Nūhou

I kēia mau lā, ua ʻae ʻo China State Food and Drug Administration (SFDA) i ka noi kūʻai ʻana o tafolecimab (PCSK-9 Monoclonal antibody i hana ʻia e INNOVENT BIOLOGICS, INC), INC no ka mālama ʻana i ka hypercholesterolemia mua (me ka heterozygous familial hypercholesterolemia a me ka non-familial hypercholesterolemia. hypercholesterolemia) a me ka dyslipidemia hui ʻia. ʻO kēia ka mea hoʻopaneʻe PCSK-9 mua loa i noi no ke kūʻai aku ma Kina.

ʻO Tafolecimab kahi lāʻau olaola hou i hoʻomohala kūʻokoʻa e INNOVENT BIOLOGICS, INC. ʻO IgG2 kanaka monoclonal antibody e hoʻopaʻa pono i ka PCSK-9 e hoʻonui i nā pae LDLR ma o ka hoʻohaʻahaʻa ʻana i ka PCSK-9-mediated endocytosis, ma laila e hoʻonui ai i ka LDL-C elimination a hoʻohaʻahaʻa i nā pae LDL-C.

I nā makahiki i hala iho nei, ua piʻi nui ka maʻi o ka dyslipidemia ma Kina. ʻO ka nui o ka dyslipidemia a me ka hypercholesterolemia i nā pākeke he 40.4% a me 26.3%. Wahi a ka hōʻike 2020 e pili ana i ka Cardiovascular Health a me nā maʻi ma Kina, ʻo ka mālama ʻana a me ka mālama ʻana o ka dyslipidemia i nā pākeke aia nō ma kahi haʻahaʻa, a ʻoi aku ka liʻiliʻi o ka hoʻokō LDL-C o nā maʻi maʻi dyslipidemia.

Ma mua, ʻo nā statins ka lāʻau lapaʻau nui no ka hypercholesterolemia ma Kina, akā nui ka poʻe maʻi i hiki ʻole ke hoʻokō i ka pahuhopu mālama o ka hōʻemi LDL-C ma hope o ka mālama ʻana. ʻO ka kūʻai ʻana o PCSK-9 ua lawe mai i ka maikaʻi maikaʻi i nā maʻi.

ʻO ka waiho ʻana o ka tafolicimab mai INNOVENT BIOLOGICS, INC ma muli o nā hopena o ʻekolu mau hoʻokolohua hoʻokolohua i hoʻopaʻa inoa ʻia ma ke kahua democratic, He kūlana palekana holoʻokoʻa maikaʻi ia, e like me nā ʻano palekana o nā huahana i kūʻai ʻia, a ua hoʻokō i nā manawa lōʻihi (i kēlā me kēia 6 pule) o ka hooponopono ana. Ua ʻae ʻia nā hopena o ka noiʻi CREDIT-2 e ka 2022 Annual Meeting of the American College of Cardiology (ACC) ma ke ʻano he abstract a paʻi ʻia ma ka pūnaewele.

Inā ʻae ʻia ka noi, e uhaʻi ia i ka deadlock o PCSK-9 impoeted, e lilo ʻo Kina i ʻāina ʻehā i loaʻa PCSK-9 ma hope o ʻAmelika Hui Pū ʻIa (Amgen), Palani (Sanofi) a me Switzerland (Novartis).