clinical development, manufacturing, and commercialization of innovative therapeutics, today announced the Taiwan Food and Drug Administration (TFDA) has approved the supplementary application for NEFECON®. NEFECON® is indicated to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression, irrespective of proteinuria levels..

临床开发、制造和商业化创新疗法，今日宣布台湾食品药物管理局（TFDA）已批准 NEFECON® 的补充申请。NEFECON® 适用于降低原发性免疫球蛋白 A 肾病（IgAN）成人患者肾功能丧失的风险，无论其蛋白尿水平如何，这些患者均有疾病进展的风险。

With this label update, the previous requirement in accelerated approval stage to submit full confirmatory trial analysis to demonstrate clinical benefit has been formally removed. Additionally, data demonstrating NEFECON®’s efficacy in delaying kidney function decline has been included in the approved product label.

通过此次标签更新，之前在加速批准阶段要求提交完整的确证性试验分析以证明临床获益的要求已被正式取消。此外，证明NEFECON®在延缓肾功能下降方面有效性的数据已包含在获批的产品标签中。

IgAN is highly prevalent among Asian populations, with a 56% higher risk of progression to end-stage renal disease compared to other groups and often progresses more rapidly1..

IgAN在亚洲人群中高度流行，与其他群体相比，进展为终末期肾病的风险高出56%，并且通常进展更快。

Taiwan region became the last region across all Everest’s territories to grant full approval for NEFECON®, together with Mainland China, Singapore, Macao SAR, Hong Kong SAR and South Korea. This further demonstrates NEFECON®’s foundational first-line cornerstone treatment for IgAN patients.

台湾地区成为继中国大陆、新加坡、澳门特别行政区、香港特别行政区和韩国之后，最后一个在所有艾伯维领地内全面批准NEFECON®的地区。这进一步证明了NEFECON®作为IgAN患者基础一线治疗的基石地位。

'NEFECON® has received full approval in Taiwan, further validating its outstanding clinical value and offering physicians a more solid clinical foundation for treatment decisions.” Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines, said. “As the first and only fully approved etiological treatment for IgAN, NEFECON® has now achieved full approval across Asia.

“NEFECON® 已在台湾获得完全批准，进一步验证了其卓越的临床价值，并为医生的治疗决策提供了更为坚实的临床依据。”云顶医药首席执行官罗永庆表示，“作为 IgAN 首个也是唯一一个获得完全批准的病因治疗药物，NEFECON® 现已在亚洲全面获批。”

This milestone will benefit a broader patient population by enabling more individuals with IgAN to access this etiological treatment earlier, helping to slow disease progression and improve quality of life. We will continue to expand the accessibility and affordability of NEFECON® across Asia, aiming to benefit more IgAN patients and improve their quality of life.'.

这一里程碑将使更广泛的患者群体受益，让更多IgAN患者能够更早地接受这种针对病因的治疗，有助于减缓疾病进展并提高生活质量。我们将继续提升NEFECON®在亚洲市场的可及性和可负担性，以期造福更多IgAN患者，改善他们的生活质量。

The approval is based on the global Phase 3 NefIgArd clinical trial, which showed that compared to placebo, it not only brought about a durable reduction in proteinuria and reduced the frequency of microscopic hematuria but also demonstrated clinically relevant and statistically significant treatment benefits in estimated glomerular filtration rate (eGFR), reducing the decline in kidney function by 50% over a period of 2 years2, comprising 9 months of treatment and 15 months of observation, and potentially delaying the progression to dialysis or kidney transplantation by 12.8 years3..

该批准基于全球 III 期 NefIgArd 临床试验，试验结果显示，与安慰剂相比，它不仅实现了蛋白尿的持久减少并降低了镜下血尿的发生频率，还在估算肾小球滤过率（eGFR）方面表现出具有临床意义且统计学显著的治疗益处，在为期两年的时间内（包括 9 个月的治疗和 15 个月的观察）将肾功能下降幅度减少了 50%，并可能延缓进展至透析或肾移植的时间达 12.8 年。

Additionally, the complete 2-year data of the NefIgArd study4 further analyzed the potential differences in the response to NEFECON® treatment between Asians (n=83) and Caucasians (n=275). The results showed that compared to placebo, treatment with NEFECON® for 9 months in both Asians and Caucasians can significantly delay the decline of eGFR, protect kidney function, and bring about a sustained reduction in proteinuria and reduce the risk of microscopic hematuria..

此外，NefIgArd研究4的完整2年数据进一步分析了亚洲人（n=83）和高加索人（n=275）对NEFECON®治疗反应的潜在差异。结果显示，与安慰剂相比，亚裔和高加索人接受9个月的NEFECON®治疗均可显著延缓eGFR下降、保护肾功能，并带来持续的蛋白尿减轻以及显微镜下血尿风险的降低。

NEFECON® has been recommended by several authoritative treatment guidelines, including the “KDIGO 2024 Clinical Practice Guideline for the Management of Immunoglobulin A Nephropathy (IgAN) and Immunoglobulin A Vasculitis (IgAV) (Public Review Draft)”5, and the 'Clinical Practice Guideline for IgA Nephropathy and IgA Vasculitis in Chinese Adults (For Public Review)'.

