生物药国产替代再进一步!信达生物「匹康奇拜单抗」获批,银屑病市场格局生变
Ge Long Hui·2025-12-02 20:27

Core Insights - The article reports that Innovent Biologics has received approval for its first domestically developed IL-23 p19 targeted drug, Pikanqi Baiduan (匹康奇拜单抗), for the treatment of moderate to severe plaque psoriasis, marking a significant milestone in the Chinese pharmaceutical industry [1][3]. Drug Approval and Development - Pikanqi Baiduan is a recombinant anti-IL-23p19 antibody that specifically binds to the IL-23p19 subunit, blocking the IL-23 receptor-mediated signaling pathway to exert anti-inflammatory effects [1][3]. - The approval is based on the positive results from the Phase III CLEAR-1 clinical trial, which met all primary and key secondary endpoints [3]. Company Portfolio - As of now, Innovent Biologics has a total of 16 new drugs approved for market, including 12 innovative drugs and 2 improved biological products, with a focus on oncology, metabolism, and autoimmune diseases [6].