Core Insights - There are currently no approved drugs for the treatment of primary membranous nephropathy globally [1] - The emergence of small molecule targeted BTK inhibitors is leading to a shift towards "chemotherapy-free" treatment options in hematological malignancies [1] - Cloudbreak New Horizon (01952.HK) presented preliminary results of its novel covalent reversible BTK inhibitor EVER001 at the 62nd European Renal Association Congress, showing efficacy and good tolerability in patients with primary membranous nephropathy [1][3] Group 1: Clinical Study Results - The 1b/2a study of EVER001 involved 31 patients with confirmed anti-PLA2R antibody-positive primary membranous nephropathy, divided into low-dose and high-dose groups, treated for 36 weeks [3] - At the 24-week mark, both low-dose and high-dose groups showed a 93% reduction in anti-PLA2R antibodies, with complete immunological remission rates of 76.9% and 81.8% respectively [3] - Proteinuria levels decreased by 78.0% in the low-dose group at 36 weeks (maintained to 52 weeks) and by 70.1% in the high-dose group at 24 weeks, with 80% of patients achieving clinical remission [3] Group 2: Market Context and Future Plans - Currently, five BTK inhibitors have been approved in China, with three imported and two domestic, primarily focusing on the hematological malignancy market, which is becoming increasingly competitive [4] - The company plans to accelerate the global clinical development of EVER001 and explore indications for IgA nephropathy, minimal change disease, focal segmental glomerulosclerosis, and lupus nephritis [4] - There are potential plans for global market expansion and licensing collaborations for EVER001 in the future [4]
云顶新耀盘中股价涨逾10%，BTK抑制剂治疗肾病潜力数据揭晓