NEFECON®已被多个权威治疗指南推荐，包括《KDIGO 2024免疫球蛋白A肾病（IgAN）和免疫球蛋白A血管炎（IgAV）管理临床实践指南（公开审查草案）》5，以及《中国成人IgA肾病和IgA血管炎临床实践指南（公开征求意见稿）》。

NEFECON® was included in China’s National Reimbursement Drug List (NRDL) in November 2024, and the supplemental application for the production expansion of NEFECON® has been officially approved by NMPA in August 2025..

NEFECON®于2024年11月被纳入中国国家医保药品目录（NRDL），并且NEFECON®的产能扩充补充申请已于2025年8月获得NMPA正式批准。

NEFECON® is currently the world’s first IgAN treatment to have received full approval from the National Medical Products Administration (NMPA) in China, the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), the Medicines and Healthcare products Regulatory Agency（MHRA）in the United Kingdom , as well as in other Asian territories where Everest Medicines holds the rights, including Hong Kong SAR, Macao SAR, Taiwan region (China), Singapore, and South Korea..

NEFECON® 是目前全球首款获得中国国家药品监督管理局 (NMPA)、美国食品药品监督管理局 (FDA)、欧洲药品管理局 (EMA)、英国药品和健康产品管理局 (MHRA)，以及其他由云顶医药拥有权益的亚洲地区（包括中国香港特别行政区、澳门特别行政区、台湾地区、新加坡和韩国）全面批准的 IgAN 治疗药物。

About NEFECON®

关于NEFECON®

NEFECON® is a patented oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first pass metabolism. The formulation is designed as a delayed release capsule that is enteric coated so that it remains intact until it releases budesonide to the distal ileum.

NEFECON® 是一种获得专利的口服布地奈德缓释制剂，布地奈德是一种具有强效糖皮质激素活性和较弱盐皮质激素活性的皮质类固醇，会经历显著的首过代谢。该制剂设计为肠溶包衣的缓释胶囊，使其保持完整直至在回肠末端释放布地奈德。

Each capsule contains coated beads of budesonide that target mucosal B-cells present in the ileum where the disease originates, as per the predominant pathogenesis models..

每个胶囊含有布地奈德的包衣微丸，这些微丸针对疾病起源的回肠中存在的黏膜B细胞，符合主要的发病机制模型。

In June 2019, Everest Medicines entered into an exclusive, royalty-bearing license agreement with Calliditas Therapeutics, which gives Everest Medicines exclusive rights to develop and commercialize NEFECON® in mainland China, Hong Kong SAR, Macao SAR, Taiwan, China and Singapore. The agreement was extended in March 2022 to include South Korea as part of Everest Medicine's territories..

2019年6月，云顶新耀与Calliditas Therapeutics签订了独家的、基于特许权使用的许可协议，该协议授予云顶新耀在中国大陆、香港特别行政区、澳门特别行政区、台湾地区以及新加坡开发和商业化NEFECON®的独家权利。2022年3月，该协议范围扩展至包括韩国作为云顶新耀的授权区域。

About Everest Medicines

关于 Everest Medicines

Everest Medicines is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing transformative pharmaceutical products and vaccines that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations.

Everest Medicines是一家生物制药公司，专注于发现、开发、生产和商业化能够满足亚洲市场患者关键未满足医疗需求的变革性药物和疫苗。Everest Medicines的管理团队在高质量的药物发现、临床开发、法规事务、CMC、业务发展和运营方面，拥有来自全球领先制药公司和中国本地制药公司的深厚专业知识和丰富业绩记录。

Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules in the company’s core therapeutic areas of renal diseases, infectious diseases and autoimmune disorders. For more information, please visit its website at www.everestmedicines.com..

云顶医药公司在其核心治疗领域——肾病、传染病和自身免疫性疾病——建立了潜在的全球首创新药或最佳创新药的分子组合。欲了解更多信息，请访问其网站 www.everestmedicines.com。

Forward-Looking Statements:

前瞻性声明：

This news release may make statements that constitute forward-looking statements, including descriptions regarding the intent, belief or current expectations of the Company or its officers with respect to the business operations and financial condition of the Company, which can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “confident” and similar statements.

本新闻稿可能包含构成前瞻性陈述的声明，包括关于公司或其管理层对公司业务运营和财务状况的意图、信念或当前预期的描述，这些可以通过诸如“将”、“预期”、“预计”、“未来”、“打算”、“计划”、“相信”、“估计”、“有信心”等术语和类似陈述加以识别。

Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, or other factors, some of which are beyond the control of the Company and are unforeseeable. Therefore, the actual results may differ from those in the forward-looking statements as a result of various factors and assumptions, such as future changes and developments in our business, competitive environment, political, economic, legal and social conditions.

此类前瞻性陈述并非对未来业绩的保证，且涉及风险和不确定性，或其他因素，其中部分因素超出公司的控制范围且无法预见。因此，实际结果可能因各种因素和假设而与前瞻性陈述中的结果不同，例如我们业务、竞争环境、政治、经济、法律和社会条件的未来变化和发展。

The Company or any of its affiliates, directors, officers, advisors or representatives has no obligation and does not undertake to revise forward-looking statements to reflect new information, future events or circumstances after the date of this news release, except as required by law..

公司或其任何附属公司、董事、高级职员、顾问或代表均无义务，也不承诺在本新闻稿发布日期之后修订前瞻性声明以反映新的信息、未来事件或情况，除非法律要求。

Reference

参考文献

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Source: everestmedicines.com

来源：everestmedicines.com