Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) announced that China’s National Medical Products Administration (NMPA) has accepted for review the marketing application for HSK39297, an oral small molecule inhibitor of complement factor B (FB), for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH). The candidate represents a next-generation alternative pathway inhibitor with demonstrated advantages over standard-of-care eculizumab in anemia improvement and transfusion reduction, while offering the convenience of oral administration.
Novartis’ iptacopan (Factor B inhibitor, approved 2023) first oral entrant; Haisco targets China market leadership
Differentiation
HSK39297 demonstrated superior anemia outcomes vs. eculizumab in head-to-head comparisons; pricing power potential
Pipeline Synergy
Factor B platform applicable across multiple complement-mediated diseases (GN, aHUS, AMD)
Strategic Outlook
China Launch: 2027 commercialization anticipated; NRDL negotiation for national reimbursement
Global Ambitions: U.S./EU filing preparation ongoing; potential for FDA Fast Track based on China data package
Platform Value: Oral complement inhibition addresses IV therapy burden; HSK39297 validates Haisco’s immunology drug discovery capabilities
Manufacturing: Integrated small molecule capacity supports commercial supply and cost competitiveness
Forward‑Looking Statements This brief contains forward‑looking statements regarding regulatory approval timelines, commercial launch, and pipeline expansion for HSK39297. Actual results may differ due to NMPA review decisions, competitive dynamics with iptacopan, and pricing negotiations.-Fineline Info & Tech
