Day: 9 6 月, 2025

HONG KONG, Jun 9, 2025 - (ACN Newswire via SeaPRwire.com) - At the 62nd European Renal Association Congress (ERA 2025), Everest Medicines unveiled new clinical data on EVER001 (previously known as XNW1011), a next-generation covalent reversible Bruton's tyrosine kinase (BTK) inhibitor, in patients with primary membranous nephropathy (pMN). This marks the first time EVER001’s clinical data have been unveiled at an international academic congress. This initial unveiling of the preliminary data at an international congress focuses on pMN. The results showed encouraging signals in terms of novel mechanism, preliminary efficacy, and safety. These findings provide a solid foundation for future therapeutic strategies in proteinuric autoimmune glomerular diseases including pMN and demonstrate Everest’s advancing innovation capabilities and global development momentum.EVER001 is a covalent reversible BTK inhibitor with potentially best-in-class characteristics for the treatment of primary membranous nephropathy (pMN) and other autoimmune renal diseases, including IgA nephropathy (IgAN), minimal change disease (MCD), focal segmental glomerulosclerosis (FSGS), and lupus nephritis (LN). These conditions affect over 10 million patients worldwide. There are approximately 2 million pMN patients in China alone and nearly 220,000 across the United States, Europe, and Japan. There are currently no approved therapies globally, and existing treatments rely heavily on non-specific immunosuppressants, which have limited efficacy and safety concerns, highlighting the urgent need for novel mechanism-based therapies.Everest Medicines holds global rights to EVER001 for the treatment of renal diseases. As a covalent reversible BTK inhibitor, EVER001 combines high target-binding affinity with enhanced selectivity, helping to reduce off-target toxicity seen in earlier-generation BTK inhibitors. Its favorable safety and efficacy profile supports its potential to become a new standard of care across proteinuric glomerular diseases.At ERA 2025, preliminary data from the ongoing Phase 1b/2a trial showed that EVER001 was well tolerated and demonstrated promising efficacy in patients with primary membranous nephropathy (pMN). The study enrolled 31 biopsy-confirmed pMN patients who were positive for anti-PLA2R autoantibodies and received either low or high doses of EVER001 over a 36-week treatment period, with extended follow-up for someparticipants. By week 12, anti-PLA2R autoantibody levels dropped by 62.1% in the low-dose group and 87.3% in the high-dose group. Both cohorts saw reductions of approximately 93% by week 24, with 76.9% and 81.8% of patients, respectively, achieving immunologic complete remission. For 24-hour proteinuria, the low-dose group achieved a 78.0% reduction at week 36, sustained through week 52, with 69.2% reaching clinical remission. In the high-dose group, proteinuria declined by 70.1% at week 24, with 80.0% of patients achieving clinical remission.EVER001 was generally well tolerated. No clinically significant adverse events commonly associated with covalent irreversible BTK inhibitors—such as bleeding, arrhythmia, severe infections, or liver dysfunction—were observed. Most treatment-related adverse events were mild to moderate (Grade 1–2), further supporting its long-term therapeutic potential.EVER001 is expected to generate strong portfolio synergies with Everest’s commercial-stage product, NEFECON®, the first and only fully approved etiological treatment for IgAN in China, the U.S., and Europe. NEFECON® was added to China’s National Reimbursement Drug List (NRDL) in November 2024, and has been included in the KDIGO 2024 Clinical Practice Guideline For The Management Of Immunoglobulin A Nephropathy (IgAN) And Immunoglobulin A Vasculitis (IgAV) (public review draft), making it the only targeted therapy endorsed by both international and Chinese guidelines, establishing its position as a first-line therapy. To further enhance its IgAN strategy, Everest is also developing a diagnostic test for Gd-IgA1, enabling earlier detection, more accurate disease stratification, and treatment monitoring.By integrating diagnostics and therapeutics into a unified care model, Everest is leading the transition from supportive care to precision, disease-modifying treatment for immune-mediated kidney diseases such as IgAN. This holistic strategy aims to improve disease detection and management standards and establish a comprehensive, long-term renal care platform.With EVER001 and NEFECON® advancing in parallel, Everest is driving innovation in nephrology with the goal of setting new global treatment standards. The presentation of EVER001 at ERA 2025 marks a pivotal milestone in its clinical development and demonstrates the international visibility of China-originated innovations. Everest continues to pave the way for globally competitive novel therapies to reach patients around the world. Copyright 2025 ACN Newswire via SeaPRwire.com.

