证券代码：002653 证券简称：海思科 公告编号：2026-003

Core Viewpoint - The company has received a notice of acceptance from the National Medical Products Administration for its drug HSK39297, a selective complement factor B inhibitor aimed at treating paroxysmal nocturnal hemoglobinuria (PNH) in adult patients who have not previously received complement inhibitors [1][2][3] Group 1: R&D Project Overview - HSK39297 is a self-developed small molecule inhibitor that blocks the activation of the alternative pathway of the complement system, targeting diseases mediated by abnormal complement activation [2] - Clinical research indicates that HSK39297 has good safety and tolerability, showing significant therapeutic advantages over eculizumab in improving anemia, reducing transfusion needs, and alleviating fatigue symptoms [2] - The drug is classified as a Class 1 chemical drug in China and is the first-tier CFB inhibitor for PNH, addressing a significant unmet clinical need with promising market prospects [2] Group 2: Regulatory Approval and Clinical Trials - The application for HSK39297 has been prioritized for review due to its classification as an innovative drug for treating urgent clinical needs and rare diseases [3] - HSK39297 is currently undergoing Phase II clinical trials for lupus nephritis and is set to initiate Phase III clinical research for primary IgA nephropathy [3]