecimab ndi mankhwala osokoneza bongo a biologic omwe amapangidwa paokha ndi INNOVENT BIOLOGICS, INC. IgG2 human monoclonal antibody imamangiriza makamaka PCSK-9 kuti ionjezere milingo ya LDLR mwa kuchepetsa PCSK-9-mediated endocytosis, potero kuwonjezera kuchotsa LDL-C ndi kuchepetsa LDL-C milingo.

M'zaka zaposachedwa, kufalikira kwa dyslipidemia kwakula kwambiri ku China. Kuchuluka kwa dyslipidemia ndi hypercholesterolemia mwa akulu ndi 40.4% ndi 26.3% motsatana. Malinga ndi lipoti la 2020 la Cardiovascular Health and Diseases ku China, chithandizo ndi kuwongolera kwa matenda a dyslipidemia mwa akulu akadali otsika, ndipo kutsata kwa LDL-C kwa odwala omwe ali ndi dyslipidemia ndikocheperako.

M'mbuyomu, ma statins anali chithandizo chachikulu cha hypercholesterolemia ku China, koma odwala ambiri adalepherabe kukwaniritsa cholinga chamankhwala chochepetsa LDL-C atalandira chithandizo. Kutsatsa kwa PCSK-9 kwabweretsa bwino kwa odwala.

Kutumizidwa kwa malondacimab kuchokera ku INNOVENT BIOLOGICS, INC kutengera zotsatira za mayesero atatu azachipatala omwe adalembetsedwa mu gawo la demokalase, Ili ndi mbiri yabwino yachitetezo chonse, yofanana ndi chitetezo cha zinthu zomwe zagulitsidwa, ndipo yapeza nthawi yayitali (masabata 6 aliwonse) za utsogoleri. Zotsatira za kafukufuku wa CREDIT-2 zidavomerezedwa ndi Msonkhano Wapachaka wa 2022 wa American College of Cardiology (ACC) ngati wongopeka komanso wofalitsidwa pa intaneti.

Ngati pempholi livomerezedwa, lidzathetsa vuto la PCSK-9, China idzakhala dziko lachinayi kukhala ndi PCSK-9 pambuyo pa United States (Amgen), France (Sanofi) ndi Switzerland (Novartis).