香港，2025年6月9日 - (亚太商讯 via SeaPRwire.com) - 在第62届欧洲肾脏协会年会（ERA 2025）上，云顶新耀（HKEX：1952.HK）自主研发、拥有全球权益的新一代共价可逆BTK抑制剂EVER001首次以集中口头报告形式发布其在原发性膜性肾病（pMN）中的阶段性临床研究数据。这是EVER001首次在国际学术会议上披露相关成果，聚焦于在原发性肾小球肾炎中发病率处于第2位的原发性膜性肾病。数据显示该产品在机制创新、初步疗效以及安全性方面均展现出积极信号。此次研究的发布为该领域未来的治疗探索提供了新的临床依据，也体现了中国创新药企业在复杂肾病治疗领域持续提升的研发能力与国际化进程。EVER001是一款创新性的共价可逆BTK抑制剂，潜在用于治疗包括原发性膜性肾病等肾脏疾病在内的多种自身免疫性肾脏疾病，有望为全球逾1000万患有原发性膜性肾病、IgA肾病、微小病变性肾病、局灶节段性肾小球硬化和狼疮性肾炎等疾病的患者提供更多治疗选择。中国目前有约200万原发性膜性肾病患者，欧美与日本约有近22万患者，且逾三分之一最终进展为终末期肾病（ESRD），目前全球没有获批此适应症的药物。现有方案普遍依赖非特异性免疫抑制，疗效有限、安全性存疑，临床急需机制创新的新治疗方式。在此背景下，EVER001作为一款潜在的同类最佳产品，在保持高效的同时具有高选择性，其用于原发性膜性肾病的突出临床优势带来了广阔的市场前景。根据ERA 2025大会公布的1b/2a期研究数据，EVER001在不同剂量组均显示出快速起效、免疫学和临床缓解高度一致的优势：24周时，76.9%的低剂量组患者和81.8%的高剂量组患者已达到免疫学完全缓解；低剂量组在36周蛋白尿水平较基线下降78.0%，并维持至第52周，69.2%的低剂量组患者在36周达到了临床缓解；高剂量组则在24周即达70.1%蛋白尿下降，其中80.0%的患者已达到临床缓解。除了优异疗效，EVER001的安全性同样突出。作为新一代共价可逆BTK抑制剂，EVER001在保持强效靶点抑制的同时，显著降低了对EGFR、ITK等脱靶激酶的抑制风险。临床研究未观察到传统共价不可逆BTK抑制剂常见的严重不良反应，如出血、心律失常、严重感染及肝功能损伤等，展现出良好的耐受性，为长期治疗提供基础，也强化其作为慢性病长期管理的竞争潜力。EVER001是云顶新耀首个完全拥有全球开发、生产与商业化权益的管线产品。目前该产品正稳步推进多适应症临床布局，除pMN外，还包括IgA肾病（IgAN）、微小病变病（MCD）、局灶节段性肾小球硬化（FSGS）和狼疮性肾炎（LN）等免疫性肾病领域，具备全球市场潜力，并已被纳入公司国际化战略重点，未来有望通过授权合作、国际注册等多元路径实现"自研出海"。在肾病战略板块中，EVER001与云顶新耀另一核心产品耐赋康®正逐步形成机制互补与适应症覆盖的协同效应。耐赋康®是全球首个且唯一在中国、美国和欧洲获得完全批准的IgA肾病对因治疗药物，2024年11月纳入中国国家医保目录，并先后被纳入改善全球肾脏病预后组织（KDIGO）发布的《2024版KDIGOIgA肾病和IgA血管炎临床管理实践指南（公开审查版）》，以及《中国成人IgA肾病及IgA血管炎临床实践指南（预审版本）》，确立其一线治疗基石地位。为进一步提升从早筛、治疗到长期管理的系统能力，公司正同步推进Gd-IgA1诊断试剂的开发，助力IgAN等慢性病实现更早识别、更精准分型及疗效监测。通过"诊断+治疗"全流程一体化布局，云顶新耀正推动IgAN等免疫相关肾病从支持性治疗迈向精准对因管理，系统提升疾病识别效率与治疗规范性，为肾病构建具长期价值的综合解决方案平台。在全球肾病领域临床挑战与创新机遇并存的当下，云顶新耀正通过耐赋康®与EVER001双路径并进的策略，推动中国创新药构建全球治疗新标准。ERA 2025上EVER001的亮相，不仅标志其临床开发进入关键节点，也展现了中国自研药物在国际学术平台上的影响力，为中国原研药"走出去"提供范例，也为全球患者带来机制创新、疗效优异的治疗新方案。 Copyright 2025 亚太商讯 via SeaPRwire.com.